Fluent Essays

Ethical ADHA follow the directions Ethical Research Due to significant violations of federal and institutional rules and regulations, ethical issues in human participant research have received increasing attention over the past 50 years. While it might seem obvious that respect, integrity, fidelity, and justice should serve as the ethical foundation for all research activities, this has not always been the case for research involving human participation. Instructions: After reviewing Standard 8: Research and Publication of the APA Ethics Code, select three of the substandards and discuss their importance with respect to research activities. The fifteen substandards include: 8.1 Institutional Approval 8.2 Informed Consent to Research 8.3 Informed Consent for Recording Voices and Images in Research 8.4 Client/Patient, Student, and Subordinate Research Participants 8.5 Dispensing with Informed Consent for Research 8.6 Offering Inducements for Research Participation 8.7 Deception in Research 8.8 Debriefing 8.9 Humane Care and Use of Animals in Research 8.10 Reporting Research Results 8.11 Plagiarism 8.12 Publication Credit 8.13 Duplicate Publication of Data 8.14 Sharing Research Data for Verification 8.15 Reviewers Consider a proposed research study on ADHA that interests you and discuss how these standards would apply during the research process, including how you might ensure the protection of human subjects in a study on your topic. Locate at least two scholarly references from the Ashford University Library to support your discussion. Your paper should be 700-1050 words in length (not counting the title and References pages). References Guillemin M, Gillam L. Ethics, Reflexivity, and “Ethically Important Moments” in Research. Qualitative Inquiry. 2004;10(2):261-280. doi:10.1177/1077800403262360 Braun R, Ravn T, Frankus E. What constitutes expertise in research ethics and integrity? Research Ethics. 2020;16(1-2):1-16. doi:10.1177/1747016119898402 Elena Villamañán, Margarita Ruano, Enma Fernández-de Uzquiano, Paz Lavilla, Diana González, Mercedes Freire, Carmen Sobrino, & Alicia Herrero. (2016). Informed consent in clinical research; Do patients understand what they have signed? Farmacia Hospitalaria, 40(3), 209–218. https://doi-org.proxy-library.ashford.edu/10.7399/fh.2016.40.3.10411 Larsen Stray, L., Kristensen, Ø., Lomeland, M., Skorstad, M., Stray, T., & Egil Tønnessen, F. (2013). Motor regulation problems and pain in adults diagnosed with ADHD. Behavioral & Brain Functions, 9(1), 1–10. 10.1177/1077800403262360 ARTICLEQUALITATIVE INQUIRY / April 2004Guillemin, Gillam / “ETHICALLY IMPORTANT MOMENTS” Ethics, Reflexivity, and “Ethically Important Moments” in Research Marilys Guillemin Lynn Gillam University of Melbourne Ethical tensions are part of the everyday practice of doing research—all kinds of research. How do researchers deal with ethical problems that arise in the practice of their research, and are there conceptual frameworks that they can draw on to assist them? This article examines the relationship between reflexivity and research ethics. It focuses on what con- stitutes ethical research practice in qualitative research and how researchers achieve ethi- cal research practice. As a framework for thinking through these issues, the authors dis- tinguish two different dimensions of ethics in research, which they term procedural ethics and “ethics in practice.” The relationship between them and the impact that each has on the actual doing of research are examined. The article then draws on the notion of reflexivity as a helpful way of understanding both the nature of ethics in qualitative research and how ethical practice in research can be achieved. Keywords: research ethics; reflexivity; research practice Picture this scene. You are a researcher working on a study examining women’s experiences of heart disease. You are interviewing Sonia, a woman in her late 40s with diagnosed heart disease. Sonia lives on a remote farming property in a rural region. She is married and has one teenage daughter living at home with herself and her hus- band. The interview is progressing well. Over a cup of tea in Sonia’s kitchen, you inquire about the impact of heart disease on her life. Sonia stops and closes her eyes. After a few moments’ silence, you notice tears welling up in Sonia’s eyes. Sonia tells you that she is not coping—not because of her heart disease, but because she has just found out that her husband has been sexually abusing her daughter since she was a child. This kind of scenario is not unusual when conducting qualitative re- search. Most qualitative researchers can describe similar experiences they 261 Authors’ Note: We would like to gratefully acknowledge the suggestions and com- ments of our colleagues at the Reflexivity seminar series at which a draft version of this article was presented. Qualitative Inquiry, Volume 10 Number 2, 2004 261-280 DOI: 10.1177/1077800403262360 © 2004 Sage Publications have encountered, usually with considerable emotion and crystal-clear re- call. The issues raised in this scenario have ethical and legal implications. How as researchers do we respond to such disclosures when they occur, and are there existing conceptual frameworks and principles that we can draw on to assist us? Our focus in this article is on what we refer to as the “ethically important moments” in doing research—the difficult, often subtle, and usu- ally unpredictable situations that arise in the practice of doing research. We are interested in the ethical practice of research and how this is achieved. We examine existing ethical principles and frameworks for both their limitations and what they offer researchers and then turn to reflexivity as a potential tool for ethical research practice. Ethical dilemmas and concerns are part of the everyday practice of doing research—all kinds of research. Ethics is certainly not confined to qualitative research or necessarily to research that involves humans. Ethical issues are equally pertinent in clinical trials that are primarily quantitative, in research that involves animals rather than humans, in research that involves humans only indirectly (such as that which investigates human remains or documents that relate to people), and even in nonempirical research where the indirect or long-term consequences can be significant. The traditional starting point and focus for discussions of research ethics has been the ethical principles for- mulated for biomedical research, usually quantitative in nature. However, since the 1960s, social scientists have also explored ethics in qualitative social research (Bulmer, 1982; Homan, 1991; Kimmel, 1988; Orb, Eisenhauer, & Wynaden, 2001; Robley, 1995). In this article, we build on this work by focus- ing on what constitutes ethical research practice in qualitative research and how researchers achieve ethical research practice. Specifically, we examine the particular concerns of ethics in qualitative research and how they relate to biomedical research ethics as traditionally defined. In particular, we ask whether there are theoretical resources within the tradition of qualitative research for dealing with ethical aspects of research practice or whether these resources must be drawn from elsewhere. This question arises in a context where externally generated principles of research ethics have been applied to qualitative social research and where disquiet about the appropriateness of this has periodically been expressed (American Association of University Professors, 2000; Bouma & Diemer, 1996). As a framework for thinking through these issues, we distinguish two dif- ferent dimensions of ethics in research, which we term procedural ethics and “ethics in practice.” We examine the relationship between them and the impact that each has on the actual doing of research. Having shown that pro- cedural ethics cannot in itself provide all that is needed for dealing with ethi- cally important moments in qualitative research, we then draw on the notion of reflexivity as a resource. This is the key step. Although reflexivity is a famil- iar concept in the qualitative tradition, we suggest that it has not previously been seen as an ethical notion. We propose that reflexivity is a helpful concep- 262 QUALITATIVE INQUIRY / April 2004 tual tool for understanding both the nature of ethics in qualitative research and how ethical practice in research can be achieved. DIMENSIONS OF ETHICS IN RESEARCH We suggest that there are at least two major dimensions of ethics in qualita- tive research (indeed in all research, but we will not pursue that issue here). These are (a) procedural ethics, which usually involves seeking approval from a relevant ethics committee to undertake research involving humans; and (b) “ethics in practice” or the everyday ethical issues that arise in the doing of research. It could be argued that there is another dimension— research ethics as articulated in professional codes of ethics or conduct. Most professions and organizations have professional codes of conduct (Bulmer, 1982; Coady & Bloch, 1996; Homan, 1991). Although these codes do exist and are often essential components of the constitution of professions and orga- nizations, we, like other analysts such as Mason (1996, p. 166), would ques- tion the relevance of these codes for actual research practice. Hornsby-Smith (1993) claimed that organizational codes of conduct are often too restrictive, and that there is a general move in many organizations toward more general guidelines for ethical practice. In terms of usefulness in addressing ethical issues that arise in practice, professional ethical codes are largely not practical or applicable and can serve only as general guidelines. Although we do not wish to totally dismiss the role of professional codes in guiding ethical research practice, we focus in this article on procedural ethics and “ethics in practice” and the relationship between them. We begin by reflecting on the impact that these different dimensions actually have on research. Procedural Ethics In qualitative research that involves humans, one of the early stages of the research process is the completion of the application form for a research ethics committee.1 For many researchers, the completion of the research ethics com- mittee’s application form is a formality, a hurdle to surmount to get on and do the research. Like many of our qualitative research colleagues, we diligently answer the questions on the ethics application form, even though they may be irrelevant to our research. We have learned to write our responses to the ques- tions in “ethics-committee speak.” This involves using language that the committee will understand, is free of jargon, but will nonetheless reassure the committee that we are competent and experienced researchers who can be trusted. This also involves explaining methodology to a committee who may be unfamiliar with qualitative methods and in some cases, may be antagonis- tic toward this type of research. Moreover, we have learned to gloss over some Guillemin, Gillam / “ETHICALLY IMPORTANT MOMENTS” 263 issues that we know may cause the committee concern, for example, giving a transcriber, who is external to the research team, access to interview tapes without seeking direct consent from the participants, or not to draw too much attention to potential, although unlikely, risks to the researchers when con- ducting the research (in particular, risks to research assistants or less- experienced researchers on the research team). The form asks what measures the researcher/s have put in place in the event of unexpected outcomes or adverse effects. As indicated in the opening scenario, there are many situa- tions that are unexpected when doing research that can potentially have adverse consequences—how can you foresee and plan for all of these? Most researchers learn quickly that they need to be savvy in addressing the poten- tial issues of concern of the committee: using the appropriate discourse to en- sure that applications will be approved as quickly as possible with minimum changes and dispute, while remaining true to their research integrity. “Ethics in Practice” The second dimension of ethics we consider is “ethics in practice.” These pertain to the day-to-day ethical issues that arise in the doing of research. Consider the example of Sonia’s disclosure that her husband has been sexu- ally abusing her daughter. This can be interpreted as a classic ethical dilemma of whether to breach Sonia’s confidentiality to prevent harm to her daughter. Even with this interpretation, this is not an ethical question that receives much attention at the procedural ethics level, where the focus is much more on how confidentiality will be maintained rather than on when a breach of confidentiality might be ethically required. More important, we suggest that this is not the only ethical issue here or even the most pressing one. There are many more immediate ethical concerns. The researcher has to decide how to respond to what Sonia has said. Does the researcher let the disclosure pass or take it up in some way? And in what way—what words to say, what tone of voice to use? Turn off the tape recorder or keep it running? Abandon the inter- view plan or try to return to it? Offer to discuss the situation or offer to help in some way? These are issues about the ethical obligations a researcher has toward a research participant in terms of interacting with him or her in a humane, nonexploitative way while at the same time being mindful of one’s role as a researcher. These issues are not usually addressed in research ethics committee appli- cations, nor are they events that are often anticipated when applying for approval. Some researchers may not even regard them as ethical in the sense that they may not be “dilemmas” or appear to be of great consequence. It is certainly true that some of them are not dilemmas, if we take dilemma to refer to a situation in which there is a stark choice between different options, each of which seem to have equally compelling ethical advantages and disadvan- 264 QUALITATIVE INQUIRY / April 2004 tages. Perhaps these issues may seem unimportant because they have an “everyday” sort of quality. However, there is much more to ethics than red- letter dilemmas, and much is missed by not being aware of this. The questions that we have posed about responding to Sonia represent what we call “ethi- cally important moments,” where the approach taken or the decision made has important ethical ramifications, but where the researcher does not neces- sarily feel himself or herself to be on the horns of a dilemma. In fact, in some cases, it might be relatively clear how the researcher should respond or pro- ceed, and yet there is still something ethically important at stake. For exam- ple, it might be clear that the researcher should not just continue with the interview as if nothing has happened but instead, should respond directly to Sonia in some way. That this is clearly the right thing to do does not make the situation ethically trivial; the moment of response is an ethically important moment for there is the possibility that a wrong could be done. There can be all sorts of ethically important moments: when participants indicate discom- fort with their answer, or reveal a vulnerability; when a research participant states that he or she does not want to be assigned a pseudonym in the writing up of the research but wants to have his or her real name reported; or the case described by Orb et al. (2001) of interviewing victims of violence where the researcher has to decide how far to probe a participant about a difficult and distressing experience. It is this dimension of ethics made up of “ethically important moments” that is of primary interest in this article. Although this ethical dimension of research practice is often apparent to researchers, there is little conceptual work available to draw on to make sense of it. We need both a language to articulate and understand these ethical issues and an approach that assists us to deal with these issues when they arise. We will now go on to suggest a way into this “ethics in practice” dimension and then consider how “ethics in practice” relates to procedural ethics. Microethics in Research Practice A potentially useful term for thinking about “ethics in practice” is micro- ethics. This term comes from the literature on ethics in clinical (medical) prac- tice rather than from research ethics, but we suggest that it has obvious appli- cation to research ethics. The term microethics was originally proposed by Komesaroff (1995) to address what he saw as the disjuncture between “big issue” bioethics and everyday ethics in clinical practice. Bioethics has tradi- tionally focused on what are now the classic “neon light” debates centered on such issues as euthanasia, cloning, reproductive technologies, and so on. Bio- ethics, especially in its mainstream form, where it arises out of analytic moral philosophy, provides philosophical tools of analysis to understand the funda- mental ethical issues at stake in these debates and goes on to logically argue Guillemin, Gillam / “ETHICALLY IMPORTANT MOMENTS” 265 toward conclusive statements about what should be done in dealing with these issues. The debates are usually conducted in general rather than partic- ular terms and may readily be interpreted as recommendations for public policy rather than as a guide to individual ethical reflection or action. Although it has been a useful contributor at this general level, bioethics has been critiqued, from both within and outside its philosophical base, for either ignoring or being unable to deal with the ethical questions at the local or individual level. The increased focus on what is now often called “clinical ethics” or “medical ethics” has gone only part way toward dealing with this criticism. Although clinical ethics addresses itself to individual doctors (and to a lesser extent, other health professionals) on matters that arise in the clini- cal setting, the focus has still tended to be on “dilemma-type” issues, such as refusal of treatment. Clinical ethics has still been couched in general and ab- stract terms, as witnessed by the continuing tendency to cast all communica- tion between doctors and patients in terms of informed consent. Komesaroff (1995) addressed all these sorts of concerns when he claimed that medical ethics is not just about the dramatic questions that are discussed widely in the popular media or in the philosophical texts. Ethics is what happens in every interaction between every doctor and every patient. (p. 68) By using the term microethics, Komesaroff attempted to capture the everyday ethical issues that arise in clinical practice—the establishment of trust be- tween doctor and patient, the taking of a sexual history, the dealing with past fears, the probing about the patient’s illness experience. None of these pre- sents a “dilemma” in the classic sense that we described earlier, but Komesaroff wanted to both validate them as important ethical matters worthy of the clini- cian’s attention and also provide a language for reflecting on them. For Komesaroff, microethics is about the complex dynamics between doc- tor and patient in clinical practice. However, it is also potentially applicable to the complex dynamics between researcher and participant in research.2 To talk about microethics in research practice is to give credence to the “ethically important moments” we articulated earlier: what to say in response to Sonia’s disclosure of sexual abuse, deciding how much to probe a participant about a difficult experience, and so on. Although the term microethics has been critiqued for setting up a false dichotomy between the abstractness of bio- ethics and the specificity of ethics in clinical practice, it nonetheless provides a language to describe and understand the “ethics in practice” in research. The Relationship Between Procedural Ethics and Microethics Earlier, we suggested that for many qualitative researchers, the research ethics committee application is primarily a hurdle to surmount. Being made 266 QUALITATIVE INQUIRY / April 2004 to jump this hurdle can be a frustrating experience for qualitative social re- searchers, as a recent discussion paper produced by the American Associa- tion of University Professors (2000) attests. The discussion paper documents concerns expressed by a wide range of social researchers that institutional review boards in the United States are inappropriately applying models from the biomedical sciences to ethical review of social sciences research. The dis- cussion paper reports that in the view of these social researchers, the ap- proach taken by the institutional review boards “was established and has evolved within a clinical and biomedical framework that does not fit their research” (American Association of University Professors, 2000, section I, p. 3). In this context, it is worthwhile to reflect further on the role of research ethics committee approval. Is it really the case that research ethics at the pro- cedural level does not fit the practice of qualitative research? Does the process of applying for approval in any way contribute to ethical research practice? It is indeed true that the principles and processes used to conduct the ethi- cal review of qualitative social research were developed initially in the con- text of biomedical research. The beginnings of procedural ethics are usually traced to the Nuremberg Trials that occurred after World War II. Among those tried at Nuremberg were Nazi doctors who had committed terrible abuses on concentration camp inmates in the name of medical research. One of the out- comes of the trials was the so-called Nuremberg Code that expressly stated the obligation of medical researchers to gain the consent of those on whom they conducted research and not to harm them. The Nuremberg Code was soon followed by the World Medical Association’s Declaration of Helsinki that restated similar principles. This remains an extremely important interna- tional reference point for the regulation of medical research, as witnessed by the recent heated international debate over proposed changes to the Declara- tion that would have reduced standards of care required for clinical trials in developing countries (for a discussion of this, see Zion, Gillam, & Loff, 2000). After these international documents were drafted, individual countries be- gan to produce and revise their own codes and guidelines, which were gener- ally modeled on the Declaration of Helsinki.3 Initially, these codes and guidelines were aimed only at biomedical re- search, but in many countries they came gradually to be extended to all research involving humans, including social and qualitative research of all kinds. In the United States in the 1960s, guidelines issued by the Department of Health and Human Services through the Office of Protection from Research Risks were initially cast in broad terms to apply in principle to “all research involving human subjects” (Federal Policy for the Protection of Human Sub- jects [hereafter, the U.S. Common Rule], 2001, 46.101); however, this applied only to research that was funded or conducted by 17 federal government departments. There was also a list of exclusions regarding the types of research that did not require ethical approval. Many types of social research appeared on this list of exclusions, including surveys, interviews, and obser- Guillemin, Gillam / “ETHICALLY IMPORTANT MOMENTS” 267 vation of public behavior (U.S. Common Rule, 2001, 46.101[b]). However, most individual institutions voluntarily extended ethical review in various ways, such as requiring review of nonfunded research as well as funded re- search and requiring researchers who believe their work is exempt to apply for exemption, a process that actually requires as much documentation and review as applying for approval (American Association of University Profes- sors, 2000, section I, p. 3). Hence, in many universities in the United States, all qualitative research is subject to review at the level of procedural ethics. A very similar process occurred in Australia at the instigation of the National Health and Medical Research Council—the key national research funding body and organization that issues research ethics guidelines—rather than at the initiative of the universities. Although the National Health and Medical Research Council guidelines were initially directed only at biomedi- cal research, the Council issued a directive stating that it would fund research only at institutions where all research on humans was conditional on ethical review. Australian universities therefore complied, and social research of all kinds became subject to procedural ethics. In 1999, the substantially revised version of the guidelines, the National Statement on Ethical Conduct of Research Involving Humans (NS) (Commonwealth of Australia, 1999), formalized this by making the extension to all types of research explicit (McNeill, 1993, pp. 74- 75). Likewise in Canada, The Tri-Council Policy Statement (TCPS) (Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, & Social Sciences and Humanities Research Council of Canada, 1998) covers all research, including qualitative research. In short, in the United States, Canada, and Australia,4 a single ethics committee, often based at a university, reviews all types of research involving humans (unless subcommittees are set up for institutional convenience, but the same guide- lines still apply). All social research, whether or not it is health related, whether or not it is conducted at a health care facility, is conditional on this process. It appears that ethics at the procedural level has been imposed on qualita- tive research from outside. Does this foreignness mean that it is irrelevant to qualitative research or worse, destructive to it? We argue that it does not. First, research ethics committees satisfy an obvious need to protect the basic rights and safety of research participants from obvious forms of abuse. We do not dispute this and would strongly support the role and importance of research ethics committees in the research process in this regard. Second, it can at least be said that procedural ethics offers researchers an ethics “checklist” by reminding the researcher to consider such issues as the potential risks to par- ticipants, the balancing of the benefits of the research against those risks, the steps needed to ensure confidentiality of data, and the inclusion of consent forms and plain language statements in the material provided to participants. This is a helpful aid in designing a research project that will be ethically acceptable in its broad methodology. Further, in fulfilling the procedural obli- 268 QUALITATIVE INQUIRY / April 2004 gations of this ethics checklist, the researcher is also granted institutional credibility to carry out the research. However, this still leaves quite a gulf between procedural ethics and “eth- ics in practice.” The checklist is not much help once the researcher is out in the field and dealing with the realities of research practice, such as Sonia’s disclo- sure about the abuse of her daughter. So what is the ultimate significance of research ethics committee approval? By gaining approval of a committee, do researchers conduct their research in a more ethical way than they would have if they had not gained approval? There is no direct or necessary relation- ship between ethics committee approval of a research project and what actu- ally happens when the research is undertaken. The committee does not have direct control over what the researcher actually does. Ultimately, responsibil- ity falls back to the researchers themselves—they are the ones on whom the conduct of ethical research depends. Arguably, procedural ethics has little or no impact on the actual ethical conduct of research. This view of the research ethics committee process as quite divorced from the ethics of research practice is common among qualitative researchers for whom, as we noted above, the ethics committee process comes out of a for- eign paradigm (this is discussed in Daly, 1996, p. xvii). We have two responses to it. First, we suggest that the gulf between procedural ethics and “ethics in practice” (microethics) is not as great as it may first appear. On the contrary, we argue that there is considerable continuity between ethical concerns at the procedural and practical levels and moreover, there would be something drastically wrong if this were not the case. Second, we suggest that at the level of “ethics in practice,” the “homegrown” notion of reflexivity actually encap- sulates and extends the concerns of procedural ethics. When the responsibil- ity for ethical conduct falls, as it must, on the researcher and not on the re- search ethics committee, there is still a framework for thinking about ethical conduct that is not utterly divorced from procedural ethics and yet is already integral to the good practice of qualitative research. We now argue for each of these claims in turn. Continuity Between Procedural Ethics and “Ethics in Practice” It would be naïve and mistaken for ethicists to suggest that procedural eth- ics is the whole of ethics—that ethical issues in the practice of research can be entirely covered by the ethics committee process. It is within the dimension of “ethics in practice” that the researcher’s ethical competence comes to the fore. By this we mean the researcher’s willingness to acknowledge the ethical dimension of research practice, his or her ability to actually recognize this eth- ical dimension when it comes into play, and his or her ability to think through ethical issues and respond appropriately. However, we argue that all of this is Guillemin, Gillam / “ETHICALLY IMPORTANT MOMENTS” 269 directly related to, and enhanced by, what happens in the ethics committee process, even though it cannot be ensured or enforced by it. To make our case, we will identify the fundamental ethical values on which procedural ethics is based and attempt to show that these values are both (a) relevant to quali- tative social research and (b) not radically different from the issues and concerns that have already been identified as arising in the microethical dimension. Although in general, ethical codes and guidelines are often not a great source of ethical enlightenment and typically contain vague motherhood statements, guidelines for research ethics tend to be much more precise. The U.S. Common Rule (2001), the Australian NS (Commonwealth of Australia, 1999), and the Canadian TCPS (Medical Research Council of Canada et al., 1998) all provide reasonable summary statements of the ethical principles that are central in the standard approaches to research ethics in the discipline of bioethics. In the U.S. Common Rule (46.111[a]), these are in the form of a list of criteria that must be met for ethics committee approval, which includes minimizing harm, informed consent, and protection of privacy. In the Austra- lian NS, a general principle is enunciated. The NS says that its “guiding value” is integrity, which it defines as a commitment to the search for knowl- edge and to honest and ethical conduct (Commonwealth of Australia, 1999, 1.1, p. 11). The NS’s “guiding ethical … RESEARCH Open Access Motor regulation problems and pain in adults diagnosed with ADHD Liv Larsen Stray1,2*, Øistein Kristensen1, Martha Lomeland1, Mette Skorstad1, Torstein Stray2,3 and Finn Egil Tønnessen3 Abstract Background: Most children who are diagnosed with attention deficit-hyperactivity disorder (ADHD) have moderate-to-severe motor problems using the Motor Function Neurological Assessment battery (MFNU). The MFNU focuses on specific muscle adjustment problems associated with ADHD, especially motor inhibition problems and high muscle tone. Here we investigated whether adults with ADHD/hyperkinetic disorder (HKD) have similar motor problems. In our clinical experience, adults with ADHD often complain about back, shoulder, hip, and leg pain. We also investigate reported pain in adults with ADHD. Methods: Twenty-five adult outpatients diagnosed with ADHD/HKD who were responders to methylphenidate (MPH) were compared to 23 non-ADHD controls on 16 MFNU subtests and using a ‘total score’ (‘TS’) parameter. The MFNU test leader was blinded to group identity. The two groups were also compared using the Pain Drawing and Numerical Pain Rating Scale. Results: The adult ADHD group had significantly (p < .001) more motor problems (higher TS) than controls. On the muscle regulation subtests, 36–96\% of the ADHD group showed ‘moderate’ to ‘severe’ problems compared to 13–52\% of the control group, and 80\% of the ADHD group reported widespread pain. Highly significant differences were found between the ADHD and control groups for the variables ‘pain level’ (p < .001) and ‘pain location’ (p < .001). Significant correlations were found between TS and ‘pain location’ and between TS and ‘pain level’. Conclusions: These findings suggest that similar to children with ADHD, adults diagnosed with ADHD also have motor inhibition problems and heightened muscle tone. The presence of significantly higher pain levels and more widespread pain in the ADHD group compared to non-ADHD controls might indicate that pain is a long-term secondary effect of heightened muscle tone and restricted movement that can be demonstrated in children and adults by the MFNU battery. Keywords: ADHD, Motor problems, MFNU, Muscular regulation, Tonus, Inhibition, Pain, Adult Background ADHD in Adults Prevalence of ADHD among children and adolescents is estimated to 5,3\% worldwide [1-5]. Sixty per cent of children diagnosed with ADHD in early childhood continue to demonstrate ADHD symptoms as adults [6]. Although some have argued that the severity of ADHD diminishes with age [7], others assert that the symptoms of ADHD simply change over time [8]. Specifically, symptoms such as hyperactivity are thought to diminish from childhood/adolescence to adulthood, whereas symptoms of inattention persist or even worsen with age [8]. In the context of the WHO World Mental Health Survey Initiative, researchers screened more than 11,000 people aged 18 to 44 years old in ten countries in the Americas, Europe, and the Middle East [1]. The data suggested that an average of 3.5\% (range 1.2–7.3\%) met the ADHD criteria. A significantly lower prevalence of ADHD was shown in low-income countries (1.9\%) com- pared to high-income countries (4.2\%). The researchers concluded that adult ADHD often co-occurs with other disorders and that it is associated with substantial * Correspondence: [email protected] 1Addiction Unit, Sørlandet Hospital, Kristiansand, Norway 2Department of Child and Adolescent Health, Sørlandet Hospital, Kristiansand, Norway Full list of author information is available at the end of the article © 2013 Stray et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Stray et al. Behavioral and Brain Functions 2013, 9:18 http://www.behavioralandbrainfunctions.com/content/9/1/18 impairment in adult role functioning. Although they found that few adults are treated for ADHD itself, in many instances treatment is given for co-occurring disorders. For example, up to 80\% of adults with ADHD have some form of psychiatric comorbidity [9]. Less is known about somatic problems associated with the condition. ADHD and motor problems as assessed with the MFNU Using the Motor Function Neurological Assessment (MFNU) [10] moderate to severe motor problems were found on all 16 subtests in 80–96\% of boys with ADHD- combined [11]. Motor problems in children with ADHD are often diagnosed as the DSM-IV diagnosis Develop- mental Coordination Disorder (DCD) [12]. They are seen in 40-60\% of these children, and typically interpreted as comorbid to the ADHD condition [13-17]. The MFNU was developed because clinical observed motor problems were not detected by standard motor test batteries like the Movement ABC-test [18] nor by the Halstead-Reitan neuropsychological test battery [10,19]. In our prior re- search, the MFNU revealed marked heightened muscle tone in gross movement muscles like the latissimus dorsi, sacrospinalis, iliopsoas, and calf muscles in children with ADHD [11]. High muscle tone in these muscles, which are used in a compensatory manner for stabilizing the torso, may restrict the movement of the shoulders, hips, vertebral column, and thorax. In the study by Stray et al. [11], 80\% of the ADHD group and none of the control group showed highly restricted hip movement. In adoles- cents, lower back pain is associated with reduced hip mo- bility [20]. Reduced movement of the thorax may result in restriction of respiration and lead to shortness of breath [21,22]. The calf muscles (the gastrocnemius and the soleus) are active in maintaining and adjusting body alignment [23,24]. High tone in these muscles may reduce the flexibility of the foot and have a negative affect on balance. Balance problems are well known in ADHD [25-27]. Disinhibition in children with ADHD is present not only in higher order executive functions like motor plan- ning, timing, and evaluation, but also seems to be in- volved in more basic motor functions. Stray et al. [10] demonstrated that children with ADHD typically exhibit a gradual increase in muscle tone when flexion-extension movements are repeated several times in succession, as in several of the MFNU subtests. This pattern, which is not seen in normal control subjects, results in a restricted movement range and in jerkiness [see videofilms in the DVD following the manual and the electronic Paper 10, 11]. These findings may explain why children with ADHD often appear clumsy and uncoordinated in daily activities [10,11], even though some of them are described by parents and teachers as being very skilled athletes. In another study, Stray et al. [28] demonstrated that a single dose of methylphenidate (MPH, Ritalin©) improved the motor inhibition problems and muscle tone in boys with ADHD and had a corresponding weaning effect after the MPH was metabolized, very similar to what is seen in the behavioural symptoms of ADHD [see videofilms 10, 28]. In a retrospective study of 73 children with ADHD symp- toms (62 boys and 11 girls aged 5–17 years) the motor problems identified by the MFNU were present more often as part of the core behavioural problems of ADHD in MPH-responders than in non-responders [29]. No significant gender or age differences were found in either of the groups on any of the MFNU subtests used in that study. These results challenge the current belief that motor problems in ADHD are either side effects or symptoms of inattention [the differential section for DCD 12, 30] or a separate (comorbid) condition [31]. The close link between positive behavioural and motor responses to MPH suggests that further research is needed to investi- gate the role of muscular regulation as an integrative as- pect of ADHD and possibly as a physical marker of the condition. In our clinical work, we have observed that adults diagnosed with ADHD display similar patterns of motor inhibition problems and heightened muscle tone as children with ADHD [32]. Despite the high preva- lence of motor problems in children with ADHD [33-37], there has been little research into whether adults with ADHD have similar problems [38]. ADHD and musculoskeletal pain In our clinical practice, adult patients with ADHD often report skeletal muscle pain and physical discomfort [39]. As a permanent condition, the muscular state that is associated with ADHD may elicit muscular pain and other secondary somatic effects, such as fatigue and restricted movement and respiration [40]. Kessler et al. [41] found that workers with ADHD reported signifi- cantly more chronic pain than other workers. Young and Redmond [42] found that a number of adult patients with core symptoms of ADHD also reported unex- plained fatigue, widespread musculoskeletal pain, or a pre-existing diagnosis of fibromyalgia or chronic fatigue; in addition, some patients reported amelioration of pain and fatigue symptoms when medicated with ADHD medicine. In a Norwegian study, 22\% of patients who were diagnosed with ADHD as adults had a history of substance abuse disease (SUD) [43]. Clinically, some reported that the SUD started after discomfort and pain that was often attributed to the negative effects of a par- ticular lifestyle or career. One might ask if some of this discomfort and pain was also attributable to side effects of chronic muscular dysregulation that is associated with Stray et al. Behavioral and Brain Functions 2013, 9:18 Page 2 of 10 http://www.behavioralandbrainfunctions.com/content/9/1/18 the ADHD condition itself. Little research has been done in this area. Aims of the present study The aims of the present study were to investigate whether adults with ADHD exhibit the motor function problems demonstrated in children with ADHD and to investigate whether such motor problems were related to the presence of reported pain. Our research questions and hypotheses were as follows: 1. What are the differences in motor problems in adults with ADHD as compared to non-ADHD controls as measured by the MFNU? 2. Do adults with ADHD report a) more widespread pain or b) higher levels of pain than non-ADHD controls? We hypothesized that adults with ADHD would display consistently higher scores and show significantly more motor problems on all of the MNFU subtests used in this study as compared to non-ADHD controls. We also hypothesized that adults with ADHD would report more widespread pain and higher levels of pain than adults in the non-ADHD control group. Methods Sample Verbal and written information about the project was given to outpatients at the Addiction Unit, Sørlandet Hospital, who were diagnosed with HKD F90.0/ADHD, had no active substance abuse, and who were positive responders to MPH. Affirmative written replies were received from 28 patients. Three of these were excluded, one for medical reasons, one who could not be taken off MPH medication due to work, and one for substance abuse. Thus the ADHD group consisted of 25 subjects with a mean age of 33 years (SD 8.9), range 20–51 years. The group included 14 men with a mean age of 34 years (SD 9.5), range 20–51 years, and 11 women with a mean age of 32 years (SD 8.3), range 20–47 years. Three subjects were university students, 12 had regular work, and 10 received social security. The patients medicated with MPH were taken off medication a least one day before the motor assessment. The non-ADHD controls group consisted of students from the University of Agder, employees from a rehabili- tation department at Sørlandet Hospital HF, and em- ployees from a care home for the intellectually challenged in Kristiansand. Non-ADHD controls were recruited by posting flyers on bulletin boards and by study personnel and student leaders through verbal communication and written information about the project. Written affirmative answers were received from 29 subjects. To exclude possible ADHD problems in the control group, the participants were rated using the ‘M.I.N.I. Plus’ module W interview [44]. People with rheumatic diseases or with physical or medical conditions precluding participation in all of the 16 subtests of the MFNU were excluded. No precautions were taken to exclude other clinical groups. The final non-ADHD control group consisted of 23 adults without ADHD with a mean age of 41 years (SD 14.1), range 24–64 years. This group included 8 men with a mean age of 44 years (SD 14.1), range 26–64 years, and 15 women with a mean age of 40 years (SD 14.2), range 24–61 years. Instruments MFNU The current version of the MFNU consists of 16 subtests that are described briefly in Table 1. The tester continu- ally monitors and guides the participant through each subtest. There is a detailed video presentation of all sub- tests in the DVD accompanying the Norwegian MFNU manual [10]. In an earlier study an Intraclass Correlation (ICC) of consistency, using the two-way mixed Cronbach’s model, was calculated to measure rater agreement. An average ICC of .99 (95\% confidence inter- val, 0.98-1.00) was found, p < .001[21]. All 16 subtests were scored by the tester or by an in- dependent observer according to three scoring categor- ies as described in Table 2. The scoring criteria for each scoring category on each subtest are described in greater detail in the MFNU manual. Subtests 1–10 are performance tests in which the person who is being tested is instructed to perform a particular task. ‘Subtest 16: Synkinesis’ evaluates the presence of overflow movements during the MFNU as- sessment. Four subtests (12–15) are subtests of passive movements of the hips and feet in which the tester evaluates muscular resistance. ‘Subtest 11: Palpation’ provides important physical/proprioceptive information about muscular consistency and possible high muscle tone in muscles such as the sacrospinalis and the latissimus dorsi and about restricted movements of the thorax [10]. A reliability study of the MFNU showed high internal consistency within the total set of 17 subtests (Cronbachs alpha of .97) and a high rater agreement with an average ICC of .99 (95\% confidence interval, 0.98–1.00; p < .001) [45]. Subtest 11, ‘Palpation’ was not included in this study due to problems with scoring non-visual information from the video recordings used in the evaluation proce- dures. The total score of the MFNU, termed the ‘TS’, can range from 0 (no problems) to 32 (severe problems, i.e. scores of 2, on all 16 subtests). Stray et al. Behavioral and Brain Functions 2013, 9:18 Page 3 of 10 http://www.behavioralandbrainfunctions.com/content/9/1/18 Pain drawing The Pain Drawing procedure, which is commonly used in studies of pain [46-48], was chosen to categorize the patients into 4 pain groups, including a group with no pain. Areas of the body that were painful during the previous 14 days are marked on a drawing by each participant. Participants with pain localized only above a horizontal line in the thoracolumbar region (T12) were categorized into Pain group 1. Participants with pain localized only below the horizontal line were categorized into Pain group 2. Pain localized both above and below the line was defined as widespread, and subjects with widespread pain were categorized into Pain group 3. Those with no pain were categorized into Pain group 0. Numerical pain rating scale The intensity of the pain experienced during the previ- ous two weeks was rated by each participant on an 11-point Numerical Pain Scale (NRS) that ranged from 0 (“No pain”) to 10 (“Pain as bad as it could be”) [49]. The NRS has been shown to be an appropriate measurement of pain in patients with chronic pain [50]. M.I.N.I. Plus This study used the Mini-International Neuropsychiatric Interview (M.I.N.I.) version 5.0.0 with the attention deficit/hyperactivity disorder module W in the M.I.N.I.- Plus. The M.I.N.I. is an short psychiatric interview for assessing psychiatric disorders according to the DSM-IV and ICD-10 classification systems [44]. The M.I.N.I. is widely accepted and has high validity [51,52]. Assessment Each participant was assessed using the MFNU, Pain Drawing, and NRS. Possible ADHD symptoms in the control group were addressed by a M.I.N.I plus interview Table 1 The MFNU subtests used in this study [for videos see 25] Name of subtest Description 01. Dynamic balance-2 legs Three sideway jumps within marked squares (back and forth). The entire process is repeated three times without stopping. 02. Dynamic balance-1 leg Three sideway jumps on one leg within marked squares (back and forth). The entire process is repeated three times without stopping. Both legs are tested. 03. Diadochokinesis-right Pronation-supination of one hand with the elbow flexed 90 degrees. The hand is held as an “extension” of the lower arm. The exercise is performed for approximately 15–20 seconds. 04. Diadochokinesis-left 05. Reciprocal coordination Alternate clenching of one fist while stretching the other in a rhythmic manner for about 15 seconds. Fingers should be almost completely extended after the hand has been clenched. Elbows are at a 90-degree angle with palms facing upwards. 06. Thumb movement The tips of the fingers other than the thumb are successively touched with the palmar surface of the tip of the thumb. After each opposition, the subject extends and abducts the thumb. Both hands are tested for approximately 20 seconds. 07. Walking Walking with toes alternately pointing outwards (“Chaplin”) and inwards followed by walking on the outer foot rend (Fog’s test) and inner foot rend. 08. Lifting arm Lies prone with arms at a 45 degree angle from midline; lifts one arm with the palm of the hand facing the floor. 09. Lifting leg Lies prone with the anterior superior iliac spine touching the floor while lifting one stretched leg at a time. 10. “Flying” Lies prone, the arm in a 45 degree angle from midline, lifting head, arms and legs. 11. Palpation Lies prone. The test leader palpates the back, especially the longissimus and latissimus dorsi. The test leader assesses the mobility of the thorax. 12. Passive abduction-right hip Lies supine. Tester holds the subject’s knee and hip in a flexed position. 13. Passive abduction-left hip The tester stretches and flexes the leg to elicit relaxation of the hip muscles and abducts the leg. The sides are evaluated separately. 14. Passive movement-right foot Lies supine. Tester examines passive movement with dorsal flexion and eversion/plantar flexion of the right and the left feet. 15. Passive movement-left foot 16. Synkinesis ‘Synkinesis’ is not a separate test but is an item for evaluating the synkinetic movements registered in one or more subtests. When synkinesis is observed, the tester tries to correct it. The synkinesis remaining after correction is scored. Stray et al. Behavioral and Brain Functions 2013, 9:18 Page 4 of 10 http://www.behavioralandbrainfunctions.com/content/9/1/18 conducted by a physician or a social educator with many years of clinical and research experience in psychiatric assessment of patients with ADHD. The MNFU test leader, an experienced physiotherapist with no prior per- sonal or professional knowledge of the subjects in either of the groups, was blinded to which group the partici- pant was in. The assessments of the Pain Drawing, NRS, and the M.I.N.I. interview were performed prior to the MFNU assessment. The MFNU test leader did not know the results of these assessments. Statistical analyses The statistical analyses were carried out using PASW (SPSS) Statistics, version 18 for Windows (SPSS Inc., Chicago, IL, USA). Descriptive statistical analyses were performed on data from each subtest in order to view the distribution of the participants (\%) in the scoring categor- ies (0, 1, or 2) and for the TS variable. As the samples and the measurements did not satisfy the conditions for para- metric tests, the non-parametric Mann–Whitney U-test was used to compare the ranked scores of the ADHD group and control group on each of the 16 subtests. The Mann–Whitney U-test was used to compare the TS and the ‘Pain level’ of the ADHD group and control group for the same reason. Pearson’s Chi-square test was used to compare frequencies in the groups for the categorical variable ‘Pain location’. Spearman’s rho was run for all participants as a whole for finding the correlation between the TS of the MFNU and the ‘Pain level’ and between the TS and ‘Pain location’. Approval The study was approved by The Norwegian Data Inspectorate, The National Committee for Medical Research Ethics in Norway, 2011/1947 D. Results Group differences on the MFNU The ADHD group showed a high percentage of ‘severe problems’ (a score of 2) on many of the subtests: ‘Palpation’, ‘Passive abduction of the hip’ and ‘Passive movement of the feet’, ‘Lifting arm’, ‘Lifting leg’, ‘Diadochokinesis of the left arm’, and ‘Reciprocal coord- ination’. The control group typically had few problems on any of the subtests (Table 3). There were significant differences between the ADHD group and the control group for all subtests except for ‘Flying’ (Table 3). The Mann–Whitney U-tests (Table 3) showed that the ADHD group had significantly more motor problems (higher TS; median = 25) than the control group (me- dian = 2) (U = 485.00, p < .001). The mean TS of the ADHD group was 21.20, SD = 9.5, and the mean TS of the control group was 6.30, SD = 9.9, Cohens d of the TS between the groups was 1.52, indicating a large effect size [53]. There were no significant gender differences in either of the groups as shown by Mann–Whitney U-test analysis of the TS. Most subjects in the control group had no problems on the MFNU. Three subjects had high TS, and all three showed both inattention and impulsive ADHD problems on the M.I.N.I. Plus, although they did not fulfil the ADHD diagnostic criteria. Group differences in ‘pain location’ and ‘pain level’ The Pearson’s Chi-Square test showed significant differ- ences between the ADHD group and the control group for the variable ‘Pain location’ (P < .001). Widespread pain was reported by 80\% of the ADHD group compared to 17.4\% of the control group. Only 8\% of the ADHD group reported having no pain in the previous two weeks compared to 34.8\% of the controls. There were no significant gender differences regarding pain level or pain location in either of the groups (Table 4). The Mann–Whitney U-tests showed a significant difference in self-reported pain (‘Pain level’) between the ADHD group (mean rank = 31.76, median =5) and the control group (mean rank = 16.61, median = 1) (U = 469.00, p < .001). The mean ‘Pain level’ for the ADHD group was 4.76, SD = 2.16, and the mean ‘Pain level’ for the control group was 1.96, SD = 2.27. The Cohen’s d for ‘Pain level’ was 1.26, which is a large effect Table 2 Scoring criteria for the MFNU subtests Score: Criteria Subtests 01–10 Subtests 12–15 Subtest 16 Subtest 11 0 No problems The task is performed with no problems and little effort Normal resistance against the movement is registered Only sporadic synkinetic movements are registered Normal muscle tone, good mobility in the thorax 1 Moderate problems The task is performed according to instructions but requires a lot of attention and effort or performance quality is below what is expected according to age Resistance against the movement is registered Moderate synkinetic movements are registered in one or more subtest Slightly greater muscle tone, some resistance against movement of the thorax 2 Severe problems The subject cannot perform the task according to the instructions Strong resistance against the movement is registered Pronounced synkinetic movements are registered in one or more subtest High muscle tone, strong resistance against movement of the thorax Stray et al. Behavioral and Brain Functions 2013, 9:18 Page 5 of 10 http://www.behavioralandbrainfunctions.com/content/9/1/18 size. There was a significant correlation (p < .01) between the TS on the MFNU and ‘Pain level’ and between the TS and ‘Pain location’ (p < .05) (Spearmans rho). Discussion Motor problems We hypothesised that adults with ADHD would have more problems than controls in regulating movement and muscle tone as assessed by the MFNU. This hypoth- esis was supported by the results on all subtests except the ‘Flying’ subtest. These results strongly suggest that muscle regulation problems are very similar in adults with ADHD as in children with ADHD. Most of the ADHD subjects had a moderate to severe TS, indicating that just as in children, the adults had motor problems that affected many facets of movement and muscle control. Comparison of the results for the adult ADHD group to results for 8–12-year-old boys showed minor differences in two subtests. The results on subtest 16, ‘Synkinesis’, and subtest 07, ‘Walking’ indicated that adults with ADHD may be less affected by overflow movement (synkinesis) than children (see [11]). Over- flow movements reflect immaturity of the cortical sys- tems involved in automatic inhibition [54] and are also present in many children without ADHD. Overflow movements are normally less apparent in adolescence and adulthood than in childhood, which is the natural consequence of more mature nervous systems [55,56]. Thus, it is likely that the low scores on the ‘Synkinesis’ subtest in adults with ADHD compared to children with ADHD are due to maturation. Even so, our results indi- cated that adults with ADHD have more problems with overflow movement than non-ADHD adults. Similarly, for subtest 10, ‘Flying’, more subjects in the ADHD group had problems compared to the control group, but a high percentage of the ADHD group showed normal per- formance on this subtest. Motor problems in ADHD have been seen as being co-effects or a motor consequence of inattention and impulsivity [12]. This view has been challenged by sev- eral researchers. In fact, some of these have noted that the poor fine motor abilities of children with ADHD cannot be attributed to deficits in attention or concen- tration but rather are due to factors related to motor ability [14,15]. ADHD and motor problems may have a Table 3 Percentages of the ADHD group (N = 25) and control group (N = 23) with the indicated motor problems on the MFNU subtests and comparison of the two groups Motor problem scores of 1 or 2 MFNU subtests ADHD Control p value Mann–Whitney U \% Median \% Median 01. Dynamic balance-2 legs 56.0 1 13.0 0 .004 407.5 02. Dynamic balance-1 leg 76.0 2 37.4 0 .000 440.5 03. Diadochokinesis-right 68.0 2 17.3 0 .000 452.5 04. Diadochokinesis-left 80.0 2 34.7 0 .000 459.5 05. Reciprocal coordination 76.0 2 17.3 0 .000 478.5 06. Thumb movement 72.0 2 26.1 0 .002 422.5 07. Walking 56.0 1 17.4 0 .005 404.5 08. Lifting the arms 88.0 2 39.1 0 .000 443.0 09. Lifting the legs 84.0 2 21.7 0 .000 462.0 10. “Flying” 36.0 0 13.0 0 .102 347.5 11. Palpation 96.0 1 52.2 0 .000 473.5 12. Passive abduction-r. hip 84.0 2 26.1 1 .000 458.5 13. Passive abduction-l. hip 84.0 2 25.7 0 .000 464.0 14. Passive movement-r. foot 84.0 2 17.2 0 .000 481.0 15. Passive movement-l. foot 84.0 2 17.4 0 .000 471.0 16. Synkinesis 60.0 2 26.0 0 .027 383.5 Scoring: 0, ‘No problems’; 1, ‘Moderate problems’; 2, ‘Severe problems’. Table 4 Percentages of the ADHD group and control group with pain at the indicated location Pain location Group Control (N = 23) ADHD (N = 25) No pain 34.8\% 8.0\% Localized pain (only in upper body) 34.8\% 8.0\% Localized pain (only in lower body) 13.0\% 4.0\% Widespread pain 17.4\% 80.0\% Total 100\% 100\% Stray et al. Behavioral and Brain Functions 2013, 9:18 Page 6 of 10 http://www.behavioralandbrainfunctions.com/content/9/1/18 common basis that may be due to genetic factors and/or shared environmental factors [57]. Few of the subtests of the MFNU require focused attention for more than half a minute, and the subject is continually monitored and guided throughout each subtest, thus preventing distrac- tion. As in children with ADHD [11,29], motor inhibition problems were highly present in the adult ADHD group as demonstrated by subtests 03 and 04, ‘Diadochokinesis’, subtest 06, ‘Thumb movement’, and subtest 05, ‘Reciprocal inhibition’. Similar to findings in children in our previous study [11], a very high percentage of the adult ADHD group showed problems on subtests that reveal height- ened muscle tone in the latissimus dorsi, iliopsoas, and the gastrocnemius-soleus (calf) muscles (subtest 08, ‘Lifting arm’, subtests 12 and 13, ‘Passive abduction of the hips’, subtest 09, ‘Lifting leg’, and subtests 14 and 15, ‘Passive … Farm Hosp. 2016;40(3):209-218 ARTÍCULO DE OPINIÓN Informed consent in clinical research; Do patients understand what they have signed? El consentimiento informado en investigación clínica; ¿Entienden los pacientes lo que firman? Elena Villamañán1, Margarita Ruano1, Enma Fernández-de Uzquiano2, Paz Lavilla2, Diana González3, Mercedes Freire1, Carmen Sobrino1 and Alicia Herrero1 1Hospital Pharmacy Unit. Hospital Universitario La Paz. IdiPaz, Madrid. 2Technical Secretary of Clinical Research Ethic Committee. Hospital Universitario La Paz, Madrid. 3Spanish Agency of Medicines and Medical Devices. Ministry of Health, Social Services and Equality. Spain. Artículo bilingüe inglés/castellano Abstract Informed consent is an essential element of research, and sig- ning this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an im- portant and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the poten- tial participants in a clinical trial. KEYWORDS Informed consent; Clinical research; Readability Farm Hosp. 2016;40(3):209-218 Resumen El consentimiento informado es una parte esencial de la in- vestigación y su firma es imprescindible para llevar a cabo la mayor parte de los estudios clínicos. Su fin es poner en cono- cimiento del paciente lo que implica su participación en el es- tudio que se le propone. Sin embargo, cada vez más, su com- plejidad y extensión los hacen difícilmente comprensibles, por lo que se corre el riesgo de que el paciente dé su autorización sin haberlo leído previamente o sin haber entendido lo que en él se le expone. En este sentido, los comités éticos de investigación clínica y los farmacéuticos, especialistas en farmacia hospitalaria y atención primaria como parte integrante de los mismos, cumplen un im- portante y difícil papel en la defensa de los derechos de los pa- cientes. En ellos se revisan exhaustivamente estos documentos para garantizar que todos los requisitos que exige la normati- va estén contemplados y, al mismo tiempo, que sean de fácil comprensión para los potenciales participantes en un estudio. PALABRAS CLAVE Consentimiento informado; Investigación clínica; Legibilidad Farm Hosp. 2016;40(3):209-218 * Autor para correspondencia. Correo electrónico: [email protected] (Elena Villamañán). Recibido el 24 de noviembre de 2015; aceptado el 5 de marzo de 2016. DOI: 10.7399/fh.2016.40.3.10411 Los artículos publicados en esta revista se distribuyen con la licencia: Articles published in this journal are licensed with a: Creative Commons Attribution 4.0. https://creativecommons.org/licenses/by-nc-nd/4.0/ La revista Farmacia Hospitalaria no cobra tasas por el envío de trabajos, ni tampoco cuotas por la publicación de sus artículos. Villamañán E, Ruano M, Fernández-de Uzquiano E, Lavilla P, González D, Freire M, et al. Informed consent in clinical research; Do patients understand what they have signed? Farm Hosp. 2016;40(3):209-218. Villamañán E, Ruano M, Fernández-de Uzquiano E, Lavilla P, González D, Freire M, et al. El consentimiento informado en investigación clínica; ¿Entienden los pacientes lo que firman? Farm Hosp. 2016;40(3):209-218. How to cite this article/Cómo citar este artículo: 006_10411 - El consentimiento informado.indd 209 18/12/18 12:21 210 - Farm Hosp. 2016;40(3):209-218 Elena Villamañán et al. Introduction The signed Informed Consent (IC) is a key element in clinical research; and as well as a legal requirement, it is also the starting point for the application of the autonomy principle and the right of patient privacy. This means that the person chooses freely to take part in a research, and gives authorization for processing and analyzing all data collected in his/her clinical record. However, frequent- ly the process is not easy, and represents a burden for researchers and patients. To obtain the signed Informed Consent implies that information has been provided pre- viously, adapted to their level of understanding, about aspects which are often complex, such as the study objec- tives, expected benefits, rights and duties as a participant, risks, potential alternatives, or voluntary nature. These documents, moreover, have been thoroughly reviewed by an Ethics Committee for Clinical Research (ECCR), which will check that they include all requirements established by current legislation, before receiving the authorization to initiate the study1. The objective of the Informed Consent is to protect patients and ensure that the research is conducted accor- ding to ethical criteria; but frequently ECCRs will confirm that their contents are based on the assumption that the most information provided will be better for decision ma- king by patients, though it is known that this is not always the case2. Falagas et al.3, for example, on an IC review from 1961 to 2006, proved that only 54\% of patients understood the objective of the study adequately, 50\% understood what randomization meant, 47\% unders- tood the meaning of voluntary nature, 44\% understood their right to withdraw from the study, 50\% understood the risks accepted, and 57\% of patients understood the benefits expected. The objective of this article is to review the aspects as- sociated with understanding the Informed Consent by patients in the setting of clinical research, its basics, le- gislation, and the role of Ethics Committees of Clinical Research in the preparation of said document. Background of informed consent In the research setting, written Informed Consent dates back to 1900, when Walter Reed requested it from pa- tients who participated in his studies about yellow fever in Cuba4. Subsequently, the Nüremberg Code5 established in 1947 the lines for ethical conduct in clinical research, and laid the foundation for future rules in this setting. According to this document, research will be considered ethically adequate when it is based on previous experi- mental outcomes in animals, it must be justified by the outcomes expected, and in order to be developed, pa- tients must have granted previously their authorization. Informed Consent is defined as that “process through which a person confirms willingly their decision to partici- pate in a specific clinical trial, after having been adequa- tely informed about all the aspects of the study which are relevant for the decision to participate by the subject”1. This term was first used in U.S.A. in 1957, in the State of California6; and this represented leaving for the first time the traditional medical paternalism to start giving re- levance to patient’s autonomy. Californian Law developed the first IC model for clinical research, which collected the following key elements: purpose of the research, its po- tential consequences, potential harm, expected benefits, risks, and alternatives to the research. Knowledge of the- se aspects by the patient, before granting consent to par- ticipate in a clinical trial, is currently considered essential. Later on, the Declaration of Helsinki7 divided research into two large groups: that conducted in patients (clini- cal research) and the research conducted with non-the- rapeutic objectives (non-clinical biological research). This declaration added new elements, such as the fact that IC must be informed as well as voluntary, and can be wi- thdrawn at any time of the research; or that in the case of incompetent persons, their legal tutor can grant the IC. The American Congress created a National Committee with the objective of preparing a report on the protec- tion of human beings involved in a clinical research: the Belmont Report published in 19788, which collected the basic ethical principles for application in clinical research, and considered in the first place the respect for persons or autonomy principle, the practical application of which is represented by obtaining the IC. One year earlier, and also in the U.S.A., the Food and Drug Administration (FDA) published the rules for Good Clinical Practice (GCP)9 , as an answer to the need to ensure the quality and pro- tection of patients’ rights in clinical research. These rules were subsequently adopted in Europe, where they have been enforced since 199110. In our setting, the so-called Convenio de Oviedo11 (Oviedo Convention) by the European Council, which was included in the Spanish legislation in the year 2000, spe- cified the conditions necessary for conducting research in human beings. According to these, besides the lack of any alternative method with proven efficacy, it is required that risks are not out of proportion with the benefits expec- ted, that there has been approval by a ECCR or relevant authorities, and that the candidate has been adequately informed through a Patient Information Sheet, and has granted written consent. Basic principles of Informed Consent Informed Consent has two essential objectives: on one hand, to respect and promote patient’s autonomy, and on the other hand, to protect patients against any po- tential harm derived from their participation in a clinical trial. In order to achieve these objectives, it is necessary to take into account some aspects which are the basis for re- search in humans, such as the fact that patients generally 006_10411 - El consentimiento informado.indd 210 18/12/18 12:21 Informed consent in clinical research; Do patients understand what they... Farm Hosp. 2016;40(3):209-218 - 211 won’t have any medical knowledge, they have the right to decide what they do with their body and about their treatment, they must give consent after being adequate- ly informed, and that their final decision will depend on receiving truthful and reliable information by the physi- cian12,13. All this means that the IC should not be considered just a document to be signed, but a process with the ultima- te end of achieving the adequate inclusion of patients in clinical research. In this process, the contents of the do- cuments provided to patients are essential, and the basic sections that must be included are14: • Objectives of the study. • Methodology. • Description of treatment. • Benefits. • Risks. • Adverse events. • Alternative treatments. • Voluntary nature and possible withdrawal. • Confidentiality. • Economic compensation. • Responsible researcher. Controversies regarding the Informed Consent As already stated, the written IC is an essential part of the requirements necessary to conduct the majority of clinical trials, and its objective is to advice patients about the study where they have been asked to parti- cipate. However, the increasing complexity and length of Patient Information Sheets have often made them di- fficult to understand by patients15. In many cases, these are presented like a document seen as a legal protection instrument by the institutions promoting the study, ra- ther than the provision of understandable information for patients to decide on their voluntary participation16. Signing the IC confirms participation in the clinical trial, and the acceptance of everything included, such as the risks involved. However, this is not always the case, and this does not ensure that the consequences of participation in the study have been understood17,18,19,20. There are numerous articles which have analyzed the readability of Patient Information Sheets, by applying validated measure scales for reading comprehension21 such as the Flesch-Kincaid Index22, which is the most widely used, or the SMOG formula (Simplified Measure Of Gobbledygook)23. Thus, in a survey conducted with participants in Oncology studies, Joffe et al.15 found that 90\% of respondents were satisfied with the informa- tion received, but many of them declared they had no knowledge about the characteristics of the study they were taking part in, and the possibility of not obtaining any benefits19. Sharp et al.16, analyzed 107 Patient In- formation Sheets for Oncology Clinical Trials, and found that none of them was written in an understandable way for persons with education below the 2nd year of Se- condary Education (12-13-year-old), and only 1.5\% was understandable by a 4th level of Secondary Education (13-14-year-old). Taking into account that in countries like Spain, 46\% of the adult population in the 25-to- 64-year-old range has not completed a level of educa- tion above the second stage of Secondary Education24, or that in U.S.A. almost 50\% of the adult population has a reading comprehension below a level equivalent to 1st year of Secondary Education (11-13-year-old)25,26, around half of the population would have important problems to understand what these documents intend to convey. It is overall accepted that the Patient Informa- tion Sheet should be written for a level of education at least three courses below the educational mean level of the target population for the study27. Many studies have been conducted in recent years to assess how to improve the comprehension of Patient Information Sheets. Some of them have detected that these are more easily understood when written in a sim- ple manner28-31. Others suggest that these can be better understood if read slowly and allowing enough time32,33 or if their length is shortened34. However, unlike what should be expected, different studies have demonstrated that a text simplification to facilitate its reading won’t always entail its better comprehension35,36. On 2003, the Eastern Cooperative Oncology Group (ECOG) conducted a study on this subject32 which confirmed that when in- formation easy to understand was provided to oncology patients who were candidate to inclusion in a clinical trial, their anxiety was reduced and there was an impro- vement in their satisfaction, and this could be achieved without omitting any relevant information. However, it was not possible to demonstrate that text simplification led to its better comprehension. Davis et al.36 consulted healthy people about their hypothetical participation in a clinical trial and confirmed the same that the previous study: when faced with two versions of the Patient In- formation Sheet (simplified and standard), even though patients preferred the simplified version, their level of understanding about what was conveyed was similar for both formats. Other authors have researched about complementary strategies that would allow to improve the comprehension of the IC. Flory et al.37 found that personal interaction and feedback are the most effective way to achieve an adequate understanding of the in- formation conveyed to the patient. Besides, it has been proved that the modification of the Patient Information Sheet in terms of more simplified and reduced contents and wording is not better for their understanding than the use of multimedia supports or the participation of a neutral educator who can spend more time with the patient. On the other hand, a drawback also underlying the process of obtaining Informed Consent is that, generally, 006_10411 - El consentimiento informado.indd 211 18/12/18 12:21 212 - Farm Hosp. 2016;40(3):209-218 Elena Villamañán et al. the patient’s physician is usually the same person who suggests their participation in the study; therefore, said physician could prompt the patient’s participation, and there could be a conflict of interests. However, all these drawbacks should not lead to a discontinuation in the efforts to simplify Patient Informa- tion Sheets in order to improve their comprehension, for various reasons: as already mentioned, this will alleviate the anxiety generated in patients, and they will appear more satisfied with the information received, and at the same time, a simplified language will allow other persons (relatives, other healthcare professionals not in- volved in the study) to understand the information. As a general rule, these documents must be brief, simple and clear, so that the explanation of risks won’t generate anxiety, avoiding an alarming or threatening tone; it is also advisable to allow patient involvement, by asking multiple choice questions38. It is recommended, in order to achieve a better com- prehension of the Informed Consent39: • To use a language and ideas familiar to patients and known by them. • To use short words (preferably with 2 syllables), and short sentences too, if possible. • To avoid confusing or misleading ideas. • To apply measurement formulas for estimating the le- vel of comprehension, according to the cultural and educational level of the patient. • To explain clearly what the experimental treatment in- volves, and the standard treatment or alternatives to the Clinical Trial. • To encourage patients to discuss it with other persons. • To provide written information that the patient can read with time and carefully. • To check to what extent the information provided has been understood. The role of Ethics Committees for Clinical Research in the preparation of Informed Consents In recent years, ECCRs, in their role as guarantors of patient rights, have made important efforts to improve both the quantity and quality of information provided in the Patient Information Sheets. This improvement has contributed to the fact that obtaining the IC won’t only be based on handing a written document, but that it will be considered as a process where the methodology and purpose of the study are explained adequately to the level of understanding of each patient. But ECCRs must also ensure that Patient Information Sheets collect all aspects required by the current legislation, and that patients might not be aware of, or consider irrelevant. Frequently, when reviewing and approving clinical trials from an ethical point of view, ECCRs will find that Patient Information Sheets are faulty and need to be modified before their approval. According to a study conducted in Spain on 2007, Fernández de Uzquiano et al.40, in a retrospective analysis of 1219 clinical trials evaluated by an ECCR, observed that these were only approved without any need for modifications or clarifi- cations in 20\% of cases, and that out of the rest, some change in contents was requested to the promoters in 59.3\% of cases. In agreement with these authors, other studies conducted about ECCR activities in other coun- tries have found similar results. In the United Kingdom, according to data from the National Research Ethics Service41, only 17\% of the applications for review and approval of clinical trials will receive a favourable deci- sion at first evaluation by the ECCRs, without any need for clarifications or modifications. The majority of the- se decisions are approvals depending on modifications (66\%), while 8\% are denied. According to this institu- tion, the majority of non-approvals granted by the EC- CRs in a first evaluation for oncological clinical trials will be due to faults in Patient Information Sheets (96\%), either by poor wording or by the use of terminology not easy to understand by patients. In 18\% of cases, they understood that false expectations were offered to pa- tients. Another reason for concern in these committees regarding Patient Information Sheets is associated with the tissue samples taken from patients and their storage, particularly in Oncological Clinical Trials42. At the same time, the adequate transmission of information about the potential risks accepted by patients is a frequent rea- son for concern by the ECCRs, including adverse effects, additional procedures, or aspects such as confidentiality. In spite of the national and international guidelines and recommendations already mentioned, about which aspects must be included in a document for patient in- formation, and of the actions taken by ECCRs for their enforcement, these will often differ from the informa- tion demanded by patients. In this sense, Kirby et al.43, in a study about patient preferences regarding the in- formation they want to receive when they are asked to participate in a clinical trial, observed that in first place they preferred to receive information about the study outcomes (91\%), secondly about its objective (76\%) or its duration (61\%) and, however, assigned lower impor- tance to aspects thoroughly reviewed by ECCRs, such as voluntary nature (39\%) or confidentiality (44\%). Therefore, when evaluating the Patient Information Sheets for clinical trials, ECCRs will often find themselves in a complicated position. On one hand, they must try to achieve that all information is easily understandable by the patient; and on the other hand, that all aspects required by the legislation are included, so that patients who have given their consent won’t be legally unprotec- ted should any contingency occur. As a conclusion, we will say that Informed Consent is an essential part of clinical research, and that by signing it, patients will grant freely their authorization to par- 006_10411 - El consentimiento informado.indd 212 18/12/18 12:21 Informed consent in clinical research; Do patients understand what they... Farm Hosp. 2016;40(3):209-218 - 213 ticipate in a clinical trial. However, Patient Information Sheets are increasingly too long and difficult to unders- tand by patients, and they seem to be more aimed to exempting the study sponsor from responsibilities than to inform. This way, there is some risk that patients will grant authorization and sign the IC without having read or understood what the physician is proposing. In this sense, ECCRs will play an important and diffi- cult role in the protection of patient rights, by reviewing these informative documents and ensuring that they in- clude all requirements demanded by the legislation and, at the same time, that they are as easy to understand as possible. The opinions expressed in this work are a responsibili- ty of the authors for what they do not reflect necessarily the point of view of the organisms at which they are employed. Bibliography 1. International Conference on Harmonization. Harmonised Tripar- tite Guideline for Good Clinical Practice. Ginebra: IFPMA, 1996. [Consultado 11/02/2016]. Disponible en  : http://www.ich.org/ fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/ Q1A_R2/Step4/Q1A_R2__Guideline.pdf. 2. Manson NC, O’Neill O: Rethinking Informed Consent in Bioe- thics. 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Randomized, controlled trial of an easy-to-read informed consent 006_10411 - El consentimiento informado.indd 213 18/12/18 12:21 214 - Farm Hosp. 2016;40(3):209-218 Elena Villamañán et al. statement for clinical trial participation: a … ETHICAL PRINCIPLES OF PSYCHOLOGISTS AND CODE OF CONDUCT Printed in the United States of America Adopted August 21, 2002 Effective June 1, 2003 (With the 2010 Amendments to Introduction and Applicability and Standards 1.02 and 1.03, Effective June 1, 2010) With the 2016 Amendment to Standard 3.04 Adopted August 3, 2016 Effective January 1, 2017 INTRODUCTION AND APPLICABILITY PREAMBLE GENERAL PRINCIPLES Principle A: Beneficence and Nonmaleficence Principle B: Fidelity and Responsibility Principle C: Integrity Principle D: Justice Principle E: Respect for People’s Rights and Dignity ETHICAL STANDARDS 1. Resolving Ethical Issues 1.01 Misuse of Psychologists’ Work 1.02 Conflicts Between Ethics and Law, Regulations, or Other Governing Legal Authority 1.03 Conflicts Between Ethics and Organizational Demands 1.04 Informal Resolution of Ethical Violations 1.05 Reporting Ethical Violations 1.06 Cooperating With Ethics Committees 1.07 Improper Complaints 1.08 Unfair Discrimination Against Complainants and Respondents 2. Competence 2.01 Boundaries of Competence 2.02 Providing Services in Emergencies 2.03 Maintaining Competence 2.04 Bases for Scientific and Professional Judgments 2.05 Delegation of Work to Others 2.06 Personal Problems and Conflicts 3. Human Relations 3.01 Unfair Discrimination 3.02 Sexual Harassment 3.03 Other Harassment 3.04 Avoiding Harm 3.05 Multiple Relationships 3.06 Conflict of Interest 3.07 Third-Party Requests for Services 3.08 Exploitative Relationships 3.09 Cooperation With Other Professionals 3.10 Informed Consent 3.11 Psychological Services Delivered to or Through Organizations 3.12 Interruption of Psychological Services 4. Privacy and Confidentiality 4.01 Maintaining Confidentiality 4.02 Discussing the Limits of Confidentiality 4.03 Recording 4.04 Minimizing Intrusions on Privacy 4.05 Disclosures 4.06 Consultations 4.07 Use of Confidential Information for Didactic or Other Purposes 5. Advertising and Other Public Statements 5.01 Avoidance of False or Deceptive Statements 5.02 Statements by Others 5.03 Descriptions of Workshops and Non-Degree-Granting Educational Programs 5.04 Media Presentations 5.05 Testimonials 5.06 In-Person Solicitation 6. Record Keeping and Fees 6.01 Documentation of Professional and Scientific Work and Maintenance of Records 6.02 Maintenance, Dissemination, and Disposal of Confidential Records of Professional and Scientific Work 6.03 Withholding Records for Nonpayment 6.04 Fees and Financial Arrangements 6.05 Barter With Clients/Patients 6.06 Accuracy in Reports to Payors and Funding Sources 6.07 Referrals and Fees 7. Education and Training 7.01 Design of Education and Training Programs 7.02 Descriptions of Education and Training Programs 7.03 Accuracy in Teaching 7.04 Student Disclosure of Personal Information 7.05 Mandatory Individual or Group Therapy 7.06 Assessing Student and Supervisee Performance 7.07 Sexual Relationships With Students and Supervisees 8. Research and Publication 8.01 Institutional Approval 8.02 Informed Consent to Research 8.03 Informed Consent for Recording Voices and Images in Research 8.04 Client/Patient, Student, and Subordinate Research Participants 8.05 Dispensing With Informed Consent for Research 8.06 Offering Inducements for Research Participation 8.07 Deception in Research 8.08 Debriefing 8.09 Humane Care and Use of Animals in Research 8.10 Reporting Research Results 8.11 Plagiarism 8.12 Publication Credit 8.13 Duplicate Publication of Data 8.14 Sharing Research Data for Verification 8.15 Reviewers 9. Assessment 9.01 Bases for Assessments 9.02 Use of Assessments 9.03 Informed Consent in Assessments 9.04 Release of Test Data 9.05 Test Construction 9.06 Interpreting Assessment Results 9.07 Assessment by Unqualified Persons 9.08 Obsolete Tests and Outdated Test Results 9.09 Test Scoring and Interpretation Services 9.10 Explaining Assessment Results 9.11 Maintaining Test Security 10. Therapy 10.01 Informed Consent to Therapy 10.02 Therapy Involving Couples or Families 10.03 Group Therapy 10.04 Providing Therapy to Those Served by Others 10.05 Sexual Intimacies With Current Therapy Clients/Patients 10.06 Sexual Intimacies With Relatives or Significant Others of Current Therapy Clients/Patients 10.07 Therapy With Former Sexual Partners 10.08 Sexual Intimacies With Former Therapy Clients/Patients 10.09 Interruption of Therapy 10.10 Terminating Therapy AMENDMENTS TO THE 2002 “ETHICAL PRINCIPLES Of PSYCHOLOGISTS AND CODE Of CONDUCT” IN 2010 AND 2016 Effective June 1, 2003 (as amended 2010, 2016). Effective January 1, 2017 1 Copyright © 2017 by the American Psychological Association. 0003-066X ETHICAL PRINCIPLES Of PSYCHOLOGISTS AND CODE Of CONDUCT CONTENTS INTRODUCTION AND APPLICABILITY The American Psychological Association’s (APA’s) Ethical Principles of Psychologists and Code of Conduct (hereinafter referred to as the Ethics Code) consists of an Introduction, a Preamble, five General Principles (A-E), and specific Ethical Standards. The Introduction discusses the intent, organization, procedural considerations, and scope of application of the Ethics Code. The Preamble and General Principles are aspirational goals to guide psycholo- gists toward the highest ideals of psychology. Although the Preamble and General Principles are not themselves en- forceable rules, they should be considered by psychologists in arriving at an ethical course of action. The Ethical Stan- dards set forth enforceable rules for conduct as psycholo- gists. Most of the Ethical Standards are written broadly, in order to apply to psychologists in varied roles, although the application of an Ethical Standard may vary depending on the context. The Ethical Standards are not exhaustive. The fact that a given conduct is not specifically addressed by an Ethical Standard does not mean that it is necessarily either ethical or unethical. This Ethics Code applies only to psychologists’ ac- tivities that are part of their scientific, educational, or profes- sional roles as psychologists. Areas covered include but are not limited to the clinical, counseling, and school practice of psychology; research; teaching; supervision of trainees; public service; policy development; social intervention; development of assessment instruments; conducting as- sessments; educational counseling; organizational consult- ing; forensic activities; program design and evaluation; and administration. This Ethics Code applies to these activities across a variety of contexts, such as in person, postal, tele- phone, Internet, and other electronic transmissions. These activities shall be distinguished from the purely private con- duct of psychologists, which is not within the purview of the Ethics Code. Membership in the APA commits members and stu- dent affiliates to comply with the standards of the APA Ethics Code and to the rules and procedures used to enforce them. Lack of awareness or misunderstanding of an Ethical Stan- dard is not itself a defense to a charge of unethical conduct. The procedures for filing, investigating, and resolving complaints of unethical conduct are described in the current Rules and Procedures of the APA Ethics Committee. APA may impose sanctions on its members for violations of the standards of the Ethics Code, including termination of APA membership, and may notify other bodies and individuals of its actions. Actions that violate the standards of the Ethics Code may also lead to the imposition of sanctions on psy- chologists or students whether or not they are APA mem- bers by bodies other than APA, including state psychological associations, other professional groups, psychology boards, other state or federal agencies, and payors for health services. In addition, APA may take action against a member after his or her conviction of a felony, expulsion or suspension from an affiliated state psychological association, or suspension or loss of licensure. When the sanction to be imposed by APA is less than expulsion, the 2001 Rules and Procedures do not guarantee an opportunity for an in-person hearing, but gen- erally provide that complaints will be resolved only on the basis of a submitted record. The Ethics Code is intended to provide guidance for psychologists and standards of professional conduct that can be applied by the APA and by other bodies that choose to adopt them. The Ethics Code is not intended to be a basis of civil liability. Whether a psychologist has violated the Eth- ics Code standards does not by itself determine whether the psychologist is legally liable in a court action, whether a contract is enforceable, or whether other legal consequences occur. 2 Introduction and Applicability Effective January 1, 2017 The American Psychological Association’s Council of Representatives ad- opted this version of the APA Ethics Code during its meeting on August 21, 2002. The Code became effective on June 1, 2003. The Council of Represen- tatives amended this version of the Ethics Code on February 20, 2010, effec- tive June 1, 2010, and on August 3, 2016, effective January 1, 2017. (see p. 16 of this pamphlet). Inquiries concerning the substance or interpretation of the APA Ethics Code should be addressed to the Office of Ethics, American Psychological Association, 750 First St. NE, Washington, DC 20002-4242. This Ethics Code and information regarding the Code can be found on the APA website, http://www.apa.org/ethics. The standards in this Ethics Code will be used to adjudicate complaints brought concerning alleged conduct occurring on or after the effective date. Complaints will be adjudicated on the basis of the version of the Ethics Code that was in effect at the time the conduct occurred. The APA has previously published its Ethics Code, or amendments there- to, as follows: American Psychological Association. (1953). Ethical standards of psycholo- gists. Washington, DC: Author. American Psychological Association. (1959). Ethical standards of psycholo- gists. American Psychologist, 14, 279-282. American Psychological Association. (1963). Ethical standards of psycholo- gists. American Psychologist, 18, 56-60. American Psychological Association. (1968). Ethical standards of psycholo- gists. American Psychologist, 23, 357-361. American Psychological Association. (1977, March). Ethical standards of psychologists. APA Monitor, 22-23. American Psychological Association. (1979). Ethical standards of psycholo- gists. Washington, DC: Author. American Psychological Association. (1981). Ethical principles of psycholo- gists. American Psychologist, 36, 633-638. American Psychological Association. (1990). Ethical principles of psycholo- gists (Amended June 2, 1989). American Psychologist, 45, 390-395. American Psychological Association. (1992). Ethical principles of psycholo- gists and code of conduct. American Psychologist, 47, 1597-1611. American Psychological Association. (2002). Ethical principles of psycholo- gists and code of conduct. American Psychologist, 57, 1060-1073. American Psychological Association. (2010). 2010 amendments to the 2002 “Ethical Principles of Psychologists and Code of Conduct.” American Psycholo- gist, 65, 493. American Psychological Association. (2016). Revision of ethical standard 3.04 of the “Ethical Principles of Psychologists and Code of Conduct” (2002, as amended 2010). American Psychologist, 71, 900. Request copies of the APA’s Ethical Principles of Psychologists and Code of Conduct from the APA Order Department, 750 First St. NE, Washington, DC 20002-4242, or phone (202) 336-5510. The modifiers used in some of the standards of this Ethics Code (e.g., reasonably, appropriate, potentially) are in- cluded in the standards when they would (1) allow profes- sional judgment on the part of psychologists, (2) eliminate injustice or inequality that would occur without the modi- fier, (3) ensure applicability across the broad range of ac- tivities conducted by psychologists, or (4) guard against a set of rigid rules that might be quickly outdated. As used in this Ethics Code, the term reasonable means the prevailing professional judgment of psychologists engaged in similar activities in similar circumstances, given the knowledge the psychologist had or should have had at the time. In the process of making decisions regarding their professional behavior, psychologists must consider this Ethics Code in addition to applicable laws and psychol- ogy board regulations. In applying the Ethics Code to their professional work, psychologists may consider other ma- terials and guidelines that have been adopted or endorsed by scientific and professional psychological organizations and the dictates of their own conscience, as well as consult with others within the field. If this Ethics Code establishes a higher standard of conduct than is required by law, psy- chologists must meet the higher ethical standard. If psy- chologists’ ethical responsibilities conflict with law, regu- lations, or other governing legal authority, psychologists make known their commitment to this Ethics Code and take steps to resolve the conflict in a responsible manner in keeping with basic principles of human rights. PREAMBLE Psychologists are committed to increasing scientific and professional knowledge of behavior and people’s un- derstanding of themselves and others and to the use of such knowledge to improve the condition of individuals, organi- zations, and society. Psychologists respect and protect civil and human rights and the central importance of freedom of inquiry and expression in research, teaching, and publica- tion. They strive to help the public in developing informed judgments and choices concerning human behavior. In do- ing so, they perform many roles, such as researcher, edu- cator, diagnostician, therapist, supervisor, consultant, ad- ministrator, social interventionist, and expert witness. This Ethics Code provides a common set of principles and stan- dards upon which psychologists build their professional and scientific work. This Ethics Code is intended to provide specific standards to cover most situations encountered by psy- chologists. It has as its goals the welfare and protection of the individuals and groups with whom psychologists work and the education of members, students, and the public re- garding ethical standards of the discipline. The development of a dynamic set of ethical stan- dards for psychologists’ work-related conduct requires a personal commitment and lifelong effort to act ethically; to encourage ethical behavior by students, supervisees, employees, and colleagues; and to consult with others con- cerning ethical problems. GENERAL PRINCIPLES This section consists of General Principles. General Principles, as opposed to Ethical Standards, are aspiration- al in nature. Their intent is to guide and inspire psycholo- gists toward the very highest ethical ideals of the profes- sion. General Principles, in contrast to Ethical Standards, do not represent obligations and should not form the basis for imposing sanctions. Relying upon General Principles for either of these reasons distorts both their meaning and purpose. Principle A: Beneficence and Nonmaleficence Psychologists strive to benefit those with whom they work and take care to do no harm. In their profession- al actions, psychologists seek to safeguard the welfare and rights of those with whom they interact professionally and other affected persons, and the welfare of animal subjects of research. When conflicts occur among psychologists’ obli- gations or concerns, they attempt to resolve these conflicts in a responsible fashion that avoids or minimizes harm. Be- cause psychologists’ scientific and professional judgments and actions may affect the lives of others, they are alert to and guard against personal, financial, social, organizational, or political factors that might lead to misuse of their influ- ence. Psychologists strive to be aware of the possible effect of their own physical and mental health on their ability to help those with whom they work. Principle B: fidelity and Responsibility Psychologists establish relationships of trust with those with whom they work. They are aware of their pro- fessional and scientific responsibilities to society and to the specific communities in which they work. Psychologists uphold professional standards of conduct, clarify their pro- fessional roles and obligations, accept appropriate respon- sibility for their behavior, and seek to manage conflicts of interest that could lead to exploitation or harm. Psycholo- gists consult with, refer to, or cooperate with other profes- sionals and institutions to the extent needed to serve the best interests of those with whom they work. They are con- cerned about the ethical compliance of their colleagues’ scientific and professional conduct. Psychologists strive to contribute a portion of their professional time for little or no compensation or personal advantage. Principle C: Integrity Psychologists seek to promote accuracy, honesty, and truthfulness in the science, teaching, and practice of Effective January 1, 2017 Preamble–Principle C 3 4 Principle D–Standard 1.06 Effective January 1, 2017 psychology. In these activities psychologists do not steal, cheat, or engage in fraud, subterfuge, or intentional mis- representation of fact. Psychologists strive to keep their promises and to avoid unwise or unclear commitments. In situations in which deception may be ethically justifiable to maximize benefits and minimize harm, psychologists have a serious obligation to consider the need for, the possible consequences of, and their responsibility to correct any re- sulting mistrust or other harmful effects that arise from the use of such techniques. Principle D: Justice Psychologists recognize that fairness and justice entitle all persons to access to and benefit from the con- tributions of psychology and to equal quality in the pro- cesses, procedures, and services being conducted by psy- chologists. Psychologists exercise reasonable judgment and take precautions to ensure that their potential biases, the boundaries of their competence, and the limitations of their expertise do not lead to or condone unjust practices. Principle E: Respect for People’s Rights and Dignity Psychologists respect the dignity and worth of all people, and the rights of individuals to privacy, confiden- tiality, and self-determination. Psychologists are aware that special safeguards may be necessary to protect the rights and welfare of persons or communities whose vulnerabili- ties impair autonomous decision making. Psychologists are aware of and respect cultural, individual, and role differ- ences, including those based on age, gender, gender iden- tity, race, ethnicity, culture, national origin, religion, sexual orientation, disability, language, and socioeconomic status, and consider these factors when working with members of such groups. Psychologists try to eliminate the effect on their work of biases based on those factors, and they do not knowingly participate in or condone activities of others based upon such prejudices. ETHICAL STANDARDS 1. Resolving Ethical Issues 1.01 Misuse of Psychologists’ Work If psychologists learn of misuse or misrepresenta- tion of their work, they take reasonable steps to correct or minimize the misuse or misrepresentation. 1.02 Conflicts Between Ethics and Law, Regulations, or Other Governing Legal Authority If psychologists’ ethical responsibilities conflict with law, regulations, or other governing legal authority, psychologists clarify the nature of the conflict, make known their commitment to the Ethics Code, and take reasonable steps to resolve the conflict consistent with the General Principles and Ethical Standards of the Ethics Code. Under no circumstances may this standard be used to justify or defend violating human rights. 1.03 Conflicts Between Ethics and Organizational Demands If the demands of an organization with which psy- chologists are affiliated or for whom they are working are in conflict with this Ethics Code, psychologists clarify the nature of the conflict, make known their commitment to the Ethics Code, and take reasonable steps to resolve the con- flict consistent with the General Principles and Ethical Stan- dards of the Ethics Code. Under no circumstances may this standard be used to justify or defend violating human rights. 1.04 Informal Resolution of Ethical Violations When psychologists believe that there may have been an ethical violation by another psychologist, they at- tempt to resolve the issue by bringing it to the attention of that individual, if an informal resolution appears appropri- ate and the intervention does not violate any confidential- ity rights that may be involved. (See also Standards 1.02, Conflicts Between Ethics and Law, Regulations, or Other Governing Legal Authority, and 1.03, Conflicts Between Ethics and Organizational Demands.) 1.05 Reporting Ethical Violations If an apparent ethical violation has substantially harmed or is likely to substantially harm a person or organi- zation and is not appropriate for informal resolution under Standard 1.04, Informal Resolution of Ethical Violations, or is not resolved properly in that fashion, psychologists take further action appropriate to the situation. Such ac- tion might include referral to state or national committees on professional ethics, to state licensing boards, or to the appropriate institutional authorities. This standard does not apply when an intervention would violate confidential- ity rights or when psychologists have been retained to re- view the work of another psychologist whose professional conduct is in question. (See also Standard 1.02, Conflicts Between Ethics and Law, Regulations, or Other Governing Legal Authority.) 1.06 Cooperating with Ethics Committees Psychologists cooperate in ethics investigations, proceedings, and resulting requirements of the APA or any affiliated state psychological association to which they be- long. In doing so, they address any confidentiality issues. Failure to cooperate is itself an ethics violation. However, making a request for deferment of adjudication of an eth- ics complaint pending the outcome of litigation does not alone constitute noncooperation. Effective January 1, 2017 Standard 1.07–Standard 2.06 5 1.07 Improper Complaints Psychologists do not file or encourage the filing of ethics complaints that are made with reckless disregard for or willful ignorance of facts that would disprove the allegation. 1.08 Unfair Discrimination Against Complainants and Respondents Psychologists do not deny persons employment, advancement, admissions to academic or other programs, tenure, or promotion, based solely upon their having made or their being the subject of an ethics complaint. This does not preclude taking action based upon the outcome of such proceedings or considering other appropriate information. 2. Competence 2.01 Boundaries of Competence (a) Psychologists provide services, teach, and con- duct research with populations and in areas only within the boundaries of their competence, based on their education, training, supervised experience, consultation, study, or professional experience. (b) Where scientific or professional knowledge in the discipline of psychology establishes that an understand- ing of factors associated with age, gender, gender identity, race, ethnicity, culture, national origin, religion, sexual ori- entation, disability, language, or socioeconomic status is essential for effective implementation of their services or research, psychologists have or obtain the training, experi- ence, consultation, or supervision necessary to ensure the competence of their services, or they make appropriate re- ferrals, except as provided in Standard 2.02, Providing Ser- vices in Emergencies. (c) Psychologists planning to provide services, teach, or conduct research involving populations, areas, techniques, or technologies new to them undertake rel- evant education, training, supervised experience, consulta- tion, or study. (d) When psychologists are asked to provide servic- es to individuals for whom appropriate mental health ser- vices are not available and for which psychologists have not obtained the competence necessary, psychologists with closely related prior training or experience may provide such services in order to ensure that services are not denied if they make a reasonable effort to obtain the competence required by using relevant research, training, consultation, or study. (e) In those emerging areas in which generally rec- ognized standards for preparatory training do not yet exist, psychologists nevertheless take reasonable steps to ensure the competence of their work and to protect clients/pa- tients, students, supervisees, research participants, organi- zational clients, and others from harm. (f ) When assuming forensic roles, psychologists are or become reasonably familiar with the judicial or adminis- trative rules governing their roles. 2.02 Providing Services in Emergencies In emergencies, when psychologists provide ser- vices to individuals for whom other mental health services are not available and for which psychologists have not ob- tained the necessary training, psychologists may provide such services in order to ensure that services are not denied. The services are discontinued as soon as the emergency has ended or appropriate services are available. 2.03 Maintaining Competence Psychologists undertake ongoing efforts to develop and maintain their competence. 2.04 Bases for Scientific and Professional Judgments Psychologists’ work is based upon established scien- tific and professional knowledge of the discipline. (See also Standards 2.01e, Boundaries of Competence, and 10.01b, Informed Consent to Therapy.) 2.05 Delegation of Work to Others Psychologists who delegate work to employees, supervisees, or research or teaching assistants or who use the services of others, such as interpreters, take reasonable steps to (1) avoid delegating such work to persons who have a multiple relationship with those being served that would likely lead to exploitation or loss of objectivity; (2) authorize only those responsibilities that such persons can be expected to perform competently on the basis of their education, training, or experience, either independently or with the level of supervision being provided; and (3) see that such persons perform these services competently. (See also Standards 2.02, Providing Services in Emergencies; 3.05, Multiple Relationships; 4.01, Maintaining Confiden- tiality; 9.01, Bases for Assessments; 9.02, Use of Assess- ments; 9.03, Informed Consent in Assessments; and 9.07, Assessment by Unqualified Persons.) 2.06 Personal Problems and Conflicts (a) Psychologists refrain from initiating an activity when they know or should know that there is a substantial likelihood that their personal problems will prevent them from performing their work-related activities in a compe- tent manner. (b) When psychologists become aware of personal problems that may interfere with their performing work- related duties adequately, they take appropriate measures, such as obtaining professional consultation or assistance, and determine whether they should limit, suspend, or ter- minate their work-related duties. (See also Standard 10.10, Terminating Therapy.) 6 Standard 3.01–Standard 3.08 Effective January 1, 2017 3. Human Relations 3.01 Unfair Discrimination In their work-related activities, psychologists do not engage in unfair discrimination based on age, gender, gender identity, race, ethnicity, culture, national origin, re- ligion, sexual orientation, disability, socioeconomic status, or any basis proscribed by law. 3.02 Sexual Harassment Psychologists do not engage in sexual harassment. Sexual harassment is sexual solicitation, physical advances, or verbal or nonverbal conduct that is sexual in nature, that occurs in connection with the psychologist’s activities or roles as a psychologist, and that either (1) is unwelcome, is offensive, or creates a hostile workplace or educational environment, and the psychologist knows or is told this or (2) is sufficiently severe or intense to be abusive to a rea- sonable person in the context. Sexual harassment can con- sist of a single intense or severe act or of multiple persistent or pervasive acts. (See also Standard 1.08, Unfair Discrimi- nation Against Complainants and Respondents.) 3.03 Other Harassment Psychologists do not knowingly engage in behavior that is harassing or demeaning to persons with whom they interact in their work based on factors such as those per- sons’ age, gender, gender identity, race, ethnicity, culture, national origin, religion, sexual orientation, disability, lan- guage, or socioeconomic status. 3.04 Avoiding Harm (a) Psychologists take reasonable steps to avoid harming their clients/patients, students, supervisees, re- search participants, organizational clients, and others with whom they work, and to minimize harm where it is foresee- able and unavoidable. (b) … https://doi.org/10.1177/1747016119898402 Research Ethics 2020, Vol. 16(1-2) 1–16 © The Author(s) 2020 Article reuse guidelines: sagepub.com/journals-permissions DOI: 10.1177/1747016119898402 journals.sagepub.com/home/rea Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). What constitutes expertise in research ethics and integrity? Robert Braun Institute for Advanced Studies, Vienna, Austria Tine Ravn Aarhus University, Aarhus, Denmark Elisabeth Frankus Institute for Advanced Studies, Vienna, Austria Abstract In this paper we reflect on the looming question of what constitutes expertise in ethics. Based on an empirical program that involved qualitative and quantitative as well as participatory research elements we show that expertise in research ethics and integrity is based on experience in the assessment processes. We then connect traditional concepts of expertise as “improved performance” with deliberate practice activities and, based on our research findings, show that ethical assessment experience is a form of deliberate practice. This in our view has further ramifications in the design and recruitment processes of ethical assessment units performing research ethics and integrity assessment. Keywords Research ethics and integrity, expertise, experience, deliberate practice, consensus conference Corresponding author: Robert Braun, Institute for Advanced Studies, Josefstädter Strasse 39, 1080 Vienna, Austria. Email: [email protected] 898402REA0010.1177/1747016119898402Research EthicsBraun et al. research-article2019 Original Article: Empirical 2 Research Ethics 16(1-2) Introduction Research ethics and integrity: achieving clarity, transparency and reliability through defining expertise Research ethics and research integrity, the two strands of dealing with the ethical aspects of doing research and innovation, have been mainstreamed in the past decade (Mertz et al., 2016; Ormerod and Ulrich, 2013, Pratt et al., 2017). However, there is still discernible work to be done to improve standards on good scientific practice in order to achieve clarity and calculability for participants, transparency for users, and reliability for policymakers in ethical considerations related to research. While there are several scholars and communities working on the unifi- cation of the two conceptual approaches1 and their shared focus on how research behavior can be understood within the framework of responsible conduct of research (RCR) (Steneck, 2006: 55), it is also understood that the remits of research ethics units and research integrity committees are quite different. Ethics commit- tees perform ethical evaluation of research projects and issue approvals before- hand, while research integrity offices typically are engaged in retrospective handling of alleged cases of ethical misconduct. The different institutions for research ethics and research integrity are also committed to different regulations and have developed their separate guidelines. At the same time, they have much in common: both types of institutions are involved in the promotion of responsible conduct of research, and there is a number of overlapping issues that both institu- tions deal with, for example, data protection, conflicts of interest, and safeguard- ing research transparency, to mention but a few (Komić et al., 2015). It is also argued that ethical reflections of all sorts need shared consideration through a process of mutual exchange and learning among those who are actively engaged in ethical reviews and are participating in and sponsoring research integ- rity (Mooney-Somers and Olsen 2016, Petillion et al., 2016). Also, “users” of the two territories need to have clarity, transparency, and reliability as to how and from whom to request expert opinion in ethical issues related to research (McKenna and Gray, 2018). There is a convergence between the two fields of ethics assess- ment that may lead to a growing need for experts in ethics who would be able to participate in ethical assessment units (EAUs) dealing with both strands of ethical inquiries. Thus, it is important to define what constitutes expertise in ethics in sci- entific practice and explore who could be considered an expert in matters of research ethics or integrity issues. In this article, we bring into focus the intersec- tion of research ethics and research integrity expertise as the imbricated nature of the two significantly characterizes the empirical findings of the study. This paper reports on empirical findings and draws conclusions that may assist in reconcep- tualizing expertise in research ethics and research integrity, strategies of design, and recruitment of assessment units performing ethics and integrity assessments. Braun et al. 3 Hence, in order to answer the research question, “what constitutes expertise in research ethics and research integrity?” we created an empirical research program to systematically explore and develop acceptable indicators representing expertise in the heterogeneous fields of research ethics and integrity. The rationale of the empirical research was to: (a) systematically review previous research on ethical expertise in literature and ongoing research projects; (b) harvest positions on expertise in ethics from those practitioners who currently work in different strands of ethical review processes as well as determine the field via their participation in the most important organizations and networks of the territory; and (c) involve potential users of such expertise in determining what their expectations would be. This paper summarizes the findings of the empirical program and draws conclu- sions on the research question of what constitutes expertise within the ambits of both research ethics and research integrity. We also address how empirically grounded comprehensions of expertise within the two fields can add to a concep- tual framework of understanding expertise as expert performance. We will first discuss our methods and present key empirical findings. This will be followed by a discussion of what this means for defining expertise in ethics, constitution of EAUs, and placing our results in wider epistemic developments and debates across scientific cultures and communities as to how scientific knowledge/expertise may be perceived and generated. We will close the paper with conclusions related to the design of ethical assessment processes and point to areas where further research may be required. Specifically, in our analysis, we connect traditional concepts of expertise as “improved performance” (Ericsson, 2006) with deliberate practice activities (Ericsson et al., 1993) and, based on our research findings, show that assessment experience constitutes a form of deliberate practice. The basic assumption of deliberate practice is that expert performance is acquired gradually and that effec- tive improvement of performance requires sequentially mastered tasks initially outside the current realm of reliable performance. Deliberate practice, as opposed to routine performance and playful engagement, requires concentration, repeti- tion, and feedback (Ericsson, 2006: 694). In our view, assessing expertise in research ethics and research integrity in terms of deliberate practice has further ramifications for the design and recruitment processes of assessment units per- forming research ethics and integrity assessment. Method Methodology By virtue of the vast and heterogeneous fields of research ethics and research integrity and the observation that expertise relates to diverse types of involve- ment spanning from participation in research ethics committees (RECs) and 4 Research Ethics 16(1-2) research integrity offices (RIOs) to legal/administrative experiences, we applied a mixed-methods research design to systematically elicit a multifaceted under- standing of research ethics and research integrity expertise. The empirical pro- gram was initiated with a literature review focusing on existing literature (i.e., key EU documents, research and project findings, institutional reports, and EU network material) on research ethics and research integrity expertise. Next, we conducted a qualitative study among current experts within the two fields, com- plemented by a quantitative survey among a wider group of practitioners in research ethics and integrity. This was followed by a participatory research design comprising of a series of one-day consensus conferences in four European cities involving assumed users of a potential European database of experts (for details, see Braun, 2019). In general, only limited resources are available on detailing research ethics and integrity expert skills and qualifications. This is particularly evident for expertise beyond the involvement in research ethics committees and research integrity offices. In these cases, too, expert qualifications seem more often to characterize collective units of expertise rather than the individual level of expertise. To rem- edy this apparent knowledge lacuna, a multimethod research design was con- structed to expound on the constituents of expertise and develop indicators that take the individual level as a starting point. For the particular objective of the empirical program and, predominately, for the focus of this article, two EU projects, SATORI (Stakeholders Acting Together On the ethical impact assessment of Research and Innovation) and MoRRI (Monitoring the Evolution and Benefits of Responsible Research and Innovation), are consid- ered especially relevant. The ENERI (European Network of Research Ethics and Research Integrity project) research team has reviewed these research projects. Our main aim was to systematically assess the documents that deal with ethics and expertise produced during the lifetime of the projects. As SATORI aimed at devel- oping a common European framework for ethical assessment of research and innovation, it did extensive research on which qualifications, skills, and processes are required in ethical assessment processes. We reviewed its documents, and these documents served as an input for developing our interview guidelines and questionnaire in the qualitative and quantitative elements of our research. MoRRI, on the other hand, aimed at monitoring the benefits of a more responsible research and innovation culture and develop indicators to monitor the progress toward more responsibility; ethics played but a small part of its research work. However, we also reviewed project outputs, especially the extensive literature review that pro- vided input for our consensus conference setup. Following the review, we have conducted 12 in-depth expert interviews. Based on the literature, experts were defined as people with proven experience in the field. Experience was identified as having been part of assessment units or ethics Braun et al. 5 evaluation processes, teaching or lecturing on research ethics or integrity issues, and having been part of professional networks of the two strands of ethical inquiry. All expert interviews were carried out in September and early October 2017 and were performed by phone, Skype, or face-to-face. The interviews lasted 30–60 minutes. The selection of experts/interviewees was based on an “information-ori- ented” selection strategy (Flyvbjerg, 2006), as experts were carefully chosen for their significance, with the aim of reaching a broad group of research ethics and integrity experts and achieving variation according to the “criteria of maximum variation” in order to enhance in-depth understandings of potential expert criteria and qualifications (Patton, 1990). Variation has been pursued according to criteria such as research ethics/research integrity focus, institutional category, geo- graphical location, gender, or age. The institutional category endeavored to include national research ethics committees (REC); regional/local research committees (REC); European network of RECs (EUREC); national research integrity commit- tees/offices (RIO); local/university research integrity committees/offices (RIO); European network of research integrity offices (ENRIO); national funding organi- zation (involved in ethics review); European funding organization (involved in ethics review); government agency (ministry); industrial advisor/consultant on ethics/CSR/corporate sustainability. Interviews were recorded and subsequently transcribed verbatim by student assistants. Next, all interviews were coded the- matically in the software program Nvivo, which allows for a transparent and com- parable management and analysis of the empirical data. The structured coding strategy was in alignment with the set of focused codes derived from the key themes explored in the interviews. Based on the analysis of the interviews and focusing on the main points of study regarding our research question, an online questionnaire for the quantita- tive survey was created in January 2018. It was distributed by the European Network of Research Integrity Offices (ENRIO) network and shared at the EUREC members’ meeting in Berlin on 15 February 2018. As addressees were asked to forward the request within their networks, the exact number of recipi- ents cannot be determined. However, the total number of experts reached within the ENRIO and EUREC networks have most probably not exceeded 250 people. The target sample was 100 respondents and after intensive communication and repeated reminders, 125 respondents filled out the questionnaire. In selecting the respondents, we used nonprobability sampling as randomization was not possi- ble in order to obtain a representative sample. Following up on the expert inter- views and utilizing the core expert networks of research ethics and integrity, ENRIO and EUREC, we used expert sampling as a subset of nonprobability sampling. We contacted and utilized the membership of the two organizations as they have the broadest range of research ethics and integrity expert base with good geographic distribution. 6 Research Ethics 16(1-2) Preliminary conclusions from the qualitative and quantitative survey were tested, discussed, and fine-tuned in a series of consensus conferences. The ration- ale for the consensus conferences was based on (a) the critique of a technocratic treatment of (ethics-related) techno-policy issues (Laird, 1993; Lakoff, 1977; Tribe, 1972) as well as (b) the growing concern that citizens and nonexpert users have a stake (Freeman, 1994) in the outcome of research ethics and integrity and may have important views and insights to contribute. The consensus conference design followed traditional consensus conference methodology (Einsiedel and Eastlick, 2000; Joss, 1998, Nielsen et al., 2006) altered to fit the purpose. The long, resource-intensive original consensus conference design—involving meet- ing and deliberation for several successive weekends—was shortened to a one-day session. One-day consensus conferences have already been used to reach expert consensus in medical research (Grudzen et al., 2016). To fit the required time- frame and align resources with the character of the topic, we asked for consensus on questions that originated from our qualitative and quantitative research and focused only on ambiguities expressed by the experts surveyed. The method was altered to include a number of predefined consensus options to better align stake- holder decisions with the qualitative and quantitative research findings and help decide between ambiguities stemming from the research. Stakeholders were at liberty to alter potential consensus answers or reflect on anything they found to be substantial for the topic in question. The consensus conferences took part in four European cities (Aarhus, Athens, Vienna, and Vilnius) during the month of June 2018. Altogether, 50 stakeholders selected from diverse groups, such as university management, funding agency, students, and science journalists, participated in the four cities. In accordance with Laird (1993), “substantial education” was involved in the project, on research ethics and integrity controversies as well as preliminary findings of the quantitative and qualitative research. All sessions followed a simi- lar format comprising of an introduction, an understanding session, and a delibera- tion session managed in a World Café format (Brown and Isaacs, 2005). After the session, a consensus sheet and an “impact or consensus statement” (Beighton, 2017) were created and summarized the questions, remarks, issues discussed, and the consensual answers arrived at as well as the consensus in a narrative format, respectively. Photo protocols of the discussion flip charts were created and sent to participants, so they had a further option to reflect on the consensus achieved and offer further remarks, should they have had any. Findings In the limited literature available on ethical expertise, the focus is on expertise being “knowing what ought to be done or being better at making moral judgments” (Iltis and Sheehan, 2016); or “the ability to understand and integrate knowledge Braun et al. 7 from various disciplines and viewpoints” as well as “reconcile the disparate per- spectives that impinge” in a research setting (Yoder, 1998). Some scholars chal- lenge the very concept of ethical expertise or would consider it only for focusing on procedural matters (Gordijn and Dekkers, 2008). In this paper, we take a different path. Based on our research findings and previ- ous literature on expertise claiming that the “amount of time an individual is engaged in deliberate practice activities is monotonically related to that individu- al’s acquired performance” (Ericsson et al., 1993: 368), we argue that expertise in ethics and integrity may also be theorized as acquired through de facto deliberate practice, adding an empirically grounded conceptual understanding to what con- stitutes expertise in research ethics and integrity. Our hypothesis for our empirical investigation was, based on our reading of literature and findings in other research project, that experience may be conceptualized as expertise gain through deliber- ate practice. Experience is de facto deliberate practice in-as-much as expert per- formance acquisition is not designed as such but represents in most cases what participants themselves feel and would like to learn during the process. Expertise is thus conceptualized as ethical concerns and normativities embedded in assess- ment processes and expertise acquired through such practices (Hankins and Von Schomberg, 2019; Rip, 2010). Elements of such conceptualization were already present in our review of the relevant literature of previous EU project deliverables. In SATORI, the most extensive research in research ethics and integrity assessment units to date, ethics expertise was defined as having experience in ethics assessment processes. In their overview of the literature, SATORI researchers came to the conclusion that experi- ence was valued over formal qualification, and training as a form of deliberate practice was advised for members (Brey et al., 2017). Specific knowledge and qualification was required for ‘“ethics specialists” and “legal experts,” to be gained through specific forms of training, which, again, may be considered as forms of deliberate practice (Ericsson, 2006: 701). A key question in reference to skills and qualifications of assessment unit members, thus of “expertise,” was the validation of such skills and qualifications. While certifications were seen as one potential form of validation, implementing them into practice was debated in SATORI (Reijers et al., 2018). In MoRRI, a research service set up in late 2014, the objec- tive was “to provide scientific evidence, data, analysis and policy intelligence to directly support Directorate General for Research and Innovation (DG-RTD) research funding activities and policy-making activities in relation to Responsible Research and Innovation (RRI)” (cf. http://morri-project.eu/). Ethics is one of the keys or pillars of RRI as defined by the European Commission (EC, 2014). MoRRI focused on lay or civic participation as an extension to traditional expert-based concepts of ethics expertise. While MoRRI found that civic or lay participation may be beneficial to the social embeddedness of the ethical assessment process, 8 Research Ethics 16(1-2) the research did not specifically reflect critically on the question of what consti- tutes expertise in ethics. The question of how expertise is to be defined reflects wider epistemic develop- ments and debates across scientific cultures and communities as to how scientific knowledge/expertise should be perceived and generated. In general, within the social science research on expertise and, particularly, within the sociology of knowledge and public understanding of science literature, clear horizontal distinc- tions between lay and expert knowledge have long been challenged. Traditional views of expertise were reconsidered as the social construction of knowledge gained currency and therefore contested the view of the expert as an “agent of truth and authority” (Bogner et al., 2009: 3). Whereas some refer to these develop- ments as “crises of expertise” (Gerold and Liberatore in Felt et al., 2008), others focus on the “democratization of expertise” (Bogner et al., 2009: 3) to reflect rein- vigorations of citizen–science interrelations that are often referred to as a move from “understanding to engagement” (Stilgoe et al., 2014: 4). Others, again, like Bogner and Menz (2010), deliberatively, do not provide a definition of what con- stitutes expertise in ethics as they focus on ethical assessment teams and political controversies and also claim that the specific expertise of professional ethicists may be challenged openly altogether as expertise in value questions is often sup- posed to be a basic competence of daily life. Our exploratory and critical empirical research points to similar directions. In terms of assessment processes, we also find a positive attitude toward including lay publics into ethical decision-making processes (Braun, 2019). Based on the interviews carried out, there is a broad agreement among inter- viewed experts that expertise in research ethics and integrity needs to be addressed with an inclusive, diverse, and transparent approach. Our interviewees are skepti- cal of an overall set of knowledge that may constitute a normative basis for exper- tise in research ethics and integrity. As an overall impression, interviewees seem to share a general consensus as to the rather nebulous notion of what research ethics and integrity expertise is, with interviewees agreeing on a series of key points. There are many types of experts, such as practitioners, policy/law experts, academic experts etc. Expertise can be possessed within a large number of topics, such as publication ethics, codes of conduct, ethics review, data management, fal- sification, fabrication, plagiarism [FFP], questionable research practices [QRPs], teaching curriculum development, etc., and may relate to one or several organiza- tional levels (e.g., local, regional, national, European, or international areas of knowledge). Moreover, while expert interviewees provide explicit examples of core competences and skills in regard to their own position, it is also evident that no fixed expertise definition exists and that research ethics and integrity qualifica- tions in many ways can be regarded as intrinsic to research processes and may occur as a kind of tacit knowledge (Polanyi, 1966). Braun et al. 9 The contingent nature of research ethics and integrity and the ephemeral notion of what constitutes expertise within a given time frame and within different cul- tural, geographical, and epistemic contexts are clearly conveyed in the expert interviews. For instance, one expert explicitly states that the guiding principle of expertise should originate from a multidisciplinary, inclusive, and broad perspec- tive that “gives room to other ways of showing expertise” (Braun, 2019: 70). Overall, interviewees emphasize formal education and relevant experience as the most important competences to possess as an expert. In addition, different types of experts highlight various types of experience and competences in accordance with their field of expertise. Hence, ethics assessment and review competences are accentuated for ethics research project reviewers, while knowledge of integrity guidelines and codes of conduct are mentioned as important competences for jour- nal editors, for instance. Despite variation, similarities in core competences and skills appear somewhat consistent across different areas of expertise. In terms of competences, experts point to the following types of acquired knowledge: ethical competences (deep knowledge of national and international regulation, cases, awareness of moral dilemmas and ethical deliberation); integrity competences (deep knowledge of national and international regulation, policy, and guidelines); research/science experience [having performed research activities in the past]; legal competences; ethics assessment/review experience [having performed ethics assessment in the past]; and integrity assessment/review experience [having per- formed integrity assessment in the past]. Moreover, experts agree on the importance of a number of skills related to communication, deliberation, collaboration, and management. In Figure 1, these are summarized and grouped according to hard skills (e.g., education, technical), soft skills (e.g., communicative), process skills (e.g., administrative/management), and emotional skills (e.g., commitment, open-mindedness). Irrespective of research ethics and integrity expertise type, expert interviewees give emphasis to and prioritize a number of emotional skills and competencies as essential for working with and within areas related to research ethics and integrity. Being open-minded toward other perspectives as well as being able to collaborate, for instance, is seen to minimize potential frictions between different discipline practices/guidelines and more broadly between different (normative) perceptions of ethical/integrity standards across research fields, institutions, and countries (See Braun, 2019). The contingent and contextual nature of research ethics and integrity expertise confirms previous assessments of the literature arguing that expertise in ethics is not premised on one type of moral knowledge or that a specific, distinct kind of ethics expertise can be identified (Yoder, 1998). At the same time, inter- viewees establish a number of potentially shared skills and competencies that fall within deliberate practice activities as well, especially experience in ethical assess- ment processes where such skills can be acquired, cultured, and refined. 10 Research Ethics 16(1-2) Our quantitative survey substantiates the conceptual framework of theorizing expertise in ethics and integrity as deliberate practice, thus confirms our initial hypothesis. Respondents found “research/science” competence the most impor- tant (4.45 on a scale of 1–5 where “1” means absolutely unimportant, and “5” stands for very important) closely followed by “ethics assessment” (4.27) and “integrity assessment” (4.39) competencies. This confirms our findings in both the literature review and the expert interviews that experts highly value experience in assessment as an important competence in being an “expert” in research ethics and integrity. Aside from experience, respondents’ value “ethics/philosophy compe- tences” (4.10) to be important, while “legal competences” (3.18) is considered relatively lower. When assessing the required skills of research ethics and integrity expertise, “impartiality” (4.29) and “open mindedness” (4.14) are rated as the most important skills, while “personal commitment” (4.14) is also highly valued. “Administrative” (2.57) and “technical” (2.43) skills are valued the least, while “analytical” (4.10), “problem-solving” (4.00), and “debate/deliberation” (4.02) skills are also exceedingly valued. When it comes to specific skills and compe- tences, respondents value research ethics and integrity experience (4.71) as well as previous experience in research ethics and integrity commissions experience (4.28) the most, closely followed by scientific/research experience (4.13). Specific education, current position as research ethics and integrity expert, or research eth- ics and integrity teaching experience, are all valued …