Journal Article Analysis on ethics audit - Business Finance
Attached is the PDF for ethics audit. Please look at the attached document and write a 600 word document in APA format and include the references. The document should consist of the following:Key Term: ethics auditDEFINITION: a brief definition of the key term followed by the APA reference for the term; this does not count in the word requirement. SUMMARY: Summarize the article in your own words- this should be in the 150-200 word range. Be sure to note the articles author, note their credentials and why we should put any weight behind his/her opinions, research or findings regarding the key term. DISCUSSION: Using 300-350 words, write a brief discussion, in your own words of how the article relates to the selected chapter Key Term. A discussion is not rehashing what was already stated in the article, but the opportunity for you to add value by sharing your experiences, thoughts and opinions. This is the most important part of the assignment. REFERENCES: All references must be listed at the bottom of the submission--in APA format. Be sure to use the headers in your submission.
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Original Article
Current status of standardized, quality and ethical oversight
of clinical research in the country: An audit of the Central
Drugs Standard Control Organization (registration of ethics
committees) and national accreditation board for hospital
and healthcare providers (accreditation) databases
Tushar Bhimrao Nishandar, Amit Ravindra Birajdar, Nithya J. Gogtay, Urmila M. Thatte
Department of Clinical Pharmacology, Seth G S Medical College and KEM Hospital, Mumbai, Maharashtra, India
Abstract
Purpose: The Prof. Ranjit Roy Chaudhury committee report recommended the accreditation of Institutional
Ethics Committees (IECs). Rule 122DD of the Drugs and Cosmetics Act (and Rules) mandates that only
registered ECs can accord approval for regulatory studies. We evaluated the current status of registered,
reregistered, and accredited ECs in the country to assess the impact of both the recommendation and rule.
Materials and Methods: Websites of stakeholders‑the Central Drugs Standard Control Organization (CDSCO),
National Accreditation Board for Hospitals and Healthcare Providers (NABH) were assessed. Information on
registration status was then compared with regulatory clinical trials in the Clinical Trials Registry of India,
population demographics of all states, and the Medical Council of India recognized postgraduate medical
colleges in the various states.
Results: A total of 1268 ECs were registered with CDSCO. Of these, 1008 (79.5\%) were institutional and
256 (20.18\%) independent ECs. A total of 499/1268 (39.4\%) ECs were reregistered. Of which 449/499 (90\%)
were institutional and 50/499 (10\%) were independent. Institutional ECs were five times more likely to
be reregistered with CDSCO relative to independent ECs (cOR 4.52 [3.12, 6.54], P < 0.0001). A total of
15/233 (7\%) applications to NABH had received accreditation. A wide skew was seen in the distribution of
ECs across various states as also their oversight of regulatory clinical trials.
Conclusions: Registration and reregistration of ECs along with accreditation is not commensurate with the
needs of the country at this time and must be vigorously promoted.
Keywords: Ethics committee accreditation, ethics committee registration, independent ethics committee,
institutional ethics committee
Address for correspondence: Dr. Urmila M. Thatte, Department of Clinical Pharmacology, 1st Floor, New MS Building, Seth G S Medical College and KEM
Hospital, Parel, Mumbai ‑ 400 012, Maharashtra, India.
E‑mail: urmilathatte@gmail.com
This is an open access journal, and articles are distributed under the terms of the Creative Commons
Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and
build upon the work non-commercially, as long as appropriate credit is given and the new creations
are licensed under the identical terms.
Access this article online
Quick Response Code:
For reprints contact: reprints@medknow.com
Website:
www.picronline.org
DOI:
10.4103/picr.PICR_93_18
84
How to cite this article: Nishandar TB, Birajdar AR, Gogtay NJ, Thatte UM.
Current status of standardized, quality and ethical oversight of clinical
research in the country: An audit of the Central Drugs Standard Control
Organization (registration of ethics committees) and national accreditation
board for hospital and healthcare providers (accreditation) databases.
Perspect Clin Res 2019;10:84-90.
© 2019 Perspectives in Clinical Research | Published by Wolters Kluwer - Medknow
Nishandar, et al.: An audit of registered ECs in India
INTRODUCTION
Ethics committees (ECs) safeguard the rights, dignity,
and well‑being of research participants by reviewing all
aspects of clinical research, approving its initiation as
well as providing continued oversight.[1] An important
amendment was made to the schedule Y of the drugs
and cosmetics act (1940) and rules (1945) on February
8, 2013, with the introduction of rule 122DD issued by
the ministry of health and family welfare, Government
Of India. This rule states that “no ethics committee (EC)
shall review and accord its approval to a clinical trial
protocol without prior registration with the licensing
authority i.e., the Central Drugs Standard Control
Organization (CDSCO) in India.” The rule also states that
the registration of an EC is valid for 3 years and needs
to be renewed every 3 years.[2]
The report of the Prof. Ranjit Roy Chaudhury Committee
in July 2013 recommended the accreditation of institutional
ECs (IECs), principal investigators (PIs) of clinical trials
and centers desirous of carrying out clinical trials.[3] It was
believed that the accreditation of ECs would play a pivotal
role in improving the protection of research participants.[4,5]
The CDSCO has tasked the National Accreditation Board
For Hospitals And Healthcare Providers (NABH) to
accredited ECs in India.
With this background, we carried out the present study
with the primary objective of assessing the current status
of registered, reregistered and accreditated ECs in the
country to evaluate the impact of both the rule and the
recommendation. Our secondary objectives were to assess
whether the numbers of ECs state wise was commensurate
with the population of the state. Since it is mandatory to
register clinical trials which are regulatory in nature at the
Clinical Trials Registry of India (CTRI), we also evaluated
the number of such trials per state vis à vis the population
and registered ECs of that state. We also wanted to assess
whether the Medical Council of India (MCI) recognized
medical colleges (teaching postgraduate [PG] courses and
therefore conducting clinical research) had ECs that were
registered.
MATERIALS AND METHODS
Ethics
Exemption from the review was received from the IECs
since the information collected for this study is freely
available in the public domain (EC/OA‑158/2017).
Methodology
All relevant data were collected from the following sites
Perspectives in Clinical Research | Volume 10 | Issue 2 | April-June 2019
1. EC registration and reregistration http://www.cdsco.
nic.in/forms/list.aspx?lid=1859andId=1 Apart from
looking at the total numbers as portrayed on the
website, the letter of approval for the EC registration of
each EC was also downloaded and analyzed for the date
of registration (to assess eligibility for reregistration)
2. NABH accreditation status of ECs http://www.nabh.
co/ClinicalTrial.aspx
3. Registered regulatory clinical trials http://ctri.nic.
in/Clinicaltrials/advancesearchmain.php. This was
searched between January 1, 2013 to February 28, 2018
4. MCI recognized colleges for PG teaching https://
www.mciindia.org/CMS/infor mation‑desk/
indian‑medical‑register. [last accessed on June 27, 2018]
5 Population demographics of the country were obtained
from http://censusindia.gov.in/Data collection was
started after EC exempted the study on January 12,
2018 and all databases (except the website of the MCI)
were last accessed on February 28, 2018.
Outcome measures
From the websites, we assessed: (a) the total number
of independent and institutional ECs registered‑both
initially and reregistered and their accreditation status, (b)
The state‑wise distribution of all ECs, (c) Time (range)
in days to registration of independent and institutional
ECs, (d) Population of states versus number of registered
ECs, (e) Number of regulatory trials registered in CTRI
per state versus the number of ECs registered per state,
and (f) Number of MCI recognized colleges versus number
of colleges with registered ECs.
Statistical analysis plan
Both descriptive and inferential statistics were applied.
Categorical data (Number of independent and institutional
ECs registered and reregistered, the population of states,
number of regulatory clinical trials in CTRI and number
of MCI recognized medical colleges, number of NABH
accredited ECs) are presented as proportions.
Comparison of (a) Population of states versus number of
registered ECs, (b) Number of regulatory trials registered in
CTRI per state versus number of ECs registered per state,
and (c) Number of MCI recognized colleges versus number
of colleges with registered ECs was done using descriptive
statistics. Quantitative data (time to initial registration of
the ECs) are expressed as median (range) after assessing
for normality.
The difference between the time to registration between
institutional and independent ECs was compared using
the Mann–Whitney U‑test. Comparison of reregistration
85
Nishandar, et al.: An audit of registered ECs in India
status of Institutional versus Independent ECs was done
using Chi‑square statistics. All analyses were performed at
5\% significance using Microsoft Excel® 2016.
RESULTS
Number of registered, reregistered and accredited ethics
committees
A total of n = 1268 ECs were registered with CDSCO.
Of these n = 1008 (79.5\%) were Institutional ECs,
n = 256 (20.18\%) were independent ECs and four
applications were rejected. A total of 499/1268 (39.4\%)
ECs were reregistered of which 449/499 (90\%) were
institutional and 50/499 (10\%) were independent.
Of the 1268 ECs, data contained in 167/1268 (13.1\%)
documents could not be analyzed for dates of reregistration
because of various reasons, as summarized in Figure 1.
Thus, a total of 1101 documents were available for further
analysis related to reregistration and the distribution
between institutional and independent ECs is also
summarized in Figure 1.
Institutional ECs were five times more likely to be
reregistered with CDSCO relative to independent
ECs (cOR 4.52 [3.12, 6.54], P < 0.0001).
A total number of 233 applications were received by NABH
for accreditation. Of these, 15 ECs are accredited as of now.
State‑wise distribution of registered and reregistered
ethics committees
The state‑wise distribution of initially registered ECs is
shown in Figure 2a. The state of Maharashtra had the
Figure 1: Schematic representation of initially registered and reregistered Ethics Committees
86
Perspectives in Clinical Research | Volume 10 | Issue 2 | April-June 2019
Nishandar, et al.: An audit of registered ECs in India
a
b
Figure 2: (a) State-wise distribution of initially registered ethics committees. (b) State wise distribution of re-registered ethics committees
highest number of registered ECs at 290/1268 (22.9\%)
while the states of the northeast region (14/1268; 1.1\%)
Perspectives in Clinical Research | Volume 10 | Issue 2 | April-June 2019
and Andaman and Nicobar Islands (1/1268; 0.07\%) have
the least number of registered ECs.
87
Nishandar, et al.: An audit of registered ECs in India
The state‑wise distribution of reregistered ECs is shown
in Figure 2b. Maharashtra leads the list of states in the
number of ECs reregistered at 130/499 (26.1\%), whereas
out of the five eligible ECs in the North East region only
two are reregistered. The EC in Andaman and Nicobar
Islands is not yet eligible for reregistration.
Time and range to initial registration of ethics
committees
The median time (range) required for registration
for institutional ECs was 66.5 (2–1269) days while
Independent ECs required 153 (22–822) days for
initial registration (P < 0.0001). The time required for
reregistration could not be measured as majority of the
approval letters of reregistration of ECs did not provide
the date of application.
State population versus number of registered ethics
committees
The state of Maharashtra with 9.28\% of the country’s
population had 28.8\% of registered ECs in the
country. The state of Bihar that has a similar population
proportion (8.5\%) but has only 0.7\% of the registered ECs.
The population (percentage) of representative states
(highly populated) and registered ECs (percentage) is
depicted in Figure 3.
Registered clinical trials versus registered ethics
committees
The total number of regulatory studies registered in
the CTRI between January 2013 and February 28 2018
were 3689 of which Maharashtra had the highest
number (n = 772/3689; 20.9\%). In states like Delhi and
Bihar, ten and nine regulatory clinical trials, respectively,
were overseen by each EC, whereas this ratio was two to
four in states such as Maharashtra, Kerala, and Madhya
Pradesh. The comparison of number of regulatory trials
to registered Institutional ECs in major states across the
country is shown in Table 1.
Medical Council of India recognized medical colleges
versus registered ethics committees
A total of n = 494 medical colleges are currently recognized
by the MCI in the country for PG education. In Sikkim,
Meghalaya, and Goa all the MCI recognized medical
colleges have registered ECs (n = 1 each). However, the
states of Karnataka, Maharashtra, Bihar, UP, Assam, and
Haryana have far fewer medical college ECs registered (for
example, in Bihar which has 13 recognized medical
colleges only one medical college EC is registered). Table 2
summarizes the numbers of MCI recognized medical
colleges and the number of medical colleges with registered
ECs across the states in India.
DISCUSSION
The study on the registration and accreditation status
of ECs in India found that 80\% of registered ECs are
institutional (who are permitted to oversee the regulatory
clinical research along with academic studies of an institute)
whereas the remaining 20\% are IECs (which are allowed
to only oversee bioavailability/bioequivalence (BA/BE)
studies) with a mere 7\% (all institutional ECs) accredited
Figure 3: Population of the state (percentage) versus registered ethics committees (percentage)
88
Perspectives in Clinical Research | Volume 10 | Issue 2 | April-June 2019
Nishandar, et al.: An audit of registered ECs in India
Table 1: Comparison of regulatory clinical trials to registered
institutional ethics committees
State
Number of
regulatory clinical
trials (A)
Number of
registered
ECs (B)
Ratio of A
and B
772
529
56
162
667
659
465
547
359
343
45
209
50
6
66
100
105
105
101
60
48
16
3.69
10.58
9.33
2.45
6.67
6.28
4.43
5.42
5.98
7.15
2.81
Maharashtra
Delhi
Bihar
Kerala
Gujarat
Karnataka
Andhra Pradesh
Tamil Nadu
Uttar Pradesh
West Bengal
Madhya Pradesh
ECs=Ethics committees
Table 2: Comparison between Medical Council of India
recognized medical colleges and registered institutional ethics
committees
State
Meghalaya
Goa
Sikkim
Pudduchery
Karnataka
Odisha
Uttarakhand
Kerala
Rajasthan
Maharashtra
Punjab
Gujarat
Madhya Pradesh
Delhi
Jammu and Kashmir
Andhra Pradesh
West Bengal
Chattisgarh
Jharkhand
TamilNadu
Assam
Himachal Pradesh
Uttar Pradesh
Haryana
Bihar
Number of MCI
recognised
colleges
Number of MCI recognised
colleges with registered
institutional ECs
1
1
1
9
63
13
7
36
18
47
11
26
19
22
4
32
28
10
5
56
8
7
45
12
13
1
1
1
8
39
8
4
20
10
26
6
14
10
11
2
15
13
4
2
22
3
2
10
1
1
ECs=Ethics committees, MCI=Medical Council of India
with the NABH. Along with regulatory clinical trials the
total responsibility of overseeing academic clinical trials
now lies only with institutional ECs without co‑supervision
by the regulator. This further highlights the need for
registration of institutional ECs – and a total of 1008
registered institutional ECs does not reflect the total
number of ECs that exist in the country.
Interestingly, we found as many as 167/1268 registration
documents could not be assessed for the date of
registration due to which we were unable to assess eligibility
for reregistration, for various reasons including majorly
Perspectives in Clinical Research | Volume 10 | Issue 2 | April-June 2019
an inability to download these documents. This suggests
an incompleteness of the database and implies a need
for a timely update of the database to allow for complete
transparency of the process.
More (63\%) of the institutional ECs, which were eligible
for reregistration was actually reregistered, whereas only
27\% of the eligible independent ECs were reregistered.
This may be because of the tremendous documentation
required (which needs an investment of time and money
as well as training) and lack of fair incentives to do so.
Accreditation of only 7\% ECs with the NABH over a
period of 10 months points toward a slow process of
accreditation along with probably a lack of motivation of
ECs toward getting this done. This could be attributed to a
lack of workforce, the fact that accreditation is a voluntary
self‑improvement process and a large study overload with
most ECs. In view of this, the CDSCO should conduct
inspections of ECs that oversee regulatory trials as well
as others (that oversee academic trials) to ensure greater
adherence to regulations and maintenance of a uniform
standard of functioning.
The skewed distribution of initially as well as reregistered
ECs across the various states of the country suggests just
like a skewed distribution of access to health care facilities[6]
and medical teaching institutes,[7] the concentration of
registered ECs in certain states suggests an improper
distribution of clinical trials in the country. This has great
ethical implications as access to research is as important
as access to health care particularly for orphan diseases.[8]
The licensing authority appears to favor IECs based on
the finding of a statistically significantly greater time
to registration for an independent EC compared to an
institutional EC. This is possibly also due to the greater
efforts and time needed to check the independent EC
documentation as they do not have an institutional
oversight. However, IECs could play an important role
in protecting the rights of participants in BA/BE studies
which carry with them several ethical challenges including
participant recruitment strategies and informed consent
procedures.[9] Independent ECs also oversee nonregulatory
studies conducted in smaller clinics and nursing homes
which are not BA/BE in nature and their registration with
the CDSCO is also desired to happen as fast as institutional
committees to promote such type of clinical research
important for the population of India.
There was a skewed distribution of the number of ECs
with respect to the population in states. This is in coherence
89
Nishandar, et al.: An audit of registered ECs in India
with the finding by Bhide et al.[10] In places with less number
of registered ECs, participants may have less protection.
There is a need for more ECs in states with a larger
population sush as Bihar and UP, to safeguard their rights,
safety, dignity, and well‑being. As we have mentioned above,
this has great ethical implications as access to research is as
important as access to health care, especially for diseases
relevant to that state, for example, Leishmaniasis in Bihar
and Encephalitis in the state of Uttar Pradesh.[11,12]
From observations of the present study, it is evident that
ECs in certain states are overburdened with the number
of regulatory clinical trials they oversee. This might be
due to more number of clinical trials being registered in
certain states owing to the availability of good quality of
healthcare and trained investigators in those states such
as Maharashtra, Karnataka, New Delhi, and Gujarat.
However, there is a need for registered and hence
empowered ECs appropriate to the number of clinical
trials permitted in the state.
MCI sets uniform standards of higher education in
medicine and recognition of medical qualification in India
and abroad.[7] MCI recognized PG medical colleges need to
be registered ECs to oversee PG theses apart from clinical
trials and other academic research. The current scenario in
Bihar with only 1 out of 13 of MCI recognized medical
college having a registered EC, puts academic research on
the radar.
In the world’s most populated democracy, with increasing
clinical research, empowered ECs are the need of the
hour. ECs play a great role in the quality of clinical
research.[4] Timely reregistration of both institutional as well
90
as independent EC should be encouraged. To strengthen
the functioning of EC ...
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Losinski forwarded the article on a priority basis to Mary Scott
Losinksi wanted details on use of the ED at CGH. He asked the administrative resident