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ORIGINAL ARTICLE
Year : 2014  |  Volume : 5  |  Issue : 3  |  Page : 115-120

An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: A pilot study


1 Consultant Clinical Pharmacologist and Medical Superintendent (Academics, Quality and Research), Peerless Hospitex Hospital And Research Center Limited, Kolkata, West Bengal, India
2 Student of Public Service Management (Hospital & Healthcare), IISWBM (Calcutta University), Kolkata, West Bengal, India
3 Executive, Department of Clinical Research, Peerless Hospitex Hospital And Research Center Limited, West Bengal, India
4 Director, Clinical Research Centre, Jadavpur University, Kolkata, West Bengal, India

Date of Web Publication11-Jun-2014

Correspondence Address:
Shreya Sikdar
Department of Clinical Research, Peerless Hospitex Hospital And Research Center Limited, Kolkata - 700 094, West Bengal
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2229-3485.134310

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   Abstract 

Purpose of study: The vital responsibility of Institutional Ethics Committee (IEC) members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. Materials and Methods: A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals) in Kolkata conducting active clinical research and having functional Ethics Committees (ECs) in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to all EC members through telephone/e-mail for completion and returning of the forms. The filled in forms were returned to their respective Member Secretaries, from whom authors' collected the forms. Data were analyzed using SPSS version 16.0 software and MS-Excel 2007. Categorical data were analyzed using Chi-square test and a P < 0.05 was considered statistically significant. Results: Out of the 100 distributed questionnaires, 40 were returned of which 10 were not filled properly. Overall awareness regarding different pharmacovigilance terminologies and activities among EC members from nonmedical background (71.43%) was found to be more than that of the medical members (68.75%), though the figure was not statistically significant. Majority of the members (75%) felt that EC should decide compensation in case of a serious adverse event. Conclusion: The present study signifies that there is a low level of awareness in IEC members of Kolkata regarding pharmacovigilance activities conducted during clinical trials; and, hence the functioning of the ECs to safeguard the safety of patients during clinical trials remains questionable. There is a definite need for immediate intervention in the form of mandatory training hours for EC members about pharmacovigilance activities and reporting timelines to ensure clinical trial s ubject safe t y in the long run.

Keywords: Attitude, Eastern India, Institutional Ethics Committee, knowledge, pharmacovigilance, practice


How to cite this article:
Bhowmick S, Banerjee K, Sikdar S, Chatterjee TK. An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: A pilot study. Perspect Clin Res 2014;5:115-20

How to cite this URL:
Bhowmick S, Banerjee K, Sikdar S, Chatterjee TK. An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: A pilot study. Perspect Clin Res [serial online] 2014 [cited 2019 Nov 16];5:115-20. Available from: http://www.picronline.org/text.asp?2014/5/3/115/134310


   Introduction and background Top


Clinical research is defined as a systematic investigation in human beings designed to discover or contribute to a body of generalizable knowledge. As clinical research involves human participants, researchers and their teams are legally and ethically obligated to protect them. [1] Over the last decade, India has become an important country for clinical trials of international pharmaceutical companies. India's potential for fast recruitment of patients and reduction of clinical trial cost made the country one of the most attractive strategic imperatives for global clinical trials. However, globally, there has been a concern about ethical and scientific implications of globalization of clinical trials to developing countries. [2],[3]

ECs in India are still insufficiently trained and have limited resources. [4] While sponsor representatives are well trained in good clinical practices (GCPs) and sponsors arrange for training of investigators and site staff, there is no formal training on bioethics assigned for EC members. Due to this lack of training in bioethics, EC members do not have a clear understanding of complicated ethical issues like reduced autonomy, cultural specificities in obtaining informed consent, vulnerable population, therapeutic misconception, conflict of interest, use of placebo, distributive justice, management of and compensation for study-related injury, and posttrial access. [4]

As EC members play a vital role in ensuring the safety of the trial subjects, [5] their awareness about the pharmacovigilance activities conducted during trials is of extreme importance. Scarce data are available in the literature about the knowledge, attitude, and practice of EC members regarding the pharmacovigilance activities during clinical trials, more so, in our country India. Hence, we have conducted a questionnaire based study on knowledge, attitude, and practice of IEC members in the city of Kolkata (five private and five public hospitals) to understand the current scenario.

Objective

The present study was designed to assess the knowledge, attitude, and practice of IEC members of Kolkata, India about EC functioning and pharmacovigilance activities conducted during clinical trials.


   Materials and methods Top


0Instrument for correctness

To assess the knowledge, attitude, and practice of EC members of Kolkata regarding pharmacovigilance activities followed during clinical trials, a questionnaire containing 24 questions was designed. The questionnaire was validated by doing a pilot study in one of the author's IEC with 10 EC members.

This questionnaire consisted of four parts:

  • The first part concentrated on obtaining demographic data about the age, sex, and educational qualification of respondents; information about the number of members on an ethics committee
  • The second part was dedicated to a self-assessment of the knowledge, attitude, and practice of each respondent regarding the awareness about the participation and the respective role played in the EC, that is, the frequency of meetings; the issues they dealt with in everyday ractice, and the respondents' views on their position in a committee as well as on the work of the committee
  • The third part was dedicated to a self-assessment of the knowledge of each respondent regarding the awareness about the different safety terminologies used in clinical trials
  • The fourth and final part consisted of questions to assess the recommendations of each respondent regarding the improvement of EC functioning.


Participants

This was a cross-sectional survey conducted among members (both medical and non medical) of 10 IECs (five government and five private hospitals) in the city of Kolkata. An IEC approval was taken for this study and adequate measures were taken to ensure the confidentiality of the study participants. The questionnaire was given to each member of these 10 ECs. Willing members completed and returned the forms to the conductors. No names or other identifying information were included in the self-administered questionnaire to assure anonymity.

Despite reminders (at least two reminders were given to each EC member through telephone/e-mail), no replies were received from three government and two private institutions and therefore data could not be included from those sites. This was a questionnaire-based survey; therefore, results rely upon the replies that were received.

Out of the 100 distributed questionnaires, 40 were returned of which 10 were not filled properly and were not included for analysis.

The present paper analyses and compares the responses of the medical and nonmedical members (n = 30) through the survey.

Statistical analysis

Data were analyzed using SPSS version 16.0 software and MS-Excel 2007. Descriptive analyses were done for all the data. The knowledge, attitude, and practice regarding the approval process and safety monitoring strategies followed during clinical trials were compared between medical and nonmedical members of IECs (both government and private institutions) using a Chi-square test. A P < 0.05 was considered statistically significant.


   Results Top


The findings of the present study clearly show the difference in the knowledge, attitude, and practice between medical and nonmedical members of different IECs (both government and private).

[Table 1] shows the basic demography of the respondents. A total of 53.33% of the medical and 46.67% of the nonmedical members were respondents for the study.
Table 1: Basic demography of the respondents

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[Table 2] shows the awareness of different safety terminologies used in clinical trials. The members of IECs should be aware of these terminologies, but in our study we found the level of awareness to be low. Interestingly the nonmedical members were found to be more aware than the medical members but the figure obtained was statistically insignificant.
Table 2: Awareness of different safety terminologies used in clinical trials

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[Table 3] compares the awareness among medical and nonmedical members about the participation and the respective role played in the EC. There was a significant difference between medical and nonmedical EC members about the participation during the EC meeting in the last 1 year. But there was no significant difference found between medical and nonmedical members regarding involvement during EC meeting.

From [Table 3], it was heartening to note that 100% of the medical members knew correctly about the serious adverse event (SAE) reporting timelines to the EC by the Principal Investigator (PI), whereas only 62.50% of the nonmedical members knew the correct timelines. The study had been conducted prior to the reporting timelines being changed on 30 th January, 2013 as per Central Drugs Standard Control Organization (CDSCO) notification. [6]
Table 3: Comparison of the awareness among medical and non-medical members about the participation and the respective role played in the Ethics Committee

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Majority of the members (both medical = 66.67% and nonmedical = 75%) felt that EC should decide the compensation to the trial subject in case of SAE.

There was a significant difference between medical and nonmedical EC members who felt that patients suffering from disease should be included in EC meeting as 66.67% EC members from medical background and 25% EC members from nonmedical background voted for yes. Majority of the EC members from nonmedical background felt that belonging to a nonmedical background did not restrict their participation during EC meeting.


   Discussion Top


All members of IECs should be aware of the different safety terminologies and pharmacovigilance activities conducted during clinical trials to safeguard the subjects. However, in our study the level of awareness was found to be low among both medical and nonmedical members.

To minimize harms in clinical trials, clinical trial risk review needs to be done by ECs to ensure safety of trial subjects. [7] In the present study, there was no significant difference with regard to knowledge of adverse event monitoring and reporting, among members of medical background and members of nonmedical background. Members of EC (both government and private institution) felt that there was a need for some training regarding EC functioning and responsibility and also safety reporting guidelines in clinical trials and there was a significant difference between medical and nonmedical EC members who felt that patients suffering from disease should be included in EC meeting for its better functioning. Majority of the EC members (both from medical background and nonmedical background) felt that in case of SAE, EC should decide the compensation to the trial subject, though most of them (nonmedical members) did not know the exact SAE reporting timelines to EC by the PI. ECs can be an important medium to aid research workers, particularly the less experienced, in amending an ethically unsound and risky clinical trial protocol, thus benefiting both research professionals and the general population.

Questionnaire-based studies regarding the issues and challenges faced by the EC members (medical and nonmedical) are relatively scarce in literature. A thorough search through the existing medical literature database yielded only one study from India titled "A Survey of Institutional Ethics Committees in India-a preliminary report" by Dr. Roli Mathur, Ph.D; Dr. Vasantha Muthuswamy, MD, published in the poster format at the Annual HRPP Conference, 2008. [8] Although 71 ECs were approached to study their functioning and record-keeping practices, there is no mention of how many ECs were approached from Eastern India and neither was there any information sought about awareness levels of EC members regarding pharmacovigilance activities conducted during clinical research. Hence, to the best of our knowledge, our study is the largest study till date done among IEC members in Eastern India, where we have attempted to evaluate the awareness level about EC functioning and pharmacovigilance activities.

A very recent study of IECs in selected hospitals in New Delhi also stresses on the need for a definitive role for ECs for protecting the safety and well-being of subjects. [9] It is imperative that EC members should have requisite knowledge on pharmacovigilance activities, which was found to be low in our study.

In another recent study from India, a survey questionnaire was developed and mailed to clinical research professionals. Among the items covered were EC functioning and training and whether GCP training should be mandatory for all EC members and requirement of other training. All the 34 responders agreed that GCP training must be mandatory for EC members, along with training on other topics such as: (a) applicable regulations; (b) compulsory continuing medical education; (c) protocol review process; d) ethics and ethical thinking; (e) EC standard operating procedures; and (f) roles and responsibilities of each quorum member. [10] Our study also reiterates the need for compulsory training for EC members in regulations pertaining to clinical research.

Study by Pauline Allen, W E Waters University of Southampton, entitled "Attitudes to research ethical committees" also highlights that there was a need for some ''training'' before becoming a member of an EC and indicates some lack of confidence in the subject of medical ethics, which is often felt to be a matter of individual conscience rather than a subject for open discussion. [11] Results obtained in our study also showed that formal mandatory training is required for EC members to ensure safety of the subjects participating in clinical trials.

Another study on "Ethics committees in Croatia in the healthcare institutions: The first study about their structure and functions, and some reflections on the major issues and problems" by Borovecki et al., [12] also highlights that there are concerns about members' knowledge levels. More efforts need to be made to use education to improve the quality of work. Results obtained in our study also emphasized that all members of IECs should be aware of the different safety terminologies used in clinical trials but the existing situation is far from satisfaction. Nonmedical members were found to be more aware than medical members though the figure obtained was not statistically significant.

A recent published paper by Tripathi [13] emphasizes on the daily challenges along with changing guidelines and regulations faced by EC members, in order to keep abreast of the knowledge and action plans for unethical issues in research (which may be more extensive for nonmedical members). A Herculean task the EC member faces is supervising the compensation process being executed by the researcher/sponsor. With the advent of the new compensation guidelines, the EC will have to develop inbuilt mechanisms/vigilant operations to ensure that the compensation amount and the representative receiving the compensation are as per the newly proposed Indian regulations. [13] In our study too, it was seen that majority of the members (both medical = 66.67% and nonmedical = 75%) felt that EC should decide the compensation to the trial subject in case of SAE. An overwhelming 100% of the medical members knew correctly about the SAE reporting timelines to the EC by the PI but only 62.50% of the nonmedical members knew the correct timelines.

The isolated existence of the ECs and the lack of communication framework between the ECs and the regulatory bodies make it essential for ECs in our country to come together and work in a collaborative manner to develop a uniform code of conduct. [14] A joint network of ECs is required, first at a local level and then at the regional and national levels, which would serve as forums to discuss issues of importance to them. A study conducted in 2009, to study the profile and roles of EC members in Pune, noted that even with an appropriate EC constitution, the members had suboptimal understanding of the ethical issues and principles. Out of the 52 EC members representing 12 health and biomedical research institutions in Pune city, a majority (79%) of EC members felt that formal training was necessary and 84% said that there should be networking of the various ECs to share thoughts and experiences. [15] In the present study, the overall awareness regarding various safety terminologies was found to be rather low among both medical and nonmedical EC members who justify the requirement for compulsory training for them regarding pharmacovigilance activities and reporting timelines.

There were certain limitations in our present study. Despite reminders, no replies were received from four government and two private institutions; and, therefore data could not be included from those sites. This was a questionnaire-based survey; and, hence the results rely upon the replies that were received. However, this pilot study from Eastern India is an effort to capture the existing situation of the level of Knowledge, Attitude, and Practice (KAP) of EC members about pharmacovigilance activities conducted during clinical trials in the country, which can be validated further by undertaking a larger study across India in the near future.


   Conclusion and recommendations Top


  • All members of IECs should be aware of the different safety terminologies used in clinical trials; but the results in our study portray that the existing situation is far from satisfaction
  • This study highlights the need for mandatory training hours of ECs and appropriate institutional support for its functioning
  • Majority of the EC members (both from medical background and nonmedical background) felt that in case of SAE, EC should decide the compensation to the trial subject, which interestingly has been implemented by the government in the recent regulatory changes made this year in relation to SAE management and compensation
  • There is a need to carry out a larger and extensive study across different ECs in the country to understand the level of knowledge and attitude of the members regarding pharmacovigilance activities conducted during clinical research and devise effective training strategy to ensure clinical trial subject safety in the long run.



   Acknowledgments Top


The authors would like to sincerely thank Dr. Avijit Hazra (SSKM Hospital), Dr. Piyu Palit (B. M. Birla Heart Research Centre), Dr. Soma Bhattacharya (B. M. Birla Heart Research Centre), Ms. Shiveta Samadar (Ruby General Hospital), Ms. Priyanka Gupta (Medica Superspecialty Hospital), and Prof. S. K. Tripathi (Calcutta School of Tropical Medicine) for extending their support in conducting the study.

 
   References Top

1.Boroveèki A, ten Have H, Oreškoviæ S. Education of ethics committee members: Experiences from Croatia. J Med Ethics 2006;32:138-42.  Back to cited text no. 1
    
2.Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med 2009;360:816-23.  Back to cited text no. 2
    
3.Nundy S, Gulhati CM. A new colonialism?--Conducting clinical trials in India. N Engl J Med 2005;352:1633-6.  Back to cited text no. 3
    
4.Pandiya A. Quality of independent review board/ethics committee oversight in clinical trials in India. Perspect Clin Res 2011;2:45-7.  Back to cited text no. 4
[PUBMED]  Medknow Journal  
5.Available from: http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf [Last accessed on 16 Oct 2013].  Back to cited text no. 5
    
6.Available from: http://cdsco.nic.in/GSR%2053(E)%20dated%2030.01.2013.pdf; G. S. R. 53(E), Ministry of Health and Family Welfare (Department of Health) Notification, published in The Gazette of India, New Delhi, 30 th January, 2013. [Last accessed on 3 Nov 2013].  Back to cited text no. 6
    
7.Kimmelman J. Valuing risk: The ethical review of clinical trial safety. Kennedy Inst Ethics J 2004;14:369-93.  Back to cited text no. 7
    
8.Available from: www.primr.org/WorkArea/DownloadAsset.aspx?id=6107; Survey of Institutional Ethics Committees in India- a preliminary report by Dr. Roli Mathur, Ph. D; Dr. Vasantha Muthuswamy, MD, represented at Annual HRPP conference (2008). Affiliated by Indian Council of Medical Sciences, Ansari Nagar, New Delhi-29, India. [Last accessed on 3 Nov 2013].  Back to cited text no. 8
    
9.Kandhari R. Justice in Jeopardy: A qualitative study of institutional ethics committees in New Delhi. Indian J Med Ethics 2013;10:176-83.  Back to cited text no. 9
    
10.Jadhav M, Bhatt A. Ethics in clinical research in India: A survey of clinical research professionals› perceptions. Perspect Clin Res 2013;4:4-8.  Back to cited text no. 10
[PUBMED]  Medknow Journal  
11.Allen P. Attitudes to research ethical committees. J Med Ethics 1983;9:61-5.  Back to cited text no. 11
    
12.Borovecki A, ten Have H, Oreskoviæ S. Ethics committees in Croatia in the the healthcare institutions: The first study about their structure and functions, and some reflections on the major issues and problems. HEC Forum 2006;18:49-60.  Back to cited text no. 12
    
13.Tripathi R. Ethics committee member: Reviewing the 'Ethics' in clinical research. Perspect Clin Res 2013;4:17-20.  Back to cited text no. 13
[PUBMED]  Medknow Journal  
14.Kadam R, Karandikar S. Ethics committees in India: Facing the challenges! Perspect Clin Res 2012;3:50-6.  Back to cited text no. 14
    
15.Brahme R, Mehendale S. Profile and role of the members of ethics committees in hospitals and research organisations in Pune, India. Indian J Med Ethics 2009;6:78-84.  Back to cited text no. 15
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

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