Profile and role of the members of ethics committees in hospitals and research organisations in Pune, India

Brahme, Radhika; Mehendale, Sanjay

doi:10.20529/ijme.2009.026

Cited by 15 publications

(16 citation statements)

References 16 publications

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“…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.…”

Section: Discussionmentioning

confidence: 62%

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

et al. 2014

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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 subject safety in the long run.

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Section: Discussionmentioning

confidence: 62%

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

et al. 2014

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“…30 Certainly, a deficit in knowledge of some review committee members was blamed for previous 'rough rides ' 12 of qualitative studies through the review process. This adds to the argument for increased training for committee members 18,29,33,34 as well as ensuring a variety of methodological expertise among membership so that studies can be championed through the process.…”

Section: Discussionmentioning

confidence: 99%

Clinical research ethics in Irish healthcare

Condell

Begley

2012

Nurs Ethics

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Gaining ethical clearance to conduct a study is an important aspect of all research involving humans but can be time-consuming and daunting for novice researchers. This article stems from a larger ethnographic study that examined research capacity building in Irish nursing and midwifery. Data were collected over a 28-month time frame from a purposive sample of 16 nurse or midwife research fellows who were funded to undertake full-time PhDs. Gaining ethical clearance for their studies was reported as an early 'rite of passage' in the category of 'labouring the doctorate'. This article penetrates the complexities in Irish clinical research ethics by describing the practices these nurse and midwife researchers encountered and the experiences they had. The key issue of representation that occurred in the context of 'medicalized' research ethics is further explored including its meaning for nursing or midwifery research.

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“…Even with an appropriate EC constitution, the members had sub-optimal understanding of ethical issues and ethical principles. [8] However, it has been noticed that nonscientific members in most ECs do not participate actively in the deliberations of scientific and ethical merit of a study protocol. Probably, the very fact that there are senior, highly educated members from the medical fraternity and the lack of bioethics understanding inhibit the nonscientific members from voicing their opinion.…”

Section: Ethics Committee Functioning In India: Responsibilities and mentioning

confidence: 99%

Quality of independent review board/ethics committee oversight in clinical trials in India

Pandiya¹

2011

Perspect Clin Res

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Profile and role of the members of ethics committees in hospitals and research organisations in Pune, India

Cited by 15 publications

References 16 publications

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

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

Clinical research ethics in Irish healthcare

Quality of independent review board/ethics committee oversight in clinical trials in India

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