Establishing institutional ethics committees: challenges and solutions–a review of the literature

Kuyare, Mukta Sunil; Taur, Santosh; Thatte, Urmila M

doi:10.20529/ijme.2014.047

Cited by 8 publications

(15 citation statements)

References 19 publications

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“…Literature review enlisted challenges which included improper knowledge of appointment of committee members, availability/scarcity of trained legal expert and layperson in the quorum and very few consultant having the research background with no formal training in GCP. [45] Most of the challenges faced during IEC set up remained same however few well trained and experienced IEC external members guided in selection of quorum. Major hurdle of training of new members in SOP and IEC review procedure was accomplished with help of experienced external members.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of performance of the Medical Research Department in ′Research naive′ non-academic hospital: An audit

et al. 2016

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Introduction:Conducting medical research is not limited to academia and pharmaceutical industry but even multispeciality hospitals need to venture in this area along with patient care. To develop research culture among well-established non-acedemic hospital is always difficult and challenging task. This article attempts to evaluate the performance of the department in ‘Research naïve’ hospital in the last two years and review the strengths and challenges it faced at each step.Methods:This was a retrospective document analysis study evaluating the steps towards setting and sustaining of Medical Research Department of Bhaktivedanta Hospital during the period of January 2013 to June 2015 (30 Months). The authors developed a checklist (along with performance indicators) to assess the Preparatory phase and Activity phase of the research department which were evaluated by Institute Quality Management Team. Each step of both phases was also reviewed in terms of strengths and challenges as perceived by the authors.Results:During 2 year journey of research naïve Hospital, Institute had witnessed Hospital initiated (n=24, 59%) and sponsored projects (n=17, 41%) in all specialties. HRC reviewed (n=2.13) projects per meeting for administrative consideration while IEC reviewed (n=2.15) projects for scientific and ethical review. Challenges during preparatory phases were circumvent by immense cooperation of hospital management for initial investment, sensitization through research workshops for consultants, established procedures and trained support manpower and constant encouragement by research coordinator.Conclusion:Considering evaluation of 41 studies in very first 2 years in ‘Research naive non academic institute demonstrated successful implementation of trio model of Hospital Research Committee for administrative review, IEC for scientific-ethical review, centralized MRD for coordinating all research projects under one roof which may act as role model for Research naive institutes

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Section: Discussionmentioning

confidence: 99%

Evaluation of performance of the Medical Research Department in ′Research naive′ non-academic hospital: An audit

et al. 2016

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“…A review[ 24 ] identified 31 articles published between 2004 and 2012 related to the topic of the challenges faced while establishing Institutional ECs (IECs) and their functioning. The most common challenge mentioned in these articles was inappropriate functioning of IECs ( n = 17), followed by inappropriate structure ( n = 14).…”

Section: The Past (2005–2013)mentioning

confidence: 99%

Ethics Committees in India: Past, present and future

Thatte

Marathe

2017

Perspect Clin Res

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Following watershed amendments in Schedule Y India's star rose rather rapidly on the clinical research (especially clinical trials) horizon. Just as dramatic was the fall of this empire. At the centre of these events has been the participant and indirectly, the Ethics Committee (EC) that is established primarily to protect this individual. This paper traces the evolution of the concept of ECs in India, examines the current state of these committees in the country and suggests the way forward.The Past:The requirement for an EC to oversee clinical research was first made in the ICMR Policy Statement for Ethics published in 1980 and then again in the Schedule Y (1988). Later, both the Amended Schedule Y (2005) assigned regulatory responsibility on the EC and the ICMR Guidelines (2006) described the functioning of ECs. Several challenges including inadequate formal training, contribution from non-technical members, administrative support as well no SOPs and a heavy workload were identified. In the absence of regulatory oversight of ECs, the introduction of the Clinical Trial Registry - India (CTRI) and self-regulation through voluntary accreditation programs brought a measure of accountability and transparency.The Present:A slew of regulatory reforms led to more than 1000 ECs to be registered with CDSCO although the actual impact on participants' protection and safety of these new regulations still remains to be seen.Way Forward:A method to oversee all ECs, improved functioning of ECs including on site monitoring, central ECs for multicentric studies, the development of metrics to assess the ability of ECs to protect the participant are other ideas for the future.Conclusions:Although ECs in India have evolved from being mere rubber stamps for approval of protocols to efficiently functioning accredited ECs, yet there is much to be done for and by Ethics Committees.

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“…Several studies on performance of Indian ECs have reported deficiencies in EC functioning,[23] for example, inappropriate composition and functioning, inadequate training, conflict of interest, lack of standard operating procedures, deficiencies in approval letters. However, these studies were conducted before the registration of ECs.…”

mentioning

confidence: 99%

Are registered ethics committees empowered to ensure human research protection?

Bhatt¹

2016

Perspect Clin Res

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Establishing institutional ethics committees: challenges and solutions–a review of the literature

Cited by 8 publications

References 19 publications

Evaluation of performance of the Medical Research Department in ′Research naive′ non-academic hospital: An audit

Evaluation of performance of the Medical Research Department in ′Research naive′ non-academic hospital: An audit

Ethics Committees in India: Past, present and future

Are registered ethics committees empowered to ensure human research protection?

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