‘One lay person from the community should be on Ethics committee (EC) to represent the differed points of view’ - ICMR 2006, Schedule Y 2005 The Community Member provides perspective of research participant and community

How to choose? Whom to choose? From where to choose? How to train? Limited data from literature assessing the role of Community members serving on IRB Klitzman R. Acad Med. 2012; 87:975–981, Sengupta S, Lo B. Acad Med 2003;78:212-8.

Mukta Kuyare*, Padmaja Marathe, Sunil Kuyare, Urmila Thatte *BhaktiVedanta Hospital & Research Institute, Mira Road and Seth G. S. Medical College & K.E.M. Hospital, Mumbai, India Perceptions and Experiences of Community Members Serving on Institutional Review Boards : A Questionnaire Based Study

Understand perceptions of community members regarding their role in IRBs Learn about their experiences as members of IRBIdentify their difficulties Obtain their suggestions to improve participation in the ethics review process

Cross-sectional, Questionnaire based Study Interviews using a structured study specific questionnaire community members of IRBs of Medical colleges, govt institutions/ private hospitals Mumbai, Navi Mumbai, Thane Approval of IRBs and written informed consent obtained

Approached IRBs directly (telephonically or through ) / through member secretary/ dean Administrative permission Interviews using structured validated questionnaire Data analysis using descriptive statistics 57 IRBs registered with Drug Controller General of India

General demographic information (7items) Community members’ perceptions of their role (13 items) Experiences while serving on IRB (22 items) Assessment of difficulties and community members’ suggestions for improvement in practices (4 items) Validation of questionnaire: Responses found to be reliable with Cohen's kappa coefficient of 0.84

15 Results

All 30 were nominated by IRB member/Head of Institute Not interested, honoured IRB’s request (1) Research participant in a study(1) Translator asked to join IRB(1) Results

Age : 33 years to 77 years Median : 52.5yrs Results No. of Community member

Results

No. of Community Member Qualification of Community Member

Opportunity to serve society (14) To understand scientific research(6) Non-scientific neutral view point(1) Joined as were invited(4) No comments(4) Not interested in IRB(1) Results

Perception 10% (3/30) – GCP training not required 17% (5/30) – SOP training not needed Practice 40% (12/30) did not receive GCP training 37% (11/30) – no SOP training 37%(11/30) had no training on review process Results On the job

DocumentPerceptionPractice Summary protocol / Protocol2924 ICD(English/Vernacular)2723 Advertisement199 Incentives/retention materials/ gifts to participants 1815 Clinical Trial Agreement1813 Investigator’s Brochure1615 Results

All were actively participating in the meeting proceedings except 5 members “ I do not understand anything” “most of the members have clinical background” “ There is no time to clarify our doubts ” Results < 50% involved in SAE(13)/deviations(13) /amended protocols(16) 50 % do not review the amendments in ICDs (14) 93% did not witness consent process/site monitoring(28)

Difficulties faced by the community members Complex medical terms Insufficient time for review Alternate member- review once in 6 months Lack of specialized training and no involvement in post review process Results

Suggestions provided by community members Periodic training required Need for scientific and humanity based background Specifying review requirements Research studies to be explained at the time of meeting Participation in post review process and onsite monitoring More time to review proposals Should be informed about their job on the IRB Results

Aware about their role but review practices not uniform Less response from private hospitals IRB compared to Government hospitals IRB Only around 50% received initial training in SOP and / or GCP Response to review advertisement, incentives, participation in post review process were unsatisfactory CTA and Investigator Brochure were reviewed when not needed

Can nurse and paramedics serve as community member? Should community member be affiliated or non- affiliated? What should be selection process?What should be qualifications? Can community member serve on multiple IRBs? We had 5 participants serving on 2/more IRBs ? How this affects quality of review and further confidentiality protection?

Need for imparting specific training to community members Development of training modules Checklist for all IRB related activities Glossary of medical terms for community members

Kuyare MS, Marathe PA, Kuyare SS, Thatte UM. Perceptions and experiences of community members serving on institutional review boards: a questionnaire based study. HealthCare Ethics Committee Forum. Volume 27, 2015, Available at BhaktiVedanta hospital & Research Institute Seth GS Medical College and KEM hospital