INDIACLEN - Institutional Review Board (IRB)
The IndiaCLEN Institutional Review Board (IRB) was formed on 11.4.99. Prior to its formations, all INCLEN research projects & proposals required only a local institutional ethical clearance before it was approved for funding. In keeping with the requirements of funding agencies, particularly USAID, the IndiaCLEN IRB was formed.
Chair Person:
- Dr. M.K Mitra, KGMC, Lucknow
Non IndiaCLEN Members:
- Dr. MS. Jawahar, Chennai
- Ms. Shoba Iyer, Chennai
- Mr. K V Narasimhan,
Tiruttani
- Dr. M K Ramachandran,
Kerala
- Dr. Geethalakshmi,
Chennai
- DR J P Muliyil, Vellore
IndiaCLEN Members:
- Dr. Suresh Ughade,
Nagpur
- Dr. Arun Chaturvedi,
Lucknow
- Dr. Murtaza Akhtar,
Nagpur
- Dr. Shashikant, New
Delhi
- Dr. C. S. Pandav,
New Delhi
IRB Co-Ordinator:
-
Dr. C.K. Gariyali, Chennai
Objectives:
- Aim is to safeguard the welfare and rights of participants to research
- Entrusted not just with initial review but also monitor complaince to ethical norms
- Ensure competent review of all ethical aspects of proposals received
- Provide advice to researchers on aspects of welfare and safety of research participants
- Ensure scientifics soundness of proposed research through appropriate scientific review committees
Constitution:
- It is multidisciplinary
- Independance and Competence - two hallmarks
- Members are a mix of medical/non-medical, scientific/non-scientific and lay persons
- Has adequate gender representation
- Comprises 13 members, 7 who are IndiaCLEN members and 6 who are non-IndiaCLEN members
- Chairperson, a non-IndiaCLEN member
Operation:
- Meet once in three months
- Once date decided, RFP sent out to members for submission of proposals
- Proposals received in the IndiaCLEN office, checked for completeness and sent by courier to each IRB member for review
- Primary and Secondary reviewers decided for each proposals
- All members have also to review and provide their comments
- Negative comments must be supported by adequate justification
- Decisions generally by consensus
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