Research ethics and guidelines

Research ethics and guidelines

Institutional Research Committee

 

  • 20 Members + 2 Ex-Officio Members

  • All our own Faculty

  • Minimum Quorum 50%

 

Institutional Ethics Committee

 

  • 14 Members in 7 categories as per the ICMR Guidelines

  • Quorum is one person per category

  • At least 50% are non affiliated to BCMCH

 

Elements of Review

 

  • Scientific design and conduct of the study.

  • Approval of appropriate scientific review committees.

  • Examination of predictable risks/harms.

  • Examination of potential benefits.

  • Procedure for selection of subjects: Exclusion/ Inclusion criteria

  • Management of research related injuries, side effects, ADRs.

  • Compensation provisions.

  • Justification for placebo in control arm, if any.

  • Availability of products after the study, if applicable.

  • Patient information sheet and informed consent form in local language.

  • Protection of privacy and confidentiality.

  • Involvement of the community, wherever necessary.

  • Plans for data analysis and reporting

  • Adherence to all regulatory requirements.

 

 Decision Making

 

       The committee will give its opinion on the project in writing in one of the following ways:

  • Members will discuss the various issues before arriving at a consensus decision.

  • Decisions will be made only in meetings where quorum is complete.

  • Only members can make the decision. The expert consultants will only offer their opinions.

  • Decision may be to approve, reject or modify the proposals. Specific suggestions should be given for modifications.

  • Modified proposals may be reviewed by an interim review through identified members.

  • Negative decisions should always be substantiated by appropriate reasons.

  • All documents pertaining to the Institutional Ethics Committee will be held in the Department of Medical Research