IRBDMR Process of Review


  • Proposals will be registered when the complete application package is checked by the secretariat/secretary, and the required copies and processing fees (if applicable) is received. A registration number will be assigned and it should be quoted in all the correspondences.
  • Investigators can expect the full committee review of their proposals within 6-8 weeks of submission. ERC office will correspond (by email) with the principal investigator 2 weeks before the meeting.
  • The ethical review is done through formal meetings and the committee do not resort to decision through circulation of proposal.
  • All members review the proposals, and one primary reviewer is assigned for each proposal to review in detail.
  • In case of studies that entails minimal risk (criteria will be set by the ERC), minimal risk review may be carried out instead of formal meetings. Chair, secretary & 1-2 scientific members may review the minimal risk study and arrive at decisions.
  • The principal investigator is required to present at the meeting to present the study.
  • Decision is made through consensus, where possible, when it appears unlikely, ERC voting is recommended.
  • Most of the studies require clarifications, minor amendments, scientific justifications, or major amendments. ERC’s suggestions/comments has to be incorporated into the revised version which is to be sent within 2 weeks after the meeting.
  • A conditional decision on applications will be re-reviewed following revision.
  • A negative decision on an application will be supported by clearly stated reasons.
  • The ERC may decide to reverse its positive decision on a study in the event of receiving information that may adversely affect the risk/benefit ratio.
  • The discontinuation of a trial may be recommended if the ERC finds that the goals of the trial have already been achieved midway or unequivocal results are obtained.
  • Subject experts may be invited to offer their views but should not take part in the decision making process. However, her/his opinion must be recorded