About Ethical Approval

The NHRC was established to promote responsible conduct of health research and as such is authorized to regulate all health related research conducted in Nepal. Through the ethics review process, research that is not scientifically and ethically sound will not be approved. The NHRC has developed the National Ethical Guidelines for Health Research in Nepal and formed Ethical Review Board (ERB) to regulate research conduct in Nepal. Similarly, Institutional Review Committees (IRCs) have been formed in different institutions and are responsible for ethical review process.

Elements of the Ethics Review Process

Technical Review by the Reviewers: Submitted proposals are screened for completeness and reviewed by the internal reviewer. The proposal is then assigned to external subject experts to review the the scientific and technical content.

Communication of review to the researcher: Reviewers’ feedback is given to the researcher(s) who must then respond to the comments.

Ethical Review: Technically and scientifically sound proposals that have addressed reviewers’ comments are then submitted to the Member-Secretary of the Ethical Review Board (ERB) for a thorough discussion in an ERB meeting for ethical approval.

Decision Making: Normally the ERB will make approval decisions by consensus, but the majority will rule if the timely agreement is not reached. The ERB may offer conditional approval with specific suggestions to the researcher or may disapprove the proposal with clear and compelling reasons.

Communicating a Decision: The Member Secretary, on behalf of the ERB, will deliver the decision to the researchers in written form within two weeks of ERB meeting.

Follow-Up: ERB monitors the progress of all approved studies. ERB has the right to monitor approved studies from the time the approval until the completion or termination of the research.

 

Flowchart of Ethical Review Process