Evaluation of a Minimal Risk Research Protocol by a Research Ethics Subcommittee

Approval from a research ethics committee (REC) is required before any research involving human participants can be conducted. In one Southeast Asian country, Committee A is an REC that provides independent ethical review of health research conducted at government-funded health facilities. The membership of Committee A follows this country’s Guidelines for Good Clinical Practice (GCP), which reflect the ethical principles outlined in the Declaration of Helsinki, the International Ethical Guidelines for Biomedical Research Involving Human Subjects, and the International Council for Harmonization GCP Guideline. A subgroup of the REC (Committee B) was established to review minimal risk protocols and make recommendations for approval to Committee A. Committee B’s reviews normally involved the evaluation of 1) scientific value and merit of the proposed research; 2) research methodology, such as its design and sample-size calculation (if applicable); 3) feasibility of implementing research at proposed site(s); and 4) potential risks and benefits to participants.

Prior to data collection, a researcher submitted a proposal to Committee A for a minimal risk research study to be conducted in a government-funded hospital within this country. Deciding that the protocol was minimal risk, Committee A submitted it to Committee B for review. Dissatisfied with the feedback received from Committee B, the researcher asked Committee A to reveal the names of the Committee B reviewers, presumably so they could take the matter up personally with reviewers and/or lodge complaints to others within the institution.