Issues in Clinical Studies Leading to Medical Research Ethics Committee (MREC) Negative Decisions

The rationale behind a Medical Research Ethics Committee (MREC) negative decision is always shared directly with the applicants. However, insight into the review process and common reasons for a negative decision may also be valuable for other researchers, clinical research organizations and people with an interest in MREC processes. To our knowledge Medical Research Ethics Committees (MRECs) do generally not report on the negative decisions they issue and on the underlying rationale for such decisions. Here we give insight into the MREC review process by briefly describing procedures and discussing the negative decisions issued by MREC NedMec in the past five years.