The development and validation of a guide for Peruvian research ethics committees to assist in the review of ethical-scientific aspects of clinical trials

Abstract

Peru has made great strides in clinical trials (CTs) regulation in recent years. However, by 2008, Peru did not have guidance on how to review the ethical and scientific aspects of clinical trials for use by research ethics committees (RECs). In 2009, REC inspections by the Peruvian National Institute of Health (NIH) indicated that there were serious deficiencies in their ability to perform their moral functions, mainly because it appeared that the ethical-scientific reviews had become a mere administrative formality. This project developed and validated a guide for reviewing the ethical and scientific aspects of CTs to be used as an institutional standard for the Peruvian RECs. We took the following steps: (a) Review-synthesis of relevant bibliography on the ethics of research with human subjects and analysis of their applicability in the local Peruvian context; (b) development and validation of the format and content of a guide for reviewing the ethical-scientific aspects of CTs, and (c) identification and analysis of the ethical and scientific issues which surfaced during CT reviews by RECs that were included in their decision reports. The guide described here is the result of a collaboration of multinational experts in ethics and clinical research, Peruvian NIH officials and members of 12 RECs.