Institutional Review Boards and Independent Ethics Committees

Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs) are charged with protecting the rights and safety of clinical trial participants. The regulations that guide the review, approval, and conduct of human research refer to these independent boards as IRBs or IECs. In 2001 the Association for the Accreditation of Human Research Protection Programs (AAHRPP) was formed. Since that time many institutions have reorganized the various support and review services connected with human subject research including the IRB as one component of their Human Research Protection Program (HRPP). Similarly to the IRB, these programs have as their primary mission the protection of human research subjects. Some IRB responsibilities such as clinical trial monitoring, investigator and research participant education, and auditing of research records may be shifted to specialized units within the HRPP. These programs may also facilitate investigator–sponsor relationships to promote safe, ethical research practices. In many institutions in the USA the committee also serves as the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy board for research-related activities. There are at least three systems used by institutions to fulfill human research ethics review requirements. It is important to determine the IRB that will be responsible for reviewing and approving the research. Some institutions require their own IRB to review all research, while others rely solely on the use of a central IRB, or permit central IRB review for certain types of studies. Central IRBs are particularly useful for multicenter studies because only one IRB is responsible for approval of the protocol and informed consent form. This can make meeting this regulatory requirement more efficient. The possible advantages and disadvantages of central versus local IRB