How the IRB works

The Institutional Review Board is a committee made up of volunteer faculty members, representatives from outside the BU community who are not formally affiliated with the university, non-scientists, and representatives from the IRB office staff.  The IRB is charged with the responsibility of protecting the rights and welfare of human subjects involved in research.  Examples of these rights and welfares and the responsibilities for protecting them are outlined in the Belmont Report. The IRB provides this protection by reviewing all proposed human subject protocols.

Some protocols will be deemed “exempt” from IRB review.  This does not mean that the IRB does not retain responsibility and authority over the research.  It simply means that the research is not subject to all of the regulations that govern human subject research.  The IRB makes the determination whether a research protocol is exempt or not. The IRB Exempt determination only applies to the protocol that is submitted to the IRB. If the PI modifies that protocol, s/he must obtain IRB approval for the modified protocol.

For non-exempt research, the IRB reviews research applications through either an “expedited” process or a review by the “full board”.  In this context, “expedited” does not mean faster (although it often is).  “Expedited” means that the review can be conducted by a single experienced IRB board member or staff rather than needing review by the full board.  Protocols that can be reviewed in the expedited process are typically those with minimal risk to subjects (although other criteria apply as well).  “Full board” protocols require review, discussion, and approval by a convened meeting of the entire IRB board. The IRB decides whether expedited or full-board review is required.

The CRC IRB meets once each month, typically on the third Tuesday of each month.

The IRB reports to the “Institutional Official” (currently, Ara Tahmassian, Ph.D, Associate Vice President, Research Compliance).  The IRB is expected to apply the regulations that govern human research using its best scientific, moral, and ethical judgment.  The institution can make a decision not to pursue a research study that the IRB has approved.  However, the institution cannot decide to allow a study that the IRB has found unacceptable.

The federal regulations that govern human research can be found at the “Policies and Regulations” link on the top button bar.