Mandatory IRB Registration

On July 6, 2004, the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) published a joint proposed rule in the Federal Register (v. 69 no. 128) regarding mandatory registration of Institutional Review Boards (IRBs) that review federally-funded research or research conducted under the jurisdiction of FDA. The comment period closed on July 21, 2004. When this proposed rule will be formally adopted and become regulation is unclear at this time.

For those conducting federally-funded research, this proposed rule will have little to no effect on the way they conduct research at Aurora Health Care, since Aurora's IRBs have been registered with OHRP for many years.

However, the FDA proposed rule contains a few additional requirements that have not previously been part of the federal regulations governing human subject research and IRBs.

The FDA proposed rule makes the following statement:

"Therefore, to the extent that any existing FDA regulation requires a sponsor or investigator to comply with part 56 [FDA regulations pertaining to IRBs] or to use an IRB that complies with part 56, FDA will consider sponsors and investigators using an unregistered IRB to be in conflict with their regulatory obligations."

In short, this means that FDA will expect all sponsors and investigators conducting FDA-regulated research to use a properly registered IRB when reviewing clinical trials utilizing an investigational drug, biologic, or device.

In anticipation of sponsors requesting this documentation, we are making available on our Web site the RSPP/Aurora IRB memo outlining our compliance with various OHRP, FDA, and ICH regulations pertaining to IRBs and research conducted with human subjects. After the proposed rule is formally adopted, the memo will be further revised to address any additional regulatory requirements.

If you have questions about this matter, please don't hesitate to contact the RSPP office by calling (414) 219-7744 or via email.

Download the RSPP/Aurora IRB compliance memo.