Created by on 11/05/2010

 FASEB submitted comments on the Office for Human Research Protections (OHRP) draft revised Federalwide Assurance (FWA) and Terms of Assurance forms on October 25th. Institutions engaged in non-exempt human subjects research conducted or supported by the Department of Health and Human Services (HHS) must hold an OHRP-approved FWA under which they commit to compliance with the requirements for human subjects research set forth in the Common Rule and the Terms of Assurance. The current FWA form requires that institutions specifically designate all of the institutional review boards (IRBs) on which they rely to review research involving human participants.

In a June 2009 letter, FASEB recommended that OHRP not require institutions to designate specific IRBs on their FWAs so long as they make a commitment to rely only on registered IRBs. FASEB noted that this change, which had also been suggested by the Secretary’s Advisory Committee on Human Research Protections, would facilitate collaborative review arrangements insofar as institutions would not be required to modify their FWAs each time they enter an arrangement with a new IRB, a process that can slow the progress of multi-center projects. OHRP’s proposed revision would allow institutions to use registered IRBs that are not listed on their forms, yet it would still require them to designate specific IRBs. Institutions would be required to list their internal IRBs on their FWAs, or, if they do not have an internal IRB, they would be required to list the external IRB that reviews the largest percentage of their research.

While the proposed change would improve upon the current process in that it would give institutions the flexibility to use IRBs that they have not designated, it was not clear what purpose listing specific IRBs would serve, particularly if institutions would not have to use them. In its recent comments to OHRP, FASEB reiterated its recommendation that OHRP do away with the mandate to designate specific IRBs on the FWA. The letter stated that the requirement may lead to uncertainty as to whether the use of non-designated IRBs is permissible. It would also mean that institutions that rely upon multiple external IRBs would have to monitor the number of reviews each of those IRBs conducts to ensure that the one conducting the greatest percentage of reviews is the entity listed on its FWA. These monitoring and reporting mandates would neither facilitate regulatory compliance nor serve to protect human research participants.

OHRP also proposed several other changes to the FWA and Terms of Assurances. These include combining the forms for domestic and international institutions into a single document; removing items from the Terms of Assurance that are either not required or addressed in the FWA; eliminating the request for submission of the HHS institutional profile code or Federal Entity Identification number; enabling institutions to sign the FWA electronically; and increasing the period of approval from three to five years.