Checking the Boxes on the FWA–Current Trends

Many organizations holding federalwide assurances (FWAs) of compliance with the Office of Human Research Protections (OHRP) consider whether to check the boxes on the FWA, which commits the organization to applying the DHHS regulations (45 CFR 46 Subpart A and Subparts B, C, and D) to all human participant research conducted at their organization.  Subpart A contains the general regulations for IRBs reviewing human participant research whereas Subparts B, C, and D cover review and additional protections for pregnant women, fetuses and neonates; prisoners; and children. The choice is found in section 4(b) of the FWA application:

(b) Optional for U.S. institutions: This Institution voluntarily elects to apply the following to all of its non-exempt human subjects research regardless of the source of support, except for research that is covered by a separate assurance issued by another U.S. federal department or agency that has adopted the Common Rule:

[ ] The Common Rule (see section 3 of the Terms of the FWA for a list of U.S. federal departments and agencies that have adopted the Common Rule and the applicable citations to the Code of Federal Regulations)

[ ] The Common Rule and subparts B, C, and D of the HHS regulations at 45 CFR part 46

Reference: OHRP website, http://www.hhs.gov/ohrp/assurances/assurances/fwaform.docx

Among AAHRPP-accredited organizations, 81 percent have FWAs. No data were analyzed for non-VA organizations because VA facilities are required to maintain an FWA and apply the DHHS regulations (Subparts B–D) to research, when applicable. In 2011, only 29 percent of organizations checked both boxes on their FWA. This represents a decrease between 11 and 15 percent from 2009 and 2010, respectively. The percent of organizations that did not check both boxes rose only slightly to 53 percent in 2011.  The difference between these two findings  results from a greater number of organizations that checked the box indicating they will apply Subpart A to all research but did not check the box to apply Subparts B, C, and D.

Extension of some or all of the HHS regulations to other research is less likely among AAHRPP-accredited organizations. OHRP reports (personal communication with Ivor Pritchard on March 2, 2012) that 32 percent of organizations have not checked either box, 31 percent have checked the box to extend Subpart A to all research but not the subparts, and 37 percent have checked both boxes.
 
In 2011, among the organizations that did not check one or both boxes, 28 percent had written policies and procedures addressing equivalent protections for non-DHHS-sponsored research. One common change was to limit the reporting of serious or continuing non-compliance, unanticipated problems involving risks to participants or others, and suspensions and terminations of IRB approval only to OHRP for DHHS-sponsored research. Other common changes related to the requirements in Subparts B, C, and D. These ranged from simple changes, such as modifying the phrase “biomedical knowledge” to “scientific knowledge” in Subpart B, to not applying some or all of the requirements stipulated in a subpart to research involving no more than minimal risk. Some organizations are implementing changes in procedures related to requirements in Subpart A, such as adding new exempt categories or implementing a two-year approval period for research involving no more than minimal risk.  The remaining 72 percent of organizations that did not check one or both boxes applied the DHHS regulations to all research regardless of funding source.