Introducing Standard I.9
Standard I-9: The organization has written policies and procedures to ensure that, when sharing oversight of research with another organization, the rights and welfare of research participants are protected.
Standard I-9 Tip Sheet 24: Single IRB Review
Research increasingly involves multiple organizations, and organizations will soon be required more than ever to work together to share oversight of research. The National Institutes of Health’s recent policy on single institutional review board review and upcoming requirements in the revised Common Rule reflect the growing trend in this area.
Standard I.9 brings together all of AAHRPP’s requirements when sharing IRB or ethics committee oversight, and helps organizations implement new NIH and Common Rule requirements for shared oversight of research. In addition to IRB or EC review, Standard I.9 covers other responsibilities, such as oversight of conflicts of interest, radiation safety, biosafety and other ancillary reviews.
The new standard was developed with extensive input from an advisory group established by AAHRPP in June 2016. The group included representatives from universities, hospitals, research consortia and independent IRBs. In addition to the significant, hands-on role played by the working group, AAHRPP also invited comments from external readers, members of the AAHRPP Council on Accreditation and AAHRPP’s Board of Directors.
Tip Sheet 24 has also been revised to provide what we hope are helpful ideas regarding implementation of the new Standard. As with every AAHRPP Tip Sheet, organizations are encouraged to view this document as non-prescriptive points to consider in the administration of an ever-evolving area of human research oversight.
New organizations wishing to apply for accreditation after January 19, 2018 will follow Standard I.9. Currently accredited organizations whose reaccreditation applications are due March 15, 2018 or later will provide written materials describing how they are implementing shared oversight, and how they meet Standard I.9. All other currently accredited organizations will describe their plans to implement Standard I.9 in their annual reports.
Learn about the Standard