On June 12, 2012, the Office for Human Research Protections (OHRP) announced in the Federal Register the availability of a draft guidance document entitled, “Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution” and is seeking comment on the draft guidance.
The draft guidance document, when finalized, will represent OHRP’s current thinking on this topic and OHRP’s first formal guidance on this topic. The guidance would apply to non-exempt human subjects research conducted or supported by HHS. OHRP will consider comments received before issuing the final guidance document.
The draft document is intended primarily for institutional review boards (IRBs), institutions, and investigators that are responsible for the review, conduct, or oversight of human subjects research conducted or supported by HHS. It presents common scenarios for transfer of a previously-approved research project to another institutional review board (IRB) or to a new engaged research institution, and outlines the administrative actions to be considered by IRBs, engaged institution(s), and investigators. In particular, the guidance addresses the following questions:
1.What is the regulatory background for research project transfer?
2.What actions may apply when the research project remains at the same institution, but responsibility for IRB review is transferred either from an internal to an external IRB, or from an external IRB to another external IRB ?
3.What actions may apply when the research project remains at the same institution, but responsibility for IRB review is transferred from one internal to another internal IRB?
4.What actions may apply when the research project is transferred to a new engaged institution?
To enhance human subject protections and reduce regulatory burden, OHRP and the Food and Drug Administration (FDA) have been actively working to harmonize the agencies' regulatory requirements and guidance for human subject research.
FDA has simultaneously published in the same issue of the Federal Register notice of the availability of a draft guidance document entitled “Guidance for IRBs, Clinical Investigators, and Sponsors, Considerations When Transferring Clinical Investigation Oversight to Another IRB” that is similar to OHRP’s draft document.
OHRP’s Federal Register notice of availability can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2012-06-12/html/2012-14287.htm, or http://www.gpo.gov/fdsys/pkg/FR-2012-06-12/pdf/2012-14287.pdf. The draft guidance can be accessed at: http://www.hhs.gov/ohrp/newsroom/rfc/transferdraftdoc.html, or http://www.hhs.gov/ohrp/newsroom/rfc/pdftransferdraftdoc.pdf.
The Federal Register’s notice of availability of FDA’s draft guidance document can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2012-06-12/html/2012-14295.htm, or http://www.gpo.gov/fdsys/pkg/FR-2012-06-12/pdf/2012-14295.pdf.
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