United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2012_register executive 2012-06-12 article Notices D09002ee1c7fcdeef D09002ee1c7fcdf84 United States Department of Health and Human Services originator org United States Government Agency or Subagency The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, is announcing the availability of a draft guidance document entitled "Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution," and is seeking comment on the draft guidance. The draft guidance document, when finalized, would provide OHRP's first formal guidance on this topic. The draft document, which is available on the OHRP Web site at http://www.hhs.gov/ohrp/newsroom/rfc/ index.html, is intended primarily for institutional review boards (IRB), institutions, and investigators that are responsible for the review, conduct, or oversight of human subjects research conducted or supported by HHS. OHRP will consider comments received before issuing the final guidance document. 77 FR 34949 https://www.govinfo.gov/app/details/FR-2012-06-12/2012-14287 2012-14287 fr12jn12-63 4150-36-P https://www.govinfo.gov/app/details/FR-2012-06-12/2012-14287 https://www.govinfo.gov/content/pkg/FR-2012-06-12/html/2012-14287.htm https://www.govinfo.gov/content/pkg/FR-2012-06-12/pdf/2012-14287.pdf 2 p. 34949 34950 77 FR 34949 Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution; Federal Register Vol. 77, Issue NOTICE 2012-14287 DEPARTMENT OF HEALTH AND HUMAN SERVICES 2012-08-13 4150-36-P 2012-14287 Notice.

The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, is announcing the availability of a draft guidance document entitled "Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution," and is seeking comment on the draft guidance. The draft guidance document, when finalized, would provide OHRP's first formal guidance on this topic. The draft document, which is available on the OHRP Web site at http://www.hhs.gov/ohrp/newsroom/rfc/ index.html, is intended primarily for institutional review boards (IRB), institutions, and investigators that are responsible for the review, conduct, or oversight of human subjects research conducted or supported by HHS. OHRP will consider comments received before issuing the final guidance document.

Submit written comments by August 13, 2012. Irene Stith-Coleman, Ph.D., Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; email Irene.Stith-Coleman@hhs.gov. Draft Guidance: Considerations in Transferring Previously-Approved Research Project to New IRB or Research Institution , Irene.Stith-Coleman@hhs.gov http://www.hhs.gov/ohrp/newsroom/rfc/index.html http://www.regulations.gov http://www.regulations.gov/ Vol. 77, no. 113 Office of the Federal Register, National Archives and Records Administration 2012-06-12 continuing daily deposited born digital 467 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-06-12 P0b002ee18294a7bd 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr12jn12 https://www.govinfo.gov/app/details/FR-2012-06-12 https://www.govinfo.gov/content/pkg/FR-2012-06-12/pdf/FR-2012-06-12.pdf https://www.govinfo.gov/content/pkg/FR-2012-06-12/xml/FR-2012-06-12.xml fdlp 34781 35239 DGPO 2012-06-12 2024-06-03 FR-2012-06-12 machine generated eng FR FR-2012-06-12 77 113