OHRP Filing - IRB Registration

AGENCY:       Office of Public Health and Science, HHS.
ACTION:       Final rule.
SUMMARY:      The Office for Human Research Protections (OHRP), Office of 
              Public Health and Science, Department of Health and Human 
              Services (HHS), is adding a new subpart E to the HHS protection 
              of human subjects regulations, which requires institutional 
              review boards (IRB) that review human subjects research 
              conducted or supported by HHS and that are designated under an 
              assurance of compliance approved for federalwide use by OHRP to 
              register with HHS. The registration information includes 
              contact information, approximate numbers of all active 
              protocols and active protocols involving research conducted or 
              supported by HHS, and staffing for the IRB. The registration 
              requirements will make it easier for OHRP to convey information 
              to IRBs and will support the current IRB registration system 
              operated by OHRP. Under this final rule, the IRB registration 
              system is compatible with the IRB registration requirements of 
              the Food and Drug Administration (FDA), which are 
              simultaneously published as a final rule in this issue of the 
              Federal Register, allowing the operation of a single HHS IRB 
              registration system.
DATES:        This rule is effective July 14, 2009. This protracted effective 
              date is necessary to allow refinement of the electronic 
              registration system so that it corresponds to this final rule 
              and the FDA's final rule, and obtain Office of Management and 
              Budget (OMB) review and approval for the information collection 
              requirements of this rule.
              Initial registration with all required information must be 
              submitted within 60 days of the effective date of the rule, by 
              September 14, 2009. For any IRB currently registered with OHRP, 
              the institution or organization operating the IRB must submit 
              all information required under this rule by the three-year 
              expiration date previously assigned by OHRP or within 90 days 
              of any changes regarding the contact person who provided the 
              IRB registration information or the IRB chairperson.
FOR FURTHER   Irene Stith-Coleman, PhD, Office for Human Research 
INFORMATION   Protections,1101 Wootton Parkway, Suite 200, Rockville,
CONTACT:      MD 20852, telephone (240) 453-6900
              e-mail irene.stith-coleman@hhs.gov.
SUPPLEMENTARY INFORMATION: