2010-30198. Guidance on Institutional Review Board Continuing Review of Research

AGENCY:

Department of Health and Human Services, Office for Human Research Protections, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.

ACTION:

Notice.

SUMMARY:

The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, is announcing the availability of a guidance document entitled “Guidance on IRB Continuing Review of Research.” The guidance document supersedes OHRP's January 15, 2007 guidance entitled “Guidance on Continuing Review.” The document, which is available on OHRP's Web site at http://www.hhs.gov/​ohrp/​policy/​continuingreview2010.html or http://www.hhs.gov/​ohrp/​policy/​continuingreview2010.pdf,, is intended primarily for institutional review boards (IRB), investigators, Department of Health and Human Services (HHS) funding agencies, and others that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS. The guidance document announced in this notice finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57487). OHRP received comments on the draft guidance document from 18 individuals and organizations, and those comments were considered as the guidance was finalized.

DATES:

Comments on OHRP guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for a single copy of the guidance document entitled, “Guidance on IRB Continuing Review of Research,” to the Division of Policy and Assurances, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-402-2071. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance document.

Submit written comments to Comments on Continuing Review Guidance, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to [e-mail] or via facsimile at 240-402-2071.

FOR FURTHER INFORMATION CONTACT:

Irene Stith-Coleman, PhD, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; e-mail [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

OHRP is announcing the availability of a guidance document entitled “Guidance on IRB Continuing Review of Research.” The guidance document supersedes OHRP's January 15, 2007 guidance entitled “Guidance on Continuing Review.” The document is intended primarily for IRBs, investigators, HHS funding agencies, and others that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS.

The guidance document applies to non-exempt human subjects research conducted or supported by HHS. It provides guidance on the authority of IRBs to approve research with conditions. In particular, the guidance addresses the following 11 topics:

(1) Key IRB Considerations When Evaluating Research Undergoing Continuing Review;

(2) Process for Conducting Continuing Review;

(3) Additional Considerations for Continuing Review of Multicenter Research Projects;

(4) When Expedited Review Procedures may be Used by an IRB for Continuing Review;

(5) Determining the Frequency of Continuing Review;

(6) Determining the Effective Date of Initial IRB Approval and the Dates for Continuing Review;

(7) Lapses in IRB Approval;

(8) Communicating the IRB's Continuing Review Determination to Investigators and the Institution;

(9) Suspension or Termination of IRB Approval of Research or Disapproval of Research at the Time of Continuing Review;

(10) Identifying the Point When Continuing Review is no Longer Necessary; and

(11) Continuing Review is Not Required for Exempt Human Subjects Research Projects.

The guidance document announced in this notice finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57487). OHRP received comments on the draft guidance document from 18 individuals and organizations, and those comments were considered as the guidance was finalized. The majority of commenters expressed general support for the draft guidance document. The final guidance document is largely unchanged from what was proposed in the draft guidance, with only minor clarifying edits made in response to many of the comments.

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 subjects research. The guidance document announced in this notice was developed as a part of these efforts. When FDA finalizes its related guidance entitled “Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval,” which was made available in draft for public comment through a notice in the Federal Register on January 13, 2010 (75 FR 1790), OHRP will update the guidance document announced in this notice as needed to harmonize with FDA's final guidance document.

II. Electronic Access

The guidance document is available on OHRP's Web site at http://www.hhs.gov/​ohrp/​policy/​continuingreview2010.html or http://www.hhs.gov/​ohrp/​policy/​continuingreview2010.pdf.

III. Comments

Interested persons may submit comments regarding this guidance document to OHRP at any time. Please see the ADDRESSES section for information on where to submit written comments.

Dated: November 24, 2010.

Jerry Menikoff,

Director, Office for Human Research Protections.