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Draft Guidance on Institutional Review Board Approval of Research With Conditions

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AGENCY:

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

ACTION:

Notice.

SUMMARY:

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled “Guidance on IRB Approval of Research with Conditions,” and is seeking comment on the draft guidance. The draft guidance document, when finalized, would provide OHRP's first formal guidance on this topic.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/​requests/​, is intended primarily for institutional review boards (IRBs), 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. OHRP will consider comments received before issuing the final guidance document.

DATES:

Submit written comments by January 5, 2010.

ADDRESSES:

Submit written requests for single copies of the draft guidance document entitled “Guidance on IRB Approval of Research with Conditions” to the Division of Policy and Assurances, Office for Human Research Protections, 1101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 See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance document.

You may submit comments, identified by docket ID number HHS-OPHS-2009-0017, by one of the following methods:

  • Federal eRulemaking Portal: http://www.regulations.gov. Enter the above docket ID number in the “Enter Keyword or ID” field and click on “Search.” On the next Web page, click on the “Submit a Comment” action and follow the instructions.
  • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

Comments received, including any personal information, will be posted without change to http://www.regulations.gov.

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FOR FURTHER INFORMATION CONTACT:

Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; e-mail Michael.Carome@hhs.gov.

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SUPPLEMENTARY INFORMATION:

I. Background

A. Overview

OHRP is announcing the availability of a draft guidance document entitled “Guidance on IRB Approval of Research with Conditions.” The draft guidance document, when finalized, will represent OHRP's current thinking on this topic and will provide OHRP's first formal guidance on this topic. The draft 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 would apply 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, OHRP offers guidance on the following topics:

(1) What actions can an IRB take when reviewing research?

(2) What does IRB approval with conditions mean?

(3) What circumstances preclude the IRB from approving research?

(4) What circumstances permit the IRB to approve research with conditions?

(5) How should the IRB handle changes to research that are proposed after the IRB has approved the research with conditions?

(6) How do conditions on IRB approval at the time of initial review affect the initiation of research?

(7) How do conditions on IRB approval at the time of continuing review, or at the time of review of proposed changes in previously approved research, affect ongoing research?

(8) What must the IRB records include regarding the documentation of conditions of IRB approval of research?

B. Pertinent Recommendations by the Secretary's Advisory Committee on Human Research Protections (SACHRP) Related to Continuing Review and Expedited Review

In a March 14, 2007 letter, SACHRP transmitted to the Secretary of Health and Human Services recommendations regarding IRB continuing review and expedited review of research. Two of these recommendations are addressed by the draft guidance document. The following discussion describes OHRP's response to these SACHRP recommendations and identifies the Start Printed Page 57487section(s) of the draft guidance document that address each recommendation.

(1) SACHRP Recommendation: OHRP and the Food and Drug Administration should issue expanded guidance (a) clarifying that final approval of stipulations from convened meeting review (i.e., “contingent approval”) is not a form of expedited review; and (b) permitting IRBs to describe in their written policies and procedures “stipulation mechanisms” for verifying changes required for approval of proposed research under which (i) the IRB Chairperson, or designated member-reviewer, may exercise reasonable judgment in verifying that the stipulations of the convened IRB have been satisfied; and (ii) a qualified IRB administrator may verify that the investigator has implemented specific language (e.g., in the protocol, informed consent document, or advertisements) dictated by the convened IRB (and requiring no subjective judgment on the part of the administrator).

OHRP's Response: OHRP agrees with this recommendation. Sections B and D of the draft guidance document in particular reflect OHRP's implementation of SACHRP's recommendation.

(2) SACHRP Recommendation: OHRP should modify its guidance on continuing review so that, when the study has been reviewed by the IRB (at a convened meeting or through an expedited process, as appropriate) and the IRB finds that there are no substantive concerns in terms of the risk-benefit relationship, informed consent, or other key protections, suspension of all research activity is not required when the expiration date passes, provided that IRB review is completed within 30 days past the expiration date.

OHRP's Response: OHRP agrees in general with the intent of this recommendation. OHRP has addressed this recommendation through its discussion of conditional approval by the IRB at the time of continuing review in section G of the draft guidance document.

II. Electronic Access

The draft guidance document is available on OHRP's Web site at http://www.hhs.gov/​ohrp/​requests/​.

III. Request for Comments

OHRP requests comments on its draft guidance document. OHRP will consider all comments before issuing a final guidance document.

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Dated: November 3, 2009.

Jerry Menikoff,

Director, Office for Human Research Protections.

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[FR Doc. E9-26830 Filed 11-5-09; 8:45 am]

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