[Federal Register Volume 73, Number 206 (Thursday, October 23, 2008)]
[Notices]
[Pages 63150-63152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25177]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Final Guidance on Engagement of Institutions in Human Subjects 
Research

AGENCY: Office for Human Research Protections, Office of Public Health 
and Science, Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: The Office for Human Research Protections (OHRP), Office of 
Public Health and Science, is announcing the availability of a guidance 
document entitled, ``OHRP Guidance on Engagement of Institutions in 
Human Subjects Research.'' The guidance document describes: (1) 
Scenarios that, in general, would result in an institution being 
considered engaged in a human subjects research project; (2) scenarios 
that would result in an institution being considered not engaged in a 
human subjects research project; and (3) IRB review considerations for 
cooperative research in which multiple institutions are engaged in the 
same non-exempt human subjects research project. The guidance document 
is intended primarily for institutional review boards (IRBs), research 
administrators and other relevant institutional officials, 
investigators, and funding agencies that may be responsible for the 
conduct, review and oversight of human subject research that is 
conducted or supported by the Department of Health and Human Services 
(HHS).
    The guidance document announced in this notice finalizes the draft 
guidance with the same title that was made available for public comment 
in the Federal Register on December 8,

[[Page 63151]]

2006 (71 FR 71169). OHRP received twenty-four comments on the draft 
guidance document, and those comments were considered as the guidance 
was finalized. The final guidance document replaces two existing OHRP 
guidance documents on the engagement of institutions in human subjects 
research: (1) The January 26, 1999, document on ``Engagement of 
Institutions in Research,'' and (2) the December 23, 1999, document on 
``Engagement of Pharmaceutical Companies in HHS Supported Research.''

DATES: Comments on OHRP guidance documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled, ``OHRP Guidance on Engagement of Institutions in 
Human Subjects 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 240-453-
6909. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the guidance document. Submit written comments to 
ENGAGEMENT GUIDANCE COMMENTS, Office for Human Research Protections, 
1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may 
be sent via e-mail to [email protected] or via facsimile at 240-453-6909.

FOR FURTHER INFORMATION CONTACT: Ms. Julie Kaneshiro, Office for Human 
Research Protections, Department of Health and Human Services, 1101 
Wootton Parkway, Suite 200, Rockville, MD 20852; 240-453-6900; e-mail 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    OHRP, Office of Public Health and Science, is announcing the 
availability of a guidance document entitled, ``OHRP Guidance on 
Engagement of Institutions in Human Subjects Research.'' HHS, through 
OHRP, regulates research involving human subjects conducted or 
supported by HHS in regulations codified at 45 CFR part 46. The HHS 
human subject protection regulations stipulate substantive and 
procedural requirements for the conduct of HHS-conducted or -supported 
research, including requirements for review and approval by an IRB 
before research involving human subjects may begin, criteria for IRB 
approval of research, and requirements for informed consent or the 
waiver of informed consent.
    The HHS protection of human subjects regulations at 45 CFR 
46.103(a) and (b) require that each institution ``engaged'' in human 
subjects research that is conducted or supported by HHS (1) provide 
OHRP with a satisfactory assurance that the institution will comply 
with the regulations, and (2) certify to the HHS agency conducting or 
supporting the research that the research has been reviewed and 
approved by an IRB designated in the assurance and will be subject to 
continuing review by an IRB, unless all the research meets one or more 
of the categories for exemption from the regulatory requirements under 
45 CFR 46.101(b). The Federalwide Assurance (FWA) is the only type of 
assurance currently accepted by OHRP. The FWA generally identifies 
required policies and procedures for the institution and describes the 
activities to which the regulations apply.
    On January 26, 1999, the Office for Protection from Research Risks 
(OPRR), OHRP's predecessor office, issued guidance on ``Engagement of 
Institutions in Research.'' OPRR later issued guidance on ``Engagement 
of Pharmaceutical Companies in HHS Supported Research,'' dated December 
23, 1999.
    In the Federal Register of December 8, 2006 (71 FR 71169), OHRP 
announced the availability of a draft guidance document entitled, 
``OHRP Guidance on Engagement of Institutions in Human Subjects 
Research,'' dated October 27, 2006, which OHRP proposed would replace 
the two guidance documents that had been issued in 1999. OHRP received 
twenty-four comments on the draft guidance and those comments were 
considered as the guidance was finalized. See section II. Discussion of 
Public Comments for a summary of the main comments received and OHRP's 
responses.
    This guidance is only applicable to HHS-conducted or -supported 
research projects that have been determined to involve human subjects 
and that are not exempt under the HHS regulations at 45 CFR 46.101(b). 
Once an activity is determined to involve non-exempt human subjects 
research, this guidance can be used to determine whether an institution 
involved in some aspect of the research would be considered ``engaged'' 
in human subjects research, and would thus need to (1) hold or obtain 
an applicable OHRP-approved FWA, and (2) certify to the HHS agency 
conducting or supporting the research that the research has been 
reviewed and approved by an IRB designated in the assurance and will be 
subject to continuing review by an IRB.

II. Discussion of Public Comments

    Most of the comments expressed general support for OHRP's draft 
guidance document. Some comments suggested clarifying changes and 
others recommended more substantive changes to the scenarios described 
in the draft guidance. All of the comments received were considered as 
the guidance was finalized. A discussion of the main comments follows.

Institutions Engaged in Human Subjects Research

Awardee Institutions
    OHRP's draft guidance document proposed that institutions that 
receive an award through a grant, contract, or cooperative agreement 
directly from HHS for non-exempt human subjects research (i.e., awardee 
institutions) would generally be considered engaged in human subjects 
research, even where all activities involving human subjects are 
carried out by agents of another institution. A few of the commenters 
urged OHRP to reconsider its view that such awardee institutions should 
generally be considered engaged in human subjects research when all 
activities involving human subjects are carried out by agents of 
another institution. The commenters noted that considering such awardee 
institutions to be engaged in human subjects research often results in 
duplicative review by IRBs and administrative burden for awardee 
institutions that choose to modify their FWAs to rely on another 
institution's IRB to satisfy the regulatory requirements under 45 CFR 
part 46. These commenters questioned whether human subjects were 
offered greater protections by considering such awardee institutions to 
be engaged in human subjects research.
    OHRP believes that institutions that receive an award directly from 
HHS for non-exempt human subjects research should generally be 
considered engaged in human subjects research. However, the office 
understands these commenters' concerns and agrees that in some 
circumstances, institutions that receive an award for non-exempt human 
subjects research, but that do not carry out any of the activities 
involving human subjects, should not be considered engaged in the human 
subjects research. OHRP will continue to consider this issue in 
consultation with the HHS funding agencies.

[[Page 63152]]

Institutions Not Engaged in Human Subjects Research

Release of Identifiable Private Information or Biological Specimens
    In the Federal Register of December 8, 2006 (71 FR 71169), OHRP 
noted that the office was particularly interested in the public's 
comments on the proposal that institutions whose employees or agents 
release to investigators at another institution identifiable private 
information or identifiable biological specimens pertaining to the 
subjects of the research, not be considered engaged in human subjects 
research.
    The public comments supported this proposed scenario. OHRP retained 
this scenario in the final guidance document, with only minor 
clarifying changes (see scenario B.(6) in the final guidance).
Administration of Clinical Trial-Related Medical Services
    In the Federal Register of December 8, 2006 (71 FR 71169), OHRP 
also noted that the office was particularly interested in the public's 
comments on the proposal that institutions (including private 
practices) not selected as research sites whose employees or agents 
administer clinical trial-related medical services, not be considered 
engaged in human subjects research provided that specified conditions 
were met. One of the proposed conditions was that the institution's 
employees or agents do not administer the primary study interventions 
being tested under the protocol.
    The public comments on this proposed scenario were generally 
supportive, but several commenters sought clarifications on some of the 
proposed conditions. In addition, a few of the commenters recommended 
that OHRP expand the scenario to permit the employees or agents of an 
institution not selected as a research site to administer the study 
intervention being tested or evaluated under the protocol, and still 
not consider such an institution to be engaged in human subjects 
research.
    In the final guidance, OHRP retained the proposed scenario, with 
minor changes in response to the public comments (see scenario B.(2) in 
the final guidance). However, OHRP also has included another scenario 
in the final guidance that would allow employees or agents of an 
institution not initially selected as a research site to administer the 
study interventions being tested or evaluated under the protocol, 
provided that this occurs on a one-time or short-term basis, and 
specified conditions are met (see scenario B.(3) in the final 
guidance). OHRP believes this is responsive to the concern raised in a 
public comment that research subjects are sometimes unexpectedly 
hospitalized or otherwise unexpectedly unable to receive a study 
intervention being tested or evaluated in a protocol from an 
institution that had previously been designated as a research site.

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.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document on OHRP's Web site at http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.htm.

    Dated: October 16, 2008.
Ivor A. Pritchard,
Acting Director, Office for Human Research Protections.
[FR Doc. E8-25177 Filed 10-22-08; 8:45 am]
BILLING CODE 4150-36-P