[Federal Register Volume 71, Number 130 (Friday, July 7, 2006)]
[Notices]
[Pages 38645-38646]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10511]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Protection of Human Subjects: Interpretation of Assurance 
Requirements

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

ACTION: Notice.

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SUMMARY: The Office of Public Health and Science, Office of the 
Secretary, Department of Health and Human Services (HHS) is providing 
public notice to clarify a requirement contained in the Federalwide 
Assurance (FWA) form for international (non-U.S.) institutions, 
approved by the Office for Human Research Protections (OHRP) under the 
HHS protection of human subjects regulations. HHS clarifies that the 
requirements of HHS regulations must be satisfied for all HHS-conducted 
or -supported research covered by an FWA, regardless of whether the 
research is conducted domestically or internationally. To date, HHS has 
not deemed any other procedural standards equivalent to the protection 
of human subjects.

FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, Office for Human 
Research Protections, Office of Public Health and Science, The Tower 
Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, (240) 
453-6900, facsimile (301) 402-2071; e-mail: Irene.Stith-
Coleman@hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Health and Human Services (HHS), through the 
Office for Human Research Protections (OHRP), regulates research 
involving human subjects conducted or supported by HHS. The Federal 
Policy for the Protection of Human Subjects (the Common Rule), adopted 
by 14 other departments and agencies, is codified for HHS at 45 CFR 
part 46, subpart A.
    The HHS protection of human subjects regulations apply to all 
research involving human subjects conducted, supported or otherwise 
subject to regulation by HHS. 45 CFR 46.101(a). Each institution 
engaged in HHS-conducted or -supported human subjects research must 
provide written assurance, satisfactory to the Secretary of HHS, that 
it will comply with the HHS protection of human subjects regulations. 
[45 CFR 46.103(a)]
    The FWA is the only form of assurance currently accepted by OHRP. 
The FWA was designed to be used by HHS as well as the other departments 
and agencies that have adopted the Common Rule. The FWA consists of two 
documents, the FWA form and the FWA Terms of Assurance, which are 
incorporated by reference into the FWA form. There are separate FWA 
forms and Terms of Assurance for U.S. domestic institutions and for 
international (non-U.S.) institutions. The ``Applicability'' section of 
the FWA form for international (non-U.S.) institutions includes several 
national and international procedural standards to which the 
institution can indicate its adherence, including the HHS regulations 
for the protection of human subjects, 45 CFR part 46. The FWA Terms of 
Assurance for international (non-U.S.) institutions state as follows:

If a U.S. Federal department or agency head determines that the 
procedures prescribed by the institution afford protections that are 
at least equivalent to those provided by the U.S. Federal Policy for 
the Protection of Human Subjects, the department or agency head may 
approve the substitution of the foreign procedures in lieu of the 
procedural requirements provided above [the requirements of the U.S. 
Federal Policy], consistent with the requirements of section 101(h) 
of the U.S. Federal Policy for the Protection of Human Subjects.

II. Clarification of HHS' Position

    Some regulated institutions may have been confused by the fact that 
several national and international procedural standards are listed on 
the FWA form for international (non-U.S.) institutions, and interpreted 
this to mean that non-U.S. institutions have a choice of whether or not 
the requirements of 45 CFR part 46 must be met for HHS-conducted or -
supported research conducted at their institutions. Such an 
interpretation would be erroneous. For HHS-conducted or -supported 
research, all institutions holding an OHRP-approved FWA and engaged in 
such research must comply with the requirements of 45 CFR part 46. That 
compliance is required regardless of whether the institution marked one 
or more other procedural standards on the FWA form for international 
(non-U.S.) institutions as a standard to which the institution 
committed itself to comply.
    For example, if a non-U.S. institution selects a procedural 
standard on its FWA that does not explicitly require continuing review 
by an institutional review board (IRB) at least annually, the 
institution still must ensure that an IRB designated under the FWA 
conducts continuing review of non-exempt human subjects research 
supported by HHS at intervals appropriate to the degree of risk, but no 
less than once per year, as required by HHS regulations at 45 CFR 
46.109(e). Likewise, if a non-U.S. institution selects a procedural 
standard on its FWA that does not explicitly require that an IRB retain 
IRB records for at least three years after the completion of research 
which is conducted, the institution still must ensure that such IRB 
records are retained for at least three years after completion of any 
non-exempt human subjects research supported by HHS, as required by HHS 
regulations at 45 CFR 46.115(b).
    As stated in the FWA Terms of Assurance for international (non-
U.S.) institutions, the Secretary has the authority to determine that 
alternative procedural standards provide protections at least 
equivalent to those provided by the HHS protection of

[[Page 38646]]

human subjects regulations, and to allow compliance with the 
alternative procedures rather than with the HHS regulatory 
requirements. 45 CFR 46.101(h). However, to date, the Secretary has not 
made any determinations that other procedures provide equivalent 
protections to those afforded by the HHS regulations. HHS continues to 
consider whether, and how, to implement the regulatory authority to 
allow compliance with alternative procedural standards in place of 
compliance with 45 CFR part 46. One or more determinations that 
alternative procedural standards provide protections at least 
equivalent to those of 45 CFR part 46 may be made at some time in the 
future, but until such time, 45 CFR part 46 is the procedural standard 
which must be complied with for all HHS-conducted or -supported human 
subjects research conducted domestically or internationally.
    The heads of other Common Rule departments and agencies may 
independently reach different conclusions about which, if any, 
procedural standard(s) to accept as providing protections at least 
equivalent to the Common Rule. This is among the reasons that multiple 
procedural standards are included on the FWA form for international 
(non-U.S.) institutions, which may be relied upon by all Common Rule 
departments and agencies.
    HHS believes that this view provides the greatest protection to 
human subjects of research conducted or supported by HHS, and is the 
most ethically defensible position.

    Dated: June 23, 2006.
Bernard A. Schwetz,
Director, Office for Human Research Protections.
[FR Doc. E6-10511 Filed 7-6-06; 8:45 am]
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