[Federal Register Volume 71, Number 130 (Friday, July 7, 2006)]
[Notices]
[Pages 38645-38646]
From the Federal Register Online via the Government Publishing 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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