Protection of Human Subjects: Interpretation of Assurance Requirements, 38645-38646 [E6-10511]
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Federal Register / Vol. 71, No. 130 / Friday, July 7, 2006 / Notices
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[FR Doc. E6–10626 Filed 7–6–06; 8:45 am]
BILLING CODE 6210–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Protection of Human Subjects:
Interpretation of Assurance
Requirements
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
cprice-sewell on PROD1PC66 with NOTICES
AGENCY:
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
VerDate Aug<31>2005
15:46 Jul 06, 2006
Jkt 208001
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 HHSconducted 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 (nonU.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:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
38645
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 nonU.S. institutions have a choice of
whether or not the requirements of 45
CFR part 46 must be met for HHSconducted or -supported research
conducted at their institutions. Such an
interpretation would be erroneous. For
HHS-conducted or -supported research,
all institutions holding an OHRPapproved 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 nonU.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
E:\FR\FM\07JYN1.SGM
07JYN1
38646
Federal Register / Vol. 71, No. 130 / Friday, July 7, 2006 / Notices
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]
BILLING CODE 4150–36–P
Catalog of Federal Domestic
Assistance (CFDA) Number: 93.048,
Title IV and Title II, Discretionary
Projects.
Dates: The deadline date for the
submission of applications is August 15,
2006.
I. Funding Opportunity Description
The purpose of this announcement is
to solicit applications for POMP projects
that will complete work on the POMPdeveloped performance measurement
surveys and enhance their utility for the
Aging Network as follows:
• Conduct validity tests for POMP
surveys.
• Conduct pilot testing for statewide
performance measurement
methodology.
• Assist in the development of
performance measurement toolkits for
use by the Aging network.
A detailed description of the funding
opportunity may be found at https://
www.grants.gov.
II. Award Information
1. Funding Instrument Type: Grants.
2. Anticipated Total Priority Area
Funding per Budget Period: These
grants are two-year projects. For the first
year, AoA intends to make available,
under this program announcement,
grant awards for 6 to 10 projects at a
federal share of approximately $35,000$50,000. The maximum award will be
$50,000. Second year award amounts
will be similar to first year amounts,
contingent on the availability of federal
funds and satisfactory progress.
III. Eligibility Criteria and Other
Requirements
1. Eligible Applicants
Eligibility for grant awards is limited
to State Agencies on Aging.
2. Cost Sharing or Matching
Grantees are required to provide at
least 25 percent of the total program
costs from non-federal cash or in-kind
resources in order to be considered for
the award.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
3. DUNS Number
Availability of Funding Opportunity
Announcement
cprice-sewell on PROD1PC66 with NOTICES
Administration on Aging
All grant applicants must obtain a D–
U–N–S number from Dun and
Bradstreet. It is a nine-digit
identification number, which provides
unique identifiers of single business
entities. The D–U–N–S number is free
and easy to obtain from: https://
www.dnb.com/US/duns_update/.
Funding Opportunity Title/Program
Name: Performance Outcomes Measures
Project.
Announcement Type: Initial.
Funding Opportunity Number:
Program Announcement No. HHS–
2006–AoA–PO–0612.
Statutory Authority: The Older
Americans Act, Public Law 106–501.
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15:46 Jul 06, 2006
Jkt 208001
4. Intergovernmental Review
Executive Order 12372,
Intergovernmental Review of Federal
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Programs, is not applicable to these
grant applications.
IV. Application and Submission
Information
1. Address To Request Application
Package
Application kits are available by
writing to the U.S. Department of Health
and Human Services, Administration on
Aging, Office of Evaluation,
Washington, DC 20201, by calling 202–
357–0145, or online at https://
www.grants.gov.
Please note AoA is requiring
applications for this announcement to
be submitted electronically through
https://www.grants.gov. The Grants.gov
registration process can take several
days. If your organization is not
currently registered with
www.grants.gov, please begin this
process immediately. For assistance
with https://www.grants.gov, please
contact Arthur Miller at AoA’s
Grants.gov helpdesk at 202–357–3438.
At https://www.grants.gov, you will be
able to download a copy of the
application packet, complete it off-line,
and then upload and submit the
application via the Grants.gov Web site.
2. Address for Application Submission
Applicants unable to submit their
application via https://www.grants.gov
may request permission to submit a
hard copy from Stephen Daniels,
Director, Office of Grants Management
at Stephen.Daniels@aoa.hhs.gov.
With prior approval, applications may
be mailed to the U.S. Department of
Health and Human Services,
Administration on Aging, Office of
Grants Management, Washington, DC
20201, attn: Stephen Daniels.
With prior approval, Applications
may be delivered (in person, via
messenger) to the U.S. Department of
Health and Human Services,
Administration on Aging, Office of
Grants Management, One Massachusetts
Avenue, NW., Room 4604, Washington,
DC 20001, attn: Stephen Daniels.
If you elect to mail or hand deliver
your application, you must submit one
original and two copies of the
application. Instructions for electronic
mailing of grant applications are
available at https://www.grants.gov.
3. Submission Dates and Times
To receive consideration, applications
must be received by the deadline listed
in the Dates section of this Notice.
V. Responsiveness Criteria
Each application submitted will be
screened to determine whether it was
received by the closing date and time.
E:\FR\FM\07JYN1.SGM
07JYN1
Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4150-36-P