Final Guidance on Engagement of Institutions in Human Subjects Research, 63150-63152 [E8-25177]
Download as PDF
<![CDATA[
63150
Federal Register / Vol. 73, No. 206 / Thursday, October 23, 2008 / Notices
1843) (BHC Act) and Regulation Y (12
CFR Part 225) to engage de novo, or to
acquire or control voting securities or
assets of a company, including the
companies listed below, that engages
either directly or through a subsidiary or
other company, in a nonbanking activity
that is listed in § 225.28 of Regulation Y
(12 CFR 225.28) or that the Board has
determined by Order to be closely
related to banking and permissible for
bank holding companies. Unless
otherwise noted, these activities will be
conducted throughout the United States.
Each notice is available for inspection
at the Federal Reserve Bank indicated.
The notice also will be available for
inspection at the offices of the Board of
Governors. Interested persons may
express their views in writing on the
question whether the proposal complies
with the standards of section 4 of the
BHC Act. Additional information on all
bank holding companies may be
obtained from the National Information
Center website at www.ffiec.gov/nic/.
Unless otherwise noted, comments
regarding the applications must be
received at the Reserve Bank indicated
or the offices of the Board of Governors
not later than November 17, 2008.
A. Federal Reserve Bank of New
York (Ivan Hurwitz, Bank Applications
Officer) 33 Liberty Street, New York,
New York 10045–0001:
1. Banco Santander S.A., Boadilla,
Spain, to acquire 75.1 percent of the
voting shares of Sovereign Bancorp,
Inc., Philadelphia, Pennsylvania, and
thereby indirectly acquire Sovereign
Bank, Wyomissing, Pennsylvania, and
thereby engage in operating a savings
and loan associationm pursuant to
section 225.28(b)(4)(ii) of Regulation Y.
Board of Governors of the Federal Reserve
System, October 20, 2008.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E8–25296 Filed 10–22–08; 8:45 am]
BILLING CODE 6210–01–S
dwashington3 on PRODPC61 with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
NTP Interagency Center for the
Evaluation of Alternative Toxicological
Methods (NICEATM); Availability of the
Biennial Progress Report of the
Interagency Coordinating Committee
on the Validation of Alternative
Methods (ICCVAM): NIH Publication
No. 08–6529
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
AGENCY:
VerDate Aug<31>2005
14:58 Oct 22, 2008
Jkt 217001
Availability of the ICCVAM
Biennial Progress Report.
ACTION:
SUMMARY: NICEATM announces the
availability of the ‘‘Biennial Progress
Report: Interagency Coordinating
Committee on the Validation of
Alternative Methods: 2006–2007.’’ In
accordance with requirements of the
ICCVAM Authorization Act of 2000 (42
U.S.C. 285l–3), this report describes
progress and activities during 2006–
2007 by ICCVAM and NICEATM. The
report is available on the NICEATM–
ICCVAM Web site at https://
iccvam.niehs.nih.gov/about/
ICCVAMrpts.htm. Copies can also be
requested from NICEATM at the address
given below.
Requests for copies of the
report should be sent by mail, fax, or
email to Dr. William S. Stokes,
NICEATM Director, NIEHS, P.O. Box
12233, MD EC–17, Research Triangle
Park, NC 27709, (phone) 919–541–2384,
(fax) 919–541–0947, (e-mail)
niceatm@niehs.nih.gov. Courier address:
NICEATM, 79 T.W. Alexander Drive,
Building 4401, Room 3128, Research
Triangle Park, NC 27709.
ADDRESSES:
Dr.
William S. Stokes, NICEATM Director
(919–541–2384 or
niceatm@niehs.nih.gov).
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Background Information on ICCVAM,
NICEATM, and SACATM
ICCVAM is an interagency committee
composed of representatives from 15
Federal regulatory and research agencies
that use, generate, or disseminate
toxicological information. ICCVAM
conducts technical evaluations of new,
revised, and alternative methods with
regulatory applicability. ICCVAM also
promotes scientific validation,
regulatory acceptance, and national and
international harmonization of
toxicological test methods that more
accurately assess safety and hazards of
chemicals and products and that refine,
reduce, and replace animal use. The
ICCVAM Authorization Act of 2000 (42
U.S.C. 285l–3, available at https://
iccvam.niehs.nih.gov/docs/about_docs/
PL106545.pdf) established ICCVAM as a
permanent interagency committee of the
NIEHS under NICEATM. NICEATM
administers ICCVAM and provides
scientific and operational support for
ICCVAM-related activities. NICEATM
and ICCVAM collaborate in evaluating
new and improved test methods
applicable to the needs of Federal
agencies. Additional information about
ICCVAM and NICEATM can be found at
PO 00000
Frm 00019
Fmt 4703
Sfmt 4703
the NICEATM–ICCVAM Web site
(https://iccvam.niehs.nih.gov).
ICCVAM, NICEATM, and the Director
of the NIEHS receive advice regarding
statutorily mandated duties of ICCVAM
and activities of NICEATM from the
Scientific Advisory Committee on
Alternative Toxicological Methods
(SACATM), a Federally chartered
advisory committee. Additional
information about SACATM, including
the charter, roster, and records of past
meetings, can be found at https://
ntp.niehs.nih.gov/go/167.
Dated: October 8, 2008.
Samuel H. Wilson,
Acting Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E8–25223 Filed 10–22–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Final Guidance on Engagement of
Institutions in Human Subjects
Research
Office for Human Research
Protections, Office of Public Health and
Science, Office of the Secretary, HHS.
ACTION: Notice.
AGENCY:
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,
E:\FR\FM\23OCN1.SGM
23OCN1
Federal Register / Vol. 73, No. 206 / Thursday, October 23, 2008 / Notices
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.’’
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 ohrp@hhs.gov 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
julie.kaneshiro@hhs.gov.
DATES:
SUPPLEMENTARY INFORMATION:
dwashington3 on PRODPC61 with NOTICES
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 HHSconducted 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
VerDate Aug<31>2005
14:58 Oct 22, 2008
Jkt 217001
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
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
63151
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.
E:\FR\FM\23OCN1.SGM
23OCN1
63152
Federal Register / Vol. 73, No. 206 / Thursday, October 23, 2008 / Notices
Institutions Not Engaged in Human
Subjects Research
dwashington3 on PRODPC61 with NOTICES
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-
VerDate Aug<31>2005
14:58 Oct 22, 2008
Jkt 217001
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 https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Community-Based Abstinence
Education Performance Progress Report.
OMB No.: 0970–0272.
Description: The discretionary
funding Community-Based Abstinence
Education Program (CBAE) is
authorized by Title XI, Section 1110, of
the Social Security Act (using the
definitions contained in Title V, Section
510(b)(2) of the Social Security Act).
Performance Progress Report/Program
Narrative
The CBAE Performance Progress
Report/Program Narrative is a
semiannual report form through which
grantees report performance information
used by the Administration for Children
and Families (ACF) to evaluate each
grantee’s compliance with Federal law
and progress toward achieving its goals.
Performance information includes:
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
Description of major activities and
accomplishments during the reporting
period;
Description of deviations or
departures from the original project;
Description of significant findings and
events;
Description of dissemination
activities;
Description of other activities; and
Description of activities planned for
the next reporting period, including
goals and objectives.
Program-Specific Performance Measure
The CBAE program is developing a
program-specific performance measure
in response to the PART review (a
process by which the Office of
Management and Budget analyzes and
rates a Federal program’s procedures
and strategies for evaluating its
effectiveness), for which the program
received a rating of Adequate. In an
effort to gather program-specific data on
rates of abstinence pre- and postprogram participation, ACF and the
Office of Management and Budget
determined that a program-specific
performance measure should be
developed to assess key outcomes
among program participants. The CBAE
office convened a panel of abstinence
education experts to gather input on the
measure, and, based on the input
provided, the CBAE office is developing
the measure. CBAE grantees will be
required to ask ten to fifteen questions
of the youth served in a pre- and postsurvey, as well as a representative
sample of the youth served in a postpost-survey.
The questions are being carefully
constructed by an experienced evaluator
to measure initiation and
discontinuation of sexual intercourse as
well as two key predictors of initiation:
Sexual values and behavioral intentions.
The program office will collect and
compile data to establish baselines and
ambitious targets for the programspecific performance measure. The data
will be aggregated and results will be
shared with the public as they become
available.
Respondents: Performance Progress
Report/Program Narrative—Non-profit
community-based organizations, faithbased organizations, schools/school
districts, universities/colleges,
hospitals, public health agencies, local
governments, Tribal councils, small
businesses/for-profit entities, housing
authorities, etc. Program-Specific
Performance Measure—Youth
Participants.
E:\FR\FM\23OCN1.SGM
23OCN1
]]>Agencies
[Federal Register Volume 73, Number 206 (Thursday, October 23, 2008)]
[Notices]
[Pages 63150-63152]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25177]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 ohrp@hhs.gov 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
julie.kaneshiro@hhs.gov.
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 https://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
