Protection of Human Subjects, Proposed Criteria for Determinations of Equivalent Protection, 15322-15327 [05-5947]
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Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices
highest priority and 5.0, lowest
priority). Final grant award decisions
will be made by the Deputy Assistant
Secretary for Population Affairs
(DASPA) on the basis of priority score,
program relevance, and the availability
of funds.
VI. Award Administration Information
1. Notification of Award
The OPA does not release information
about individual applications during the
review process. When a final funding
decision has been made, each applicant
will be notified by letter of the outcome.
The official document notifying an
applicant that a project application has
been approved for funding is the Notice
of Grant Award, which specifies the
amount of money awarded, the purpose
of the grant, the length of the project
period, and the terms and conditions of
the award.
2. Administrative and National Policy
Requirements
In accepting this award, the recipient
stipulates that the award and any
activities thereunder are subject to all
provisions of 45 CFR parts 74 and 92,
currently in effect or implemented
during the period of the grant.
A Notice providing information and
guidance regarding the ‘‘Governmentwide Implementation of the President’s
Welfare-to-Work Initiative for Federal
Grant Programs’’ was published in the
Federal Register on May 16, 1997. This
initiative was designated to facilitate
and encourage grant recipients and their
sub-recipients to hire welfare recipients
and to provide additional needed
training and/or mentoring as needed.
The text of the Notice is available
electronically on the OMB home page at
https://www.whitehouse.gov/omb.
3. Reporting Requirement
At the completion of the project, the
grant recipient must submit a brief
summary in 2,500 to 4,000 words,
written in non-scientific (laymen’s)
terms and Financial Status Report (SF–
269). The narrative should highlight the
findings and their implications for
improving family planning service
delivery. A plan for disseminating
research findings should accompany the
narrative. This plan should indicate
how products of the research will be
made accessible to the Office of
Population Affairs, as well as to the
Title X family planning administrators
and practitioners, researchers, and State
and local policy-makers. The summary,
plan, and Financial Status Report must
be mailed to the Grants Management
Specialist identified on the Notice of
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Grant Award within 90 days of the
project’s completion.
VII. Agency Contacts
For information on specific research
or program requirements, contact
Eugenia Eckard, Office of Population
Affairs, 1101 Wootton Parkway, Suite
700 Rockville, MD 20852, (301) 594–
4001, or via e-mail at
eeckard@osophs.dhhs.gov. For
assistance on administrative and
budgetary requirements, contact the
OPHS Grants Management Office, 1101
Wootton Parkway, Suite 550, Rockville,
MD, (301) 594–0758, or via e-mail at
kcampbell@osophs.dhhs.gov.
Dated: March 21, 2005.
Alma L. Golden,
Deputy Assistant Secretary for Population
Affairs.
[FR Doc. 05–5945 Filed 3–24–05; 8:45 am]
BILLING CODE 4150–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Protection of Human Subjects,
Proposed Criteria for Determinations
of Equivalent Protection
Department of Health and
Human Services, Office of the Secretary.
AGENCY:
ACTION:
Notice.
SUMMARY: The Office of Public Health
and Science, Department of Health and
Human Services (HHS) solicits public
comment on criteria that have been
recommended to the Office for Human
Research Protections (OHRP) for making
determinations of whether procedures
prescribed by institutions outside the
United States afford protections that are
at least equivalent to those provided in
the Federal Policy for the Protection of
Human Subjects (codified by HHS as 45
CFR part 46, subpart A, and equivalent
regulations of 14 Departments and
Agencies, collectively referred to as the
Federal Policy or the Common Rule).
Submit written or electronic
comments on the recommended criteria
for making determinations of equivalent
protection on or before May 24, 2005.
DATES:
Submit written comments
to Ms. Gail Carter, Division of Policy
and Assurances, Office for Human
Research Protections, 1101 Wootton
Parkway, Suite 200, The Tower
Building, Rockville, MD 20852,
telephone number (301) 402–4521 (not
a toll-free number). Comments also may
be sent via facsimile to (301) 402–0527
or by e-mail to:
EQFRN@osophs.dhhs.gov.
ADDRESSES:
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Glen
Drew, Office for Human Research
Protections, Office of Public Health and
Science, The Tower Building, 1101
Wootton Parkway, Suite 200, Rockville,
MD 20852, (301) 402–4994, facsimile
(301) 402–2071; e-mail:
gdrew@osophs.dhhs.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Background
The HHS codification of the Federal
Policy states at 45 CFR 46.101(h):
(h) When research covered by this policy
takes place in foreign countries, procedures
normally followed in the foreign countries to
protect human subjects may differ from those
set forth in this policy. [An example is a
foreign institution which complies with
guidelines consistent with the World Medical
Assembly Declaration (Declaration of
Helsinki amended 1989) issued either by
sovereign states or by an organization whose
function for the protection of human research
subjects is internationally recognized.] In
these circumstances, if a Department or
Agency head determines that the procedures
prescribed by the institution afford
protections that are at least equivalent to
those provided in this policy, the Department
or Agency head may approve the substitution
of the foreign procedures in lieu of the
procedural requirements provided in this
policy. Except when otherwise required by
statute, Executive Order, or the Department
or Agency head, notices of these actions as
they occur will be published in the Federal
Register or will be otherwise published as
provided in Department or Agency
procedures.
No formal findings of equivalent
protection have been published in the
Federal Register since the Federal
policy was finalized in June, 1991. Use
of the authority provided by 45 CFR
46.101(h) has been advocated by various
parties, including the National Bioethics
Advisory Commission in its April, 2001
report ‘‘Ethical and Policy Issues in
International Research: Clinical Trials in
Developing Countries,’’ and the HHS
Inspector General in the September,
2001 Report ‘‘The Globalization of
Clinical Trials: A Growing Challenge in
Protecting Human Subjects.’’ The
authority of the Secretary of Health and
Human Services has been delegated to
OHRP (68 FR 60392), and in considering
use of the 45 CFR 46.101(h) authority,
OHRP recognized a need for using
consistent criteria as a basis for
decisions regarding equivalent
protections. During 2002, the OHRP
Director established a working group of
representatives from interested HHS
agencies, with staff support from OHRP,
to consider potential criteria for use in
making such decisions. The working
group delivered its report in July 2003.
That report recommends a framework
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for implementing the existing regulatory
authority of 45 CFR 46.101(h). The full
working group report recommends the
approach and criteria described in this
notice and is available at https://
www.hhs.gov/ohrp/international/
EPWGReport2003.pdf and the appendix
table is available at https://www.hhs.gov/
ohrp/international/
FPGWFramework.pdf, or by request to
either of the addresses given above.
3.c. What, if any, alterations or
additions to the proposed criteria would
be helpful in assessing whether
procedures followed in foreign
countries provide protections at least
equivalent to those provided by the
Federal Policy?
4. Is the procedure recommended by
the working group for seeking a finding
of equivalent protections under 45 CFR
46.101(h) appropriate?
II. Request for Comments
OHRP has solicited and considered
comments from the other agencies that
have adopted the Federal Policy, and
now solicits public comment on the
working group’s recommended criteria
for making determinations whether
procedures prescribed by institutions
outside the United States provide
protections that are at least equivalent to
those provided by the Federal Policy.
OHRP will consider all public
comments in deciding whether, and if
so how, to proceed with implementing
the authority under 45 CFR 46.101(h).
Draft guidance describing OHRP’s
proposed method of implementing this
authority would be published for public
comment before OHRP would issue
final guidance on this topic.
OHRP neither endorses nor rejects the
content, conclusions, or
recommendations in the working
group’s report, but particularly solicits
public comment on several questions
related to the approach and criteria
recommended in the report:
1. Is the recommended approach
appropriate for implementing the
authority under 45 CFR 46.101(h)?
1.a. Is it preferable to make
determinations of equivalent protections
on the basis of submissions by
individual institutions or on the basis of
national or international procedural
standards that may be relied upon by
multiple institutions without repeated
assessments?
2. Could an alternative approach
provide equal or greater effectiveness
and efficiency for implementation of
this authority?
2.a. If so, what approach and why
would effectiveness or efficiency be
improved?
3. Do the recommended criteria
appropriately and adequately describe
the protections provided to human
subjects by the Federal Policy?
3.a. Do the regulatory provisions the
working group cited as contributing to
particular protections provided by the
Federal Policy relate directly to those
protections? (See Table 1.)
3.b. Should other regulatory
provisions be cited as relating to
particular protections?
III. Framework Proposed in Working
Group Report
The working group report concluded
that
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The primary focus of the U.S. policy is the
accountability of the research institution for
the welfare and rights of human subjects. The
overarching goal of the specific
accountability mechanisms and procedures
described in the policy is to establish
expectations of ethical conduct within the
research institution. The responsibility for
achieving these aims is shared by the
institution, the Institutional Review Board
(IRB), or Research Ethics Committee (REC),
and the relevant U.S. Agency or Department
head. Although investigators are critical
actors in achieving these goals, the policy
provides very little explicit guidance to
investigators and therefore suggests that the
protection of human subjects depends largely
on the proper promotion and conscientious
execution of standard practices and
procedures, including those related to
research ethics review, within the institution.
The working group proposed an
approach to equivalent protections that
involves five separate steps, the first of
which is to identify the specific
protections provided by 45 CFR part 46
subpart A, followed by three steps of
determining the equivalence of the
protections offered by the set of
procedures employed in foreign
research institutions, and the fifth step
is to provide an assurance that these
procedures will be followed within the
institution.
Steps in determining equivalence.
(1) Articulation of the specific
protections embodied in 45 CFR part 46
subpart A.
(2) Assessment of the protections
provided by the institution’s
procedures.
(3) Comparison of the protections
provided by the institution’s procedures
with those provided by 45 CFR part 46
subpart A and determination whether or
not the institution’s procedures provide
at least equivalent protections.
(4) Approval of the relevant
department or agency head for the
substitution of the institutional
procedures in lieu of the procedures of
45 CFR part 46 subpart A.
Mechanism of assurance with OHRP.
(5) Assurance from the institution that
the substituted procedures will be
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followed in the conduct of human
subjects research funded by HHS. The
assurance will be completed and filed
with OHRP.
The working group identified 7
specific protections afforded by 45 CFR
part 46 subpart A that it recommended
be included in the determination of
equivalence:
Establish norms of ethical conduct
and due diligence in review and
performance of research within the
institution;
Ensure adequate authority and
independence of the IRB/Research
Ethics Committee;
Protect against biased decision
making and arbitrary decisions in
research ethics review;
Ensure sufficient quality and
comprehensiveness of research ethics
review;
Ensure research ethics review and
oversight are commensurate with risks
to research subjects and vulnerability of
the study population;
Protect against unnecessary or
unjustified risk throughout the course of
the study; and
Ensure voluntary participation after
adequate disclosure of information
related to the study.
The working group concluded that
each of these protections is necessary
for a determination of equivalent
protections. It also concluded that each
protection may be achieved in a number
of different ways, including the use of
procedures that differ from those
provided in 45 CFR part 46 subpart A.
In making determinations of
equivalence, the working group
recommended that OHRP assess
whether the procedures employed by
the foreign institution are able to satisfy
each of these protections individually
and in the aggregate.
The working group also
recommended that, based on a
recommendation from OHRP following
a comparison of the protections
provided by the institution’s procedures
and 45 CFR part 46 subpart A, the
Secretary of HHS may find that the
institution’s procedures provide at least
equivalent protections and approve the
substitution of these procedures in lieu
of those of 45 CFR part 46 subpart A.
The working group concluded that a
determination of equivalent protections
does not affect OHRP’s oversight
authority for HHS funded research
conducted within the institution. The
working group considered the authority
of OHRP to conduct on-going
assessment of the equivalence of the
institution’s procedures and protections
to be a protection implied in 45 CFR
part 46 subpart A, though not part of the
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assessment of the protections provided
by an institution’s procedures.
Similarly, the substitution of the
institution’s procedures in lieu of those
of 45 CFR part 46 subpart A does not
obviate the need for the institution to
enter into an assurance with OHRP that
the procedures will be followed by the
institution in the conduct of HHS
funded research. An assurance is a legal
promise to comply with certain
conditions attached to the provision of
U.S. federal research funding.
To show the relationship between the
Federal Policy and each of the seven
protections the working group discerned
in the Federal Policy, it developed a
table matching the protections with
provisions of 45 CFR part 46 subpart A
that contribute to each of the
protections. The center column of the
table provides examples of procedures
that the working group thought
institutions might use to provide the
protection related to those regulatory
provisions. The table appears below.
Appendix
TABLE 1.—FRAMEWORK FOR EQUIVALENT PROTECTIONS
Specific protection
Example procedures
45 CFR part 46 subpart A authority
INSTITUTIONAL RESPONSIBILITIES
Establish norms of ethical conduct
and due diligence in review and
performance of research within
the institution.
—Institutional statement of principles.
—Procedures for review ................
—Procedures for reporting to Research Ethics Committee (REC).
—Procedures for REC record
keeping.
—Statement of investigator responsibilities.
—Effective dissemination of REC
submission procedures.
—Investigator training ....................
Ensure adequate authority,
independence of IRB.
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—Documentation of REC authority
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46.103(a); 46.103 (f) Establish and satisfy terms of assurance.
46.103(b)(1) Develop or adopt statement of principles governing institution’s human subjects protections responsibilities.
46.103(b)(4) Ensure initial and continuing review of research; determine necessary frequency of review for each study; determine
where external verification is necessary that no material changes
have occurred since last IRB review; establish procedures for IRB
reporting of findings and actions to institution and investigator(s).
46.103(b)(5) Establish and 46.108 (a) follow written procedures for
prompt reporting to IRB and Institutional officials of:
—Unanticipated problems involving risk to subjects or others, or noncompliance with the policy;
—Suspension or termination of IRB approval.
46.103(b)(4) Ensuring prompt reporting to the IRB of proposed
changes in a research activity, and for ensuring that such changes
in approved research, during the period for which IRB approval has
already been given, may not be initiated without IRB review and
approval except when necessary to eliminate apparent immediate
hazards to the subject.
46.103(b)(5) Written procedures for ensuring prompt reporting to the
IRB, appropriate institutional officials, and the Department or Agency head of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this
policy or the requirements or determinations of the IRB; and (ii)
any suspension or termination of IRB approval.
46.115 An institution, or when appropriate an IRB, shall prepare and
maintain adequate documentation of IRB activities. The records required by this policy shall be retained for at least 3 years, and
records relating to research which is conducted shall be retained
for at least 3 years after completion of the research. All records
shall be accessible for inspection and copying by authorized representatives of the Department or Agency at reasonable times and
in a reasonable manner.
46.109(a); 46.109 (e) grant and ensure necessary authority for IRB,
including: discretion to review, approve, require modifications, or
disapprove research activities; increase information for informed
consent, observe, or have third party observe consent process and
research.
46.112 Research covered by this policy that has been approved by
an IRB may be subject to further appropriate review and approval
or disapproval by officials of the institution. However, those officials
may not approve the research if it has not been approved by an
IRB.
46.113 An IRB shall have authority to suspend or terminate approval
of research that is not being conducted in accordance with the
IRB’s requirements or that has been associated with unexpected
serious harm to subjects.
46.110(b) Under an expedited review procedure, the review may be
carried out by the IRB chairperson or by one or more experienced
reviewers designated by the chairperson from among members of
the IRB. In reviewing the research, the reviewers may exercise all
of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only
after review in accordance with the non-expedited procedure set
forth in § 46.108(b).
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15325
TABLE 1.—FRAMEWORK FOR EQUIVALENT PROTECTIONS—Continued
Specific protection
Example procedures
45 CFR part 46 subpart A authority
—REC member(s) unaffiliated with
the institution.
46.107(d) Each IRB shall include at least one member who is not
otherwise affiliated with the institution and who is not part of the
immediate family of a person who is affiliated with the institution.
Research Ethics Committee (REC) Responsibilities
Appropriate Scope and Quality of Review:
Protect against biased decision
making and arbitrary decisions in
research ethics review.
—Public accessibility of REC
membership and affiliation within
institution.
—Institutional policy on REC conflict of interest.
—REC membership to reflect:
independence, unaffiliated member(s).
Ensure sufficient quality and comprehensiveness of review.
—REC membership to reflect
competence,
comprehensiveness of review; adequate expertise for study population; diversity of representation; gender
balance.
Ensure research ethics review and
oversight are commensurate with
risks to research subjects and
vulnerability of the study population.
—Procedures for continuing review and monitoring commensurate with risk.
—Procedures for evaluating risk
and benefit.
Procedures for reviewing selection
of subjects and safeguards provided.
—Procedures for IRB reporting to
investigators.
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46.103(b)3 A list of IRB members identified by name; earned degrees; representative capacity; indications of experience such as
board certifications, licenses, etc., sufficient to describe each member’s chief anticipated contributions to IRB deliberations. Disclosure
of any employment or other relationship between each [IRB] member and the institution.
46.107(a) IRB membership. (see 45 CFR 46 for specific criteria).
46.107(b) Gender balance.
46.107(c) Each IRB shall include at least one member whose primary
concerns are in scientific areas and at least one member whose
primary concerns are in nonscientific areas.
46.107(d) Each IRB shall include at least one member who is not
otherwise affiliated with the institution and who is not part of the
immediate family of a person who is affiliated with the institution.
46.107(e) No IRB may have a member participate in the IRB’s initial
or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
46.107(b) Gender balance.
46.107(c) Each IRB shall include at least one member whose primary
concerns are in scientific areas and at least one member whose
primary concerns are in nonscientific areas.
46.107(d) Each IRB shall include at least one member who is not
otherwise affiliated with the institution and who is not part of the
immediate family of a person who is affiliated with the institution.
46.107(f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB.
These individuals may not vote with the IRB.
46.108(b) Except when an expedited review procedure is used (see
§ 46.110), review proposed research at convened meetings at
which a majority of the members of the IRB are present, including
at least one member whose primary concerns are in nonscientific
areas. In order for the research to be approved, it shall receive the
approval of a majority of those members present at the meeting.
46.109(e) An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but
not less than once per year, and shall have authority to observe or
have a third party observe the consent process and the research.
46.110(b) Expedited Review.
46.111(a)(2) In evaluating risks and benefits, the IRB should consider
only those risks and benefits that may result from the research (as
distinguished from risks and benefits of therapies subjects would
receive even if not participating in the research). The IRB should
not consider possible long-range effects of applying knowledge
gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall
within the purview of its responsibility.
46.111(a)(3) Selection of subjects as equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and
should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
46.113 Any suspension or termination or approval shall include a
statement of the reasons for the IRB’s action and shall be reported
promptly to the investigator, appropriate institutional officials, and
the Department or Agency head.
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TABLE 1.—FRAMEWORK FOR EQUIVALENT PROTECTIONS—Continued
Specific protection
Example procedures
45 CFR part 46 subpart A authority
Protect against unnecessary or unjustified risk throughout the
course of the study.
—REC membership policy reflects
adequate expertise and experience.
46.107(a) If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant
women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who
are knowledgeable about and experienced in working with these
subjects.
46.111(a)(1) Risks to subjects are minimized: (i) by using procedures
which are consistent with sound research design and which do not
unnecessarily expose subjects to risks, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
46.111(a)(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
46.111(a)(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and
should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
46.111(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners,
pregnant women, mentally disabled persons, or economically or
educationally disadvantaged persons, additional safeguards have
been included in the study to protect the rights and welfare of
these subjects.
46.111(a)(6) When appropriate, the research plan makes adequate
provision for monitoring the data collected to ensure the safety of
subjects.
46.109(e) An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but
not less than once per year, and shall have authority to observe or
have a third party observe the consent process and the research.
—Policy
has
provisions
for
supplementing expertise, experience and disciplinary perspective as required.
—Procedures for review of minimization of risk.
—Procedures for reviewing selection of subjects and safeguards
provided.
—Procedures for continued oversight and monitoring.
Ensure voluntary participation after
adequate disclosure of information related to the study.
—Policies on obtaining verifiable
informed consent.
—Policies on types of information
to be disclosed in the informed
consent process.
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46.116 Except as provided elsewhere in this policy, no investigator
may involve a human being as a subject in research covered by
this policy unless the investigator has obtained the legally effective
informed consent of the subject or the subject’s legally authorized
representative. An investigator shall seek such consent only under
circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.
46.111(a)(4) Informed consent will be sought from each prospective
subject or the subject’s legally authorized representative, in accordance with, and to the extent required by § 46.116.
46.111(a)(5) Informed consent process will be appropriately documented, in accordance with, and to the extent required by
§ 46.117.
46.116 The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.
46.117(a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the
subject’s legally authorized representative.
46.109(b) An IRB shall require that information given to subjects as
part of informed consent is in accordance with § 46.116. The IRB
may require that information, in addition to that specifically mentioned in § 46.116, be given to the subjects when in the IRB’s judgment the information would meaningfully add to the protection of
the rights and welfare of subjects.
46.109(c) An IRB shall require documentation of informed consent or
may waive documentation in accordance with § 46.117.
46.109(e) An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but
not less than once per year, and shall have authority to observe or
have a third party observe the consent process and the research.
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15327
TABLE 1.—FRAMEWORK FOR EQUIVALENT PROTECTIONS—Continued
Specific protection
Example procedures
45 CFR part 46 subpart A authority
46.111(a)(4) Informed consent will be sought from each prospective
subject or the subject’s legally authorized representative, in accordance with, and to the extent required by § 46.116.
46.116(a)(1–8) Necessary elements of disclosure.
46.116(b)(1–6) Necessary elements of disclosure.
46.116(c)(1–2) Waiver of informed consent.
46.116(d)(1–4) Approval of alternate consent procedures or waiver.
46.117(a) Written informed consent.
Bernard A. Schwetz,
Director, Office for Human Research
Protections.
[FR Doc. 05–5947 Filed 3–24–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
The National Center for Chronic
Disease Prevention and Health
Promotion
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention announces the
following meeting.
Name: Interagency Committee on Smoking
and Health.
Time and Date: 9 a.m.–4:30 p.m., April 13,
2005.
Place: Omni Shoreham Hotel, Hampton
Ballroom, 2500 Calvert Street, NW.,
Washington, DC 20008. Telephone: 202–234–
0700.
Status: Open to the public, limited only by
the space available. Those who wish to
attend are encouraged to register with the
contact person listed below. If you will
require a sign language interpreter, or have
other special needs, please notify the contact
person by 4:30 e.s.t. on April 4, 2005.
Purpose: The Interagency Committee on
Smoking and Health advises the Secretary,
Department of Health and Human Services,
and the Assistant Secretary for Health in the
(a) coordination of all research and education
programs and other activities within the
Department and with other Federal, State,
local and private agencies and (b)
establishment and maintenance of liaison
with appropriate private entities, Federal
agencies, and State and local public health
agencies with respect to smoking and health
activities.
Matters to be Discussed: The agenda will
focus on addressing the Global Tobacco
Epidemic.
For Further Information Contact:
Substantive program information as well as
summaries of the meeting and roster of
committee members may be obtained from
the Internet at https://www.cdc.gov/tobacco in
mid-May or from Ms. Monica L. Swann,
Management and Program Analyst, Office on
VerDate jul<14>2003
16:11 Mar 24, 2005
Jkt 205001
Smoking and Health, 200 Independence
Avenue, SW., Suite 317B, Washington, DC
20201, (202) 205–8500.
Agenda items are subject to change as
priorities dictate.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: March 18, 2005.
Alvin Hall,
Director, Management Analysis and Service
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–5913 Filed 3–24–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors,
National Center for Infectious Diseases
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following committee
meeting.
Name: Board of Scientific Counselors,
National Center for Infectious Diseases
(NCID).
Times and Dates: 9 a.m.–5:30 p.m., May
12, 2005. 8:30 a.m.–2 p.m., May 13, 2005.
Place: CDC, Auditorium B, Building 1,
1600 Clifton Road, Atlanta, Georgia 30333.
Status: Open to the public, limited only by
the space available.
Purpose: The Board of Scientific
Counselors, NCID, provides advice and
guidance to the Director, CDC, and Director,
NCID, in the following areas: program goals
and objectives; strategies; program
organization and resources for infectious
disease prevention and control; and program
priorities.
Matters To Be Discussed: Agenda items
will include:
1. Opening Session: NCID Update.
2. Futures Initiative Update.
3. Environmental Microbiology.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
4. Development of CDC Research Agenda.
5. Veterinary-Human Public Health
Interface.
6. Global Disease Detection Initiative.
7. Topic Updates.
a. Influenza.
b. Chronic Wasting Disease.
c. Quarantine Update.
8. Board meets with Director, CDC.
Other agenda items include
announcements/introductions; follow-up on
actions recommended by the Board
December 2004; consideration of future
directions, goals, and recommendations.
Agenda items are subject to change as
priorities dictate.
Written comments are welcome and should
be received by the contact person listed
below prior to the opening of the meeting.
Contact Person for More Information: Tony
Johnson, Office of the Director, NCID, CDC,
Mailstop E–51, 1600 Clifton Road, NE.,
Atlanta, Georgia 30333, e-mail
tjohnson3@cdc.gov; telephone 404/498–3249.
The Director, Management Analysis and
Services Office has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: March 18, 2005.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–5909 Filed 3–24–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2211–N]
Medicare, Medicaid, and CLIA
Programs; Continuance of the
Approval of the American Society for
Histocompatibility and
Immunogenetics as a CLIA
Acreditation Organization
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
E:\FR\FM\25MRN1.SGM
25MRN1
]]>Agencies
[Federal Register Volume 70, Number 57 (Friday, March 25, 2005)]
[Notices]
[Pages 15322-15327]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5947]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Protection of Human Subjects, Proposed Criteria for
Determinations of Equivalent Protection
AGENCY: Department of Health and Human Services, Office of the
Secretary.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Office of Public Health and Science, Department of Health
and Human Services (HHS) solicits public comment on criteria that have
been recommended to the Office for Human Research Protections (OHRP)
for making determinations of whether procedures prescribed by
institutions outside the United States afford protections that are at
least equivalent to those provided in the Federal Policy for the
Protection of Human Subjects (codified by HHS as 45 CFR part 46,
subpart A, and equivalent regulations of 14 Departments and Agencies,
collectively referred to as the Federal Policy or the Common Rule).
DATES: Submit written or electronic comments on the recommended
criteria for making determinations of equivalent protection on or
before May 24, 2005.
ADDRESSES: Submit written comments to Ms. Gail Carter, Division of
Policy and Assurances, Office for Human Research Protections, 1101
Wootton Parkway, Suite 200, The Tower Building, Rockville, MD 20852,
telephone number (301) 402-4521 (not a toll-free number). Comments also
may be sent via facsimile to (301) 402-0527 or by e-mail to:
EQFRN@osophs.dhhs.gov.
FOR FURTHER INFORMATION CONTACT: Glen Drew, Office for Human Research
Protections, Office of Public Health and Science, The Tower Building,
1101 Wootton Parkway, Suite 200, Rockville, MD 20852, (301) 402-4994,
facsimile (301) 402-2071; e-mail: gdrew@osophs.dhhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The HHS codification of the Federal Policy states at 45 CFR
46.101(h):
(h) When research covered by this policy takes place in foreign
countries, procedures normally followed in the foreign countries to
protect human subjects may differ from those set forth in this
policy. [An example is a foreign institution which complies with
guidelines consistent with the World Medical Assembly Declaration
(Declaration of Helsinki amended 1989) issued either by sovereign
states or by an organization whose function for the protection of
human research subjects is internationally recognized.] In these
circumstances, if a Department or Agency head determines that the
procedures prescribed by the institution afford protections that are
at least equivalent to those provided in this policy, the Department
or Agency head may approve the substitution of the foreign
procedures in lieu of the procedural requirements provided in this
policy. Except when otherwise required by statute, Executive Order,
or the Department or Agency head, notices of these actions as they
occur will be published in the Federal Register or will be otherwise
published as provided in Department or Agency procedures.
No formal findings of equivalent protection have been published in
the Federal Register since the Federal policy was finalized in June,
1991. Use of the authority provided by 45 CFR 46.101(h) has been
advocated by various parties, including the National Bioethics Advisory
Commission in its April, 2001 report ``Ethical and Policy Issues in
International Research: Clinical Trials in Developing Countries,'' and
the HHS Inspector General in the September, 2001 Report ``The
Globalization of Clinical Trials: A Growing Challenge in Protecting
Human Subjects.'' The authority of the Secretary of Health and Human
Services has been delegated to OHRP (68 FR 60392), and in considering
use of the 45 CFR 46.101(h) authority, OHRP recognized a need for using
consistent criteria as a basis for decisions regarding equivalent
protections. During 2002, the OHRP Director established a working group
of representatives from interested HHS agencies, with staff support
from OHRP, to consider potential criteria for use in making such
decisions. The working group delivered its report in July 2003. That
report recommends a framework
[[Page 15323]]
for implementing the existing regulatory authority of 45 CFR 46.101(h).
The full working group report recommends the approach and criteria
described in this notice and is available at https://www.hhs.gov/ohrp/
international/EPWGReport2003.pdf and the appendix table is available at
https://www.hhs.gov/ohrp/international/FPGWFramework.pdf, or by request
to either of the addresses given above.
II. Request for Comments
OHRP has solicited and considered comments from the other agencies
that have adopted the Federal Policy, and now solicits public comment
on the working group's recommended criteria for making determinations
whether procedures prescribed by institutions outside the United States
provide protections that are at least equivalent to those provided by
the Federal Policy. OHRP will consider all public comments in deciding
whether, and if so how, to proceed with implementing the authority
under 45 CFR 46.101(h). Draft guidance describing OHRP's proposed
method of implementing this authority would be published for public
comment before OHRP would issue final guidance on this topic.
OHRP neither endorses nor rejects the content, conclusions, or
recommendations in the working group's report, but particularly
solicits public comment on several questions related to the approach
and criteria recommended in the report:
1. Is the recommended approach appropriate for implementing the
authority under 45 CFR 46.101(h)?
1.a. Is it preferable to make determinations of equivalent
protections on the basis of submissions by individual institutions or
on the basis of national or international procedural standards that may
be relied upon by multiple institutions without repeated assessments?
2. Could an alternative approach provide equal or greater
effectiveness and efficiency for implementation of this authority?
2.a. If so, what approach and why would effectiveness or efficiency
be improved?
3. Do the recommended criteria appropriately and adequately
describe the protections provided to human subjects by the Federal
Policy?
3.a. Do the regulatory provisions the working group cited as
contributing to particular protections provided by the Federal Policy
relate directly to those protections? (See Table 1.)
3.b. Should other regulatory provisions be cited as relating to
particular protections?
3.c. What, if any, alterations or additions to the proposed
criteria would be helpful in assessing whether procedures followed in
foreign countries provide protections at least equivalent to those
provided by the Federal Policy?
4. Is the procedure recommended by the working group for seeking a
finding of equivalent protections under 45 CFR 46.101(h) appropriate?
III. Framework Proposed in Working Group Report
The working group report concluded that
The primary focus of the U.S. policy is the accountability of
the research institution for the welfare and rights of human
subjects. The overarching goal of the specific accountability
mechanisms and procedures described in the policy is to establish
expectations of ethical conduct within the research institution. The
responsibility for achieving these aims is shared by the
institution, the Institutional Review Board (IRB), or Research
Ethics Committee (REC), and the relevant U.S. Agency or Department
head. Although investigators are critical actors in achieving these
goals, the policy provides very little explicit guidance to
investigators and therefore suggests that the protection of human
subjects depends largely on the proper promotion and conscientious
execution of standard practices and procedures, including those
related to research ethics review, within the institution.
The working group proposed an approach to equivalent protections
that involves five separate steps, the first of which is to identify
the specific protections provided by 45 CFR part 46 subpart A, followed
by three steps of determining the equivalence of the protections
offered by the set of procedures employed in foreign research
institutions, and the fifth step is to provide an assurance that these
procedures will be followed within the institution.
Steps in determining equivalence.
(1) Articulation of the specific protections embodied in 45 CFR
part 46 subpart A.
(2) Assessment of the protections provided by the institution's
procedures.
(3) Comparison of the protections provided by the institution's
procedures with those provided by 45 CFR part 46 subpart A and
determination whether or not the institution's procedures provide at
least equivalent protections.
(4) Approval of the relevant department or agency head for the
substitution of the institutional procedures in lieu of the procedures
of 45 CFR part 46 subpart A.
Mechanism of assurance with OHRP.
(5) Assurance from the institution that the substituted procedures
will be followed in the conduct of human subjects research funded by
HHS. The assurance will be completed and filed with OHRP.
The working group identified 7 specific protections afforded by 45
CFR part 46 subpart A that it recommended be included in the
determination of equivalence:
Establish norms of ethical conduct and due diligence in review and
performance of research within the institution;
Ensure adequate authority and independence of the IRB/Research
Ethics Committee;
Protect against biased decision making and arbitrary decisions in
research ethics review;
Ensure sufficient quality and comprehensiveness of research ethics
review;
Ensure research ethics review and oversight are commensurate with
risks to research subjects and vulnerability of the study population;
Protect against unnecessary or unjustified risk throughout the
course of the study; and
Ensure voluntary participation after adequate disclosure of
information related to the study.
The working group concluded that each of these protections is
necessary for a determination of equivalent protections. It also
concluded that each protection may be achieved in a number of different
ways, including the use of procedures that differ from those provided
in 45 CFR part 46 subpart A. In making determinations of equivalence,
the working group recommended that OHRP assess whether the procedures
employed by the foreign institution are able to satisfy each of these
protections individually and in the aggregate.
The working group also recommended that, based on a recommendation
from OHRP following a comparison of the protections provided by the
institution's procedures and 45 CFR part 46 subpart A, the Secretary of
HHS may find that the institution's procedures provide at least
equivalent protections and approve the substitution of these procedures
in lieu of those of 45 CFR part 46 subpart A. The working group
concluded that a determination of equivalent protections does not
affect OHRP's oversight authority for HHS funded research conducted
within the institution. The working group considered the authority of
OHRP to conduct on-going assessment of the equivalence of the
institution's procedures and protections to be a protection implied in
45 CFR part 46 subpart A, though not part of the
[[Page 15324]]
assessment of the protections provided by an institution's procedures.
Similarly, the substitution of the institution's procedures in lieu
of those of 45 CFR part 46 subpart A does not obviate the need for the
institution to enter into an assurance with OHRP that the procedures
will be followed by the institution in the conduct of HHS funded
research. An assurance is a legal promise to comply with certain
conditions attached to the provision of U.S. federal research funding.
To show the relationship between the Federal Policy and each of the
seven protections the working group discerned in the Federal Policy, it
developed a table matching the protections with provisions of 45 CFR
part 46 subpart A that contribute to each of the protections. The
center column of the table provides examples of procedures that the
working group thought institutions might use to provide the protection
related to those regulatory provisions. The table appears below.
Appendix
Table 1.--Framework for Equivalent Protections
------------------------------------------------------------------------
Example 45 CFR part 46
Specific protection procedures subpart A authority
------------------------------------------------------------------------
INSTITUTIONAL RESPONSIBILITIES
------------------------------------------------------------------------
Establish norms of ethical --Institutional 46.103(a); 46.103 (f)
conduct and due diligence in statement of Establish and
review and performance of principles. satisfy terms of
research within the --Procedures for assurance.
institution. review. 46.103(b)(1) Develop
--Procedures for or adopt statement
reporting to of principles
Research Ethics governing
Committee (REC). institution's human
--Procedures for subjects protections
REC record responsibilities.
keeping. 46.103(b)(4) Ensure
initial and
continuing review of
research; determine
necessary frequency
of review for each
study; determine
where external
verification is
necessary that no
material changes
have occurred since
last IRB review;
establish procedures
for IRB reporting of
findings and actions
to institution and
investigator(s).
--Statement of 46.103(b)(5)
investigator Establish and 46.108
responsibilities. (a) follow written
--Effective procedures for
dissemination of prompt reporting to
REC submission IRB and
procedures. Institutional
--Investigator officials of:
training. --Unanticipated
problems involving
risk to subjects or
others, or non-
compliance with the
policy;
--Suspension or
termination of IRB
approval.
46.103(b)(4) Ensuring
prompt reporting to
the IRB of proposed
changes in a
research activity,
and for ensuring
that such changes in
approved research,
during the period
for which IRB
approval has already
been given, may not
be initiated without
IRB review and
approval except when
necessary to
eliminate apparent
immediate hazards to
the subject.
46.103(b)(5) Written
procedures for
ensuring prompt
reporting to the
IRB, appropriate
institutional
officials, and the
Department or Agency
head of (i) any
unanticipated
problems involving
risks to subjects or
others or any
serious or
continuing
noncompliance with
this policy or the
requirements or
determinations of
the IRB; and (ii)
any suspension or
termination of IRB
approval.
46.115 An
institution, or when
appropriate an IRB,
shall prepare and
maintain adequate
documentation of IRB
activities. The
records required by
this policy shall be
retained for at
least 3 years, and
records relating to
research which is
conducted shall be
retained for at
least 3 years after
completion of the
research. All
records shall be
accessible for
inspection and
copying by
authorized
representatives of
the Department or
Agency at reasonable
times and in a
reasonable manner.
-------------------------------
Ensure adequate authority, and --Documentation 46.109(a); 46.109 (e)
independence of IRB. of REC authority. grant and ensure
necessary authority
for IRB, including:
discretion to
review, approve,
require
modifications, or
disapprove research
activities; increase
information for
informed consent,
observe, or have
third party observe
consent process and
research.
46.112 Research
covered by this
policy that has been
approved by an IRB
may be subject to
further appropriate
review and approval
or disapproval by
officials of the
institution.
However, those
officials may not
approve the research
if it has not been
approved by an IRB.
46.113 An IRB shall
have authority to
suspend or terminate
approval of research
that is not being
conducted in
accordance with the
IRB's requirements
or that has been
associated with
unexpected serious
harm to subjects.
46.110(b) Under an
expedited review
procedure, the
review may be
carried out by the
IRB chairperson or
by one or more
experienced
reviewers designated
by the chairperson
from among members
of the IRB. In
reviewing the
research, the
reviewers may
exercise all of the
authorities of the
IRB except that the
reviewers may not
disapprove the
research. A research
activity may be
disapproved only
after review in
accordance with the
non-expedited
procedure set forth
in Sec. 46.108(b).
[[Page 15325]]
--REC member(s) 46.107(d) Each IRB
unaffiliated shall include at
with the least one member who
institution. is not otherwise
affiliated with the
institution and who
is not part of the
immediate family of
a person who is
affiliated with the
institution.
-------------------------------
Research Ethics Committee (REC) Responsibilities
Appropriate Scope and Quality of Review:
------------------------------------------------------------------------
Protect against biased --Public 46.103(b)3 A list of
decision making and arbitrary accessibility of IRB members
decisions in research ethics REC membership identified by name;
review. and affiliation earned degrees;
within representative
institution. capacity;
indications of
experience such as
board
certifications,
licenses, etc.,
sufficient to
describe each
member's chief
anticipated
contributions to IRB
deliberations.
Disclosure of any
employment or other
relationship between
each [IRB] member
and the institution.
46.107(a) IRB
membership. (see 45
CFR 46 for specific
criteria).
46.107(b) Gender
balance.
--Institutional 46.107(c) Each IRB
policy on REC shall include at
conflict of least one member
interest. whose primary
concerns are in
scientific areas and
at least one member
whose primary
concerns are in
nonscientific areas.
--REC membership 46.107(d) Each IRB
to reflect: shall include at
independence, least one member who
unaffiliated is not otherwise
member(s). affiliated with the
institution and who
is not part of the
immediate family of
a person who is
affiliated with the
institution.
46.107(e) No IRB may
have a member
participate in the
IRB's initial or
continuing review of
any project in which
the member has a
conflicting
interest, except to
provide information
requested by the
IRB.
-------------------------------
Ensure sufficient quality and --REC membership 46.107(b) Gender
comprehensiveness of review. to reflect balance.
competence, 46.107(c) Each IRB
comprehensivenes shall include at
s of review; least one member
adequate whose primary
expertise for concerns are in
study scientific areas and
population; at least one member
diversity of whose primary
representation; concerns are in
gender balance. nonscientific areas.
46.107(d) Each IRB
shall include at
least one member who
is not otherwise
affiliated with the
institution and who
is not part of the
immediate family of
a person who is
affiliated with the
institution.
46.107(f) An IRB may,
in its discretion,
invite individuals
with competence in
special areas to
assist in the review
of issues which
require expertise
beyond or in
addition to that
available on the
IRB. These
individuals may not
vote with the IRB.
46.108(b) Except when
an expedited review
procedure is used
(see Sec. 46.110),
review proposed
research at convened
meetings at which a
majority of the
members of the IRB
are present,
including at least
one member whose
primary concerns are
in nonscientific
areas. In order for
the research to be
approved, it shall
receive the approval
of a majority of
those members
present at the
meeting.
Ensure research ethics review --Procedures for 46.109(e) An IRB
and oversight are continuing shall conduct
commensurate with risks to review and continuing review of
research subjects and monitoring research covered by
vulnerability of the study commensurate this policy at
population. with risk. intervals
--Procedures for appropriate to the
evaluating risk degree of risk, but
and benefit. not less than once
Procedures for per year, and shall
reviewing have authority to
selection of observe or have a
subjects and third party observe
safeguards the consent process
provided. and the research.
--Procedures for 46.110(b) Expedited
IRB reporting to Review.
investigators. 46.111(a)(2) In
evaluating risks and
benefits, the IRB
should consider only
those risks and
benefits that may
result from the
research (as
distinguished from
risks and benefits
of therapies
subjects would
receive even if not
participating in the
research). The IRB
should not consider
possible long-range
effects of applying
knowledge gained in
the research (for
example, the
possible effects of
the research on
public policy) as
among those research
risks that fall
within the purview
of its
responsibility.
46.111(a)(3)
Selection of
subjects as
equitable. In making
this assessment the
IRB should take into
account the purposes
of the research and
the setting in which
the research will be
conducted and should
be particularly
cognizant of the
special problems of
research involving
vulnerable
populations, such as
children, prisoners,
pregnant women,
mentally disabled
persons, or
economically or
educationally
disadvantaged
persons.
46.113 Any suspension
or termination or
approval shall
include a statement
of the reasons for
the IRB's action and
shall be reported
promptly to the
investigator,
appropriate
institutional
officials, and the
Department or Agency
head.
-------------------------------
[[Page 15326]]
Protect against unnecessary or --REC membership 46.107(a) If an IRB
unjustified risk throughout policy reflects regularly reviews
the course of the study. adequate research that
expertise and involves a
experience. vulnerable category
of subjects, such as
children, prisoners,
pregnant women, or
handicapped or
mentally disabled
persons,
consideration shall
be given to the
inclusion of one or
more individuals who
are knowledgeable
about and
experienced in
working with these
subjects.
--Policy has 46.111(a)(1) Risks to
provisions for subjects are
supplementing minimized: (i) by
expertise, using procedures
experience and which are consistent
disciplinary with sound research
perspective as design and which do
required. not unnecessarily
expose subjects to
risks, and (ii)
whenever
appropriate, by
using procedures
already being
performed on the
subjects for
diagnostic or
treatment purposes.
46.111(a)(2) Risks to
subjects are
reasonable in
relation to
anticipated
benefits, if any, to
subjects, and the
importance of the
knowledge that may
reasonably be
expected to result.
--Procedures for 46.111(a)(3)
review of Selection of
minimization of subjects is
risk. equitable. In making
this assessment the
IRB should take into
account the purposes
of the research and
the setting in which
the research will be
conducted and should
be particularly
cognizant of the
special problems of
research involving
vulnerable
populations, such as
children, prisoners,
pregnant women,
mentally disabled
persons, or
economically or
educationally
disadvantaged
persons.
--Procedures for 46.111(b) When some
reviewing or all of the
selection of subjects are likely
subjects and to be vulnerable to
safeguards coercion or undue
provided. influence, such as
children, prisoners,
pregnant women,
mentally disabled
persons, or
economically or
educationally
disadvantaged
persons, additional
safeguards have been
included in the
study to protect the
rights and welfare
of these subjects.
46.111(a)(6) When
appropriate, the
research plan makes
adequate provision
for monitoring the
data collected to
ensure the safety of
subjects.
--Procedures for 46.109(e) An IRB
continued shall conduct
oversight and continuing review of
monitoring. research covered by
this policy at
intervals
appropriate to the
degree of risk, but
not less than once
per year, and shall
have authority to
observe or have a
third party observe
the consent process
and the research.
-------------------------------
Ensure voluntary participation --Policies on 46.116 Except as
after adequate disclosure of obtaining provided elsewhere
information related to the verifiable in this policy, no
study. informed consent. investigator may
involve a human
being as a subject
in research covered
by this policy
unless the
investigator has
obtained the legally
effective informed
consent of the
subject or the
subject's legally
authorized
representative. An
investigator shall
seek such consent
only under
circumstances that
provide the
prospective subject
or the
representative
sufficient
opportunity to
consider whether or
not to participate
and that minimize
the possibility of
coercion or undue
influence.
46.111(a)(4) Informed
consent will be
sought from each
prospective subject
or the subject's
legally authorized
representative, in
accordance with, and
to the extent
required by Sec.
46.116.
46.111(a)(5) Informed
consent process will
be appropriately
documented, in
accordance with, and
to the extent
required by Sec.
46.117.
46.116 The
information that is
given to the subject
or the
representative shall
be in language
understandable to
the subject or the
representative.
46.117(a) Except as
provided in
paragraph (c) of
this section,
informed consent
shall be documented
by the use of a
written consent form
approved by the IRB
and signed by the
subject or the
subject's legally
authorized
representative.
--Policies on 46.109(b) An IRB
types of shall require that
information to information given to
be disclosed in subjects as part of
the informed informed consent is
consent process. in accordance with
Sec. 46.116. The
IRB may require that
information, in
addition to that
specifically
mentioned in Sec.
46.116, be given to
the subjects when in
the IRB's judgment
the information
would meaningfully
add to the
protection of the
rights and welfare
of subjects.
46.109(c) An IRB
shall require
documentation of
informed consent or
may waive
documentation in
accordance with Sec.
46.117.
46.109(e) An IRB
shall conduct
continuing review of
research covered by
this policy at
intervals
appropriate to the
degree of risk, but
not less than once
per year, and shall
have authority to
observe or have a
third party observe
the consent process
and the research.
[[Page 15327]]
46.111(a)(4) Informed
consent will be
sought from each
prospective subject
or the subject's
legally authorized
representative, in
accordance with, and
to the extent
required by Sec.
46.116.
46.116(a)(1-8)
Necessary elements
of disclosure.
46.116(b)(1-6)
Necessary elements
of disclosure.
46.116(c)(1-2) Waiver
of informed consent.
46.116(d)(1-4)
Approval of
alternate consent
procedures or
waiver.
46.117(a) Written
informed consent.
------------------------------------------------------------------------
Bernard A. Schwetz,
Director, Office for Human Research Protections.
[FR Doc. 05-5947 Filed 3-24-05; 8:45 am]
BILLING CODE 4150-36-P
