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Part I: Principles, Policies and Applicability
1. Ethical Principles
- This institution is guided by the ethical principles
regarding all research involving humans as
subjects, as set forth in the report of the National Commission
for the Protection of Human Subjects of Biomedical
and Behavioral Research (entitled: Ethical Principles and
Guidelines for the Protection of Human Subjects
of Research [the "Belmont
Report"]), regardless of whether the research
is subject to Federal regulation or with whom
conducted or source of support (i.e., sponsorship).
- All institutional and non-institutional performance
sites for this institution, domestic or foreign,
will be obligated by this institution to conform to ethical
principles which are at least equivalent to
those of
this institution, as cited in the previous
paragraph or as may be determined by the DHHS Secretary.
2. Institutional Policy
- All requirements of Title 45, Part 46, of the Code
of Federal Regulations (45 CFR 46) will
be met for all federally-sponsored DHHS- supported research,
and all
other human subject research regardless
of
sponsorship, except as otherwise noted in this
Assurance. Federal
(all departments and agencies bound by
the Federal Policy) funds for which this Assurance applies
may not be expended
for research involving human subjects
unless the requirements of this Assurance have been satisfied.
- Except for those categories specifically exempted
or waived under Section 101(b)(1-6) or 101(i),
all research
covered by this Assurance will be reviewed
and approved by an Institutional Review Board (IRB)
which has been
established under a Federalwide Assurance
(FWA) with OHRP. The involvement of human subjects
in research covered
by this Assurance will not be permitted
until an appropriate IRB has reviewed and approved the research
protocol and
informed consent has been obtained from
the
subject or the subject's legal representative (see
Sections 111,
116, and 117), unless properly waived
by the IRB under Section 116(c), (d) or by any applicable
waiver under
Section 101(i).
- This institution assures that before human subjects
are involved in nonexempt research covered
by this Assurance, the IRB will give proper consideration
to:
- the risks to the subjects
- the anticipated benefits to the
subjects and others
- the importance of the knowledge that may reasonably
be expected to result
- the informed consent process to be employed.
- Certification of IRB review and approval for all
Federally-sponsored research involving human subjects
will be submitted to
the Office of Research and Sponsored Programs
(ORSP) for forwarding to the appropriate Federal
department or agency. Compliance will occur within the
time and
in the manner prescribed for forwarding certifications
of IRB review to DHHS or other Federal departments
or agencies for which this Assurance applies. As
provided for under section 118, applications and proposals
lacking
definate plans for involvement of human subjects
will not require IRB review and approval prior to
award.
However,
except for research exempted or waived under Section
101(b) or (i), no human subjects may be involved in any
project supported by such awards until IRB review and
approval has been certified to the appropriate Federal
department or agency. As required
under Section 119, the IRB will review and
recommend approval
for involvement of human subjects in Federal
research activities for which there was no
prior intent for such
involvement, but will not permit such involvement
until certification of the IRB's review and
approval is received
by the appropriate Federal department or
agency.
- Institutions that are not direct signatories to this
Assurance are not authorized to cite
this Assurance. This institution will ensure that such other
institutions
and investigators not bound by the provisions
of this Assurance for DHHS-sponsored research will
satisfactorily
assure compliance with 45 CFR 46, as
required
(see Part 2, I, D and II, K), as a prior condition
for involvement
in human subject research which is under
the auspices of this institution (see Part 1, III,
A). Institutions
that have entered into an Inter-Institutional
Amendment (IIA) to this Assurance must submit a
Single Project
Assurance (SPA) to the Office for Human
Research Protections (OHRP) of DHHS for DHHS-sponsored research,
on request,
when that research is not conducted under
the auspices of a signatory institution to this
Assurance.
- This institution will ensure that any collaborating
entities (i.e., those entities engaged
in human subject research by virtue of subject accrual,
transfer of identifiable
information, and/or in exchange of something
of value, such as material support [e.g., money,
drugs, or identifiable
specimens], co-authorship, intellectual
property, or credits) of its affiliates materially engaged
in
the
conduct of nonfederally-sponsored research
involving human subjects will possess mechanisms
to protect human
research subjects that are at least equivalent
to those procedures provided for in the ethical
principles to
which this institution is committed (see
Part 1, I).
- This institution will comply with the requirements
set forth in Section 114 of the regulations
regarding cooperative research projects. When research
covered
by this Assurance is conducted at or in
cooperation with another entity, all provisions of this Assurance
remain
in effect for that research. This institution
may accept, for the purpose of meeting the IRB
review
requirements,
the review of an IRB established under
another DHHS MPA or FWA. Such acceptance must be (a) in writing,
(b) approved
and signed by an official of this institution's
Office of Research Support, and (c) approved and
signed by correlative
officials of each of the other cooperating
institutions, (i.e., a Cooperative Amendment to
this
FWA). The
original of the signed understanding will
serve as an addendum to this Assurance and will
be forwarded
to the
OHRP of DHHS by the Office of Research
Compliance for OHRP approval.
- This institution will exercise appropriate administrative
overview to insure that the institution's
policies and procedures designed for protecting
the rights and welfare
of human subjects are being effectively
applied in compliance with this Assurance.
- Description of this institution's policy for the
protection of human subjects is contained in its
internal written
procedures which are available to OHRP and
other Federal departments or agencies, upon request. Appendix
D to this Assurance abstracts pertinent
organizational, personnel, and reporting procedures
sufficient
to describe the substance and relative prominence
conferred upon
the protection of subjects.
3. Applicability
- Except for research in which the only involvement of
humans is in one or more of the
categories exempted or waived under Section 101(b)(1-6) or
101(i),
this Assurance
applies to all research involving
human subjects, and all other activities which even in part
involve such
research, regardless of sponsorship,
if one or more of the following apply:
- the research is sponsored by this institution,
or
- the research is conducted by or under the direction
of any employee or
agent of this institution in connection with his or her
institutional responsibilities,
or
- the research is conducted by or under the direction
of any employee or
agent of this institution using any property or facility
of this institution, or
- the research involves the use of this institution's
non-public information
to identify or contact human research subjects or prospective
subjects.
- All human subject research which is exempt under Section
101(b)(1-6) or 101(i) will be conducted
in accordance with: (1) the Belmont Report, (2)
this institution's
administrative procedures to ensure
valid claims of exemption, and (3) orderly accounting for such
activities.
- Components of this institution are bound by the provisions
of this Assurance. Those components
which can be expected to participate in human subject research
sponsored by
DHHS or other Federal departments
or
agencies for which this Assurance will apply are
identified in Appendix
A. Appendix A will be revised as
changes occur and revisions forwarded to OHRP.
- This Assurance must be accepted by other Federal departments
or agencies that are bound by the
Federal Policy for the Protection of Human Subjects when appropriate
for
the research in question and therefore
applies to all human subject research so sponsored.
Research
that is
neither conducted nor supported
by a Federal department or agency but is subject to regulation
as defined in
Section 102(e) must be reviewed
and approved,
in compliance with Sections 101, 102, and 107 through
117.
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