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PART
1 - Statement of Principles and Policies
- Ethical
Principles
- Institutional
Policy
- Applicability
PART
2
- IRB
Review
- SHC
Research Investigator Responsibilities
- Institutional
Responsibilities
- Term/Termination
- Miscellaneous
PART
3 - Endorsements
Inter-Institutional
Amendment
Assurance
of Compliance with DHHS Regulations for
Protection of Human Research Subjects
PART
1
This
Inter-Institutional Amendment (IIA) is made as of January
1, 2000 between the Shriners Hospitals for Children (SHC)
and The General Hospital Corporation, d/b/a/ Massachusetts
General Hospital (MGH).
Shriners
Hospitals for Children (SHC) hereby gives assurance
that it will comply with the Department of Health and
Human Services (DHHS) Regulations for the Protection of
Human Research Subjects (45 CFR 46, as amended) as specified
below.
- Statement
of Principles and Policies
- Ethical
Principles
- The
SHC 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").
In addition, the applicable requirements set forth
in Title 45, Part 46 of the Code of Federal Regulations
(45 CFR 46) will be met for all research covered
by the Assurance to which this Inter-Institutional
Amendment (IIA) applies.
- Institutional
Policy
- Except
for research in which the only involvement of human
subjects is in one or more of the categories exempted
or waived under Section 46.101(b)(1-6) or 46.101(i),
this policy is applicable to all research involving
human subjects, and all other activities which even
in part involve such research, if either:
- the
research is sponsored by the MGH, or
- the
research is conducted by or under the direction
of any employee or agent of the MGH in connection
with his or her institutional responsibilities,
or
- the
research is conducted by or under the direction
of any employee or agent of the MGH using any
property or facility of the SHC, or
- the
research involves the use by the MGH of the SHC
non-public information to identify or contact
human research subjects or prospective subjects.
- The
SHC acknowledges and accepts its responsibilities
for protecting the rights and welfare of human subjects
of research covered by this policy.
- The
SHC assures that before human subjects are involved
in research covered by this policy, proper consideration
will be given 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, and
- the
informed consent process to be employed.
- The
SHC acknowledges that it bears full responsibility
for the performance of all research involving human
subjects covered by this policy.
- The
SHC bears full responsibility for complying with
applicable federal, state, or local laws as they
may relate to research covered by this policy.
- The
SHC encourages and promotes constructive communication
among the research administrators, department heads,
research investigators, clinical care staff, human
subjects, and institutional officials as a means
of maintaining a high level of awareness regarding
the safeguarding of the rights and welfare of the
subjects.
- The
SHC will exercise appropriate administrative overview
carried out at least annually to ensure that its
practices and procedures designed for the protection
of the rights and welfare of human subjects are
being effectively applied.
- The
SHC will consider additional safeguards in research
when that research involves prisoners, fetuses,
pregnant women, children, individuals institutionalized
as mentally disabled, other potentially vulnerable
groups and human in vitro fertilization.
- The
SHC shall provide each individual at the SHC conducting
or reviewing human subject research (e.g., research
investigators, department heads, research administrators,
research reviewers) with a copy of this statement
of ethical principles and policy (Part 1, 1.A. &
B.).
- Applicability
- The
SHC will abide by the provisions of the General
Hospital Corporation (d/b/a Massachusetts General
Hospital) Multiple Project Assurance (MPA)
M-1331, and will accept the final authority
of the MGH’s Institutional Review Board (IRB) when
research conducted at the SHC is conducted under
the auspices of the MPA institution and in collaboration
with SHC.
- This
assurance of compliance with 45 CFR 46 constitutes
an Amendment to the Assurance of the MGH whose IRB
will be relied upon by the SHC. This Amendment has
no independent standing of its own.
- The
SHC is not authorized to cite the MPA number of
the MGH. However, the MGH, the MPA institution,
may cite this Amendment as the basis for involvement
of the SHC in Federal human subject research which
is conducted under the auspices of the MGH. The
SHC is not authorized to cite the Assurance to which
this document is an amendment other than in conjunction
with conditions set forth in Part 1, I, C, 1, above.
- Institutions
that have entered into an Inter-Institutional Amendment
(IIA) must submit a Single Project Assurance (SPA)
to the Office for Protection from Research Risks
(OPRR) for DHHS-sponsored research, when that research
is not conducted under the auspices of the
MGH’s MPA. Therefore, upon request of the Office
for Protection from Research Risks (OPRR) of DHHS,
the SHC must submit a Single Project Assurance (SPA)
to OPRR for DHHS-sponsored research engaged in by
the SHC that is not conducted under the auspices
of the MGH’s MPA.
PART
2
In
regard to Federal human subject research conducted under
the auspices of the MGH previously cited in Part 1 of
this amendment and below, the SHC will comply with the
applicable requirements of 45 CFR 46 as specified below.
- IRB
Review
- MGH
IRB – IRB of Record
- The
SHC does not have an IRB and will rely upon the
IRB of Massachusetts General Hospital MPA M1331
as its IRB of record for human subject research
for which this Amendment applies. In accordance
with the compositional requirements of Sections
107, 103(d), and 111(a)(3), the institution for
which this Amendment applies, attests that the attached
MGH IRB membership roster documents a membership
which is suitably composed to protect the rights
and welfare of human research subjects at the SHC.
The MGH IRB is responsible for the initial and continuing
review of research activities for which this Amendment
applies and will observe the quorum requirements
of Section 108.
- The
MGH IRB will determine, in accordance with the criteria
found at Section 111, that protections for human
research subjects at the SHC are adequate.
- The
MGH IRB will determine that legally effective informed
consent will be obtained in a manner and method
which meets the requirements of Sections 116 and
117, and in the case of research involving children,
45 CFR 46.408.
- The
MGH IRB shall review, and have the authority to
approve, require modification in, or disapprove
changes proposed in this research activity. The
SHC will not administratively approve human subject
research which has been disapproved by the MGH IRB.
- The
MGH IRB may be called into an interim review session
by the Chairperson at the request of any IRB member
or Institutional Officials of either institution
to consider any matter concerned with the rights
and welfare of any subject.
- The
MGH IRB will prepare and maintain adequate documentation
of its activities in accordance with Section 115.
- The
MGH IRB will report promptly at least to officials
of the SHC and the MGH:
- any
serious or continuing noncompliance by investigators
with the requirements of the MGH IRB, and
- any
suspension or termination of MGH IRB approval.
- The
MGH IRB will report promptly to officials of the
SHC any information received concerning:
- injuries
to human subjects,
- unanticipated
problems involving risks to subjects or others,
and
- any
IRB-reviewed and approved changes in this research
activity.
- Certification
of MGH IRB Review
- Certification
means the official notification on behalf of the
SHC to the sponsoring Federal department or agency
that a research project or activity involving human
subjects has been reviewed and approved by the MGH
IRB in accordance with the MGH OPRR-approved Assurance.
- The
MGH IRB of record will complete certification to
the applicable Federal department or agency that
initial or continuing (whichever is applicable)
IRB review and approval has been conducted in accordance
with Section 103(f).
- The
SHC will receive a copy of such IRB certifications
as they are submitted on its behalf by the MGH to
the applicable Federal department or agency and
inform the MGH of its administrative concurrence
to proceed for at least all initial IRB reviews
and approvals for new research activities and substantive
changes in previously approved activities.
- SHC
Research Investigator Responsibilities
- Reporting
- SHC
Investigators will report promptly to the MGH IRB
proposed changes in these research activities under
this Amendment and the changes shall not be initiated
without IRB review and approval except where necessary
to eliminate apparent immediate hazards to the subjects.
- SHC
Investigators will report promptly to the MGH IRB
any injuries to subjects or unanticipated problems
involving risks to subjects or others.
- Other
- SHC
Investigators acknowledge and accept their responsibility
for protecting the rights and welfare of human research
subjects involved in research under this Amendment
and for complying with all applicable provisions
of the MGH OPRR-approved Assurance under which this
Amendment is authorized.
- SHC
Investigators assure that before human subjects
are involved in such research, proper consideration
will be given to:
- the
risks to the subjects,
- the
anticipated benefits to the subjects and others,
- the
importance of the knowledge that may be reasonably
expected to result,
- the
informed consent process to be employed, and
- the
need for additional safeguards if the human subjects
are especially vulnerable.
- SHC
Investigators accept their responsibility for performance
in such research and will protect human research
subjects and satisfy the intent and procedures specified
in 45 CFR 46 and other Federal, state, or local
laws or regulations which may apply.
- SHC
Investigators will abide by determinations of and
will accept the final authority and decisions of
the MGH IRB.
- SHC
Investigators acknowledge and agree to cooperate
in the MGH IRB's responsibility for initial and
continuing IRB reviews and approvals, record keeping,
reporting, and certification. In addition, continuing
reviews will be preceded by progress reports to
include overall findings of the research.
- SHC
Investigators will not accrue subjects on protocols
under this Amendment prior to its approval and without
certification of MGH IRB review and approval. Provision
of emergency medical care without prior full board
review is permitted (see 46.116[f]). However, research
data may not be used from such interventions.
- SHC
Investigators will not participate in convened discussion
or voting of the MGH IRB except by invited attendance
to provide information to the MGH IRB upon request
(46.107[e]).
- SHC
Investigators acknowledge receipt of and compliance
with applicable existing Federal policies and guidance
having to do with notification of sero positivity,
counseling, and confidentiality, where HIV research
activities are involved.
- SHC
Investigators will advise the appropriate officials
of other hospitals, clinics, or institutions of
the intent to admit human subjects who are engaged
in research protocols. When admission to such an
institution is planned, foreseen, or regular, that
institution must possess an applicable OPRR-approved
Assurance prior to involvement of such persons as
human subjects and must obtain any prior authorization
from the appropriate DHHS Program Office or its
designee as may be required. Investigators will
not delegate to others the treatment of subjects
under such research protocols without prior notification
to the MGH IRB.
- Institutional
Responsibilities
- The
SHC will abide by all conditions and determinations
of the MGH IRB for this research activity.
- The
MGH will provide both meeting space for the MGH IRB
and sufficient staff to support the MGH IRB's review
and record-keeping duties.
- The
MGH will report promptly to the OPRR:
- injuries
to human subjects,
- unanticipated
problems involving risks to subjects or others,
and
- any
changes in this research activity which are reviewed
and approved by the MGH IRB and the SHC.
- any
suspension or termination of MGH IRB approval.
- The
SHC will also ensure that all its investigators have
read and have ready access to the Assurance of the
MGH and this amendment prior to involvement in human
subject research for which they apply.
- The
SHC is responsible for educating and training its
investigators to perform research involving human
subjects covered by this Amendment and will provide
the necessary staff and resources to satisfy such
responsibilities.
- The
SHC will encourage and help to facilitate constructive
communication among the Investigators at SHC, and
MGH as a means of maintaining a high level of awareness
regarding the safeguarding of the rights and welfare
of subjects participating in research conducted under
this Amendment.
- The
SHC will be responsible for ensuring that its physician
investigators report promptly to the MGH IRB proposed
changes in research activities under this Amendment.
- The
SHC will be responsible for ensuring that its Investigators
report promptly to the MGH any injuries to subjects
or unanticipated problems involving risks to subjects
or others.
- The
SHC will maintain a complete and accurate record of
its Investigators who are authorized to participate
in research approved by the MGH IRB. This record shall
be available to MGH upon reasonable request of the
IRB Chairperson, Executive Secretary, Manager, or
other institutional official responsible for oversight
of research activities or compliance with applicable
laws and regulations.
- The
SHC assures that its investigators will abide by the
terms of this Amendment. In the event of noncompliance
by SHC or its investigators, SHC agrees to take remedial
action specified by the MGH IRB, including termination
of participation by SHC or its investigators in designated
research activities. The SHC may also take further
action where appropriate to deter and remedy such
deficiencies.
- Term/Termination
- The
provisions of this Amendment become effective on the
date first written above. Provided the MPA institution’s
MPA remains in good standing, the Amendment shall
automatically remain in full force and effect for
successive one-year periods, unless sooner terminated
as hereinafter provided. Either party shall notify
the other of an intention not to renew this Amendment
at least ninety (90) days prior to the expiration
of the then-current term of the Amendment.
- This
Amendment may be terminated by either party (i) without
cause upon ninety (90) days prior written notice;
or (ii) upon thirty (30) days prior written notice
in the event of a breach by the other party of any
material term or condition of this agreement which
breach is not cured to the reasonable satisfaction
of the non-breaching party within said thirty (30)
day notice period. In the event of termination of
this Amendment, the MPA institution will notify OPRR.
- Miscellaneous
- Disapprovals
by the reviewing IRB may not be administratively overruled
by either cooperating institution.
- This
Amendment has been executed and delivered in and shall
be construed and enforced in accordance with the laws
of the Commonwealth of Massachusetts.
- This
Amendment may be amended only by a written agreement
signed by both parties.
- If
any provision of this Amendment shall be held to be
invalid, illegal, or unenforceable, the validity,
legality and enforceability of the remaining provisions
of this Amendment shall not be affected thereby.
- Each
of SHC and MGH represent that it endorses the National
Institutes of Health’s policy concerning the inclusion
of minorities and women in study populations.
- This
Amendment is not assignable in whole or in part, and
any attempt to do so shall be void.
- All
communications, reports and notices shall be delivered
by hand, by facsimile or by first class mail, postage
prepaid, and addressed as follows:
If
to MGH:
Massachusetts General Hospital
Director
of Human Research Affairs
55
Fruit Street
Boston,
MA 02114
Copy
to:
Executive Secretary for Human Studies
(same address)
If
to SHC:
Chief-of-Staff
Shriners Hospitals for Children
51 Blossom Street
Boston, MA 02114
Copy
to:
(same address)
PART
3
The
officials signing below agree that all research described
in Part 1, I, C (Applicability) of this Inter-Institutional
Amendment (IIA) to the applicable OPRR-approved Assurance
of the Massachusetts General Hospital, bearing
the number M1331, will be conducted in accord with
45 CFR 46 (as amended), the cited Assurance, and this
Amendment. The MGH will assume responsibility for ensuring
required IRB reviews, approvals, and submission of certifications
to the applicable Federal department or agency.
- Endorsement
of Institution Without IRB
Authorized
Institutional Official(s)
Signature:
on file
Date:
Name
and Title: Ronald G. Tompkins,
M.D., Sc.D.
Chief-of-Staff
Institution:
Shriners Hospitals for Children
Address:
51 Blossom Street, Boston, MA 02114
Telephone:
(617) 726-3447
Facsimile:
(617) 367-8936
E-mail:
rtompkins@partners.org
- Endorsement
of the Massachusetts General Hospital, the Institution
with an approved Multiple Project Assurance and IRB
- Name
of Institution: Massachusetts General Hospital
Authorized
Institutional Official
Signature:
on file
Date:
Name
and Title: Ronald S. Newbower,
Ph.D.
Sr
Vice President for Research & Technology
Institution:
Massachusetts General Hospital
Address: Boston,
MA 02114
Telephone: (617)
726-3651
Facsimile: (617)
726-3246
E-mail:
rnewbower@partners.org
- IRB
Chairperson or Designee Certifying IRB Review and
Approval
Signature:
on file
Date:
Name
and Title: P. Pearl
O'Rourke, MD
Director,
Human Research Affairs
Institution: Massachusetts
General Hospital
Address: Boston,
MA 02114
Telephone:
(617) 724-2731
Facsimile: (617)
726-3246
E-mail: porourke@partners.org
-
SPACE BELOW FOR DHHS USE ONLY -
- All
parts of this Assurance are in compliance with the requirements
of Part 46, Title 45 of the Code of Federal Regulations,
as amended.
- DHHS
Recommending Official
Signature:
on file
Date:
Name
and Title: Katherine
Duncan, M.D.
Adjunct Medical Officer
Address:
Division of Human Subject Protections
Office for Protection from Research Risks
National Institutes of Health, DHHS
6100 Executive Boulevard, Suite 3B01
Rockville, MD 20892-7507
Telephone:
301-496-7005 x207
Facsimile:
301-402-2803
E-mail:
kd41f@nih.gov
- DHHS
Approving Official
Signature:
on file
Date:
Name
and Title:
Assurance Coordinator, Assurance Branch
Address:
Division of Human Subject Protections
Office for Protection from Research Risks
National Institutes of Health, DHHS
6100 Executive Boulevard, Suite 3B01
Rockville, MD 20892-7507
Telephone:
301-496-7041 x
Facsimile:
301-402-0527
E-mail:
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