PCHI IIA
[ BWH MPA ]
[ MGH MPA ]
[ McLean MPA ]
[ MGH BWH CA ]
[ MGH DFCI CA ]
[ SRH BWH iia ]
[ SRH DFCI IIA ]
[ SRH MGH iia ]
[ SRH McLean IIA ]
[ HMS/HSDM CA ]
[ MGH, BWH, DFCI, and HSPH CA ]
[ BWH MGH DFCI McLean CA ]
[ PCHI IIA ] [ SHC iia ]
- Background
- Statement
of Principles and Policy
- Ethical
Principles and Regulatory Requirements
- Applicability
- Institutional
Policy
- IRB
Review Procedures
- IRB
of Record
- Certification
of IRB Review
- Institutional
Responsibilities
- PCHI'S
Responsibilities
- Hospital's
Responsibilities
- Term/Termination
- Miscellaneous
- Endorsements
Inter-Institutional
Amendment to Multiple Project Assurance Numbers
M-1034, M-1049, M-1331 To Collaborate on Research
with Partners Community HealthCare, Inc.
This
Inter-Institutional Amendment ("Amendment")
is entered into on March 1, 1999 by Partners Community
HealthCare, Inc. (PCHI) and The General Hospital Corporation,
d/b/a/ Massachusetts General Hospital (MGH) (M-1331),
The Brigham and Women’s Hospital, Inc. (BWH) (M-1049),
and The Dana Farber Cancer Institute, Inc. (DFCI) (M-1034).
(MGH, BWH, and DFCI are hereinafter collectively referred
to as "the Hospitals.")
- Background
- The
Hospitals engage extensively in biomedical research,
including research involving human subjects, with
the aim of making new diagnostic and therapeutic discoveries
and ultimately improving the care of medically ill
patients. Some of this research consists of industry-sponsored
clinical trials of drugs and devices, which are subject
to regulation by the Food and Drug Administration
(FDA) and which must be reviewed and approved by an
Institutional Review Board (IRB) under the provisions
of Title 21 of the Code of Federal Regulations (CFR),
Parts 50 and 56. Accordingly, the Hospitals have a
long-standing process for establishing IRBs and having
those IRBs review research involving human subjects.
In addition, the Hospitals have submitted Multiple
Project Assurances of Compliance (MPAs) and Cooperative
Amendments to the Office of Protection from Research
Risks (OPRR) of the National Institutes of Health.
The MPAs and Cooperative Amendments, which OPRR has
approved (and periodically reviews for renewal), provide
respectively that the Hospitals will conduct research
in compliance with applicable regulations of the United
States Department of Health and Human Services (DHHS)
set forth in 45 CFR Part 46, as amended, and that
in conducting such research, each of the Hospitals
may rely upon another Hospital’s IRB when the research
involves patients at both Hospitals, in order to avoid
duplication of effort. The Hospitals’ MPAs and Cooperative
Amendments provide an established, OPRR-approved framework
for conducting a broad range of research activities
which PCHI would like to become involved in and support.
- PCHI
has developed a large network of physicians who desire
to participate in research that will lead to improved
care for patients. Some of these physicians desire
to use their relationship with PCHI to provide IRB
review for their research that involves human subjects.
PCHI, however, does not have its own IRB, and so it
desires to establish a relationship with the Hospitals
that will allow the Hospitals’ IRBs to provide the
review and approval structure for and on behalf of
research involving human subjects that will be conducted
pursuant to this Amendment. Accordingly, the existing
MPAs of the Hospitals are hereby amended to allow
for such collaborative research, with the understanding
that this Amendment does not give MPA status to PCHI.
- The
PCHI-affiliated physicians, as well as other individuals
in the PCHI network who engage in the conduct of research
protocols and are not the subjects of such investigations
(including, e.g., research nurses, coordinators,
data managers, or other members of the research team),
shall collectively be referred to as "Investigators"
in this Amendment.
- Statement
of Principles and Policy
- Ethical
Principles and Regulatory Requirements
PCHI
and the Investigators shall be 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").
PCHI shall meet, and shall be responsible for assuring
that Investigators conducting research under this
Amendment meet, the requirements set forth in 21 CFR
Parts 50, 54, 56, 312, and 812 and 45 CFR Part 46
(collectively, "Federal Research Regulations")
(attached as Attachment A). Since the regulations
in Titles 21 and 45 are not identical, the stricter
requirements will prevail whenever applicable.
- Applicability
- This
Amendment applies to all research activities involving
human subjects (except for certain categories of
research exempted or waived from review under 45
CFR Part 46), when such research is conducted under
the auspices of the MPA institution and in collaboration
with the Partners Research and Education Program
("PREP") within PCHI. Such research
shall be referred to herein as the "Protocols."
- Nothing
herein shall preclude PCHI-affiliated physicians
from participating in human subject research, provided
that they do not participate in research that one
of the Hospitals’ IRBs has rejected for safety or
ethical reasons, and they comply with the Partners
Confidentiality Policy and Guidelines.
- PCHI
understands that this Amendment is limited to initiatives
of the MPA institution. PCHI further understands
that for any research it initiates itself, it is
not authorized to cite the MPA number of the institution
whose IRB is being relied upon. However, the MPA
institution may cite this Inter-Institutional Amendment
as the basis for involvement of PCHI Investigators
in federal human subject research which is conducted
under the auspices of the MPA institution.
- Institutional
Policy
PCHI
will abide by, and will use best efforts to ensure
that its Investigators conducting research under this
Amendment abide by, the provisions of the Hospitals’
MPAs. PCHI will accept, and will ensure that its Investigators
accept, the final authority of the Hospitals’ IRBs
for research conducted under this Amendment. PCHI
will take appropriate enforcement action in accordance
with Section IV.A.11.
- IRB
Review Procedures
- IRB
of Record
- The
Hospitals will designate one of their IRBs as the
"IRB of Record" for each Protocol. PCHI
will rely upon the IRB of Record for review of and
decisions regarding such Protocol. In designating
the IRB of Record, the Hospitals will follow the
reasonable and customary practices under their MPAs
and Cooperative Amendments.
- In
accordance with applicable federal regulations,
the Hospitals will ensure that the membership of
their IRBs is suitably composed to protect the rights
and welfare of human subjects participating in research
conducted by PCHI Investigators. Upon request, the
Hospitals will make a list of their IRB members
available to PCHI or the sponsor of a clinical trial.
- The
IRB of Record is responsible for the initial and
continuing review of research activities under this
Amendment and will observe applicable quorum requirements
in carrying out such reviews.
- The
IRB of Record will determine that the protections
for human subjects involved in research under this
Amendment satisfy applicable federal regulations.
- The
IRB of Record will determine that legally effective
informed consent will be obtained in a manner and
method which meets applicable federal regulations.
- The
IRB of Record shall review, and have the authority
to approve, require modification in, or disapprove
changes proposed in research activities under this
Amendment. PCHI officials will not administratively
approve human subject research which has been disapproved
by the IRB of Record.
- At
the request of any IRB member or official of PCHI
or the Hospitals, the Chairperson of the IRB of
Record may call it into an interim review session
to consider any matter concerning the rights and
welfare of any subjects.
- The
IRB of Record will report promptly to PCHI
- any
serious or continuing noncompliance by Investigators
with the requirements of the IRB;
- any
suspension or termination of IRB approval;
- injuries
to human subjects;
- unanticipated
problems involving risks to subjects or others;
and
- any
IRB-reviewed and -approved changes relating to
research conducted by Investigators under this
Amendment.
- Certification
of IRB Review
- Certification
is the official notice that the IRB of Record, when
required under applicable federal regulations, will
provide on PCHI’s behalf to the federal department
or agency or other entity sponsoring the research
to show that the IRB of Record has reviewed research
involving human subjects and has approved it as
being consistent with the applicable OPRR-approved
MPA.
- The
IRB of Record will send PCHI a copy of such certifications.
- After
receiving a certification, PCHI shall inform the
IRB of Record 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.
- Institutional
Responsibilities
- PCHI’s
Responsibilities
- PCHI
will assure that before any of its Investigators
conduct research under this Amendment, they read,
acknowledge by signing the attached Commitment Statement
for Investigators ("Commitment") (Attachment
B), and accept their responsibilities under the
following documents to protect the rights and welfare
of human subjects of research: (a) the Federal Research
Regulations (Attachment A); (b) this Amendment and
the Commitment (Attachment B); (c) the MPAs of the
Hospitals whose IRBs will be the IRBs of Record
(Attachment C); (d) the Belmont Report (Attachment
D); and (e) the Partners Confidentiality Policy
and Guidelines (Attachment E).
- PCHI
will abide by, and will be responsible for ensuring
that its Investigators abide by, all conditions
and determinations of the IRB of Record for research
activity conducted under this Amendment.
- PCHI
understands that the Hospital IRBs have documents
and procedures that they regularly use in conducting
research, and PCHI agrees to ensure that its Investigators
use such documents and procedures, unless both PCHI
and the IRB of Record specifically agree otherwise
before the IRB of Record has reviewed and approved
the research.
- PCHI
has primary responsibility for educating and training
its Investigators to perform all research involving
human subjects covered by this Amendment, and will
provide the necessary staff and resources to satisfy
such responsibilities.
- PCHI
bears full responsibility for overseeing the performance
of research by its Investigators, and for assuring
that they comply with federal, state, or local laws
as they may relate to research covered by this Amendment.
- PCHI
will maintain a complete and accurate record of
all Investigators authorized to participate in Protocols
approved by the IRB of Record. This record will
be provided to OPRR at least quarterly and immediately
upon request. This record will also be available
to the Hospitals upon request of an IRB Chairperson,
Executive Secretary, Manager, or other institutional
official responsible for oversight of research activities
or compliance with applicable federal regulations.
- PCHI
will encourage and help to facilitate constructive
communication among the Investigators, human subjects,
and representatives of the Hospitals as a means
of maintaining a high level of awareness regarding
the safeguarding of the rights and welfare of the
subjects.
- PCHI
will review at least annually, and will update as
appropriate, its education, training, and oversight
practices and procedures to ensure that they are
effectively protecting the rights and welfare of
human subjects.
- PCHI
will maintain and will instruct its Investigators
to maintain records of all research and related
activities under this Amendment for at least three
years after completion of the research. Upon reasonable
request, PCHI shall provide a copy of such records
to the IRB of Record and to others as required by
law and regulations.
- PCHI
will notify any appropriate Investigators of reports
to it by the IRB of Record of any serious or continuing
noncompliance by Investigators with the requirements
of the IRB, any suspension or termination of IRB
approval, injuries to human subjects, unanticipated
problems involving risks to subjects or others,
and any IRB-reviewed and -approved changes
in the research being conducted under the auspices
of PCHI.
- In
the event of noncompliance with this Amendment by
PCHI or its Investigators, PCHI agrees to take remedial
action specified by the IRB of Record, including
termination of participation by PCHI or its Investigator(s)
in designated research activities. PCHI also agrees
to take further disciplinary action where appropriate
to deter and remedy effectively any such deficiencies.
- Hospitals’
Responsibilities
- The
Hospitals will provide both meeting space for the
IRBs and sufficient staff to support the IRB’s review
and record-keeping duties.
- The
Hospitals will report promptly to the FDA or OPRR,
as appropriate:
- 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 IRB and this institution
- any
serious or continuing noncompliance by Investigators
with the requirements of the IRB
- any
suspension or termination of IRB approval.
- Term/Termination
- The
provisions of this Amendment shall become effective
on the date first written above. Provided the Hospitals’
MPAs remain 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 its 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 PCHI or the
Hospitals (i) without cause upon (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 Amendment
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
- Neither
this Amendment nor Attachment B shall be construed
as conferring upon any third party, including an Investigator,
any right or benefit. Any and all claims that may
arise under this Amendment may be enforced solely
by PCHI or the Hospitals.
- This
Amendment may be amended, modified, or otherwise changed
only upon the written consent of PCHI and the Hospitals.
- Endorsements
The
duly authorized representatives of the parties have
executed this Amendment as of the date below.
Endorsement
of PCHI
Name
and Title:
Institution:
Address:
Telephone:
Facsimile:
E-mail:
Endorsement
of the Hospitals
Name
of Institution: The Brigham and Women's Hospital,
Inc.
- Authorized
Institutional Official
Name
and Title :
Barbara E. Bierer, MD
Sr
Vice President, Research Administration
Institution: Brigham
& Women's Hospital
Address: 75
Francis Street, Boston, MA 02115
Telephone:
617-732-8990
Facsimile: 617-264-6339
E-mail: bbierer@partners.org
- IRB
Chairperson or Designee Certifying IRB Review and
Approval
Name
and Title:
Joseph H. Antin, M.D.
Chairman, Human Research Committee
Institution:
Brigham & Women's Hospital
Address:
75 Francis Street, Boston, MA 02115
Telephone:
617-732-7200
Facsimile:
617-232-9216
E-mail:
jantin@partners.org
MPA#:
M-1049
Name
of Institution: The Massachusetts General Hospital
Corporation
- Authorized
Institutional Official
Name
and Title:
Ronald S. Newbower, Ph.D.
Sr.
Vice President for Research & Technology
Institution:
Massachusetts General Hospital
Address:
55 Fruit Street, Boston, MA 02114
Telephone:
617-726-1635
Facsimile:
617-726-3246
E-mail:
rnewbower@partners.org
- IRB
Chairperson or Designee Certifying IRB Review and
Approval
Name
and Title:
John P. Remensnyder, M.D.
Chair, Human Research Committee
Institution:
Massachusetts General Hospital
Address:
55 Fruit Street, Boston, MA 02114
Telephone:
617-726-3494
Facsimile:
617-726-3246
E-mail:
jremensnyder@partners.org
MPA#:
M-1331
Name
of Institution: Dana Farber Cancer Institute
- Authorized
Institutional Official
Name
and Title:
Katarzyna Karelus, M.S., M.B.A.
Acting Director, Protocol Administration Office
Institution:
DANA-FARBER Cancer Institute
Address:
44 Binney Street, Boston, MA 02115
Telephone:
617-632-3209
Facsimile:
617-632-2686
E-mail:
kkarelus@partners.org
- IRB
Chairperson or Designee Certifying IRB Review and
Approval
Name
and Title:
Faye C. Austin, Ph.D.
Director for Research
Institution:
DANA-FARBER Cancer Institute
Address:
44 Binney Street, Boston, MA 02115
Telephone:
617-632-3488
Facsimile:
617-632-4452
E-mail:
faye_austin@dfci.harvard.edu
MPA#:
M-1034
DHHS
Approving Official
Name
and Title: on
file
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:
42762V4
|
