MGH,
BWH, DFCI, and HSPH CA
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Cooperative
Amendment Among The Harvard School of Public Health and
The Massachusetts General Hospital Corporation, The Brigham
and Women's Hospital, Inc., and The Dana Farber Cancer
Institute, Inc.
This
Cooperative Amendment ("Amendment") is made
as of May 1, 2000 between Harvard School of Public Health
("HSPH") and The Massachusetts General Hospital
Corporation ("MGH"), The Brigham and Women's
Hospital, Inc. ("BWH"), and The Dana Farber
Cancer Institute, Inc. ("DFCI"). MGH and BWH
are teaching hospitals that are founding members of Partners
HealthCare System, Inc., and MGH, BWH, and DFCI shall
collectively be referred to in this Amendment as the "
Collaborating Hospitals." Each of the Collaborating
Hospitals is an acute care hospital that serves as a teaching
hospital for "Parties."
- Background
- The
Parties extensively engage in health research, including
research involving human subjects. Some of this research
consists of industrially-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, each of the Parties
has an IRB which reviews research involving human
subjects. In addition, each of the Parties has submitted
a Multiple Project Assurance of Compliance ("MPA")
to the Office of Protection from Research Risks ("OPRR")
of the National Institutes of Health. The MPAs, which
OPRR has approved (and periodically reviews for renewal),
provide that each institution will conduct research
in compliance with established ethical principles
and applicable regulations of the United States Department
of Health and Human Services (DHHS) set forth in 45
CFR Part 46, as amended. The MPAs provide an established,
OPRR-approved framework for conducting a broad range
of research activities.
- In
addition to the MPAs, the Collaborating Hospitals
have OPRR-approved Cooperative Amendments, which enable
MGH, BWH, and DFCI to cooperate in human research
studies while avoiding duplication of effort with
respect to IRB reviews. Similarly, the Parties desire
to collaborate on health research involving human
subjects while avoiding duplication of effort with
respect to IRB reviews.
- Scope
of this Cooperative Amendment
- This
Amendment concerns review of human research studies
involving HSPH and one or more of the Collaborating
Hospitals (the "Protocols"). The Parties
agree that, subject to the terms and conditions of
this Amendment, a Protocol may be reviewed by a single
IRB, either at HSPH or at a Collaborating Hospital.
The Parties further agree that, as provided in this
Amendment, such a review may be relied upon by any
of the Parties involved in the Protocol. However,
each Party reserves the right to insist upon review
by its own IRB regardless of this Amendment. The Parties
intend to use the following process for determining
appropriate IRB review:
- When
a Protocol contemplates that human subjects will
be patients at one or more Collaborating Hospitals,
the IRB of a Collaborating Hospital will review
the Protocol for all interested Parties. An IRB
selected to conduct a Protocol review as described
in this paragraph shall be referred to in this Amendment
as a "designated IRB."
- When
one of the Parties’ IRBs has been designated to
review a Protocol, the other involved Parties shall
have the opportunity to participate, through their
respective IRB Chairs or designees, in the designated
IRB's review process. This is intended to foster
familiarity, during IRB deliberations at the time
of initial and continuing review, with institutional
constraints, populations across institutions, and
other factors important to the approval and conduct
of said Protocol.
- Whenever
a Protocol contemplates using HSPH students as human
subjects, or when a Protocol contemplates the use
of human subjects who will not be patients at a
Collaborating Hospital, the involved Parties’ IRB
Chairs or designees shall confer and have the authority
to decide which of their IRBs shall review the Protocol
for all interested Parties.
- The
physicians and other scientists affiliated with the
Parties who participate in such Protocols, as well
as other individuals who are engaged in the conduct
of 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. To facilitate the conduct of such
cooperative research, the Parties' IRB Chairs or their
designees will mutually decide upon procedures and
types of documents that regularly will be used by
the Parties and their Investigators for Protocols
reviewed under this Amendment. Areas for mutual agreement
shall include, but not be limited to, the protection
of confidential patient information.
- Each
of the Parties will abide by and will be responsible
for alerting its own Investigators to the requirements
set forth in the Parties' MPAs and Cooperative Amendments,
the Belmont Report, and 21 CFR Parts 50, 54, 56 and
812 and 45 CFR Part 46 (collectively, the "Federal
Research Regulations").
- Responsibilities
of the Parties
- Each
Party agrees to cause its IRB to conduct initial and
continuing review of the Protocols on behalf of the
other Parties, as provided in this Amendment, in accordance
with its MPA, any Cooperative Amendments, the Federal
Research Regulations, and all other applicable requirements
of federal, state, and local laws and regulations
governing the protection of human research subjects.
Each Party agrees to report promptly to the other
Parties involved in a particular Protocol its IRB's
actions and findings regarding such Protocol.
- Each
Party acknowledges and accepts that, if it conducts
an IRB review for a Protocol as provided by this Amendment,
then the other involved Parties shall rely upon its
IRB review.
- Each
Party agrees that, if it conducts an IRB review for
a Protocol as provided by this Amendment, then, when
required under the Federal Research Regulations, it
will cause its IRB to provide certification with regard
to that Protocol on behalf of the other involved Parties
to the federal department or agency or other entity
sponsoring the Protocol to show that its IRB has reviewed
the Protocol and has approved it as being consistent
with its OPRR-approved MPA. In that circumstance,
the Party's IRB will send the other involved Parties
a copy of such certifications.
- The
Parties agree to cause their respective IRBs to require
that any information given to subjects as part of
an informed consent to participate in a Protocol shall
be in accordance with applicable requirements of federal,
state and local law and regulations, including but
not limited to the general requirements of informed
consent in 45 CFR 46.116. The Parties shall also cause
their respective IRBs to require documentation of
informed consent or to waive said documentation in
accordance with the Federal Research Regulations.
- The
Parties shall cause their respective designated IRBs
to notify the responsible Investigator(s) in writing
of a decision to approve or disapprove any Protocol
or of modifications required to secure IRB approval
of the Protocol. In the event that a designated IRB
disapproves a Protocol, it shall include in its written
notification a statement of the reasons for its decision
and shall give the Investigator an opportunity to
respond either in person or in writing. The Parties
also will cause their respective IRBs to notify the
other involved Parties of IRB-reviewed and approved
changes in a Protocol.
- The
Parties shall require their respective designated
IRBs to conduct continuing review of Protocols, not
less than once per year.
- A
Party may decline without cause or prejudice to participate
initially in any particular Protocol approved by another
Party's IRB under this Amendment. A Party also may
discontinue or limit its conduct of research under
a Protocol, but in such instances it must provide
reasonable prior written notice to the designated
IRB and negotiate, as appropriate, the carrying out
of that decision.
- Once
a Party decides to rely on a designated IRB to review
a Protocol, the Party must follow the decisions of
the designated IRB if it desires to continue conducting
research under the Protocol.
- A
Protocol that has been disapproved by a designated
IRB may only be conducted if it is resubmitted to,
reviewed and approved by the originally designated
IRB of record. The decision of the originally designated
IRB cannot be administratively overruled.
- The
Parties shall cause their respective IRBs to prepare
and maintain adequate documentation of their activities
in accordance with the Federal Research Regulations.
Each Party shall provide copies of the minutes of
its IRB meetings at which any action regarding a Protocol
was taken to all other Parties involved in the Protocol.
- The
Parties shall report promptly to each other and make
available copies of records adequate to document any
of the following: serious or continuing noncompliance
by Investigators with the requirements of a designated
IRB; suspension or termination of a designated IRB
approval of a Protocol, including a statement of the
IRB's reasons for such action; information received
concerning injuries to human subjects; or information
received concerning unanticipated problems involving
risks to subjects or others.
- The
Parties are responsible for educating and training
their Investigators to perform research involving
human subjects covered by this Amendment and will
provide the necessary staff and resources to satisfy
such responsibilities.
- The
Parties will assure that before any of their Investigators
conduct research on Protocols, they will read and
accept their responsibilities under this Amendment.
The Parties also will ensure that their Investigators
acknowledge and cooperate with the designated IRB's
responsibilities for initial and continuing IRB reviews
of Protocols, record keeping, reporting and certification.
- The
Parties will encourage and help to facilitate constructive
communication among their Investigators, their other
representatives, the human subjects, and each other
as a means of maintaining a high level of awareness
regarding the safeguarding of the rights and welfare
of subjects participating in Protocols.
- Where
one of the Parties IRB is designated to review a Protocol,
the other Parties will be responsible for ensuring
that their Investigators report promptly to the designated
IRB proposed changes in the Protocol. Such changes
shall not be initiated without the review and approval
of the designated IRB except where necessary to eliminate
apparent immediate hazards to the subjects.
- For
each Protocol, the involved Parties will be responsible
for ensuring that their Investigators report promptly
to the other involved Parties any injuries to subjects
or unanticipated problems involving risks to subjects
or others.
- The
Parties agree to take appropriate remedial action
in the event of noncompliance with this Amendment
by a Party or its Investigators.
- The
Parties hereby attest that the composition of their
respective IRBs as described in Exhibit A attached
hereto is such as to adequately protect the rights
and welfare of human research subjects.
- For
each Protocol approved by a designated IRB, the other
involved Parties will maintain complete and accurate
records of their Investigators who are authorized
to participate in the Protocol. These records shall
be available to the Party whose IRB was designated
upon reasonable request of the designated IRB Chairperson,
Executive Secretary, Manager, or other institutional
official responsible for oversight of research activities
or compliance with applicable laws and regulations.
- The
Parties assure that their Investigators have been
and will be made aware of the requirement to comply
with existing federal policies and guidance concerning
notification of seropositivity, counseling, and confidentiality,
where HIV research activities are involved.
- Terms/Termination
- The
provisions of this Amendment shall remain in full
force and effect for a period of one (1) year, commencing
on the date first written above, unless sooner terminated
as hereinafter provided. Provided that each Party’s
MPA remains in good standing, this Amendment shall
be automatically renewed and extended for successive
one (1) year periods on the same terms and conditions,
unless any Party shall notify the others in writing
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 any 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 any 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 or Parties within said
thirty (30) day notice period.
- Miscellaneous
- 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 the Parties.
- Changes
in voting membership shall be reported to OPRR as
they occur.
- 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.
- The
Parties represent that they endorse the National Institutes
of Health's policy concerning the inclusion of minorities,
women, and children 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 HSPH:
Harvard School of Public Health Administrator
Human Subjects Committee
677 Huntington Avenue, SPH3-334
Boston, MA 02115
Fax #:
617-432-1079
With
a copy to: Chairperson,
HSPH Human Subjects Committee
(same
address)
If
to BWH:
The Brigham and Women's Hospital, Inc.
Vice President,
Research Administration
Neville House, Room 355
10 Vining Street
Boston, MA 02115
Fax #:
617-732-5753
With
a copy to: Executive
Secretary for Human Research Committee
(same address)
If to DFCI:
The Dana Farber Cancer Institute, Inc.
Director of Protocol Administration
Human Protection Office
44 Binney Street
Boston, MA 02115
Fax #:
617-632-2686
With a copy to: Executive
Officer of IRB
(same address)
If to MGH:
The Massachusetts General Hospital Corporation
Director of Human Research Affairs
55 Fruit Street
Boston, MA 02114
Fax #:
617-726-3246
With a copy to: Executive Secretary
for Human Studies
(same address)
- A
fully executed copy of this Amendment shall be retained
by each Party and shall be made accessible to OPRR
upon request.
- Endorsements
The
duly authorized representatives of the parties have
executed this Amendment as of the date below.
Name
of Institution: Harvard School of Public Health
- Authorized
Institutional Official
Name
and Title:
John Lichten, MSW
Dean for Administration and Finance
Institution:
Harvard School of Public Health
Address:
677 Huntington Avenue
Telephone:
(617) 432-1015
Facsimile:
(617) 432-2840
E-mail:
jlichten@sphofs.harvard.edu
- IRB
Chairperson or Designee Certifying IRB Review and
Approval
Name
and Title:
Troyen A. Brennan, MD, JD
Professor of Law and Public Health
Institution:
Harvard School of Public Health
Address:
677 Huntington Avenue
Telephone:
(617) 732-8961
Facsimile:
(617) 432-1079
E-mail:
tabrennan@partners.org
MPA#: M-1208
Name
of Institution: The Brigham and Women's Hospital,
Inc.
- Authorized
Institutional Official
Name
and Title :
Keith A. Marcotte
Vice President, Research Administration
Institution:
Brigham & Women's Hospital
Address:
75 Francis Street, Boston, MA 02115
Telephone:
617-732-5740
Facsimile:
617-732-5753
E-mail:
kmarcotte@rics.bwh.harvard.edu
- 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
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