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- Background
- Scope
of this Agreement
- DF/P
Hospital Responsibilities
- McLean
Hospital Responsibilities
- Term/Termination
- Miscellaneous
- Endorsements
Cooperative
Agreement Among McLean Hospital and The General Hospital
Corporation, The Brigham and Women’s Hospital, Inc., and
The Dana Farber Center Institute, Inc.
Draft
1/26/99
This
Cooperative Agreement ("Agreement") is made
on ____________, 1999 between McLean Hospital and The
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 Agreement
as the "DF/P Hospitals." Each of the four named
entities is an acute care hospital that serves as a teaching
hospital for Harvard Medical School, and they shall collectively
be referred to as the "Collaborating Hospitals."
- Background
- The
Collaborating Hospitals extensively engage 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 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 Collaborating
Hospitals has an IRB which reviews research involving
human subjects. In addition, each of the Collaborating
Hospitals 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 DF/P 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, McLean Hospital and the DF/P Hospitals
desire to collaborate on research to be conducted
with patients at the Collaborating Hospitals while
avoiding duplication of effort with respect to IRB
reviews.
- Scope
of this Agreement
- The
Collaborating Hospitals agree that, subject to the
terms and conditions of this Agreement, the IRB of
each Collaborating Hospital may review Phase 3 and
4 human research studies involving patients at the
McLean Hospital and one or more of the DF/P Hospitals
when the research is in areas mutually agreed to be
appropriate and each of the participating institutions
agrees to such review ("Protocols"). Said
reviews may be accepted by any of the Collaborating
Hospitals involved in the Protocol, as provided in
this Agreement. The Collaborating Hospitals intend
to use the following process for selecting Protocols:
- Before
the IRB of McLean Hospital or a DF/P Hospital
reviews any Protocol, interested Collaborating
Hospitals shall cause their IRB Chairpersons or
designees to participate in an administrative
review process mutually agreed upon by McLean
Hospital and the DF/P Hospitals to determine the
desirability and suitability of allowing McLean
Hospital or a DF/P Hospital to review the Protocol
for the interested institutions.
- When
the interested Collaborating Hospitals agree that
the McLean Hospital IRB will review a Protocol,
the DF/P Hospitals participating in the Protocol
shall cause their respective IRB Chairpersons
or designees to participate in the McLean Hospital
IRB review process to ensure 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.
Similarly, when the interested institutions agree
that the IRB of a DF/P Hospital will review a
Protocol, McLean Hospital shall cause its IRB
Chairperson or designee to participate in the
DF/P Hospital review process.
- To
facilitate the conduct of such cooperative research,
the Collaborating Hospitals’ IRB Chairpersons
or their designees will mutually decide upon procedures
and types of documents that regularly will be
used by institutional officials and Investigators
in Protocols under this Agreement. Areas for mutual
agreement shall include, but not be limited to,
the protection of confidential patient information.
- The
physicians affiliated with the Collaborating Hospitals
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
Agreement.
- Each
of the Collaborating Hospitals will abide by and will
be responsible for ensuring that its own Investigators
abide by the requirements set forth in the Collaborating
Hospitals’ MPAs and Cooperative Agreements, the Belmont
Report, and 21 CFR Parts 50, 54, 56, and 812 and 45
CFR Part 46 (collectively, the "Federal Research
Regulations").
- DF/P
Hospital Responsibilities
- The
DF/P Hospitals agree to cause their IRBs to conduct
initial and continuing review of the Protocols on
behalf of McLean Hospital in accordance with their
MPAs, 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.
The DF/P Hospitals agree to report promptly to McLean
Hospital their respective IRBs’ actions and findings
regarding such Protocols.
- The
DF/P Hospitals acknowledge and accept that McLean
Hospital shall rely upon the DF/P Hospitals’ IRB review
of Protocols.
- The
DF/P Hospitals agree that when required under the
Federal Research Regulations, they will cause their
respective IRBs to provide certification on McLean
Hospital’s behalf to the federal department or agency
or other entity sponsoring the research to show that
the designated DF/P Hospital IRB has reviewed research
involving human subjects and has approved it as being
consistent with the applicable OPRR-approved MPA.
The designated DF/P Hospital IRB will send McLean
Hospital a copy of such certifications.
- The
DF/P Hospitals agree to cause their respective IRBs
to require that any information given to subjects
as part of an informed consent to participate in research
under 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 the Federal Research Regulations.
The DF/P Hospitals 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
DF/P Hospitals shall cause their respective IRBs to
notify the responsible Physician 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 the designated
DF/P Hospital IRB disapproves a Protocol, it shall
include in its written notification a statement of
the reasons for its decision and shall give the Physician
Investigator an opportunity to respond either in person
or in writing. The DF/P Hospitals also will cause
their respective IRBs to notify McLean Hospital of
IRB-reviewed and approved changes in the research
activity.
- The
DF/P Hospitals shall require their respective IRBs
to conduct continuing review of a Protocol at intervals
appropriate to the degree of risk involved in the
Protocol, but not less than once per year.
- A
DF/P Hospital may decline without cause or prejudice
to participate initially in any particular Protocol
approved by the McLean Hospital IRB under this Agreement.
A DF/P Hospital 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 McLean Hospital IRB and negotiate, as
appropriate, the carrying out of that decision.
- Once
a DF/P Hospital decides to rely on the McLean Hospital
IRB as the IRB of Record for a Protocol, the DF/P
Hospital must follow the decisions of the McLean Hospital
IRB if it desires to continue conducting research
under the Protocol.
- In
the event that the McLean Hospital IRB disapproves
a Protocol, the DF/P Hospitals may conduct such Protocol
only if the Protocol is resubmitted to the designated
DF/P Hospital IRB and obtains separate review and
approval, and not simply by administratively overruling
the McLean Hospital IRB.
- The
DF/P Hospitals shall cause their respective IRBs to
prepare and maintain adequate documentation of their
activities in accordance with the Federal Research
Regulations. The DF/P Hospitals shall provide to McLean
Hospital copies of the minutes of DF/P Hospital IRB
meetings at which any action regarding a Protocol
was taken.
- The
DF/P Hospitals shall report promptly to McLean Hospital
and make available copies of records adequate to document
any serious or continuing noncompliance by Investigators
with the requirements of the designated DF/P Hospital
IRB discovered by the DF/P Hospital; any suspension
or termination of the DF/P Hospital’s 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
DF/P Hospitals are responsible for educating and training
their Investigators to perform research involving
human subjects covered by this Agreement and will
provide the necessary staff and resources to satisfy
such responsibilities.
- The
DF/P Hospitals will assure that before any of its
Investigators conduct research on Protocols, they
will read and accept their responsibilities under
this Agreement. The DF/P Hospitals also will ensure
that their Investigators acknowledge and cooperate
in the McLean Hospital IRB’s responsibilities for
initial and continuing IRB reviews of designated Protocols,
record keeping, reporting, and certification.
- The
DF/P Hospitals will encourage and help to facilitate
constructive communication among its Investigators,
its other representatives, the human subjects, and
McLean Hospital as a means of maintaining a high level
of awareness regarding the safeguarding of the rights
and welfare of subjects participating in Protocols.
- Where
the McLean Hospital IRB is the IRB of Record, the
DF/P Hospitals will be responsible for ensuring that
their Physician Investigators report promptly to that
IRB proposed changes in research activities under
this Agreement. Such changes shall not be initiated
without the review and approval of the McLean Hospital’s
IRB except where necessary to eliminate apparent immediate
hazards to the subjects.
- The
DF/P Hospitals will be responsible for ensuring that
their Investigators report promptly to the McLean
Hospital any injuries to subjects or unanticipated
problems involving risks to subjects or others.
- In
the event of noncompliance with this Agreement by
DF/P Hospitals or their Investigators, DF/P Hospitals
agree to take appropriate remedial action.
- The
DF/P Hospitals 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 included
in the Protocols at McLean Hospital.
- The
DF/P Hospitals will maintain a complete and accurate
record of their Investigators who are authorized to
participate in Protocols approved by the McLean Hospital
IRB. This record shall be available to McLean Hospital
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
DF/P Hospitals assure that their Investigators have
received and will comply with existing federal policies
and guidance concerning notification of seropositivity,
counseling, and confidentiality, where HIV research
activities are involved.
- McLean
Hospital Responsibilities
- McLean
Hospital agrees to cause its IRB to conduct initial
and continuing review of the Protocols on behalf of
DF/P Hospitals in accordance with its MPA, the Federal
Research Regulations, and all other applicable requirements
of federal, state, and local laws and regulations
governing the protection of human research subjects.
McLean Hospital agrees to report promptly to DF/P
Hospitals its IRB’s actions and findings regarding
such Protocols.
- McLean
Hospital acknowledges and accepts that DF/P Hospitals
shall rely upon the McLean Hospital’s IRB review of
Protocols.
- McLean
Hospital agrees that when required under the Federal
Research Regulations, it will cause its IRB to provide
certification on DF/P Hospitals’ behalf to the federal
department or agency or other entity sponsoring the
research to show that the McLean Hospital IRB has
reviewed research involving human subjects and has
approved it as being consistent with the applicable
OPRR-approved MPA. McLean Hospital’s IRB will send
DF/P Hospitals a copy of such certifications.
- McLean
Hospital agrees to cause its IRB to require that any
information given to subjects as part of an informed
consent to participate in research under 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 the Federal Research Regulations. McLean
Hospital shall also cause its IRB to require documentation
of informed consent or to waive said documentation
in accordance with the Federal Research Regulations.
- McLean
Hospital shall cause its IRB to notify the responsible
Physician 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 the McLean Hospital IRB disapproves
a Protocol, it shall include in its written notification
a statement of the reasons for its decision and shall
give the Physician Investigator an opportunity to
respond either in person or in writing. The McLean
Hospital also will cause its IRB to notify DF/P Hospitals
of IRB-reviewed and approved changes in the research
activity.
- McLean
Hospital shall require its IRB to conduct continuing
review of a Protocol at intervals appropriate to the
degree of risk involved in the Protocol, but not less
than once per year.
- McLean
Hospital may decline without cause or prejudice to
participate initially in any particular Protocol approved
by the DF/P Hospital IRB under this Agreement. McLean
Hospital 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 DF/P Hospital IRB and negotiate, as
appropriate, the carrying out of that decision.
- Once
McLean Hospital decides to rely on the designated
DF/P Hospital’s IRB as the IRB of Record for a Protocol,
McLean Hospital must follow the decisions of the DF/P
Hospital’s IRB if it desires to continue conducting
research under the Protocol.
- In
the event that the DF/P Hospital IRB disapproves a
Protocol, McLean Hospital may conduct such Protocol
only if the Protocol is resubmitted to the McLean
Hospital IRB and obtains separate review and approval,
and not simply by administratively overruling the
DF/P Hospital IRB.
- McLean
Hospital shall cause its IRB to prepare and maintain
adequate documentation of its activities in accordance
with the Federal Research Regulations. McLean Hospital
shall provide to DF/P Hospitals copies of the minutes
of McLean Hospital IRB meetings at which any action
regarding a Protocol was taken.
- McLean
Hospital shall report promptly to DF/P Hospitals and
make available copies of records adequate to document
any serious or continuing noncompliance by Investigators
with the requirements of the McLean Hospital IRB discovered
by McLean Hospital; any suspension or termination
of the McLean Hospital’s 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.
- McLean
Hospital is responsible for educating and training
its Investigators to perform research involving human
subjects covered by this Agreement and will provide
the necessary staff and resources to satisfy such
responsibilities.
- McLean
Hospital will assure that before any of its Investigators
conduct research on Protocols, they will read and
accept their responsibilities under this Agreement.
McLean Hospital also will ensure that its Investigators
acknowledge and cooperate in the DF/P Hospitals’ IRB
responsibilities for initial and continuing IRB reviews
of designated Protocols, record keeping, reporting,
and certification.
- McLean
Hospital will encourage and help to facilitate constructive
communication among its Investigators, its other representatives,
the human subjects, and DF/P Hospitals as a means
of maintaining a high level of awareness regarding
the safeguarding of the rights and welfare of subjects
participating in Protocols.
- Where
a DF/P Hospital IRB is the IRB of Record, McLean Hospital
will be responsible for ensuring that its Physician
Investigators report promptly to that IRB proposed
changes in research activities under this Agreement.
Such changes shall not be initiated without the review
and approval of the designated DF/P Hospital’s IRB
except where necessary to eliminate apparent immediate
hazards to the subjects.
- McLean
Hospital will be responsible for ensuring that its
Investigators report promptly to DF/P Hospitals any
injuries to subjects or unanticipated problems involving
risks to subjects or others.
- In
the event of noncompliance with this Agreement by
McLean Hospital or its Investigators, McLean Hospital
agrees to take appropriate remedial action.
- McLean
Hospital hereby attests that the composition of its
IRB as described in Exhibit B attached hereto is such
as to adequately protect the rights and welfare of
human research subjects included in the Protocols
at DF/P Hospitals.
- McLean
Hospital will maintain a complete and accurate record
of its Investigators who are authorized to participate
in Protocols approved by DF/P Hospitals’ IRBs. This
record shall be available to DF/P Hospitals 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.
- McLean
Hospital assures that its Investigators have received
and will comply with existing federal policies and
guidance concerning notification of seropositivity,
counseling, and confidentiality, where HIV research
activities are involved.
- Term/Termination
- The
provisions of this Agreement 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. This Agreement shall be automatically
renewed and extended for successive one (1) year periods
on the same terms and conditions, unless either McLean
Hospital or the DF/P Hospitals shall notify the other
of its intention not to renew this Agreement at least
ninety (90) days prior to the expiration of the then
current term of the Agreement.
- This
agreement may be terminated by either the McLean Hospital
or the DF/P Hospitals (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.
- Miscellaneous
- This
Agreement has been executed and delivered in and shall
be construed and enforced in accordance with the laws
of the Commonwealth of Massachusetts.
- This
Agreement may be amended only by a written agreement
signed by McLean Hospital and the DF/P Hospitals.
- Changes
in voting membership shall be reported to OPRR as
they occur.
- If
any provision of this Agreement shall be held to be
invalid, illegal, or unenforceable, the validity,
legality and enforceability of the remaining provisions
of this Agreement shall not be affected thereby.
- The
McLean Hospital and the DF/P Hospitals represent that
they endorse the National Institutes of Health’s policy
concerning the inclusion of minorities, women, and
children in study populations.
- This
Agreement 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 McLean:
McLean Hospital
Peter Paskevitch
Research Administration
115 Mill Street
Belmont, Massachusetts
with
a copy to:
Executive Secretary for Human Research Committee
If
to BWH:
The Brigham and Women’s Hospital, Inc.
Vice President, Research Administration
Neville House, Room 355
10 Vining Street
Boston, MA 02115
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
with
a copy to:
Executive Secretary for Human Studies
(same address)
If
to MGH:
Massachusetts General Hospital
Director of Human Research Affairs
55 Fruit Street
Boston, MA 02114
with
a copy to:
Executive Secretary for Human Studies
(same address)
- A
fully executed copy of this Agreement shall be retained
by McLean Hospital and each of the DF/P Hospitals
and shall be made accessible to OPRR upon request.
- Endorsements
The
duly authorized representatives of the parties have executed
this Agreement as of the date below.
Name
of Institution: McLean Hospital
A.
Authorized Institutional Official
B.
IRB Chairperson or Designee Certifying IRB Review and
Approval
Name
of Institution: The Brigham and Women’s Hospital, Inc.
A.
Authorized Institutional Official
B.
IRB Chairperson or Designee Certifying IRB Review and
Approval
Name
of Institution: The Dana Farber Cancer Institute, Inc.
A.
Authorized Institutional Official
B.
IRB Chairperson or Designee Certifying IRB Review and
Approval
Name
of Institution: The General Hospital Corporation
A.
Authorized Institutional Official
B.
IRB Chairperson or Designee Certifying IRB Review and
Approval
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