HMS/HSDM
CA
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[ HMS/HSDM CA ] [ MGH, BWH, DFCI, and HSPH CA ]
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[ PCHI IIA ]
[ SHC iia ]
- Background
- Scope
and Applicability
- Statement
of Principles and Policy
- DF/P
Hospital Responsibilities
- HMS/HSDM
Responsibilities
- Term/Termination
- Miscellaneous
- Endorsements
Cooperative
Amendment to Multiple Project Assurances of Harvard
Medical School/Harvard School of Dental Medicine, The
General Hospital Corporation, The Brigham and Women’s
Hospital, Inc., and The
Dana Farber Center Institute, Inc.
Draft
7/12/99
This
Cooperative Amendment ("CA") is made on ____________,
1999 between Harvard Medical School/Harvard School of
Dental Medicine ("HMS/HSDM") (M-______) and
The General Hospital Corporation ("MGH") (M-1331),
The Brigham and Women’s Hospital, Inc. ("BWH")
(M-1049), and The Dana Farber Cancer Institute, Inc. ("DFCI")
(M-1034). MGH and BWH are teaching hospitals that are
founding members of Partners HealthCare System, Inc. ("Partners"),
and DFCI has a joint venture with Partners in adult oncology.
MGH, BWH, and DFCI shall collectively be referred to as
the "DF/P Hospitals." The DF/P Hospitals serve
as teaching hospitals for HMS.
- Background
- The
DF/P Hospitals and HMS/HSDM 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 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, HMS/HSDM and each of the DF/P
Hospitals has an IRB which reviews research involving
human subjects. In addition, HMS/HSDM and each of
the DF/P 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, BWH and DFCI each have a CA with
HMS/HSDM. To build on and simplify these relationships
and avoid duplication of effort with respect to IRB
reviews, HMS/HSDM hereby amends its existing MPA to
allow for collaborative research with any of the DF/P
Hospitals, and the MGH, BWH, and DFCI each amend their
own MPAs to allow for collaborative research with
HMS/HSDM. This CA shall supersede the existing ones
between HMS/HSDM and each of BWH and DFCI.
II.
Scope and Applicability
- HMS/HSDM
and the DF/P Hospitals agree that, subject to the
terms and conditions of this CA, each of their IRBs
may review Phase 3 and 4 human research studies involving
human subjects at HMS/HSDM and one or more of the
DF/P Hospitals when the research is in areas mutually
agreed to be appropriate and each participating institution
agrees to such review pursuant to II.C. ("Protocols").
Said reviews may be accepted by any of the DF/P Hospitals
and HMS/HSDM participating in the Protocol, as provided
in this CA.
- This
CA does not apply to research that does not involve
subjects at HMS/HSDM and one or more of the DF/P Hospitals.
HMS/HSDM and each of the DF/P Hospitals has the right
to decline to conduct a particular research study
under this CA, and/or to choose to conduct the study
on its own, provided that if the IRB of HMS/HSDM or
one of the DF/P Hospitals disapproves a Protocol,
another party to this CA may conduct such Protocol
only if the Protocol is resubmitted to its IRB and
obtains separate review and approval, and not simply
by administratively overruling the other party’s IRB.
- The
Parties intend to use the following process for selecting
Protocols which shall be subject to this CA:
- Before
the IRB of HMS/HSDM or a DF/P Hospital reviews a
Protocol, the interested parties shall cause their
IRB Chairpersons or designees to participate in
an administrative review process mutually agreed
upon by HMS/HSDM and the DF/P Hospitals to determine
the desirability and suitability of allowing HMS/HSDM
or a DF/P Hospital to review the Protocol for the
interested institutions.
- When
the interested parties agree that the HMS/HSDM IRB
will review a Protocol, the DF/P Hospitals participating
in the Protocol shall cause their respective IRB
Chairpersons or designees to participate in HMS/HSDM
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 parties agree that the IRB of
a DF/P Hospital will review a Protocol, HMS/HSDM
shall cause its IRB Chairperson or designee to participate
in the IRB review process of the DF/P Hospital.
- To
facilitate the conduct of such cooperative research,
the parties’ 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
CA. Areas for mutual agreement shall include, but
not be limited to, the protection of confidential
human subject information.
- The
physicians affiliated with the DF/P Hospitals and
HMS/HSDM 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 CA.
- Statement
of Principles and Policy
- HMS/HSDM
and each of the DF/P Hospitals will abide by and will
be responsible for ensuring that its own Investigators
abide by the requirements set forth in the parties’
MPAs and CAs, the Belmont Report, and 21 CFR Parts
50, 54, 56, 312, and 812 and 45 CFR Part 46 (collectively,
the "Federal Research Regulations"). Since
the regulations in Title 21 and Title 45 are not identical,
the stricter requirements will prevail whenever applicable.
- Each
of the parties will accept, and will be responsible
for ensuring that its Investigators accept, the final
authority of the IRB that is designated as the IRB
of Record for any Protocols conducted under this CA.
IV.
DF/P Hospital Responsibilities
Each
of the DF/P Hospitals understands that when it and HMS/HSDM
agree (pursuant to the administrative review process
described in II.C. above) that a DF/P Hospital’s IRB
will review Protocols as the IRB of Record under this
CA, then that institution will be responsible for carrying
out the responsibilities described below in Sections
A through H:
- The
DF/P Hospital will cause its IRB to conduct initial
and continuing review of the Protocol on behalf of
HMS/HSDM in accordance with its MPA, CAs, 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 Hospital agrees to report promptly to HMS/HSDM
its IRB’s actions and findings regarding such Protocols.
- The
DF/P Hospital acknowledges and accepts that HMS/HSDM
shall rely upon its IRB review of Protocols.
- The
DF/P Hospital agrees that when required under applicable
federal regulations, it will cause its IRB to provide
certification on HMS/HSDM’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 HMS/HSDM a copy of such certifications.
- The
DF/P 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 45 CFR Part 46, including
45 CFR 46.408 in the case of research involving children,
and other applicable federal, state, or local requirements.
The DF/P Hospital shall also cause its IRB to require
documentation of informed consent or to waive said
documentation in accordance with applicable federal
regulations.
- The
DF/P Hospital shall cause its IRB 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 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 Investigator an opportunity to respond either
in person or in writing. The DF/P Hospital also will
cause its IRB to notify HMS/HSDM of IRB-reviewed and
approved changes in the research activity.
- The
DF/P 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.
- The
DF/P Hospitals shall cause their respective IRBs to
prepare and maintain adequate documentation of their
activities in accordance with applicable federal regulations.
The DF/P Hospitals shall provide to HMS/HSDM copies
of the minutes of DF/P Hospital IRB meetings at which
any action regarding a Protocol was taken.
- Upon
notifying any appropriate authorities in accordance
with applicable federal regulations, the DF/P Hospitals
shall report promptly to HMS/HSDM 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; injuries to human subjects; or unanticipated
problems involving risks to subjects or others.
- Any
DF/P Hospital may decline without cause or prejudice
to participate initially in any particular Protocol
approved by the HMS/HSDM IRB under this CA. Any 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 HMS/HSDM IRB and negotiate, as appropriate, the
carrying out of that decision.
- Once
a DF/P Hospital decides to rely on the HMS/HSDM IRB
as the IRB of Record for a Protocol, the DF/P Hospital
must follow the decisions of the HMS/HSDM IRB if it
desires to continue conducting research under the
Protocol.
- The
DF/P Hospitals are responsible for educating and training
their Investigators to perform research involving
human subjects covered by this CA 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 CA. The DF/P Hospitals also will ensure that
their Investigators acknowledge and cooperate in the
HMS/HSDM 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
HMS/HSDM 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 HMS/HSDM IRB is the IRB of Record, the DF/P Hospitals
will be responsible for ensuring that their Investigators
report promptly to that IRB proposed changes in research
activities under this CA. Such changes shall not be
initiated without the review and approval of the HMS/HSDM
IRB except where necessary to eliminate apparent immediate
hazards to the subjects.
- Where
the HMS/HSDM IRB is the IRB of Record, the DF/P Hospitals
will be responsible for ensuring that their Investigators
report promptly to that IRB any injuries to subjects
or unanticipated problems involving risks to subjects
or others.
- In
the event of noncompliance with this CA 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 HMS/HSDM.
- The
DF/P Hospitals will maintain a complete and accurate
record of their Investigators who are authorized to
participate in Protocols approved by the HMS/HSDM
IRB. This record shall be available to OPRR upon request
and to HMS/HSDM 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.
V.
HMS/HSDM Responsibilities
- HMS/HSDM
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. HMS/HSDM agrees
to report promptly to DF/P Hospitals its IRB’s actions
and findings regarding such Protocols.
- HMS/HSDM
acknowledges and accepts that DF/P Hospitals shall
rely upon the HMS/HSDM’s IRB review of Protocols.
- HMS/HSDM
agrees that when required under applicable federal
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 HMS/HSDM IRB has reviewed research
involving human subjects and has approved it as being
consistent with the applicable OPRR-approved MPA.
HMS/HSDM’s IRB will send DF/P Hospitals a copy of
such certifications.
- HMS/HSDM
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 45 CFR Part 46, including 45 CFR
46.408 in the case of research involving children,
and other applicable requirements of federal, state
and local law and regulations. HMS/HSDM shall also
cause its IRB to require documentation of informed
consent or to waive said documentation in accordance
with applicable federal regulations.
- HMS/HSDM
shall cause its IRB 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 the
HMS/HSDM 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.
HMS/HSDM also will cause its IRB to notify DF/P Hospitals
of IRB-reviewed and approved changes in the research
activity.
- HMS/HSDM
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.
- HMS/HSDM
shall cause its IRB to prepare and maintain adequate
documentation of its activities in accordance with
applicable federal regulations. HMS/HSDM shall provide
to DF/P Hospitals copies of the minutes of HMS/HSDM
IRB meetings at which any action regarding a Protocol
was taken.
- Upon
notifying any appropriate authorities in accordance
with applicable federal regulations, HMS/HSDM 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 HMS/HSDM IRB discovered by
HMS/HSDM; any suspension or termination of the HMS/HSDM’s
IRB approval of a Protocol, including a statement
of the IRB’s reasons for such action; injuries to
human subjects; or unanticipated problems involving
risks to subjects or others.
- HMS/HSDM
may decline without cause or prejudice to participate
initially in any particular Protocol approved by the
DF/P Hospital IRB under this CA. HMS/HSDM 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
HMS/HSDM decides to rely on the designated DF/P Hospital’s
IRB as the IRB of Record for a Protocol, HMS/HSDM
must follow the decisions of the DF/P Hospital’s IRB
if it desires to continue conducting research under
the Protocol.
- HMS/HSDM
is responsible for educating and training its Investigators
to perform research involving human subjects covered
by this CA and will provide the necessary staff and
resources to satisfy such responsibilities.
- HMS/HSDM
will assure that before any of its Investigators conduct
research on Protocols, they will read and accept their
responsibilities under this CA. HMS/HSDM 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.
- HMS/HSDM
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, HMS/HSDM
will be responsible for ensuring that its Investigators
report promptly to that IRB proposed changes in research
activities under this CA. 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.
- Where
a DF/P Hospital IRB is the IRB of Record, HMS/HSDM
will be responsible for ensuring that its Investigators
report promptly to that IRB any injuries to subjects
or unanticipated problems involving risks to subjects
or others.
- In
the event of noncompliance with this CA by HMS/HSDM
or its Investigators, HMS/HSDM agrees to take appropriate
remedial action.
- HMS/HSDM
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.
- HMS/HSDM
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.
- HMS/HSDM
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.
VI.
Term/Termination
- The
provisions of this CA 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 the MPAs of HMS/HSDM
and the DF/P Hospitals remain in good standing, this
CA shall be automatically renewed and extended for
successive one (1) year periods on the same terms
and conditions, unless either HMS/HSDM or a DF/P Hospital
shall notify the others of its intention not to renew
this CA at least ninety (90) days prior to the expiration
of the then current term of the CA.
- This
CA may be terminated by either the HMS/HSDM 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 CA which breach is not cured to the reasonable
satisfaction of the non-breaching party within said
thirty (30) day notice period.
VII.
Miscellaneous
- This
CA has been executed and delivered in and shall be
construed and enforced in accordance with the laws
of the Commonwealth of Massachusetts.
- This
CA may be amended only by a written agreement signed
by HMS/HSDM and the DF/P Hospitals.
- Changes
in voting membership shall be reported to OPRR as
they occur.
- If
any provision of this CA shall be held to be invalid,
illegal, or unenforceable, the validity, legality
and enforceability of the remaining provisions of
this CA shall not be affected thereby.
- The
HMS/HSDM 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
CA 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 HMS/HSDM: Harvard Medical School/
Harvard School of Dental Medicine
[Research Administration]
Boston, MA
with
a copy to:
__________________
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 CA shall be retained by
HMS/HSDM and each of the DF/P Hospitals and shall
be made accessible to OPRR upon request.
VIII.Endorsements
The
duly authorized representatives of the parties have executed
this CA as of the date below.
Name
of Institution: Harvard Medical School/Harvard School
of Dental Medicine
A.
Authorized Institutional Official
Signature
__________________________ Date _____________
Name
and Title: _________________________________________
_________________________________________
Institution:
_________________________________________
Address:
_________________________________________
_________________________________________
Telephone:
__________________
Facsimile:
__________________
E-mail:
_________________________________________
B.
IRB Chairperson or Designee Certifying IRB Review and
Approval
Signature
__________________________ Date _____________
Name
and Title: _________________________________________
_________________________________________
Institution:
_________________________________________
Address:
_________________________________________
_________________________________________
Telephone:
__________________
Facsimile:
__________________
E-mail:
_________________________________________
Name
of Institution: The Brigham and Women’s Hospital, Inc.
A.
Authorized Institutional Official
Signature
__________________________ Date _____________
Name
and Title: _________________________________________
_________________________________________
Institution:
_________________________________________
Address:
_________________________________________
_________________________________________
Telephone:
__________________
Facsimile:
__________________
E-mail:
_________________________________________
B.
IRB Chairperson or Designee Certifying IRB Review and
Approval
Signature
__________________________ Date _____________
Name
and Title: _________________________________________
_________________________________________
Institution:
_________________________________________
Address:
_________________________________________
_________________________________________
Telephone:
__________________
Facsimile:
__________________
E-mail:
_________________________________________
Name
of Institution: The Dana Farber Cancer Institute, Inc.
A.
Authorized Institutional Official
Signature
__________________________ Date _____________
Name
and Title: _________________________________________
_________________________________________
Institution:
_________________________________________
Address:
_________________________________________
_________________________________________
Telephone:
__________________
Facsimile:
__________________
E-mail:
_________________________________________
B.
IRB Chairperson or Designee Certifying IRB Review and
Approval
Signature
__________________________ Date _____________
Name
and Title: _________________________________________
_________________________________________
Institution:
_________________________________________
Address:
_________________________________________
_________________________________________
Telephone:
__________________
Facsimile:
__________________
E-mail:
_________________________________________
Name
of Institution: The General Hospital Corporation
A.
Authorized Institutional Official
Signature
__________________________ Date _____________
Name
and Title: _________________________________________
_________________________________________
Institution:
_________________________________________
Address:
_________________________________________
_________________________________________
Telephone:
__________________
Facsimile:
__________________
E-mail:
_________________________________________
B.
IRB Chairperson or Designee Certifying IRB Review and
Approval
Signature
__________________________ Date _____________
Name
and Title: _________________________________________
_________________________________________
Institution:
_________________________________________
Address:
_________________________________________
_________________________________________
Telephone:
__________________
Facsimile:
__________________
E-mail:
_________________________________________
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