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Cooperative
Amendment
This
agreement is made and entered into on October 27, 1999,
by and between The Dana-Farber Cancer Institute, Inc.
("DFCI") and The General Hospital Corporation
("MGH").
Whereas,
DFCI and MGH desire to avoid duplication of effort with
regard to institutional review board ("IRB")
reviews of Adult and Pediatric Oncology and Non-Malignant
Hematology research protocols (including individual emergency
requests) to be conducted with patients registered at
DFCI and MGH;
Whereas,
MGH desires to rely upon DFCI's IRB for the review of
said protocols; and
Whereas,
DFCI desires to review said protocols on behalf of both
DFCI and MGH.
Now
therefore, in consideration of the mutual promises and
conditions set forth herein DFCI and MGH agree as follows:
- Scope
of the Agreement
DFCI
and MGH agree that, subject to the terms and conditions
of the agreement, DFCI's IRB shall review all categories
of Adult and Pediatric Oncology and Non-Malignant Hematology
Research protocols including Quality of Life, on behalf
of both DFCI and MGH.
- DFCI's
Responsibilities
- DFCI
agrees to cause its IRB to conduct initial and continuing
review of the protocols on behalf of MGH and DFCI
in accordance with applicable requirements of the
United States Department of Health and Human Services
("DHHS") Regulations for the Protection
of Human Subjects as set forth in 45 CFR Part 46,
as amended, all other applicable requirements of federal,
state and local laws and regulations governing the
protection of human subjects; and DFCI's Multiple
Project Assurance of Compliance with DHHS Regulations
for Protection of Human Subjects. DFCI agrees
to promptly report to MGH its IRB's actions and findings
regarding any such protocols.
- DFCI
acknowledges and accepts that MGH shall rely upon
DFCI's IRB review of the protocols.
- DFCI
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 for the informed
consent set forth in 45 CFR Part 46, as amended, and
the requirements of CFR 46.408 in the case of research
involving children. DFCI shall cause its IRB
to require documentation of informed consent or to
waive said documentation accordance with 45 CFR 46.117.
- DFCI
shall cause its IRB to notify MGH and any affected
investigator(s) in writing of its decision to approve
or disapprove any protocol, or of modifications required
to secure IRB approval of the protocol. In the
event of IRB disapproval of 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.
- DFCI
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.
- DFCI
shall cause its IRB to prepare and maintain adequate
documentation of its activities in accordance with
45 CFR 46, as amended. DFCI shall provide to
MGH copies of the minutes of DFCI's IRB meetings at
which any action regarding a protocol was taken.
- DFCI
shall report promptly to MGH, and make available copies
of records adequate to document:
- Any
serious or continuing noncompliance by investigators
with the requirements of DFCI IRB discovered by
DFCI; and
- Any
suspension of termination of DFCI IRB approval of
a protocol, including a statement of the IRB's reasons
for such an action.
- DFCI
hereby attests that the composition of the DFCI IRB
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 MGH. MGH may change their membership in the
DFCI IRB from time to time in accordance with DFCI
procedures concerning IRB membership.
- MGH
Responsibilities
- MGH
acknowledges that the DFCI IRB shall have the authority
to approve, require modification in (to secure approval)
or disapprove activities under a protocol.
- MGH
agrees to abide by all conditions and determinations
of the DFCI IRB with regard to activities under the
protocols and agrees to accept the final authority
of the DFCI IRB with regard to said protocols.
MGH acknowledges and agrees that the DFCI IRB's disapproval
of a protocol may not be administratively overruled
by either MGH or DFCI.
- MGH
shall report promptly to DFCI, and make available
copies of records adequate to document any serious
or continuing noncompliance by investigators with
the requirements of the DFCI IRB discovered by MGH.
- If
DFCI determines that there has been a protocol violation
by a person who is not an employee of DFCI, or is
not credentialed at DFCI, and if DFCI recommends corrective
or disciplinary action against that person, MGH agrees
to implement such proceedings and to take such action
against such person as MGH determines are appropriate
under its normal policies and procedures.
- 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 stated. Provided each of the
parties' Multiple Project Assurance remains in good
standing, this Agreement will be automatically renewed
and extended for successive (1) year periods on the
same terms and conditions, unless either party 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 party (i) without
cause upon ninety (90) days prior written notice;
or (ii) upon thirty days prior written notice in the
event of a breach by the other party of any material
term or condition of this Agreement within said thirty
(30) day notice period. Any termination of this
agreement must be communicated to DHHS in writing.
- Miscellaneous
- Notwithstanding
anything herein to the contrary, MGH may elect to
require the MGH IRB to review one or more of the protocols.
- This
Agreement has been executed and delivered in and shall
be construed and forced in accordance with the laws
of the Commonwealth of Massachusetts.
- This
Agreement may be amended only by written agreement
signed by both parties.
- 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.
- Each
of MGH and DFCI represent that it endorses the National
Institutes of Health's policy concerning the inclusion
of minorities and women in study populations.
- This
Agreement is not assignable in whole or 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 addresses as follows:
If
to MGH:
Massachusetts General Hospital
Human Research Affairs
50 Staniford Street, 10th Floor
Boston, MA 02114
Attention: Greg Koski, MD
Director of Human Research Affairs
If
to DFCI:
The Dana-Farber Cancer Institute
Human Protection Committee
44 Binney Street
Boston, MA 02115
Attention: Katarzyna Karelus
(Acting) Director of Protocol Administration Office
This
Agreement constitutes the entire agreement between
the parties with respect to the subject matter hereof
and supersedes all proposals, negotiations, and other
communications between the parties, whether written
or oral, with respect to the subject matter hereof.
A
fully executed copy of this Agreement shall be retained
by each of MGH and DFCI and shall be made accessible
to the DHHS Office of Protection from Research Risks
upon request.
IN
WITNESS WHEREOF, the parties have executed this Agreement
as of the date first written above.
Name
of Institution: The General Hospital Corporation ("MGH")
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
Name
of Institution: The Dana-Farber Cancer Institute ("DFCI")
Authorized
Institutional Official
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
DHHS
Approving Official
Name
and Title:
Froda E. Yoder
Assurance Coordinator, Assurance Branch
Institution:
OPRR, OER, OD, NIH (MSC 7507)
Address:
6100 Executive Boulevard, Suite 3801
Rockeville, MD 20892-7507
Telephone:
301-402-5793
Facsimile:
301-402-0527
E-mail:
fy9r@nih.gov
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