MGH BWH CA

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• Scope of the Agreement
• BWH's Responsibilities
• MGH's Responsibilities
• Term/Termination
• Miscellaneous
• Endorsements

Cooperative Amendment

This agreement is made and entered into as of January 1, 2000, by and between The Brigham and Women’s Hospital, Inc. ("BWH") and The General Hospital Corporation ("MGH").

Whereas, BWH and MGH desire to avoid duplication of effort with regard to institutional review board ("IRB") reviews of research protocols (including individual emergency requests) to be conducted with patients registered at BWH and/or MGH.

Now therefore, in consideration of the mutual promises and conditions set forth herein, BWH and MGH agree as follows:

1. Scope of the Agreement

BWH and MGH agree that, subject to the terms and conditions of this agreement, each IRB may review all categories of research protocols from either institution, and said reviews will be accepted by both institutions.

2. BWH’s Responsibilities
   

1. BWH agrees to cause its IRB to conduct initial and continuing review of the protocols on behalf of MGH 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 research subjects; and BWH’s Multiple Project Assurance of Compliance with DHHS Regulations for Protection of Human Subjects. BWH agrees to promptly report to MGH its IRB’s actions and findings regarding any such protocol.
   
   
2. BWH acknowledges and accepts that MGH shall rely upon BWH’s IRB review of the protocols.
   
   
3. BWH 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 laws and regulations, including, but not limited to, the general requirements for informed consent set forth in 45 CFR Part 46, as amended, and the requirements of 45 CFR 46.408 in the case of research involving children. BWH shall cause its IRB to require documentation of informed consent or to waive said documentation in accordance with 45 CFR 46.117.
   
   
4. BWH 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.
   
   
5. BWH 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.
   
   
6. BWH shall cause its IRB to prepare and maintain adequate documentation of its activities in accordance with 45 CFR 46, as amended. BWH shall provide to MGH copies of the minutes of BWH’s IRB meetings at which any action regarding a protocol was taken.
   
   
7. BWH shall report promptly to MGH, and make available copies of records adequate to document:
   

1. any serious or continuing noncompliance by investigators with the requirements of BWH’s IRB discovered by BWH; and
2. any suspension or termination of BWH’s IRB approval of a protocol, including a statement of the IRB’s reasons for such action.

8. BWH hereby attests that the composition of the BWH 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 BWH IRB from time to time in accordance with BWH procedures concerning IRB membership.
   

3. MGH Responsibilities
   

1. MGH agrees to cause its IRB to conduct initial and continuing review of the protocols on behalf of BWH 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 research subjects; and MGH’s Multiple Project Assurance of Compliance with DHHS Regulations for Protection of Human Subjects. MGH agrees to promptly report to BWH its IRB’s actions and findings regarding any such protocol.
   
   
2. MGH acknowledges and accepts that BWH shall rely upon MGH’s IRB review of the protocols.
   
   
3. MGH 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 informed consent set forth in 45 CFR Part 46, as amended, and the requirements of 45 CFR 46.408 in the case of research involving children. MGH shall cause its IRB to require documentation of informed consent or to waive said documentation in accordance with 45 CFR 46.117.
   
   
4. MGH shall cause its IRB to notify BWH 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.
   
   
5. MGH 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.
   
   
6. MGH shall cause its IRB to prepare and maintain adequate documentation of its activities in accordance with 45 CFR 46, as amended. MGH shall provide to BWH copies of the minutes of MGH’s IRB meetings at which any action regarding a protocol was taken.
   
   
7. MGH shall report promptly to BWH, and make available copies of records adequate to document:
   

1. any serious or continuing noncompliance by investigators with the requirements of MGH’s IRB discovered by MGH; and
2. any suspension or termination of MGH’s IRB approval of a protocol, including a statement of the IRB’s reasons for such action.

8. MGH hereby attests that the composition of the MGH 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 BWH. BWH may change their membership in the MGH IRB from time to time in accordance with MGH procedures concerning IRB membership.

4. Term/Termination
   

1. 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. Provided each institution’s MPA remains in good standing, this Agreement shall be automatically renewed and extended for successive one (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.
   
   
2. 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 which breach is not cured to the reasonable satisfaction of the non-breaching party within said thirty (30) day notice period. Any termination of this agreement must be communicated to DHHS in writing.

5. Miscellaneous
   

1. Disapprovals by the reviewing IRB may not be administratively overruled by either cooperating institution.
   
   
2. This Agreement has been executed and delivered in and shall be construed and enforced in accordance with the laws of the Commonwealth of Massachusetts.
   
   
3. This Agreement may be amended only by a written agreement signed by both parties.
   
   
4. 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.
   
   
5. Each of BWH and MGH represent that it endorses the National Institutes of Health’s policy concerning the inclusion of minorities and women in study populations.
   
   
6. This Agreement is not assignable in whole or in part, and any attempt to do so shall be void.
   
   
7. 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 MGH:     Massachusetts General Hospital
                        Human Research Committee
                        Fruit Street
                        Boston, MA 02114

If to BWH:     Brigham and Women’s Hospital, Inc.
                        Human Research Committee
                        Neville House, Room 355
                        10 Vining Street
                        Boston, MA 02115

8. 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.
   
   
9. A fully executed copy of this Agreement shall be retained by each of BWH and MGH and shall be made accessible to the DHHS Office of Protection from Research Risk upon request.

IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first written above.

The General Hospital Corporation                          The Brigham and Women’s Hospital, Inc.
(Massachusetts General Hospital)

By:     ____Signature on File                                    By:     ____Signature on File         
          Ronald S. Newbower                                     Keith A. Marcotte
          Sr. Vice President, Research                          Vice President, Research Administration
          and Technology (MGH)                                                  
          The General Hospital Corp.

DHHS Approving Official

By:     ____Signature on File           

Name:         Michael A. Carome, M.D.
Title:            Assurance Coordinator, Assurance Branch, DHSP
Address:     OPRR, OER, OD, NIH (MSC 7507)
                     6100 Executive Boulevard, Suite 3B01
                     Rockville, MD 20892-7507
Tel:              301-402-5567
Fax:             301-402-2071
Email:         mc2a@nih.gov