SRH DFCI IIA

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PART 1 - Statement of Principles and Policy

1. Ethical Principles
2. Institutional Policy
3. Applicability

PART 2

1. IRB Review
2. Research Investigator Responsibilities
3. Institutional Responsibilities

PART 3 - Endorsements

Inter-Institutional Amendment to Multiple Project Assurance Number M-1034 to Collaborate with Spaulding Rehabilitation Hospital

This Inter-Institutional Amendment (IIA) is made on October 29, 1999 between Spaulding Rehabilitation Hospital and the Dana-Farber Cancer Institute, Inc. ("DFCI") (M-1034).

Inter-Institutional Amendment

Assurance of Compliance with DHHS Regulations for Protection of Human Research Subjects

PART 1

Spaulding Rehabilitation Hospital, hereinafter known as the "institution", hereby gives assurance that it will comply with the Department of Health and Human Services (DHHS) Regulations for the Protection of Human Research Subjects (45 CFR 46, as amended) as specified below.

1. Statement of Principles and Policies
   

1. Ethical Principles
   

1. This institution is guided by the ethical principles regarding all research involving humans as subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report"). In addition, the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46) will be met for all research covered by the Assurance to which this Inter-Institutional Amendment (IIA) applies.

2. Institutional Policy
   

1. Except for research in which the only involvement of human subjects is in one or more of the categories exempted or waived under Section 46.101(b)(1-6) or 46.101(i), this policy is applicable to all research involving human subjects, and all other activities which even in part involve such research, if either:

1. the research is sponsored by this institution, or
2. the research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities, or
3. the research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or
4. the research involves the use of this institution’s non-public information to identify or contact human research subjects or prospective subjects.

2. This institution acknowledges and accepts its responsibilities for protecting the rights and welfare of human subjects of research covered by this policy.
   
   
3. This institution assures that before human subjects are involved in research covered by this policy, proper consideration will be given to:

1. the risks to the subjects,
2. the anticipated benefits to the subjects and others,
3. the importance of the knowledge that may reasonably be expected to result, and
4. the informed consent process to be employed.

4. This institution acknowledges that it bears full responsibility for the performance of all research involving human subjects covered by this policy.
   
   
5. This institution bears full responsibility for complying with federal, state, or local laws as they may relate to research covered by this policy.
   
   
6. This institution encourages and promotes constructive communication among the research administrators, department heads, research investigators, clinical care staff, human subjects, and institutional officials as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of the subjects.
   
   
7. This institution will exercise appropriate administrative overview carried out at least annually to ensure that its practices and procedures designed for the protection of the rights and welfare of human subjects are being effectively applied.
   
   
8. This institution will consider additional safeguards in research when that research involves prisoners, fetuses, pregnant women, children, individuals institutionalized as mentally disabled, other potentially vulnerable groups and human in vitro fertilization.
   
   
9. This institution shall provide each individual at this institution conducting or reviewing human subject research (e.g., research investigators, department heads, research administrators, research reviewers) with a copy of this statement of ethical principles and policy (Part 1, 1.A. & B.).

3. Applicability
   

1. This institution will abide by the provisions of the Dana-Farber Cancer Center Multiple Project Assurance (MPA) M1034, and will accept the final authority of that institution’s Institutional Review Board (IRB) when the research conducted at this institution is conducted under the direction of any staff member of or is sponsored by the McLean Hospital.
   
   

2. This assurance of compliance with 45 CFR 46 constitutes an Amendment to the MPA of the above cited MPA institution whose IRB will be relied upon by this institution. This Amendment has no independent standing of its own.

3. This institution is not authorized to cite the MPA number of the institution whose IRB is being relied upon. However, the MPA institution may cite this Amendment as the basis for involvement of this institution in Federal human subject research which is conducted under the auspices of the MPA institution.
   
   
4. Upon request of the Office for Protection from Research Risks (OPRR) of DHHS, this institution must submit a Single Project Assurance (SPA) to OPRR for DHHS-sponsored research that is not conducted under the auspices of the cited MPA institution.

PART 2

In regard to Federal human subject research conducted under the auspices of this institution previously cited in Part 1 of this amendment and below, This institution will comply with the requirements of 45 CFR 46 as specified below.

1. IRB Review
   

1. IRB of Record
   

1. This institution has an IRB but will rely upon the IRB of the Dana-Farber Cancer Center as its IRB of record when the research conducted at this institution is under the direction of any staff member of or is sponsored by the Dana-Farber Cancer Center. In accordance with the compositional requirements of Sections 107, 103(d), and 111(a)(3), the institution for which this amendment applies, attests that the attached institution IRB membership roster documents a membership which is suitably composed to protect the rights and welfare of human research subjects at this institution. This IRB is responsible for the initial and continuing review of research activities for which this Amendment applies and will observe the quorum requirements of Section 108.
   
   
2. The IRB will determine, in accordance with the criteria found in Section 111, that protections for human research subjects at this institution are adequate.
   
   
3. The IRB will determine that legally effective informed consent will be obtained in a manner and method which meets the requirements of Sections 116 and 117, and in the case of research involving children, 45 CFR 46.408.
   
   
4. The IRB shall review, and have the authority to approve, require modification in, or disapprove changes proposed in this research activity. This institution will not administratively approve human subject research which has been disapproved by the IRB.
   
   
5. The IRB may be called into an interim review session by the Chairperson at the request of any IRB member or Institutional Officials of either institution to consider any matter concerned with the rights and welfare of any subject.
   
   
6. The IRB will prepare and maintain adequate documentation of its activities in accordance with Section 115.
   
   
7. The IRB will report promptly at least to officials of this institution and its own institution:
   

1. any serious or continuing noncompliance by investigators with the requirements of the IRB, and
2. any suspension or termination of IRB approval.

8. The IRB will report promptly to officials of this institution any information received concerning:
   

1. injuries to human subjects,
2. unanticipated problems involving risks to subjects or others, and
3. any IRB-reviewed and approved changes in this research activity.

2. Certification of IRB Review
   

1. Certification means the official notification on behalf of this institution to the sponsoring Federal department or agency that a research project or activity involving human subjects has been reviewed and approved by the IRB of record in accordance with an OPRR-approved MPA.
   
   
2. The IRB will complete certification to the applicable Federal department or agency that initial or continuing (whichever is applicable) IRB review and approval has been conducted in accordance with Section 103(f).
   
   
3. This institution will receive a copy of such IRB certifications as they are submitted on its behalf by this institution to the applicable Federal department or agency and inform the this institution IRB of its administrative concurrence to proceed for at least all initial IRB reviews and approvals for new research activities and substantive changes in previously approved activities.

2. Research Investigator Responsibilities
   

1. Reporting
   

1. Investigators will report promptly to the IRB proposed changes in these research activities under this Amendment and the changes shall not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the subjects.
   
   
2. Investigators will report promptly to the IRB any injuries to subjects or unanticipated problems involving risks to subjects or others.

2. Other
   

1. Investigators acknowledge and accept their responsibility for protecting the rights and welfare of human research subjects involved in research under this Amendment and for complying with all applicable provisions of the OPRR-approved Assurance under which this Amendment is authorized.
   
   
2. Investigators assure that before human subjects are involved in such research, proper consideration will be given to:
   

1. the risks to the subjects,
2. the anticipated benefits to the subjects and others,
3. the importance of the knowledge that may be reasonably expected to result,
4. the informed consent process to be employed, and
5. the need for additional safeguards if the human subjects are especially vulnerable.

3. Investigators accept their responsibility for performance in such research and will protect human research subjects and satisfy the intent and procedures specified in 45 CFR 46 and other Federal, state, or local laws or regulations which may apply.
   
   
4. Investigators will abide by determinations of and will accept the final authority and decisions of that IRB.
   
   
5. Investigators acknowledge and agree to cooperate in the IRB's responsibility for initial and continuing IRB reviews and approvals, record keeping, reporting, and certification. In addition, continuing reviews will be preceded by progress reports to include overall findings of the research.
   
   
6. Investigators will not accrue subjects on protocols under this Amendment prior to its approval and without certification of IRB review and approval. Provision of emergency medical care without prior full board review is permitted (see 46.116[f]). However, research data may not be used from such interventions.
   
   
7. Investigators will not participate in convened discussion or voting of the IRB except by invited attendance to provide information to the IRB upon request (46.107[e]).
   
   
8. Investigators acknowledge receipt of and compliance with existing Federal policies and guidance having to do with notification of sero positivity, counseling, and confidentiality, where HIV research activities are involved.
   
   
9. Investigators will advise the appropriate officials of other hospitals, clinics, or institutions of the intent to admit human subjects who are engaged in research protocols. When admission to such an institution is planned, foreseen, or regular, that institution must possess an applicable OPRR-approved Assurance prior to involvement of such persons as human subjects and must obtain any prior authorization from the appropriate DHHS Program Office or its designee as may be required. Investigators will not delegate to others the treatment of subjects under such research protocols without prior IRB notification.

3. Institutional Responsibilities
   

1. This institution will abide by all conditions and determinations of the IRB for this research activity.
   
   
2. The cited MPA institution will provide both meeting space for the this institution IRB and sufficient staff to support the IRB's review and record-keeping duties.
   
   
3. The cited MPA institution will report promptly to the OPRR:
   

1. injuries to human subjects,
2. unanticipated problems involving risks to subjects or others, and
3. any changes in this research activity which are reviewed and approved by the IRB and this institution.
4. any suspension or termination of IRB approval.

4. This institution will also ensure that all its investigators have read and have ready access to the MPA of the cited institution and this amendment prior to involvement in human subject research for which they apply.

 

PART 3

The officials signing below agree that all research described in Part 1, I, C (Applicability) of this Inter-Institutional Amendment (IIA) to the applicable OPRR-approved Assurance for the McLean Hospital, bearing the number M-1287, will be conducted in accord with 45 CFR 46 (as amended), the cited MPA, and this Amendment. The cited MPA institution will assume responsibility for ensuring required IRB reviews, approvals, and submission of certifications to the applicable Federal department or agency.

1. Endorsement of the Institution Without MPA

Authorized Institutional Official

Signature: SIGNATURE ON FILE     Date: 

Name and Title:         Kari Hastings, CRA
                                      Director of Research and Training
Institution:                   Spaulding Rehabilitation Hospital
Address:                      125 Nashua Street
                                      Boston, MA 02114
Telephone:                  (617) 573-2370
Facsimile:                    (617) 573-2369
E-mail:                         KlHastings@partners.org

2. Endorsement of the Institution with Approved Assurance and IRB
   

1. Name of Institution: Dana-Farber Cancer Institute, Inc. ("DFCI")

Authorized Institutional Official

Signature: SIGNATURE ON FILE     Date: 

Name and Title:         Faye C. Austin, Ph.D.
                                      Director for Research
Institution:                   Dana-Farber Cancer Institute
Address:                      44 Binney Street, Room 1830
                                      Boston, MA 02115
Telephone:                  617-632-3488
Facsimile:                    617-632-4452
E-mail:                         faye_austin@dfci.harvard.edu

2. IRB Chairperson or Designee Certifying IRB Review and Approval

Signature: SIGNATURE ON FILE     Date: 

Name and Title:         Katarzyna Karelus, M.S., M.B.A.
                                      Acting Director
                                      Protocol Administration Office
Institution:                   Dana-Farber Cancer Institute
Address:                      44 Binney Street, Suite 25
                                      Boston, MA 02115
Telephone:                  617-632-3029
Facsimile:                    617-632-2686
E-mail:                         kkarelus@partners.org

- SPACE BELOW FOR DHHS USE ONLY -

3. All parts of this Assurance are in compliance with the requirements of Part 46, Title 45 of the Code of Federal Regulations, as amended.
   

1. DHHS Recommending Official

Signature SIGNATURE ON FILE     Date:

Name:                          Katherine Duncan, M.D.
Title:                            Adjunct Medical Officer
Address:                     Division of Human Subject Protections
                                     Office for Protection from Research Risks
                                     National Institutes of Health, DHHS
                                     6100 Executive Boulevard, Suite 3B01
                                     Rockville, MD 20892-7507
Telephone:                 301-496-7005 x207
Facsimile:                   301-402-2803
E-mail:                        kd41f@nih.gov

2. DHHS Approving Official

Signature SIGNATURE ON FILE     Date:

Name:                         Freda E. Yoder
Title:                            Assurance Coordinator, Assurance Branch
Address:                     OPRR, OER, OD, NIH (MSC 7505)
                                     6100 Executive Boulevard, Suite 3B01
                                     Rockville, MD 20892-7507
Telephone:                 301-402-5793 X
Facsimile:                   301-402-0527
E-mail:                        fy9r@nih.gov