OBTAINING IRB APPROVAL FOR HUMAN STUDIES

The Partners Human Research Committee (PHRC) is the Institutional Review Board (IRB) of the MGH and all of the Partners Hospitals. The PHRC must approve all activities that involve human subjects, materials, or data (other than those activities that are accepted standard patient care). All research activities must be approved by the PHRC prior to their activation.

Who Must Submit an IRB Application

The Partners IRB Application

Human Subjects Education

Important Readings


Who Must Submit an IRB Application

Partners Investigators
All research involving human subjects to be conducted at the Martinos Center and/or by Martinos Center investigators must be approved by the Partners HRC / IRB. Any Partners investigator (e.g. those who hold appointments at MGH, Brigham & Women's or other Partners affiliated hospitals) may submit a protocol to the Partners IRB.

Non-Partners Investigators
Non-Partners investigators conducting research at the Martinos Center must obtain IRB approval from their home institution as well as from the Partners IRB. However, non-Partners investigators are not permitted by the PHRC to be Principal Investigator on a PHRC IRB submission. Therefore, non-Partners investigators conducting research at the Martinos Center must collaborate with a Partner's investigator who will act as PI on the IRB submission and will take responsibility for the conduct of the research, the welfare of the human subjects, and the administration of the IRB protocol. The non-Partners investigators and research staff should be listed on the application along with their affiliations. Those holding the title of MGH Visiting Scientist may be Principal Investigator on a PHRC IRB protocol.

Non-Partners investigators wishing to conduct human studies at the Martinos Center not in explicit collaboration with a Partners investigator may do so with Martinos Center approval (contact Karen Dervin) and permission from the Partners IRB. To obtain permission, investigators must submit to the Partners IRB:

The consent form must include a statement that the study will be conducted in compliance with the policies of the Partners IRB. The Partners IRB reserves the right to deny use of facilities for research considered to be unacceptable for scientific, ethical or safety reasons.

If the non-Partners investigator's institution is without an appropriate IRB, the Partners IRB will obtain a Non-institutional Investigator Agreement to document the investigator's commitment to abide by the same requirements for the protection of human research subjects as Partner's investigators, and by the determination of the Partners IRB.

To avoid duplication of effort, for those institutions with which Partners holds a cooperative amendment to the Federal Wide Assurance (FWA) for Institutions within The United States, the review of either institution's IRB will be accepted. MGH holds cooperative amendments with the Brigham & Womens Hospital and McLean Hospital, and is in the process of obtaining similar agreements with Harvard Medical School, Beth Israel-Deaconess, MIT and Harvard University. For more information see the Partners Human Research Committee website.

The only condition under which an Investigator not on the MGH staff may undertake research involving MGH patients, medical records or other records, is with the collaboration of a member of the MGH staff who is willing to assume responsibility for the project. Only the investigator who is the MGH staff member is notified of the actions of the HRC related to the protocol.

The Partners IRB Application

IRB application forms and information on how to prepare submissions can be found on the Partners Human Research Committee web site:

Applications by Martinos Center investigators are to be reviewed by Karen Dervin and signed by the Center Director prior to submission.

Meeting dates for IRB protocol reviews are listed at http://healthcare.partners.org/phsirb/meetdate.htm

Expedited Review

It is possible to have your IRB application reviewed by the expedited process if the study is considered a minimal risk study, and will be conducted on the 1.5T magnet without exogenous contrast agent or drug administration. To request expedited review of your proposal see the Expedited Application form at http://healthcare.partners.org/phsirb/newapp.htm

In addition, we suggest submitting a cover letter to the Human Research Committee requesting expedited review and summarizing that the requirements described above have been met.

Human Subjects Education

All investigators and research personnel participating in the conduct of human-subject research must complete a PHRC approved education program. Certification of completion of this requirement is now required for all personnel listed on NIH grants as well. For information and program registration see: http://healthcare.partners.org/hrcedweb/

Important Readings

It is the responsibility of each investigator and their staff to understand and abide by the policies of the Partners Human Research Committee and the MGH Martinos Center regarding human subjects research. The Martinos Center has assembled a packet of pertinent documents that we recommend you read and share with your staff. These include:

Other Guidance Documents can be found at the Partners Human Research Committee Website

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