Martinos Center Policies on Studies Involving Human Subjects

  • Investigators will comply with the policies and procedures of the Partners Human Research Committee (PHRC) Internal Review Board (IRB) and the Martinos Center.

  • Failure to comply with these policies and procedures will result in loss of imaging privileges and notification of the IRB.

  • Investigators are expected to know their ethical responsibilities in conducting human subjects research.

  • Investigators are expected to know the safety hazards and risks associated with MR research and the MR research environment, or with the particular imaging modality employed.

  • Investigators and their staff will only perform duties that they are qualified to perform. (If you are uncertain, don't do it. Ask for help by contacting Mary Foley (mtf@nmr.mgh.harvard.edu), head MR technologist.

  • Investigators will submit research proposals to and obtain approval from the IRB in accordance with the Partners HRC submission instructions for each project conducted at the Martinos Center.

  • Investigators from outside the Partners system, who wish to conduct research at the Martinos Center, but who are not explicitly collaborating with a Partners investigator, may do so with (a) protocols and consent forms approved by the IRB of their home institution, and (b) written permission from the Partners HRC.

  • Investigators will not accrue subjects on a protocol prior to its approval by the IRB.

  • Investigators will obtain written IRB approval of all changes to protocols and/or consent forms prior to implementation of the changes.

  • Investigators will obtain written IRB approval of protocol deviations or exceptions to protocol prior to initiation.

  • Investigators will submit continuing review materials to the IRB on time.

  • Investigators will notify the Martinos Center of PHRC approved changes to protocols and consent forms, protocol deviations or exceptions, and continuing review.

  • If PHRC approval of a study lapses, investigators will not use outdated consent forms or continue to enroll subjects until the study is re-approved.

  • Investigators will keep accurate and up-to-date records of all interactions with the IRB.

  • Investigators will obtain and document informed consent. Informed consent will only be obtained by individuals approved to do so by the IRB. This usually includes MD and/or PhD level investigators. Research assistants, graduate students, or other qualified study staff will only obtain informed consent from subjects with written permission from the IRB.

  • Investigators will give the research subject a signed copy of the consent document.

  • Investigators will not modify consent forms (cross out or write in text) -- any changes to consent forms must be approved by the IRB.

  • Investigators will determine and document (via an inclusion/exclusion checklist) that eligibility criteria are met prior to the beginning of the study.

  • Investigators will conduct and document thorough MR compatibility screening for all MR studies.

  • To avoid confidentiality problems and issues of coercion (real or perceived), volunteers who are the investigator's students or employees may not be enrolled as research subjects.

  • For safety reasons, at least two people (the MR technologist, investigator, or research assistant), in addition to the subject, should be present during all MR studies.

  • Investigators will notify the Martinos Center and PHRC of serious or unexpected adverse events regardless of the relationship to the study.

  • Investigators will terminate scanning (or any study procedure) immediately and at any time, at the request of the subject, and will not attempt to pressure or coerce the subject to continue.

  • Investigators will ensure the privacy and confidentiality of information regarding study participants.

  • Investigators will keep thorough and accurate records of study events and subject information.

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