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Who Needs to Submit a Protocol to the IRB

All research activities supported directly or indirectly by faculty, staff and students of HMS and HSDM are covered under the policies and procedures of the CHS, which extend uniformly to all research, development, or related activities involving human participants carried out under the aegis of HMS or HSDM.

 

Research that falls under one of the following categories is subject to the review and approval by the CHS:

    • The research is funded by or through HMS or HSDM;
    • The research is conducted by HMS-based and HSDM-based faculty, acting in their capacities as such;
    • The research is conducted by students of HMS or HSDM acting in their capacity as such;
    • The research is conducted by non-faculty employees of HMS or HSDM acting in their capacities as such;
    • The population from which participants will be drawn is exclusively or substantially composed of individuals who are patients, students or employees of HMS or HSDM;
    • The Research makes substantial use of the property or facilities of HMS or HSDM or is otherwise significantly associated with, or likely to be perceived as being associated with, HMS or HSDM;
    • The Research involves the use of HMS or HSDM non-public information for the purposes of the research, or to identify or contact prospective participants.

 

No funds (federal, foundation, private, corporate, departmental, or other) may be expended for research involving human participants unless the requirements for review and approval have been satisfied and a CHS approval or exemption has been documented.

 

 

 

 

 

Updated: 22-Oct-2009

 

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