The NSMC IRB utilizes many of the same forms developed and maintained by the Partners Human Research Committee (PHRC).

Please be aware that some forms have been developed specifically for use at NSMC. The forms listed below must be used regardless of whether a similar form is used by PHRC.

If you have any questions regarding which form to use or how to fill it out, please contact the IRB Administrator.

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New Submissions:

NSMC IRB New Protocol Submission Checklist
PHRC website for required forms

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Consent Forms:

PHRC website for consent forms and templates

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Amendments:

For protocol or consent revisions, changes in study staff, enrollment, sponsor, etc., see PHRC website for forms. ALL CHANGES MUST BE APPROVED BY THE IRB PRIOR TO IMPLEMENTATION.

The only exception is when changes need to be made to eliminate apparent immediate hazard to subjects. For these cases, submit an Unanticipated Problem Reporting form within 24 hours documenting the hazard and protocol change. A formal protocol amendment must be subsequently submitted for IRB review and approval.

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Unanticipated Problems (including Adverse Events):

NSMC Unanticipated Problem Reporting form

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Continuing Review of Approved Research:

NSMC Continuing Review Submission Checklist

NSMC Continuing Review Application Form

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Designated Review:

For studies conducted at more than one Partners Institution (BWH, MGH, DFCI) and an Investigator proposes to add NSMC as a participating site, an Investigator may request the NSMC IRB to ‘designate’ overall IRB review to one of the other Partners Institutions’ IRB.

Please review the NSMC Designated Study Checklist for items to be submitted for consideration of designated review.

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Other Forms:

NSMC Research Financial Disclosure Form - NEW
 

PHRC website for all other forms