The NSMC IRB utilizes many of the same forms developed and maintained by the Partners Human Research Committee (PHRC). Please note that some forms have been developed specifically for use at NSMC and are prefaced by the word "NSMC" below (use of any previous PHRC versions will not be accepted).
If you have any questions regarding which form to use or how to fill it out, please
contact the IRB Administrator.
New Submissions:
NSMC IRB New Protocol Submission Checklist - please read first to determine which forms are needed.
NSMC New Human Research Application Form - for all human research (including expedited reviews).
Expedited Application Form - for research limited to certain categories
Detailed Protocol Instructions - for investigators who are writing their own protocol
Schema Instructions
Protocol Summary
Sponsor/Funding Information - when a research study has more than one sponsor
Co-Investigator/Study Staff Certification - to be submitted for each co-investigator and study staff member
Ancillary/Specialized Review Forms:Children - for research enrolling children as research subjects
Drugs/BiologicsIndividuals with Impaired Decision MakingIonizing Radiation
Medical Devices
Neonates in Reasearch - for research involving neonates of uncertain viability and/or nonviable neonates
Non-Ionizing Radiation
Nursing Implementation and Planning
Pregnant Women/Fetuses
Wards of the StateExcess Human Material
Health/Medical Records
Research Data Repository
Secondary Use of Research Samples/Data
Tissue or Sample Repository
Consent Forms:
Consent Preparation Worksheet
Instructions for Preparing Research Consent Forms
Children:
Parental Consent Form Template
Youth Assent FormAdults or both Adults and Children 14-17:
General Consent Form TemplateDrug Trial Consent Form Template
Spanish Consent Form TemplateBlood Draw Consent Form (PHI)
Blood Draw Consent Form (No PHI)
Tissue Repository Consent Form
Consent Form and Authorization for Studies with a Certificate of ConfidentialityParental Consent Form and Authorization for Studies with a Certificate of ConfidentialitySpanish Consent Form and Authorization for Studies with a Certificate of Confidentiality
Request for Waiver of Informed Consent and Authorization for Research
Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English
Amendments:
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.
Amendment Form
Study Staff Amendment Form
Unanticipated Problems (including Adverse Events):
NSMC Unanticipated Problem Reporting form
Continuing Review of Approved Research:
NSMC Continuing Review Submission ChecklistNSMC Continuing Review Application Form
Protocol Summary
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.
Site Responsible Investigator
Other Forms:
NSMC Emergency Use of an Investigational Drug/Biologic/Device -
NEW!
NSMC Research Determination Worksheet
NSMC Research Financial Disclosure Form Response to ReviewProtocol Exception