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.

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New Submissions:

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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/Biologics

Individuals with Impaired Decision Making

Ionizing 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 State

Excess Human Material

Health/Medical Records

Research Data Repository

Secondary Use of Research Samples/Data

Tissue or Sample Repository

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Consent Forms:

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Consent Preparation Worksheet

Instructions for Preparing Research Consent Forms

Children:

Parental Consent Form Template

Youth Assent Form

Adults or both Adults and Children 14-17:

General Consent Form Template

Drug Trial Consent Form Template

Spanish Consent Form Template

Blood Draw Consent Form (PHI)

Blood Draw Consent Form (No PHI)

Tissue Repository Consent Form

Consent Form and Authorization for Studies with a Certificate of Confidentiality

Parental Consent Form and Authorization for Studies with a Certificate of Confidentiality

Spanish 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

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 Amendments:

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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

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Unanticipated Problems (including Adverse Events):

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NSMC Unanticipated Problem Reporting form

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Continuing Review of Approved Research:

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NSMC Continuing Review Submission Checklist

NSMC Continuing Review Application Form

Protocol Summary

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Designated Review:

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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

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Other Forms:

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NSMC Emergency Use of an Investigational Drug/Biologic/Device - NEW!
 
NSMC Research Determination Worksheet  

NSMC Research Financial Disclosure Form

Response to Review

Protocol Exception