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Education, Research & Faculty Research Office of Research Human Research Protection Program Forms & Templates

Forms and Templates

Help build your protocol and submit your study

The forms and templates provided on this page will help you build your protocol and submit your study to Baystate's Human Research Protection Program for review.

Application Forms

B01 - Application - Human Subjects Research Determination (Updated February 2024)

B01.1 - Application Checklist - Human Subjects Research Determination (Updated January 2024)

B02 - Application - Request for Determination of Exemption (Updated April 2024)

B02.1 - Application Checklist - Request for Determination of Exemption

B03 - Application - Basic Part 2 (Updated April 2024)

B03.1 - Application Checklist - Investigator Initiated New Projects (Updated June 2023)

B03.2 - Application Checklist - Sponsor Initiated New Projects (Updated June 2023)

B03.3 - Application - Local Context Supplement

B04 - Application - Ancillary Services and Additional Approvals

B05 - Application - Pathology Services

B06 - Application - Conflict of Interest and Commitment Questionnaire

B07 - Application - Continuing Review Report

B08 - Application - Continuing Review for NCI CIRB

B09 - Application - Continuing Review Report for HUDs

B10 - Application - Research Status Report

B11 - Application - Study Closure Report

B12 - Application - Administrative Report Form

B13 - Application - Event Reporting Form

B16 - Application - Emergency Use Report

B17 - Application - Humanitarian Use Devices (HUD)

B18 - Application - Preparatory to Research

B19 - Application - Clinical Trials Service Request 

B20 - Application - MA DPH Controlled Substance Researcher

B23 - Application - Clinical Trial Directory Form

B24 - Application - Site Permissions Request Form (uploaded August 2023)

Pathology Service Application

CIS

B21 - CIS Alert Form

Supplemental Materials

B22.1 - Supplemental - A-D- Vulnerable Populations

B22.2 - Supplemental - E - G - Request for Waivers of Consent and HIPAA

B22.3 - Supplemental - H-J- Data Security & Confidentiality
Forms H & I Email Job Aid 

B22.4 - Supplemental - K-O- Other Considerations

B22.5 - Supplemental - R1-R4 - Vulnerable Populations for External Reliance

Protocol & Consent Templates

C01 - Template - Protocol (Experimental Design)

C02 - Template - Protocol (Non-Experimental Design)

C03 - Template - Consent Form (Clinical Trial)

C03.1 - Template - Consent Rider for Pediatric Assent

C03.2 - Template - Consent Rider for Continuing Consent

C03.3 - Template - Consent Rider for Future Research Including Banking of Information & Specimens

C03.4 - Template - Consent Rider for Genetic Testing

C03.5 - Template - Consent Rider for HIV Testing

C03.6 - Template - Consent Rider for Sub-Studies and Corollary Studies

C05 - Template - Consent Form (Information Sheets or Scripts - Waiver of ICF)

C06 - Template - Consent Form (Pregnant Partner)

C07 - Template - Consent Form (Psychotherapy Notes Authorization)

Resources

Basic Application Guide

CIS Alert FAQ

Common Rule Guidance

Conflict of Interest Form

Consent of Elements Comparison

COVID-19 Impact Statement HRPP/IRB

Data Use Agreement Template

Definitions B01

Engagement Worksheet

Exemption Categories Tool

H&I Email Job Aid

Initiating Remote Access to CIS - SARF - Non-employee

Just in Time Request Letter

Local Consent Considerations

OHRP Guidance

Study Writing Guidelines

Requirements for Waiver of Alteration Flow Chart

Requirements for Waiver and Alteration of Consent PowerPoint

ISRC Workflow Guidance

Checklists

Elements of Consent Checklist

NCI Consent Checklist

QI versus Clinical Research Checklist

Supplemental Forms

Supplemental Forms - Group 1

Supplemental Forms - Group 2

Supplemental Forms - Group 3

Supplemental Forms - Group 4

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