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Human Subjects Committee

Forms and Tools

If you have a problem viewing any of these forms, please contact Alyssa Speier.

Always download forms from th HSC website to ensure use of the correct version.  Please submit one typed oringal application with attachements.

Drop off or send all submissions by campus mail to the Human Subjects Committee, 1552 Tremont Street, Boston, MA 02120. You may also drop off submissions at the HSC mailbox at Kresge 3rd Floor. U.S. mail is the least reliable way to send us your submissions.

Use the New Application Form below to apply for initial approval of research with human subjects.

Please visit our Submission Turnaround Times page for information on timelines.

 

Forms

Administrative Oversight Report

Adverse Event Prompt Reporting Form

Amendment Request Form

Appendix A: Study Staff Log/Staff Amendment Form New!

Appendix B:  Anticipated Serious Averse Events Form New!

Application for Initial Approval of Research with Human Subjects

Close-out Form

Human Subjects Research/Exemption/Clarification Request Form Updated! (Previous versions of this form will not be accepted after July 1, 2008)

Radiation Safety Worksheet

Reapproval Application Form Updated! (Previous versions of the Reapproval Form will not be accepted after July 1, 2008)

Request for Approval of HIPAA Privacy Rule Waiver/Alteration of Patient Authorization 

Self-Report of Noncompliance by Investigator

Waiver of Emergency Use Consent Form

Web-based Survey Worksheet

 

IRB Authorization Agreement (IAA) Toolkit

Commitment Statement for Investigators

Facts Sheet for PHS-HSPH "Umbrella" IAA

FAQs about the PHS-HSPH IAA & other IRB Authorization Agreements

Instructions for Investigators:  Utilizing the PHS-HSPH IAA

Investigator Checklist for the PHS-HSPH IAA

Original PHS-HSPH IRB Authorization Agreement

Site Responsible Investigator Form

 

Consent Toolkit

FDA: A Guide to Informed Consent

Informed Consent Checklist

Informed Consent Guidelines & Sample Consent

Sample Kid's Assent Form

Sample Kid's Assent Form - Interview/Survey

Tips for Simpler Consent Forms

Tips on Designing Effective Informed Consent Processes for Children

Waiver of Documentation (signature) Requirement of Informed Consent Worksheet

Waiver of One or More Elements of Informed Consent Worksheet

 

Other Tools

Cross Reference Index of Old and New Protocol Numbers 

Federal Wide Assurance - Did You Know?

Investigator's Checklist for HSC Submissions

IRB Protocol Review Standards

IRB - RAT User Guide

Student Classroom-based Research Guidelines

Subpart B: Pregnant Women, Fetuses, and Neonates Worksheet

Subpart C: Prisoner Subjects Worksheet

Subpart D: Minor/Childern Subjects Wroksheet

Training Manual

Word Readability Tool: Instructions

 


This page is maintained by HUMAN SUBJECTS COMMITTEE. To contact us with suggestions, comments, and questions, please e-mail: hsc@hsph.harvard.edu.

Human Subjects Committee
1552 Tremont Street, Boston, MA 02120
Phone: (617) 384-5480
Fax: (617) 384-5484