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
Application for Initial Approval of Research with Human Subjects
Human Subjects Research/Exemption/Clarification Request Form Updated! (Previous versions of this form will not be accepted after July 1, 2008)
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
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 Guidelines & Sample Consent
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
Student Classroom-based Research Guidelines
Subpart B: Pregnant Women, Fetuses, and Neonates Worksheet
Subpart C: Prisoner Subjects Worksheet
Subpart D: Minor/Childern Subjects Wroksheet
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