Human Research Protection Program

HITECH Act

Social, Behavioral & Educational Research

Interested in serving on a social/behavioral/educational IRB? Click here for information.

Guide to Form Changes

We are pleased to post a significantly revised HSC application. This new form captures more information in a more organized fashion, making review here more efficient, and reducing the need for pre-approval emails between our staff and our investigators.

Human Subjects Committee (HSC) Forms, Templates & Instructions

Adverse Event and Unanticipated Problems Involving Risks to Subjects or Others (UPRISOs)

Protocol Deviations and Noncompliance

General Information

 

Information on Renewal Reminders sent to Investigators

As you know, the HSC sends out renewal reminders as a courtesy to Investigators informing you of impending protocol expirations. The following letters are sent automatically by our database:

  • Reminder notices are sent 75, 45 and 30 days prior to IRB protocol approval expiration.
  • Studies are administratively closed 15 days after IRB expiration date.

These notifications will only be sent to the person who is listed as the Investigator on the protocol as well as the person who is listed as the Correspondent*.

*All of our forms have been revised to include the study correspondent.

 

All HSC submissions should be emailed to the human.subjects@yale.edu

All new submissions should be submitted with the following:

  • completed application form,
  • consent form(s) or script(s),
  • debriefings
  • recruitment materials
  • interview, survey or focus group questions,
  • assessments, measures, questionnaires
  • any other related materials

All Re-approvals should be submitted with the following:

  • Request to Renew or Close a Study form
  • Most currently approved application
  • Most currently approved consent form(s) or script(s)

All amendments must be submitted with the following:

  • Amendment request form
  • Tracked versions of the revised document(s)