Biomedical Research

Announcements

Human Investigation Committee (HIC) Forms, Templates & Instructions

Are you a physician or physician scientist interested in serving on a biomedical IRB? Click here for information.

HIC Meeting Submission Deadline

New protocols and amendments to approved protocols requiring full board review must be submitted by midnight Monday night to be scheduled for the next week’s HIC meeting. Thank you for adhering to this deadline.

General Instructions

Please bring all non-electronic (Coeus) HIC submissions to the HRPP Office at 55 College Street. Submissions can be dropped off Monday through Friday between the hours of 8:30 AM and 5:00 PM, or left in the dropbox outside of the main doors if brought after hours. Please note that the HIC is currently unable to accept submissions by email and fax.

• How Many Copies (updated 05-21-10)
• MS Word Track Changes
• FDA Certificate of Confidentiality Application Instructions (updated 05-12-10)
• NIH Certificate of Confidentiality Application Instructions (updated 05-11-10)
• Yale New Haven Hospital Request for Excess Clinical Samples (website)
• Cancer Data Repository (CaDR) (website)
• WIRB Procedure (updated 12-14-2010)
• Pre-Study Checklist for Investigators (updated 10-1-2011)

Forms

New Applications:

• Application to Involve Human Subjects In Research (updated 03-06-12)
• Application Instructions (updated 05-25-11)
• Application for Industry Sponsored Research (updated 03-06-12)
• Application to Involve Human Subjects in Research: Yale School of Nursing (updated 05-21-12)
• Pediatric Protocol Application (updated 03-06-2012)
• Request for Approval of Medical Record Review Form (updated 04-14-12)
• Request for Exemption Form (updated 08-15-11)
• Request for Determination that a Research Project Does Not Involve Human Subjects Form (updated 05-17-11)
• Humanitarian Use Device Application (updated 12-01-11)
• Repository Application (updated 04-28-11)
• Application for Expanded Access Programs

Renewals & Closure:

• Request to Reapprove a Research Study Involving Human Subjects Form
  (updated 05/11/12)
• Request to Close a Research Study Involving Human Subjects Form (updated 08-17-11)

Amendments:

• Request for Approval of Amendment Form (updated 02-20-12)
• Request to Change Study Personnel Form (updated 08-12-11)
• Request to Change Principal Investigator Form (updated 08-15-11)

Emergency Use, Adverse Events & Unanticipated Problems:

• Notification of Emergency Use Reporting Form
• Emergency Use Informed Consent Document (updated 02-04-09)
• Adverse Event(s) Under Yale PI Reporting Form (updated 04-20-11)
• External Adverse Event(s) Under Non-Yale PI Reporting Form
• Unanticipated Problems Involving Risks to Subjects or Others Report Form (updated 04-20-11)
• Lost/Stolen Laptop Form

Other:

• Request to Transfer Human Research Records Form (updated 06-16-10)
• Collaborating Investigator Instructions
• Request to Serve as a Collaborating Investigator Form (updated 06-30-11)
• Request Permission to Serve as Principal Investigator Form (updated 11-16-10)
• DoD Supplement
• MRRC Proposal For Use Form (Website)
• Yale Investigator International Research Checklist (updated 10-27-11)

National Cancer Institute CIRB Documents:

• NCI CIRB Protocol Application Addendum
• NCI CIRB Submission Face Sheet
• NCI CIRB Reapproval Application
• NCI CIRB Validation Box

 

Templates

Informed Consent:

• Informed Consent Template (updated 02-20-12)
• Short Consent Template (updated 11-15-11)
• Compound (Consent & RAF) Authorization Template (updated 02-20-12)
• Spanish Informed Consent Template (updated 09-28-10)
• Spanish Short Consent Template (updated 09-03-09)
• Video/Audio Consent (updated 08-31-09)
• Informed Consent Addendum (updated 04-26-12)
• Sample Assent Form (updated 06-16-10)
• Repository Consent Template (updated 8-05-11)
• Verbal Consent Information Sheet (updated 11-15-11)
• Informed Consent Template for Expanded Access Programs

Other:

• Authorization & Advanced Directives Template (updated 08-31-09)
• Confidentiality Pledge Template
• Data & Safety Monitoring Plan (DSMP) Template