Biomedical Research

Human Investigation Committee (HIC) Forms, Templates & Instructions

 

Announcements

HIC Protocol Submissions for Full Board Review (6/26/12)

New protocols and amendments to approved protocols requiring full board review will undergo regulatory review by HIC staff and will be scheduled to a meeting when the review process is complete. Protocols submitted in a timely manner for annual renewal will be scheduled to a meeting within 30 days prior to expiration.

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

 

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 1-15-13)
• 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 2-14-2013)
• Application Instructions (updated 11-20-12)
• Application for Industry Sponsored Research (updated 2-14-2013)
• Application to Involve Human Subjects in Research: Yale School of Nursing (updated 2-14-2013)
• Pediatric Protocol Application (updated 2-14-2013)
• Request for Approval of Medical Record Review Form (updated 08-24-12)
• Request for Exemption Form (updated 11-21-12)
• 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 11/20/12)
• 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 08-24-12)
• 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)
• Report of Adverse Event(s) Under Yale PI (updated 04-15-13)
• Report of External Adverse Event(s) Under Non-Yale PI (updated 04-15-13)
• Unanticipated Problems Involving Risks to Subjects or Others Report Form (updated 04-15-13)
• Notification of Deviation from Protocol/Noncompliance Report Form (updated 10-26-12)
• 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: Single Study (updated 11-16-10)
• Request Permission to Serve as Principal Investigator Form: Multiple Studies
• DoD Supplement
• MRRC Proposal For Use Form (Website)
• Yale Investigator International Research Checklist (updated 10-27-11)
• Notification of Deviation from Protocol/ Noncompliance Report Form
• Protocol Exception Form

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
• Application for Including Minors on the Research Team
• Visiting Students in Yale Research Labs
• Request for Single IRB Review
• IRB Member Assessment