Human Research Protection Program

HITECH Act

Biomedical Research

Human Investigation Committee (HIC) Forms, Templates & Instructions

 

IT’S A FACT

IRB forms are periodically revised to meet changing regulatory or other requirements. For this reason, applications submitted on forms that are outdated by more than 2 months will not be accepted

 

ANNOUNCEMENT

In the upcoming months, the Yale Human Investigation Committee (HIC) will transition from accepting submissions of research protocols on paper to accepting submissions sent in via email. This transition only affects those researchers who would typically drop off physical copies of documents for review to the HIC office, and not those who routinely submit via Coeus. Anyone who currently submits in Coeus will continue to do so without change to the process. In order to allow for a smooth transition process, each department will submit protocol documents via email on a predetermined schedule. Please see below for the schedule and instructions on how to submit protocols via email. Please be advised that we cannot accept emailed submissions from departments before their scheduled deployment date; rather, such submissions will be rejected in their entirety. Paper submissions will no longer be accepted after 30 days from the transition date. If your department is not on the list or you are unsure when to start submitting via email, please send an email inquiry to hrpp@yale.edu, or call the main HIC number at 203-785-4688.

Email for submissions: hic.submissions@yale.edu Please be advised that emailing submissions to individual HIC staff members or other HIC email addresses will NOT be accepted.

 

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.

Forms

New Applications:

Renewals & Closure:

Amendments:

Expanded Access and Emergency Use:

Adverse Event and Unanticipated Problems Invloving Risks to Subjects or Others (UPIRSOs):

Protocol Deviations & Noncompliance

Other:

National Cancer Institute CIRB Documents:

 

Templates

Informed Consent:

Short Forms:

 

Other: