Human Research Protection Program

HITECH Act

Yale campus

 

IRB FORMS NOTICE

The Yale University Institutional Review Board (HIC/HSC) periodically revises forms that are required for submission (e.g., new application, renewal form, amendment form, etc.). Changes to the forms generally are based on information that is required to provide the reviewer with accurate and up-to-date information and/or due to changes in regulations or University policies. You must always use the form that is currently posted on the HRPP forms website. All forms are periodically reviewed 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  For this reason, applications submitted on forms that are outdated by more than 2 months will not be accepted. To ensure that you are using the most current form, please always refer to the HRPP website or the COEUS link each time you need to complete a form for your specific submission.  DO NOT keep template forms on your computer.

Examples of requirements and questions:

1. “Request for Approval of a Social/Behavioral/Educational Study". This form, which is posted on both the social/behavioral and biomedical forms pages, provides a structured application format for those studies that do not include treatment interventions.

2. List the Business Manager and contact information.

3. Funding Source: Indicate ALL of the CURRENT and ACTIVE funding source(s) for this study.

4. Has the funding source changed since this HIC application was last renewed?

5. Did the protocol lapse?If, so complete the following questions (omitted here):


PLEASE NOTE: It is not necessary to rewrite the full protocol application at the time of annual renewal, unless the full application on file at the HRPP is over 5 years old.

IRB FEES

Please note, Effective January 1, 2015, HIC protocols with start date on or after January 1, 2015, will be subject to the new IRB fees at prevailing rates. These rates are NOT locked for the duration of the contract. The change in IRB fees structure is the result of 2014 study of IRB fees charged for industry-sponsored applications across the United States. Please click here to view the new IRB Fees Schedule.

 

Reminder to Investigators Regarding NIH JIT Submissions:

As of June 16, 2014, for NIH JIT Submissions, a protocol /proposal congruency form (100 FR26) completed by the proposal PI must be submitted to the HIC/HSC as part of the protocol application or amendment process. The form is posted on our website under Forms.

ANNOUNCEMENT

Revised IRB Policy 710: REPORTING UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS, INCLUDING ADVERSE EVENTS, TO THE IRB

Effective April 15, 2014, the Yale University Human Research Protection Program (HRPP) revised IRB Policy 710 and related procedures (the policy and procedure for reporting adverse events and unanticipated problems involving risks to subjects or others (UPIRSOs) to the IRB). The changes are as follows:

  • The revised policy requires reporting of internal events (i.e., events that occur at a study site under the jurisdiction of a Yale IRB) within 5 calendar days of the Principal Investigator becoming aware of the event.
  • The revised policy requires, to the extent possible, immediate notification to the IRB of all events that might require a temporary or permanent interruption of research activity, and
  • The revised policy requires reporting of external events (i.e., events that occur at a study site NOT under the jurisdiction of a Yale IRB) within 15 calendar days of the Principal Investigator becoming aware, but only if an amendment to the protocol and/or consent documentation is necessary at Yale.

To aid in understanding reportable events, the new policy includes a decision tree for study personnel to use. In addition, a single reporting form has replaced the previous reporting forms and has been designed to capture required information, to direct the researcher in assessing the event, and to capture the IRB process of event review.

The revised Policy 710 and related documents went in effect as of April 15, 2014. Please review the revised documents carefully. If you have any questions, submit them via email to hrpp@yale.edu.

 

 

 

 

 



 

 

Last revised October 17, 2014

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