Human Research Protection Program

HITECH Act

Yale campus

 

Tip of the Month

July 2014

Do you do research with community agencies? Or are you considering doing this?

The HRPP has posted “Making Research Work for Your Community, a Guidebook to Successful Research Partnerships” developed by the Community Foundation for Greater New Haven and the Robert Wood Johnson Clinical Scholars Program

ANNOUNCEMENT:

The HRPP is pleased to announce the new application “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.

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.

The HRPP will conduct training sessions on May 12th, and again in June and September, on reporting adverse events and unanticipated problems involving risks to subjects or others.

 

AAHRPP Announcement

The Yale University Human Research Protection Program (HRPP) is pleased to announce that it has been awarded Full Accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) for a period of five years ending in December, 2018. AAHRPP accreditation is awarded in recognition of Yale’s commitment to scientifically and ethically sound research, and to continuous improvement.

Dr. Andrew Rudczynski, Associate Vice President for Research Administration and Jan Hewett, JD, Director, Human Research Protection Program would like to formally thank the Institutional Research staff and the HRPP staff who were involved in the preparation for the site visit last September, who participated in the accreditation visit interviews, and who worked on the subsequent site-visit response.

The HRPP is grateful for the Yale research community’s commitment to excellence in human subjects protection.

New Requirement

Effective immediately the HRPP has new consent language regarding voluntary participation and withdrawal from a study. This change incorporates specific regulatory language, and must be used in all consent forms, information sheets, compound authorizations, parental permission and adolescent assent forms that are submitted to the HSC or HIC for review, whether as a new protocol, an amendment to an existing protocol, or an annual renewal.

There is also a HIPAA change to the Compound Authorization. Written withdrawal of permission to use health information is no longer required. Subjects may withdraw simply by telling the research team. It is important to note verbal withdrawal in the subject’s research record.

New templates have been posted on the HRPP forms websites. ALWAYS USE THE FORMS ON THE WEBSITE WHEN CREATING OR MODIFYING DOCUMENTS. Doing this ensures compliance with regulation, law and University policies, and assures a more efficient review process for you.

 

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. 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.

Effective September 15, 2013: In order to facilitate a streamlined review process, older versions of forms (both paper and electronic) will not be accepted for submission.

Examples of new requirements and questions:
 
1. List the Business Manager and contact information.
2. Funding Source: Indicate ALL of the CURRENT and ACTIVE funding source(s) for this study.
3. Has the funding source changed since this HIC application was last renewed?
4. 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.

 



 

 

Last revised April 3, 2014

Federalwide Assurance:

IRB Registration Numbers:

 

Food and Drug Administration

HRPP Contact Information: