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.
The HRPP is pleased to announce that its reaccreditation site visit by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), was very successful and resulted in only one observation for corrective action. Before obtaining official reaccreditation status, Yale must ensure that the research community understands the distinction between a serious adverse event and an unanticipated problem involving risks to subjects or others (UPIRSO, or commonly referred to as UAP).
Below, please take part in a brief educational session followed by a short, four question quiz, all of which can be accessed and completed anonymously and online via Qualtrics. The quiz will include example scenarios for each of the definitions listed above.
If you do primarily Biomedical research, click here.
If you do primarily Social, Behavioral, and/or Educational research, click here.
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.
HIPAA CHANGES- CLICK HERE