A new version of the UH Research Consent Template and the UH Research Consent Tutorial are now available on-line and in the iRIS electronic IRB system.
The new UH Research Consent Template corrects a problem in the header to allow for the iRIS system to automatically stamp the consent form approval stamp on each page. Also, the template has been revised to include a section which contains required Research HIPAA Authorization Language. If you use this version of the consent template, you DO NOT need a separate HIPAA Authorization form.
The new UH Research Consent Tutorial has been updated to revise each section of the tutorial with new information and regulatory guidance to assist in developing consent forms that contain all the information required for approval by the UHCMC IRB. New features of this Tutorial include template language regarding:
- GINA (Genetics Information Non-Discrimination Act),
- GWAS (Genome Wide Association Studies),
- standardized research related injury language (required for any interventional trial to clarify who is responsible for payment of research related injuries) and
- Research HIPAA Authorization Language.
All informed consent forms should be updated to include new standard language at the time of next amendment or continuing review if the active research study is still enrolling subjects. All new studies should utilize these new versions of the informed consent as templates.