UNMC’s Institutional Review Board is advising principal investigators again that the compliance date of the Health Insurance Portability and Accountability Act (HIPAA) is April 14. As of this date, all consent forms for research involving the use of protected health information (PHI), must be updated to include the required HIPAA authorization requirements pursuant to 45 CFR 46.164.508. Only a HIPAA compliant consent form can be used to enroll new subjects in active studies as of April 14.
According to the IRB database, there are more than 200 active studies that do not have a HIPAA compliant consent form approved by the IRB. Investigators, therefore, are strongly encouraged to review their protocol files and revise consent documents as necessary for prompt submission to the IRB.
Any active protocols that are not HIPAA-compliant by April 14, will be suspended to new accrual per federal regulations. The deadline for submission of revised consent documents is March 14. If investigators delay submission, the IRB may not be able to complete its review of the revised consent documents prior to the compliance date.
Please be advised that youth and child assent forms are not required to include the HIPAA authorization. If a study has completed subject accrual, notify the IRB immediately. It is unnecessary to reconsent any subject enrolled prior to April 14, unless there is a change in the study, which warrants reconsent.
If you have any questions or require assistance, contact the Office of Regulatory Affairs at 559-6463.