As a result of internal review and to facilitate the human research protection program at UNTHSC, please note that single patient (single subject) case study reports no longer require review and approval by the North Texas Regional IRB. This includes any single patient case assessment, evaluation, study or report conducted by student enrolled at UNTHSC, or by an employee (faculty, staff, etc.) of UNTHSC or JPS. Some notes:
• This procedure change only involves IRB involvement with case study reports. All existing and relevant management of patient information, protected health information, adherence to HIPAA regulations as well as UNTHSC policy and procedures regarding patient information are still in force.
• This policy and procedure does NOT apply to personnel affiliated with or employed by, for example – HCA (Medical City) – or other institutions. Such employees must still submit their human subject projects through their own organization’s IRB, as usual.
• Any Case Study report application that was already submitted to the North Texas Regional IRB via IRBNet will still be processed as Exempt.
• Our Office has modified “case study” guidance on the IRB web site, as well as the RAD website.
Finally, note that this announcement applies ONLY to Single Subject (Patient) Case Study reports/projects. Medical record reviews and research activities that involve two or more patients are considered to be chart reviews and must be submitted to IRBNet as usual, using the Chart Review template/form.
For further information or guidance, feel free to contact the North Texas Regional IRB at x 0409