Institutional Review Boards Research Records

The IRB (Institutional Review Board) forms/checklists are used to collect and document the required information & consent while conducting approved subject research studies, as well as to ensure all proper documentation has been completed and proper procedures are followed. IRB Forms contain information related to the research project such as: title of study, study/investigator(s) (name(s), degree(s), contact information, etc.) funding sources, summary of study description, consent statement, protocol, data use agreement(s) (if required), data steward authorization (if required), identifiable information (if requested), specimens (if applicable), confidentiality pledges, type of data requested (if applicable), etc. The information gathered on these forms pertains to Research involving human subjects that are conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research (Research projects involving secondary data analysis of existing datasets that include protected health information and/or request a waiver of consen). Disclosure will comply with the requirements of this agreement and applicable law & as well as TDH (TN Dept. of Health) data release policies.