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Human Research Protection Program Post-Approval Reviews

The Human Research Protection Program (HRPP) is implementing a new Post-Approval Reviews (PAR) program this semester. PAR is an onsite review of an existing active protocol.

The purpose of the program is to comply with federal and institutional regulations on continuing review policies, help the HRPP gauge future training needs and help researchers operate within mandated standards.

The program has been a year in the making, beginning with the development of new HRPP office policies and procedures for post-approval reviews. It is based on the human research protection industry’s best practices and standards and serves to help improve the quality of proposal submissions, educate researchers and improve the overall efficiency of the HRPP and Institutional Review Board (IRB) review process.

PAR begins with the random selection of existing active protocols on file in the HRPP office. After the selections are made, a notification letter is sent to the researcher explaining the PAR and providing a tentative date for review. The review will take place with the principal investigator (PI) and other members of the research team as needed, at the location where the files for that protocol are maintained.

PAR will consist of a review of approved documentation and processes relevant to the protocol such as: the proposal, amendments, approval letters, recruitment and consent forms and data storage. The review will normally take between one and two hours. Any issues will be discussed with the PI and plans made for resolutions. All reviews will remain confidential except those cases involving serious or continuing noncompliance as mandated by 45 CFR 46 reporting mandates.

The new program is in accordance with Texas Tech University’s Federalwide Assurance agreement under 45 CFR 46.109(e) and TTU IRB Policies 5.3 and 5.4.

Please contact the HRPP office at (806) 742-2064 or email the HRPP office if you have any questions or concerns.