Congratulations to the Human Subjects Protection Assessment System (HS-PAS) Team for receiving an NIH Office of the Director Honor Award! This award, which was distributed December 17, recognizes the team’s outstanding efforts and creativity in the development and implementation of a new assessment system for human subjects inquiries. Team members include Amy Bielski (Ripple Effect), Jill Conover (LTS), Ann Hardy (NIH/OD), Yvonne Lau (Ripple Effect), Jerrold Prothero (Ripple Effect) and Maria Stagnitto (NIH/OD).

Human subjects research supported by the NIH must comply not only with NIH policies, but also DHHS Human Subjects Protections Regulations (45 CFR 46).  The NIH Office of Extramural Programs (OEP) is responsible for evaluating applications that have inadequate human subject protections and may resolve coding issues or errors that prevent NIH Institutes and Centers (ICs) from funding grants.

Until recently, the OEP human subjects staff received e-mails from ICs, manually transferred the content to an in-house database, and created both electronic and paper folders to keep track of the evaluation.  To replace this cumbersome and time-consuming process, the team developed and implemented the user-friendly HS-PAS, which is a customized SharePoint-based system that provides comprehensive content management and search capabilities.  While the customization process involved extensive behind-the-scenes work, experimentation and training, the new system provides for the reconciliation of all human subjects concerns for grant applications and streamlines the process by 50 percent. It has also has improved efficiency and simplified the process for requesting code changes.  In addition, HS-PAS embodies a new transparency feature that enables ICs to track the progress of their requests.