Current Human Subjects Research Projects
Creation of a Standard Operating Procedure (SOP) Manual: The SOP Manual serves as a cohesive guidance document for human subject research protocols conducted or supported by the Agency. The SOP manual was published in 2017 and revised in 2018. The 2018 version is currently being updated.
Training: Human subject research training programs are intended to increase EPA employees' awareness of human research ethics and regulations across the Agency. These programs include a variety of web-based training sessions, online training tutorials, and in-person workshops and interactive sessions. With increased training, EPA employees will be better suited to identify and assess questions regarding human subject research in their Program, Region, or Office.
Electronic Submission Tool: An electronic mechanism was developed to enable online submission of human subjects research projects for review by the Human Subjects Research Review Official (HSRRO). This tool called the Human Subject Research Application Portal (HSRAP) streamlines the review process and increases the efficiency of review while ensuring that human subjects are adequately protected in human subject research conducted or funded by the Agency. Enhancements to the HSRAP are ongoing.
National Academy of Sciences Project: EPA has asked the National Academy of Sciences' Board on Environmental Studies and Toxicology to address issues in risks to human subjects who participate in controlled exposure studies of environmental pollutants. The final report from NAS can be found here: