Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects

The information collection activity consists of activity-driven reporting and recordkeeping requirements for those who intend to conduct research for submission to EPA under the pesticide laws. If such research involves intentional dosing of human subjects, these individuals (respondents) are required to submit study protocols to EPA and a cognizant local Human Subjects IRB before such research is initiated so that the scientific design and ethical standards that will be employed during the proposed study may be reviewed and approved. Also, respondents are required to submit information about the ethical conduct of completed research that involved human subjects when such research is submitted to EPA.

The latest form for Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects expires 2022-04-30 and can be found here.

Research Involving Intentional Exposure of Human Subjects

Federal Enterprise Architecture: Environmental Management - Pollution Prevention and Control