Protection of Minors Policy and Human Subjects Research

For PIs who currently have or are planning to propose current study or studies involving minors (under age 18) as human subjects, the requirements of the University’s Protection of Minors Policy as they apply to human subjects research involving minors must be met. Please review the Policy’s requirements and also the PIs’ and team members’ responsibilities for the Protection of Minors in Research Studies.

NOTE: These requirements must be met for new study proposals and for renewals submitted to the IRB from this date forward. Studies involving minors that are currently underway will need to be in compliance with the Policy’s requirements when such studies are due to be renewed.

The eRIC system has recently been modifed to serve a gatekeeping function and track compliance with the Policy. Essentially, when a PI submits a proposal to the IRB for a new study involving minors or is seeking a previous approval to be renewed for an ongoing study, eRIC will identify the study as such and remind the PI of the requirements that must be met before the study proposal or renewal will be considered by the IRB. UIS documentation with instructions for submitting a study in eRIC when it involves minors as research subjects will be available on the IRB website.

For questions regarding the Policy and any other related issues that may arise, e.g., when and how to report suspected abuse or neglect, please contact Anne Koester, Protection of Minors Policy Manager, at ayk2@georgetown.edu.