Protection of Minors Policy and Human Subjects
The university reminds the community that anyone who has or is planning to propose current study or studies involving minors (under age 18) as human subjects that the requirements of the University’s Protection of Minors Policy as they apply to human subjects research involving minors must be met.
Please take a few moments to become familiar with the Policy’s requirements and the responsibilities of Principal Investigators and study team members; go to http://ora.georgetown.edu/irb/MinorPolicy.htm. Please note that these requirements must be met for new study proposals and for renewals submitted to the Institutional Review Board (IRB). 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 modified to serve a gate-keeping function and to track compliance with the Policy. When a Principal Investigator (P.I.) 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 P.I. 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 web site.
Anne Koester, Manager of the Protection of Minors Policy, is available as a resource for any questions or concerns regarding the requirements of the Policy and any other issues that might arise, e.g., when and how to report suspected abuse or neglect. Please feel free to contact her at firstname.lastname@example.org.