Princeton is registered with OHRP and has a Federal wide Assurance (FWA) for the Protection of Human Subjects. The FWA assures the federal government that we provide education and training about human subject protections to research investigators. Education and training are provided, in part, via the PAM Program. In addition, the federal regulations give the IRB the authority to observe, or have a third party observe, the consent process and the research being conducted at the institution. Post-approval monitoring (PAM) can facilitate ongoing protocol assessment and regulatory compliance by monitoring protocols after the IRB's initial protocol approval.
PAM methods include: protocol review; laboratory visits; observation of selected procedures; and follow-ups to concerns.
The purpose of this program is to ensure that ethical and regulatory requirements are followed by investigators. This program is also designed to improve the quality of research by ensuring congruence between what is described in the research protocol and what is occurring during the actual performance of research activities. This will also give researchers an opportunity to ask questions and receive information about regulations and issues regarding the protection of human subjects.
All studies, even those determined to qualify for exempt status, are subject to PAM. Receiving notification that a study has been selected for PAM does not imply that wrongdoing has occurred or is suspected in the conduct of the study.
The IRB will receive reports of the activities and findings of the PAM Program by the monthly committee meetings.