ABSTRACT

Researchers work to move the boundaries of science, and most researchers do so with a focused intent on humane care and ethical use. This chapter recognizes that, on occasion, the drive for scientic advancement and the need for regulatory processes may not suf- ciently connect. Unintended missteps have the potential of causing serious programmatic and research consequences. It is the goal of postapproval monitoring (PAM) to mitigate noncompliance on the part of the institution and the individual.