The CPHS monitoring program involves one-on-one discussions between a research monitor from our office and the principal investigator (and research coordinator separately, if applicable) regarding their research project involving human subjects. The monitoring visit is a way for the CPHS office to keep up to date on the progress of ongoing protocols and also provides an opportunity for the principal investigator to discuss human subject concerns, adverse events, or upcoming changes to the protocol.

General issues considered during the visit include, but are not limited to, recruitment of subjects, the informed consent process, sensitivity issues regarding vulnerable populations, confidentiality, human subjects education, and adverse event reporting. Current procedures, policies, and practices are evaluated and if necessary, alternate methods may be recommended to promote compliance with regulatory requirements for human subjects.

Protocols are selected at random from those up for continuing review on a monthly basis. Long-term projects and those involving vulnerable populations (for example, children or mentally impaired persons), and those with significant adverse events may, at times, be given higher priority. The monitoring program serves in an advisory capacity to the Institutional Review Board, providing the committee with routine summaries of its findings and addressing recurrent compliance issues relevant to human subjects protection.