On Site Monitoring

In order to monitor whether research is carried out as approved, federal regulations [46.109e] authorize Northeastern University to observe human subjects-related research procedures and the process of obtaining informed consent, and to conduct audits of research records and ensure that confidentiality is being maintained according to stated procedures.

Audits may also be conducted by agencies and sponsors such as the Office for Human Research Protections, the National Institutes of Health, and the Food and Drug Administration, etc.

Audits may be unannounced, so records should be readily available.