The HRPP conducts research compliance audits that are internal to the institution. The primary goal of an audit is to evaluate a research project to ensure that the rights and welfare of human research participants are protected and that the research complies with federal regulations, state laws, and institutional policies. These audits are categorized as either for-cause (directed) or not-for-cause (scheduled).
For-cause (directed): Audits requested by an IRB, IRB Chair, the director of the Human Research Protection Program, or the Institutional Official for Research, generally related to reported or suspected non-compliance.
Not-for-cause (scheduled): Audits that are part of the HSC’s Audit plan and schedule. Criteria used to select studies for a not-for-cause audit vary and are approved by the HRPP Director semi-annually. Examples of selection criteria include but are not limited to the following factors:
- Factors indicating study subjects may be at increased risk (i.e., PIs with a high volume of studies, studies with minimal or no external oversight, inclusion of vulnerable populations, past or present subject safety or noncompliant issues, involvement of investigational drugs or devices).
- The PI holds the Investigational New Drug (IND) or Investigational Device Exemption (IDE).
- Clinical studies opened by a new principal investigator (PI) or an existing clinical study that has been transferred to a new PI.