Research Microscope Lab

Human Research Protection Program

For Cause Audit

Anyone can request a For Cause Audit, which must be authorized by the HRPP Director.

Anyone can request an audit. The audit must be authorized by the Director, Human Research Protections Program before it is initiated. If you have an allegation or complaint regarding non-compliant or unsafe conduct of a human subject research project contact the Human Research Protections Program Director or the Quality Improvement Manager. 

Director, Human Research Protections Program
David C. Clark, PhD
(414) 955-8422 | dclark@mcw.edu

Manager, Quality Improvement
Roxanne Pritchard, RN, BSN
(414) 955-8844 | rpritcha@mcw.edu

 

Process to request a For Cause Audit

If you have an allegation or complaint regarding non-compliant or unsafe conduct of a study involving human subject research contact the Human Research Protections Program Director or the Quality Improvement Manager.

  • The allegation/complaint may be written or verbal, filed anonymously or associated with the reporter’s name.
  • The received allegation/complaint and associated information will be reviewed and appropriate measures will be taken.
  • The request for audit must be authorized by the Director Human Research Protections Program.
  • The Quality Improvement staff initiates the conduct of the “For Cause” audit upon receipt of authorization.
  • The individual who filed the allegation/complaint will be notified of the plan to proceed with the “For Cause” audit, except in the event of an anonymously filed complaint/grievance.

 

When to Consider Requesting a For Cause Audit

Reasons for initiating a request for a “For Cause” audit may include but are not limited to the following:

  • Study conducted outside of principal investigator’s expertise.
  • Conflict of interest poorly managed or not managed.
  • Study not conducted in accordance with IRB approved protocol, investigational plan, institutional policies, and/or federal regulations. Examples include but are not limited to the following:
    • Enrollment of ineligible individuals
    • Randomization errors
    • Serious adverse events not reported
    • Unanticipated Problems Involving Risk to Subject or Others not reported
    • Incorrect use of product
    • Protocol deviation