Research Microscope Lab

Human Research Protection Program

For Cause Audit

  • 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

 For Cause Audit

Anyone can request a For Cause Audit. All audit requests must be authorized by the Director, Human Research Protections Program before implementation.

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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