May 28, 2026 – Medical College of Wisconsin

Dear Dr. Nattinger:

The Office for Human Research Protections (OHRP) investigated allegations of noncompliance with the U.S. Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR Part 46, Subpart A) regarding a portfolio of HHS-supported studies in which the Medical College of Wisconsin (MCW) is engaged. OHRP makes no determinations of noncompliance with the HHS regulations for the protection of human research subjects. OHRP acknowledges that MCW also investigated the allegations of noncompliance and did not find evidence to support the allegations.

Background

In October 2025, OHRP received allegations of noncompliance with the HHS regulations for the protection of human research subjects (45 CFR Part 46, Subpart A) related to the HHS-supported research portfolio of an investigator at MCW. The complainant alleged the following:

1. The use of coercive practices to enroll individuals into clinical trials. The complaint describes practices including telling patients that clinical trials were a patient’s only option, failing to offer standard of care treatments outside of clinical trial participation, delaying patient treatment while awaiting a clinical trial to open without offering patients standard treatments that did not require waiting, and declining to participate in the further care of patients that do not agree to enroll in a clinical trial.
2. Enrollment of subjects into clinical trials without vetting them using established eligibility criteria. Additionally, it is alleged that all assessments as required by one or more institutional review board (IRB)-approved protocols were not performed.

OHRP reviewed MCW’s investigation report, summaries of staff interviews, MCW’s standard operating procedures, IRB records for HHS-supported studies in which MCW is engaged, and information provided by the complainant. Based on our review of these materials, OHRP is unable to substantiate these allegations and makes no determination of noncompliance with the HHS regulations for the protection of human research subjects.

We note that OHRP did not conduct an all-inclusive review of potential deficiencies related to the MCW IRB’s written procedures, the review and approval by the IRB of protocols and informed consent documents, or other regulatory requirements. It is the institution’s responsibility to ensure adherence to each requirement of the relevant HHS regulations.

This investigation is closed. We appreciate your institution’s continued commitment to the protection of human research participants. Please feel free to contact me if you have any questions.

Sincerely,

LT William Boyd DVM, MPH
Compliance Officer
Division of Compliance Oversight

CC (email only):
Dr. Ryan Spellecy, Human Protections Administrator, Human Research Protection Program, MCW
Office of Clinical Policy, Food and Drug Administration (FDA)
Division of Human Subjects Research, Office of Extramural Research, National Institutes of Health (NIH)
Division of Clinical and Healthcare Research Policy, Office of Science Policy, NIH
Center for Devices and Radiological Health, FDA
Center for Biologics Evaluation and Research, FDA
Office of Regulatory Affairs, FDA
Center for Drug Evaluation and Research, FDA