March 13, 2025 – Saint Luke’s Health System

Study Title: “SystemCHANGE: An RCT for Medication Adherence in Kidney Transplant Recipients” (“MAGIC”)

Dear Ms. Johnson,

The Office for Human Research Protections (OHRP) investigated the allegations lodged against the Saint Luke’s Health System (SLHS) Human Research Protections Program (HRPP) and makes no determinations of noncompliance with the U.S. Department of Health and Human Services (HHS) regulations for the protection of human research subjects. 

Background: In January 2017, OHRP received allegations against SLHS of noncompliance with HHS regulations for the protection of human research subjects (subpart A of 45 CFR part 46).  The allegations pertained to the HRPP’s compliance with HHS regulations for the protection of human subjects. The complaint also included allegations about the MAGIC trial, more specifically. It is our understanding that the events described in the complaint occurred prior to January 21, 2019, and were reviewed under the Common Rule as it existed at that time (the “Pre-2018 Requirements”).  Therefore, all citations in this letter are to the Pre-2018 Requirements.

The complainant alleged the following:

• The IRB does not consider the approval criteria at 45 CFR 46.111 when reviewing studies.
• The IRB regularly reviewed studies when some or all members had not received a copy of the protocol.
• The IRB waived the requirements to obtain informed consent when the elements of waiver of consent at 45 CFR 46.116(d) were not satisfied.

OHRP reviewed documentation provided by the complainant, SLHS’s response to our inquiry letter, and incident reports submitted by SLHS in June 2016 that summarized the findings of an internal HRPP audit that already identified the noncompliance referenced in the 2017 complaint.  These incident reports also summarized the corrective actions the institution was already taking to address the noncompliance found. 

The complainant also alleged the following in the MAGIC trial:

• The SLHS principal investigator (PI) did not document informed consent nor request a waiver of documentation of informed consent in contravention of 45 CFR 46.117.
• The PI implemented significant changes to the research without prior approval from the IRB, in contravention of 45 CFR 46.103(b)(4)(iii).
• The institutional official has not permitted the IRB office to report determinations of serious and continuing noncompliance to OHRP, in contravention of 45 CFR 46.103(b)(5).

Regarding the allegations of noncompliance in the MAGIC trial, SLHS confirmed that they were not engaged in this research.  The study was conducted at a different institution and the PI of that study was not affiliated with SLHS.

Based on our review of the documentation provided, we make no determinations of noncompliance with HHS regulations for the protection of human subjects.  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,

Lisa Buchanan, MAOM, CIP
Director, Division of Compliance Oversight

CC (email only):

• Mr. Ryan McDowell, MS, Human Protection Administrator, St. Luke’s Health System
• Ms. Winifred Meeker-O’Connell, Director, Office of Clinical Policy, Food and Drug Administration (FDA) 
• Dr. Michelle Bulls, Director, OPERA, Office of Extramural Research, National Institutes of Health (NIH) 
• Dr. Pamela Kearney, Director, Division of Human Subjects Research, Office of Extramural Research, NIH 
• Dr. Adam Berger, Director, Division of Clinical and Healthcare Research Policy, Office of Science Policy, NIH 
• Ms. Lydia Kline, Team Lead, Clinical Research Policy, Division of Clinical and Healthcare Research Policy, Office of Science Policy, NIH 
• Center for Devices and Radiological Health (CDRH) IRB: BIMO-CDRH@fda.hhs.gov, opens in a new window 
• Center for Biologics Evaluation and Research (CBER): CBERBIMONotification@fda.hhs.gov, opens in a new window 
• Office of Regulatory Affairs (ORA): orabimoinspectionpoc@fda.hhs.gov, opens in a new window   
• Center for Drug Evaluation and Research (CDER): BIMO-CDEROSI@fda.hhs.gov, opens in a new window