A PRIM&R Workshop
Challenges to Maintaining Confidentiality in Clinical Research and its Impact on Public Trust
March 4, 2026 1:00 – 2:30 PM ET
Overview
The conduct of clinical research often challenges our ability to keep information about research participants confidential and our ability to enhance trust from participants and the public. Extensive information may be included in medical record systems that allow a wide range of individuals ready access to confidential research information not only during a study, but long after the study is completed.
Rarely are there clear standards as to what information is necessary to be included, and what should be maintained outside of the medical record in more confidential research records. This information may be used in secondary research such as medical chart reviews or pulled to develop AI models or even be released inadvertently in medical records release requests.
Consent forms often promise that this information will be protected and only released under limited conditions or may include protections under a Certificate of Confidentiality. However, it maybe be challenging to fulfill these promises in the clinical research environment and may be contributing to an erosion of participant and public trust in research. This workshop will explore these and other challenges and discuss possible solutions.
What Will You Learn?
To identify gaps and challenges in confidentiality protections in clinical research.
Discuss conflicts between protections under a Certificate of Confidentiality and how information is shared in clinical research
Evaluate strategies to enhance confidentiality protections for clinical research information and impact on public trust including strategies for how to convey the inclusion of research related information in the medical record through the informed consent form and process.
Speakers
- Julie Ozier, MHL, CHRC, CIP Senior Vice President & IO for Regulatory Advarra, Inc
- Martha F. Jones, MA, CIP Vice President, Human Research Affairs Mass General Brigham Incorporated
- Megan Kasimatis Singleton, JD, MBE, CIP Associate Dean for Human Research Protections and Director of the Human Research Protections Program Johns Hopkins University School of Medicine
Accommodations
PRIM&R is committed to hosting inclusive, accessible events that enable all individuals to engage and participate fully. For inquiries about session accessibility or requests for specific accommodations, please contact Scott Rule at srule@primr.org or 617.303.1876. Requests for American Sign Language interpreters and/or CART providers should be made at least two weeks in advance of the event. Please note that PRIM&R will make every effort to secure services, but that these services are subject to availability.
CE Credit
Participants will receive a certificate of attendance that documents up to 1.5 continuing education credit hours for their attendance at this [workshop/webinar]. Certificates of attendance are useful for obtaining CE credits from professional associations. Each association's guidelines for accepting CE credit hours (in-person or virtual) may differ. Please consult the appropriate association representative for information on if, and how many, CE credits from this PRIM&R workshop may be used.
CIP®
Participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification. Please refer to the CIP® recertification guidelines for additional information.
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