CTN Webinar: Privacy and Confidentiality Protections for Research Participants with Substance Use Disorders: 42 CFR Part 2 Revisions.
Presented by Maureen Boyle, PhD (NIDA Office of Science Policy and Communications) and Carmen L. Rosa, MS (NIDA Center for the Clinical Trials Network).
Produced by the NIDA Clinical Trials Network's Clinical Coordinating Center, March 9, 2016.
Maintaining the privacy and confidentiality of research participants is a critical aspect of conducting quality research investigations and reflects compliance with Good Clinical Practice guidelines and regulations. There are specific rules and protections established for nondisclosure of research and medical records of study participants with substance use disorders (SUDs) and currently changes proposed to ensure the privacy protections sufficiently meet the needs of a changing healthcare environment.
This one-hour webinar, sponsored by the NIDA Clinical Coordinating Center, acquainted attendees with 42 CFR Part 2 privacy protections, discuss the proposed changes, and implications for SUD treatment programs and healthcare provider interactions in various clinical settings.
Presenters were be Dr. Maureen Boyle, Chief of the Science Policy Branch in NIDA's Office of Science Policy and Communications; and Carmen Rosa, MS, Regulatory Officer at the CCTN providing regulatory consultations to investigators and NIDA staff.
Describe the basic privacy protections afforded by 42 CFR Part 2, what information is protected, and to whom the regulations apply.
Review the proposed changes to 42 CFR Part 2 as substance abuse treatment becomes increasingly available in non-traditional medical settings.
Consider implications of the proposed changes to substance use data flow between health organizations for research and medical records.
This webinar is aimed at all interested investigators, clinicians, statisticians, and other research staff. (Webinar, Video, PDF, English, 2016)