28 May 2024
Privacy and Confidentiality in Clinical Research
Review statutes and regulations governing privacy and confidentiality of patient information in clinical trials involving drugs, medical devices, and other life sciences products. Counsel your healthcare organization clients on the Health Insurance Portability and Accountability Act (HIPAA), federal Common Rule, and Food and Drug Administration (FDA) regulations, which set the standards for maintaining the privacy and confidentiality of data obtained from participants in clinical trials.
Related Content
- HIPAA Authorization to Use and Disclose PHI in Clinical Research
Adopt this HIPAA authorization for use when a clinician or researcher anticipates disclosing an individual's protected health information (PHI) in the course of conducting research or as a result of collecting such data during clinical research. Obtain authorizations before: (1) disclosing PHI to a third party other than for treatment, payment, or healthcare operations; (2) using PHI for marketing or fundraising reasons; and (3) providing PHI to a research organization. - HIPAA Data Use Agreement
Employ this template data use agreement for all exchanges of PHI between a covered entity subject to HIPAA and a third-party researcher to whom the covered entity may disclose a limited data set for research, public health, or healthcare operations. Understand how the HIPAA Privacy Rule, which typically requires that covered entities meet certain conditions to use or disclose PHI for research purposes, permits a covered entity to enter into a data use agreement to use or disclose a limited data set when obtaining authorization of the research participant is not possible or practical. - Clinical Research State Law Survey
Rely on this state law survey to understand state rules and regulations on clinical trial coverage, including mandatory insurer coverage, protected patient populations, access to or “right to try” clinical trial programs, and informed consent and confidentiality requirements.
Practical Guidance Updates
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