Developing Language to Communicate Privacy and Confidentiality Protections to Potential Clinical Trial Subjects: Meshing Requirements under Six Applicable Regulations, Laws, Guidelines and Funding Policies

Clinical trials must address a number of laws, regulations, and other sources of requirements when communicating privacy and confidentiality protections to potential participants. This article outlines relevant requirements from Common Rule regulations, Food and Drug Administration regulations, Heal...

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Veröffentlicht in:	The journal of research administration 2019-03, Vol.50 (1), p.20-44
Hauptverfasser:	Ennever, Fanny K, Nabi, Sean, Bass, Patricia A, Huang, Lilly O, Fogler, Emily C
Format:	Artikel
Sprache:	eng
Schlagworte:	21st century Accountability Clinical trials Compliance Confidential communications Confidentiality Consent Definitions Drug use Ethics FDA approval Federal regulation Government regulation Guidelines Health insurance Health Insurance Portability & Accountability Act 1996-US Human subjects Informed Consent Language Language Usage Laws, regulations and rules Medical records Medical Research Medical Services Privacy Privacy, Right of Records (Forms) Right of privacy Substance use disorder
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