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 |
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| creator | Ennever, Fanny K Nabi, Sean Bass, Patricia A Huang, Lilly O Fogler, Emily C |
| description | 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, Health Insurance Portability and Accountability Act regulations, International Council for Harmonisation guidelines, the Confidentiality of Substance Use Disorder Patient Records statute, and Certificates of Confidentiality provisions under the 21st Century Cures Act. A consent form template is presented as one example of language that incorporates all of these requirements in an integrated manner that addresses some of the tensions among the various requirements. |
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| ispartof | The journal of research administration, 2019-03, Vol.50 (1), p.20-44 |
| issn | 1539-1590 2573-7104 |
| language | eng |
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| source | ERIC - Full Text Only (Discovery); EBSCOhost Business Source Complete; Alma/SFX Local Collection |
| subjects | 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 |
| title | Developing Language to Communicate Privacy and Confidentiality Protections to Potential Clinical Trial Subjects: Meshing Requirements under Six Applicable Regulations, Laws, Guidelines and Funding Policies |
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