The truth about the truth: What matters when privacy and anonymity can no longer be promised to those who participate in clinical trial research?

TitleThe truth about the truth: What matters when privacy and anonymity can no longer be promised to those who participate in clinical trial research?
Publication TypeJournal Article
Year of Publication2013
AuthorsCook, AFreeman, Hoas, H
JournalResearch Ethics
Volume9
Issue3
Pagination97-108
Date Published2013
Publication Languageeng
Keywordsbiobanking , Clinical , GENETICS , GENOMICS , Human , Medical , Pharmaceutical , QUALITATIVE , research
AbstractThe ramifications of including genetic components in the clinical studies conducted in non-academic settings create unique ethical challenges. We used a qualitative research design consisting of semi-structured interviews that took place between October 2010 and September 2012. The sample consisted of 80 participants − 38 physicians and 42 coordinators − who worked across a number of different settings, including clinics, private practices, small hospitals, free standing research centers, and blended hospital-institutes in both rural and urban communities in 13 states across the United States. The respondents primarily conducted industry sponsored trials and recruited their own patients as research participants. A majority of the respondents (65%) reported that most of the studies they conducted included an additional genetics component, and so participants were asked to donate specimens for genomics or biobanking. While genomics association studies were perceived as being of benefit, awareness of ethical implications associated with such studies was limited. The rapid advances in genetic technologies make it hard for clinicians and coordinators to help patients make informed decisions about participating in clinical research, and underscore the need to ensure that the regulations governing research on human subjects keep pace with the social and technological changes. It seems essential to discern legitimate ethical concerns and find ways to convey what is going on, what is possible and what might not be possible in terms of protecting privacy, anonymity, and confidentiality.
NotesFreeman Cook, Ann Hoas, Helena; Source Info: Sep2013, Vol. 9 Issue 3, p97; Subject Term: CLINICAL trials; Subject Term: MEDICAL research; Subject Term: PHARMACEUTICAL policy; Subject Term: QUALITATIVE research; Subject Term: RESEARCH institutes; Subject Term: RESEARCH -- Methodology; Author-Supplied Keyword: biobanking; Author-Supplied Keyword: clinical trials; Author-Supplied Keyword: genetics; Author-Supplied Keyword: genomics; Author-Supplied Keyword: human subject protection; Author-Supplied Keyword: research ethics; NAICS/Industry Codes: 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); NAICS/Industry Codes: 414510 Pharmaceuticals and pharmacy supplies merchant wholesalers; NAICS/Industry Codes: 325410 Pharmaceutical and medicine manufacturing; NAICS/Industry Codes: 424210 Drugs and Druggists' Sundries Merchant Wholesalers; NAICS/Industry Codes: 541720 Research and Development in the Social Sciences and Humanities; NAICS/Industry Codes: 541711 Research and Development in Biotechnology; Number of Pages: 12p; Document Type: Article
DOI10.1177/1363460713494647

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