Digitizing Consent: The Food and Drug Administration's Draft Guidance on Electronic Informed Consent

TitleDigitizing Consent: The Food and Drug Administration's Draft Guidance on Electronic Informed Consent
Publication TypeJournal Article
Year of Publication2016
AuthorsSimon, CM, Klein, DW, Schartz, HA
JournalIRB: Ethics & Human Research
Volume38
Issue5
Pagination15-18
Date Published2016
Publication Languageeng
ISBN Number01937758
KeywordsClinical , Data , Electronic , Government , Informed , Medical , Privacy , United , World
AbstractThe article discusses the draft guidance on electronic informed consent (eIC) issued by the Food and Drug Administration (FDA). Topics include possibility of electronic information delivery improvements, security of clients personal data, and FDA regulations regarding participants copy of informed consent document.
NotesSIMON, CHRISTIAN M. 1 KLEIN, DAVID W. 2 SCHARTZ, HELEN A. 3; Affiliation: 1: Associate professor of bioethics and humanities, Program in Bioethics and Humanities, Department of Internal Medicine, University of Iowa Carver College of Medicine 2: Director of technology, Law, Health Policy & Disability Center, College of Law, University of Iowa 3: Director of research, Law, Health Policy & Disability Center, College of Law, University of Iowa; Source Info: Sep/Oct2016, Vol. 38 Issue 5, p15; Subject Term: Clinical trials; Subject Term: Informed consent (Medical law); Subject Term: Medical ethics; Subject Term: Privacy; Subject Term: World Wide Web; Subject Term: Electronic publications; Subject Term: Government regulation; Subject Term: Data security; Subject Term: United States; Company/Entity: United States. Food & Drug Administration; NAICS/Industry Codes: 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); NAICS/Industry Codes: 519130 Internet Publishing and Broadcasting and Web Search Portals; NAICS/Industry Codes: 541519 Other Computer Related Services; NAICS/Industry Codes: 541514 Computer systems design and related services (except video game design and development); Number of Pages: 4p; Document Type: Article

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