Toward Meeting the Obligation of Respect for Persons in Pragmatic Clinical Trials
Research ethics oversight systems have traditionally emphasized the informed consent process as the primary means by which to demonstrate respect for prospective subjects. Yet how researchers can best fulfill the ethical obligations of respect for persons in pragmatic clinical trials (PCTs)—particul...
| Autori: | ; ; ; ; ; ; |
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| Tipo di documento: | Elettronico Articolo |
| Lingua: | Inglese |
| Verificare la disponibilità: | HBZ Gateway |
| Interlibrary Loan: | Interlibrary Loan for the Fachinformationsdienste (Specialized Information Services in Germany) |
| Pubblicazione: |
2022
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| In: |
The Hastings Center report
Anno: 2022, Volume: 52, Fascicolo: 3, Pagine: 9-17 |
| Altre parole chiave: | B
PCT
B Consent B Respect B Bioethics B pragmatic clinical trials B research ethics B clinical ethics |
| Accesso online: |
Volltext (lizenzpflichtig) Volltext (lizenzpflichtig) |
| Riepilogo: | Research ethics oversight systems have traditionally emphasized the informed consent process as the primary means by which to demonstrate respect for prospective subjects. Yet how researchers can best fulfill the ethical obligations of respect for persons in pragmatic clinical trials (PCTs)—particularly those that may alter or waive informed consent—remains unknown. We propose eight dimensions of demonstrating respect in PCTs: (1) engaging patients and communities in research design and execution, (2) promoting transparency and open communication, (3) maximizing agency, (4) minimizing burdens and promoting accessibility, (5) protecting privacy and confidentiality, (6) valuing interpersonal interactions with clinicians and study team members, (7) providing compensation, and (8) maximizing social value. While what respect requires in the context of PCTs will vary based on the nature of the PCT in question, the breadth of these dimensions demonstrates that respect obligations extend beyond informed consent processes. |
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| ISSN: | 1552-146X |
| Comprende: | Enthalten in: Hastings Center, The Hastings Center report
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| Persistent identifiers: | DOI: 10.1002/hast.1391 |
