Towards an Understanding of the Ethics of Electronic Consent in Clinical Trials

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2024 Aug 16

PMID 39152507

Authors

Katherine Sahan

Rohan Wijesurendra

David Preiss

Marion Mafham

Mark Sheehan

Affiliations

Soon will be listed here.

Abstract

There are good practical reasons to use electronic consent (e-consent) in randomised trials, especially when conducting large-scale clinical trials to answer population-level health research questions. However, determining ethical reasons for e-consent is not so clear and depends on a proper understanding of what e-consent means when used in clinical trials and its ethical significance. Here we focus on four features of ethical significance which give rise to a range of ethical considerations relating to e-consent and merit further focused ethics research.

References

De Sutter E, Borry P, Geerts D, Huys I . Personalized and long-term electronic informed consent in clinical research: stakeholder views. BMC Med Ethics. 2021; 22(1):108. PMC: 8325412. DOI: 10.1186/s12910-021-00675-7. View

Jayasinghe N, Moallem B, Kakoullis M, Ojie M, Sar-Graycar L, Wyka K . Establishing the Feasibility of a Tablet-Based Consent Process with Older Adults: A Mixed-Methods Study. Gerontologist. 2018; 59(1):124-134. PMC: 6326252. DOI: 10.1093/geront/gny045. View

Coyle J, Rogers A, Copland R, De Paoli G, MacDonald T, Mackenzie I . A secondary qualitative analysis of stakeholder views about participant recruitment, retention, and adherence in decentralised clinical trials (DCTs). Trials. 2022; 23(1):614. PMC: 9338512. DOI: 10.1186/s13063-022-06521-4. View

Sheehan M, Thompson R, Fistein J, Davies J, Dunn M, Parker M . Authority and the Future of Consent in Population-Level Biomedical Research. Public Health Ethics. 2020; 12(3):225-236. PMC: 7020771. DOI: 10.1093/phe/phz015. View

Almeida-Magana R, Maroof H, Grierson J, Clow R, Dinneen E, Al-Hammouri T . E-Consent-a guide to maintain recruitment in clinical trials during the COVID-19 pandemic. Trials. 2022; 23(1):388. PMC: 9096749. DOI: 10.1186/s13063-022-06333-6. View

Harle C, Golembiewski E, Rahmanian K, Krieger J, Hagmajer D, Mainous A . Patient preferences toward an interactive e-consent application for research using electronic health records. J Am Med Inform Assoc. 2017; 25(3):360-368. PMC: 5992814. DOI: 10.1093/jamia/ocx145. View

de Melo-Martin I, Ho A . Beyond informed consent: the therapeutic misconception and trust. J Med Ethics. 2008; 34(3):202-5. DOI: 10.1136/jme.2006.019406. View

Plaut V, Bartlett R . Blind consent? A social psychological investigation of non-readership of click-through agreements. Law Hum Behav. 2012; 36(4):293-311. DOI: 10.1037/h0093969. View

Khairat S, Tirtanadi K, Ottmar P, Sleath B, Obeid J . Evaluating the Perceptions of Teleconsent in Urban and Rural Communities. Eur J Biomed Inform (Praha). 2020; 15(2). PMC: 7427121. View

10.

Appelbaum P, Roth L, Lidz C, Benson P, Winslade W . False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep. 1987; 17(2):20-4. View

11.

Wilbanks J . Design Issues in E-Consent. J Law Med Ethics. 2018; 46(1):110-118. PMC: 6062847. DOI: 10.1177/1073110518766025. View

12.

Rowbotham M, Astin J, Greene K, Cummings S . Interactive informed consent: randomized comparison with paper consents. PLoS One. 2013; 8(3):e58603. PMC: 3590180. DOI: 10.1371/journal.pone.0058603. View

13.

Dunn M, Sheehan M, Hope T, Parker M . Toward methodological innovation in empirical ethics research. Camb Q Healthc Ethics. 2012; 21(4):466-80. DOI: 10.1017/S0963180112000242. View

14.

de Jong A, van Rijssel T, Zuidgeest M, van Thiel G, Askin S, Fons-Martinez J . Opportunities and Challenges for Decentralized Clinical Trials: European Regulators' Perspective. Clin Pharmacol Ther. 2022; 112(2):344-352. PMC: 9540149. DOI: 10.1002/cpt.2628. View

15.

Marquis-Gravel G, Roe M, Robertson H, Harrington R, Pencina M, Berdan L . Rationale and Design of the Aspirin Dosing-A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) Trial. JAMA Cardiol. 2020; 5(5):598-607. DOI: 10.1001/jamacardio.2020.0116. View

16.

Simon C, Schartz H, Rosenthal G, Eisenstein E, Klein D . Perspectives on Electronic Informed Consent From Patients Underrepresented in Research in the United States: A Focus Group Study. J Empir Res Hum Res Ethics. 2018; 13(4):338-348. DOI: 10.1177/1556264618773883. View

17.

Kaye J, Whitley E, Lund D, Morrison M, Teare H, Melham K . Dynamic consent: a patient interface for twenty-first century research networks. Eur J Hum Genet. 2014; 23(2):141-6. PMC: 4130658. DOI: 10.1038/ejhg.2014.71. View

18.

Lentz J, Kennett M, Perlmutter J, Forrest A . Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative. Contemp Clin Trials. 2016; 49:65-9. DOI: 10.1016/j.cct.2016.06.005. View

19.

Aung T, Haynes R, Barton J, Cox J, Murawska A, Murphy K . Cost-effective recruitment methods for a large randomised trial in people with diabetes: A Study of Cardiovascular Events iN Diabetes (ASCEND). Trials. 2016; 17(1):286. PMC: 4907276. DOI: 10.1186/s13063-016-1354-9. View

20.

Petrini C, Mannelli C, Riva L, Gainotti S, Gussoni G . Decentralized clinical trials (DCTs): A few ethical considerations. Front Public Health. 2023; 10:1081150. PMC: 9797802. DOI: 10.3389/fpubh.2022.1081150. View