Framework and Practical Guidance for the Ethical Use of Electronic Methods for Communication With Participants in Medical Research

Overview

Journal J Med Internet Res

Publisher JMIR Publications

Specialty Medical Informatics

Date 2022 Apr 20

PMID 35442208

Authors

Atsushi Kogetsu

Kazuto Kato

Affiliations

Soon will be listed here.

Abstract

Online communication with participants, including online recruitment, electronic informed consent, and data communication, is one of the fields to which information and communication technology (ICT) has been applied in medical research. Online communication provides various benefits, especially for genome research and rare disease research. However, ethical challenges that are derived from or exacerbated by online communication need to be addressed. Here, we present an overview of such ethical issues and provide practical guidance for the ethical implementation of ICT. We specify the ethical issues in the context of using online communication for medical research by an analysis based on the eight ethical principles for clinical research. Informed by this ethical context, we then develop a novel framework for the governance of medical research involving ICT, which consists of eight categories: five research processes (ie, design of research, recruitment, informed consent, data communication, and dissemination and return of results) and three overarching perspectives related to multiple processes of research (ie, access to research and online dialog, community involvement, and independent review). Finally, we present a practical guidance chart for researchers, patient partners, independent reviewers, and funding agencies. We believe that our study will contribute to the ethical implementation of online communication in medical research.

Citing Articles

Moving beyond Technical Issues to Stakeholder Involvement: Key Areas for Consideration in the Development of Human-Centred and Trusted AI in Healthcare.

Kaye J, Shah N, Kogetsu A, Coy S, Katirai A, Kuroda M Asian Bioeth Rev. 2024; 16(3):501-511.

PMID: 39022370 PMC: 11250765. DOI: 10.1007/s41649-024-00300-w.

References

De Sutter E, Zace D, Boccia S, DI Pietro M, Geerts D, Borry P . Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders' Perspectives: Systematic Review. J Med Internet Res. 2020; 22(10):e19129. PMC: 7582148. DOI: 10.2196/19129. View

Frost J, Massagli M . Social uses of personal health information within PatientsLikeMe, an online patient community: what can happen when patients have access to one another's data. J Med Internet Res. 2008; 10(3):e15. PMC: 2553248. DOI: 10.2196/jmir.1053. View

Eysenbach G, Wyatt J . Using the Internet for surveys and health research. J Med Internet Res. 2003; 4(2):E13. PMC: 1761932. DOI: 10.2196/jmir.4.2.e13. View

Perakslis E . Using digital health to enable ethical health research in conflict and other humanitarian settings. Confl Health. 2018; 12:23. PMC: 5950196. DOI: 10.1186/s13031-018-0163-z. View

Demiris G . The diffusion of virtual communities in health care: concepts and challenges. Patient Educ Couns. 2006; 62(2):178-88. DOI: 10.1016/j.pec.2005.10.003. View

Schwab-Reese L, Hovdestad W, Tonmyr L, Fluke J . The potential use of social media and other internet-related data and communications for child maltreatment surveillance and epidemiological research: Scoping review and recommendations. Child Abuse Negl. 2018; 85:187-201. PMC: 7112406. DOI: 10.1016/j.chiabu.2018.01.014. View

Rothstein M, Zawati M, Beskow L, Brelsford K, Brothers K, Hammack-Aviran C . Legal and Ethical Challenges of International Direct-to-Participant Genomic Research: Conclusions and Recommendations. J Law Med Ethics. 2020; 47(4):705-731. DOI: 10.1177/1073110519898297. View

Henderson E, Law E, Palermo T, Eccleston C . Case study: ethical guidance for pediatric e-health research using examples from pain research with adolescents. J Pediatr Psychol. 2012; 37(10):1116-26. PMC: 3529561. DOI: 10.1093/jpepsy/jss085. View

Kogetsu A, Ogishima S, Kato K . Authentication of Patients and Participants in Health Information Exchange and Consent for Medical Research: A Key Step for Privacy Protection, Respect for Autonomy, and Trustworthiness. Front Genet. 2018; 9:167. PMC: 5992519. DOI: 10.3389/fgene.2018.00167. View

10.

Lamas E, Salinas R, Vuillaume D . A New Challenge to Research Ethics: Patients-Led Research (PLR) and the Role of Internet Based Social Networks. Stud Health Technol Inform. 2016; 221:36-40. View

11.

Teare H, Hogg J, Kaye J, Luqmani R, Rush E, Turner A . The RUDY study: using digital technologies to enable a research partnership. Eur J Hum Genet. 2017; 25(7):816-822. PMC: 5520069. DOI: 10.1038/ejhg.2017.57. View

12.

Javaid M, Forestier-Zhang L, Watts L, Turner A, Ponte C, Teare H . The RUDY study platform - a novel approach to patient driven research in rare musculoskeletal diseases. Orphanet J Rare Dis. 2016; 11(1):150. PMC: 5101709. DOI: 10.1186/s13023-016-0528-6. View

13.

Karlson E, Boutin N, Hoffnagle A, Allen N . Building the Partners HealthCare Biobank at Partners Personalized Medicine: Informed Consent, Return of Research Results, Recruitment Lessons and Operational Considerations. J Pers Med. 2016; 6(1). PMC: 4810381. DOI: 10.3390/jpm6010002. View

14.

Kaye J, Curren L, Anderson N, Edwards K, Fullerton S, Kanellopoulou N . From patients to partners: participant-centric initiatives in biomedical research. Nat Rev Genet. 2012; 13(5):371-6. PMC: 3806497. DOI: 10.1038/nrg3218. View

15.

Chalil Madathil K, Koikkara R, Obeid J, Greenstein J, Sanderson I, Fryar K . An investigation of the efficacy of electronic consenting interfaces of research permissions management system in a hospital setting. Int J Med Inform. 2013; 82(9):854-63. PMC: 3779682. DOI: 10.1016/j.ijmedinf.2013.04.008. View

16.

Bender J, Cyr A, Arbuckle L, Ferris L . Ethics and Privacy Implications of Using the Internet and Social Media to Recruit Participants for Health Research: A Privacy-by-Design Framework for Online Recruitment. J Med Internet Res. 2017; 19(4):e104. PMC: 5399223. DOI: 10.2196/jmir.7029. View

17.

Puhan M, Steinemann N, Kamm C, Muller S, Kuhle J, Kurmann R . A digitally facilitated citizen-science driven approach accelerates participant recruitment and increases study population diversity. Swiss Med Wkly. 2018; 148:w14623. DOI: 10.4414/smw.2018.14623. View

18.

Budin-Ljosne I, Teare H, Kaye J, Beck S, Bentzen H, Caenazzo L . Dynamic Consent: a potential solution to some of the challenges of modern biomedical research. BMC Med Ethics. 2017; 18(1):4. PMC: 5264333. DOI: 10.1186/s12910-016-0162-9. View

19.

Nishimura A, Carey J, Erwin P, Tilburt J, Murad M, McCormick J . Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics. 2013; 14:28. PMC: 3733934. DOI: 10.1186/1472-6939-14-28. View

20.

Ravoire S, Lang M, Perrin E . Advantages and limitations of online communities of patients for research on health products. Therapie. 2017; 72(1):135-143. DOI: 10.1016/j.therap.2016.11.058. View