Towards a Design Toolkit of Informed Consent Models Across Fields: A Systematic Review

Science and Engineering Ethics - Tập 28 - Trang 1-19 - 2022
Iris Loosman1, Philip J. Nickel1
1Department of Philosophy and Ethics, School of Innovation Sciences, Eindhoven University of Technology, Eindhoven, The Netherlands

Tóm tắt

In the 60+ years that the modern concept of informed consent has been around, researchers in various fields of practice, especially medical ethics, have developed new models to overcome theoretical and practical problems. While (systematic) literature reviews of such models exist within given fields (e.g., genetic screening), this article breaks ground by analyzing academic literature on consent models across fields. Three electronic research databases (Scopus, Google Scholar, and Web of Science) were searched for publications mentioning informed consent models. The titles, abstracts, and if applicable, full publications were screened and coded. The resulting data on fields, models, and themes were then analyzed. We scanned 300 sources from three databases to find 207 uniquely named consent models, and created a network visualization displaying which models occur primarily in one field, and which models overlap between fields. This analysis identifies trends in the consent debate in different fields, as well as common goals of consent models. The most frequently occurring consent models are identified and defined. The analysis contributes toward a cross-disciplinary “consent design toolkit” and highlights that there are more interrelationships between models and fields than are acknowledged in the literature. Where some models are designed to solve distinctively field-specific issues and are specific to biomedical ethics, some may be adaptable and applicable for other fields including engineering and design.

Tài liệu tham khảo

Alblas, M., Schermer, M., Vergouwe, Y., & Bolt, I. (2019). Autonomy challenges in epigenetic risk-stratified cancer screening: How can patient decision aids support informed consent? Journal of Personalized Medicine, 9(1), 14. https://doi.org/10.3390/jpm9010014 Allen, J., & Mcnamara, B. (2011). Reconsidering the value of consent in biobank research. Bioethics, 25(3), 155–166. https://doi.org/10.1111/j.1467-8519.2009.01749.x Anderson, E. E., Newman, S. B., & Matthews, A. K. (2017). Improving informed consent: Stakeholder views. AJOB Empirical Bioethics, 8(3), 178–188. https://doi.org/10.1080/23294515.2017.1362488 Armstrong, S., Langlois, A., Laparidou, D., Dixon, M., Appleton, J. P., Bath, P. M., Snooks, H., & Siriwardena, A. N. (2017). Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: A systematic review. BMC Medical Research Methodology, 17(1), 142. https://doi.org/10.1186/s12874-017-0423-4 Bunnik, E. M., Janssens, A. C. J. W., & Schermer, M. H. N. (2013). A tiered-layered-staged model for informed consent in personal genome testing. European Journal of Human Genetics. https://doi.org/10.1038/ejhg.2012.237 Bunnik, E. M., Janssens, A. C. J. W., & Schermer, M. H. N. (2014). Informed consent in direct-to-consumer personal genome testing: The outline of a model between specific and generic consent. Bioethics, 28(7), 343–351. https://doi.org/10.1111/bioe.12004 Burns, K. E. A., Magyarody, N. M., Duffett, M., Nisenbaum, R., & Cook, D. J. (2011). Attitudes of the general public toward alternative consent models. American Journal of Critical Care, 20(1), 75–83. https://doi.org/10.4037/ajcc2010645 Cheung, A. S. Y. (2018). Moving beyond consent for citizen science in big data health research. Northwestern Journal of Technology and Intellectual Property, 16(1), 15. https://doi.org/10.2139/ssrn.2943185 Chouinard, I., & Scott, R. E. (2009). Informed consent for videoconsultations in Canada. Journal of Telemedicine and Telecare, 15(4), 171–174. https://doi.org/10.1258/jtt.2008.080905 Coiera, E., & Clarke, R. (2004). e-Consent: The design and implementation of consumer consent mechanisms in an electronic environment. Journal of the American Medical Informatics Association, 11(2), 129–140. https://doi.org/10.1197/jamia.M1480 Coppola, L., Cianflone, A., Grimaldi, A. M., Incoronato, M., Bevilacqua, P., Messina, F., Baselice, S., Soricelli, A., Mirabelli, P., & Salvatore, M. (2019). Biobanking in health care: Evolution and future directions. Journal of Translational Medicine, 17(1), 1–18. https://doi.org/10.1186/s12967-019-1922-3 Custers, B. (2016). Click here to consent forever: Expiry dates for informed consent. Big Data & Society, 3(1), 205395171562493. https://doi.org/10.1177/2053951715624935 da Silva, M. E. M., Coeli, C. M., Ventura, M., Palacios, M., Magnanini, M. M. F., Camargo, T. M. C. R., & Camargo, K. R. (2012). Informed consent for record linkage: A systematic review. Journal of Medical Ethics, 38(10), 639–642. https://doi.org/10.1136/medethics-2011-100208 Delany, C. (2008). Making a difference: Incorporating theories of autonomy into models of informed consent. Journal of Medical Ethics, 34(9), e3. https://doi.org/10.1136/jme.2007.023804 Deutsch, M. B. (2012). Use of the informed consent model in the provision of cross-sex hormone therapy: A survey of the practices of selected clinics. International Journal of Transgenderism, 13(3), 140–146. https://doi.org/10.1080/15532739.2011.675233 Doerr, M., Maguire Truong, A., Bot, B. M., Wilbanks, J., Suver, C., & Mangravite, L. M. (2017). Formative evaluation of participant experience with mobile econsent in the app-mediated Parkinson mPower study: A mixed methods study. JMIR MHealth and UHealth, 5(2), e14. https://doi.org/10.2196/mhealth.6521 Dove, E. S., Joly, Y., & Knoppers, B. M. (2012). Power to the people: A wiki-governance model for biobanks. Genome Biology, 13(5), 158. https://doi.org/10.1186/gb-2012-13-5-158 Duffett, M., Burns, K. E., Kho, M. E., Lauzier, F., Meade, M. O., Arnold, D. M., Adhikari, N. K. J., Lamontagne, F., & Cook, D. J. (2011). Consent in critical care trials: A survey of Canadian research ethics boards and critical care researchers. Journal of Critical Care, 26(5), 533.e11–533.e22. https://doi.org/10.1016/j.jcrc.2010.12.009 Faden, R., & Beauchamp, T. (1986). A history and theory of informed consent. Oxford University Press. Fatema, K., Hadziselimovic, E., Pandit, H., Debruyne, C., Lewis, D., & O’sullivan, D. (2017). Compliance through informed consent: Semantic based consent permission and data management model. In CEUR workshop proceedings, 1951. Gefenas, E., Dranseika, V., Serepkaite, J., Cekanauskaite, A., Caenazzo, L., Gordijn, B., Pegoraro, R., & Yuko, E. (2012). Turning residual human biological materials into research collections: Playing with consent. Journal of Medical Ethics, 38(6), 351–355. https://doi.org/10.1136/medethics-2011-100113 Gobat, N. H., Gal, M., Francis, N. A., Hood, K., Watkins, A., Turner, J., Moore, R., Webb, S. A. R., Butler, C. C., & Nichol, A. (2015). Key stakeholder perceptions about consent to participate in acute illness research: A rapid, systematic review to inform epi/pandemic research preparedness. Trials, 16(1), 591. https://doi.org/10.1186/s13063-015-1110-6 Grady, C. (2015). Enduring and emerging challenges of informed consent. New England Journal of Medicine, 372(9), 855–862. https://doi.org/10.1056/nejmra1411250 Grady, C., Cummings, S. R., Rowbotham, M. C., McConnell, M. V., Ashley, E. A., & Kang, G. (2017). Informed consent. New England Journal of Medicine, 376(9), 856–867. https://doi.org/10.1056/NEJMra1603773 Husedzinovic, A., Ose, D., Schickhardt, C., Fröhling, S., & Winkler, E. C. (2015). Stakeholders’ perspectives on biobank-based genomic research: Systematic review of the literature. European Journal of Human Genetics: EJHG, 23(12), 1607–1614. https://doi.org/10.1038/ejhg.2015.27 Iwanowski, P., Budaj, A., Członkowska, A., Wąsek, W., Kozłowska-Boszko, B., Olędzka, U., & Masełbas, W. (2008). Informed consent for clinical trials in acute coronary syndromes and stroke following the European Clinical Trials Directive: Investigators’ experiences and attitudes. Trials, 9(1), 45. https://doi.org/10.1186/1745-6215-9-45 Jurate, S., Zivile, V., & Eugenijus, G. (2014). Mirroring‘ the ethics of biobanking: What analysis of consent documents can tell us? Science and Engineering Ethics, 20(4), 1079–1093. https://doi.org/10.1007/s11948-013-9481-0 Kass, N., Faden, R., Fabi, R. E., Morain, S., Hallez, K., Whicher, D., Tunis, S., Moloney, R., Messner, D., & Pitcavage, J. (2016). Alternative consent models for comparative effectiveness studies: Views of patients from two institutions. AJOB Empirical Bioethics, 7(2), 92–105. https://doi.org/10.1080/23294515.2016.1156188 Kaye, J., Whitley, E. A., Lund, D., Morrison, M., Teare, H., & Melham, K. (2015). Dynamic consent: A patient interface for twenty-first century research networks. European Journal of Human Genetics: EJHG, 23(2), 141–146. https://doi.org/10.1038/ejhg.2014.71 Kelly, S. E., Spector, T. D., Cherkas, L. F., Prainsack, B., & Harris, J. M. (2015). Evaluating the consent preferences of UK research volunteers for genetic and clinical studies. PLoS ONE, 10(3), e0118027. https://doi.org/10.1371/journal.pone.0118027 Kim, S. Y. H., & Miller, F. G. (2014). Informed consent for pragmatic trials—The integrated consent model. New England Journal of Medicine, 370(8), 769–772. https://doi.org/10.1056/NEJMhle1312508 Lidz, C. W., Appelbaum, P. S., & Meisel, A. (1988). Two models of implementing informed consent. Archives of Internal Medicine, 148(6), 1385–1389. https://doi.org/10.1001/archinte.1988.00380060149027 McGuire, A. L., & Beskow, L. M. (2010). Informed consent in genomics and genetic research. Annual Review of Genomics and Human Genetics, 11, 361–381. https://doi.org/10.1146/annurev-genom-082509-141711 McKneally, M. F., & Martin, D. K. (2000). An entrustment model of consent for surgical treatment of life-threatening illness: Perspective of patients requiring esophagectomy. Journal of Thoracic and Cardiovascular Surgery, 120(2), 264–269. https://doi.org/10.1067/mtc.2000.106525 Mikkelsen, R. B., Gjerris, M., Waldemar, G., & Sandøe, P. (2019). Broad consent for biobanks is best—Provided it is also deep. BMC Medical Ethics, 20(1), 71. https://doi.org/10.1186/s12910-019-0414-6 Moher, D., Liberati, A., Tetzlaff, J., & Altman, D. G. (2009). Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. BMJ (Online), 339(7716), 332–336. https://doi.org/10.1136/bmj.b2535 Petriş, A. O., Cimpoeşu, D. C., & Ungureanu, D. (2015). What’s new in ethics of cardio-pulmonary resuscitation research: Too little time and too many rules? Intensive Care Medicine, 41(1), 120–122. https://doi.org/10.1007/s00134-014-3557-4 Ploug, T., & Holm, S. (2013). Informed consent and routinisation. Journal of Medical Ethics, 39(4), 214–218. https://doi.org/10.1136/medethics-2012-101056 Ploug, T., & Holm, S. (2016). Meta consent—A flexible solution to the problem of secondary use of health data. Bioethics, 30(9), 721–732. https://doi.org/10.1111/bioe.12286 Ploug, T., & Holm, S. (2017). Eliciting meta consent for future secondary research use of health data using a smartphone application—A proof of concept study in the Danish population. BMC Medical Ethics, 18(1), 1–8. https://doi.org/10.1186/s12910-017-0209-6 Schermer, B. W., Custers, B., & van der Hof, S. (2014). The crisis of consent: How stronger legal protection may lead to weaker consent in data protection. Ethics and Information Technology, 16(2), 171–182. https://doi.org/10.1007/s10676-014-9343-8 Semprini, A., Hills, T., Braithwaite, I., Weatherall, M., & Beasley, R. (2017). A priori consent within pragmatic randomised controlled trials: A web-based survey of statin use in primary care. BMJ Innovations, 3(4), 206–211. https://doi.org/10.1136/bmjinnov-2017-000193 Sheehan, M. (2011). Can broad consent be informed consent? Public Health Ethics, 4(3), 226–235. https://doi.org/10.1093/phe/phr020 Simon, C. M., L’Heureux, J., Murray, J. C., Winokur, P., Weiner, G., Newbury, E., Shinkunas, L., & Zimmerman, B. (2011). Active choice but not too active: Public perspectives on biobank consent models. Genetics in Medicine, 13(9), 821–831. https://doi.org/10.1097/GIM.0b013e31821d2f88 Spencer, K., Sanders, C., Whitley, E. A., Lund, D., Kaye, J., & Dixon, W. G. (2016). Patient perspectives on sharing anonymized personal health data using a digital system for dynamic consent and research feedback: A qualitative study. Journal of Medical Internet Research, 18(4), e66. https://doi.org/10.2196/jmir.5011 Stein, D. T., & Terry, S. F. (2013). Reforming biobank consent policy: A necessary move away from broad consent toward dynamic consent. Genetic Testing and Molecular Biomarkers, 17(12), 855–856. https://doi.org/10.1089/gtmb.2013.1550 Steinsbekk, K. S., Kare Myskja, B., & Solberg, B. (2013). Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem. European Journal of Human Genetics, 21(9), 897–902. https://doi.org/10.1038/ejhg.2012.282 Teare, H., Prictor, M., & Kaye, J. (2021). Reflections on dynamic consent in biomedical research: The story so far. European Journal of Human Genetics: EJHG, 29(4), 649–656. https://doi.org/10.1038/s41431-020-00771-z Thompson, R., & McNamee, M. J. (2017). Consent, ethics and genetic biobanks: The case of the Athlome project. BMC Genomics, 18(Suppl 8), 830. https://doi.org/10.1186/s12864-017-4189-1 Usher, K. J., & Arthur, D. (1998). Process consent: A model for enhancing informed consent in mental health nursing. Journal of Advanced Nursing, 27(4), 692–697. https://doi.org/10.1046/j.1365-2648.1998.00589.x van der Loos, K. I., Longstaff, H., Virani, A., & Illes, J. (2015). Consent in escrow. Journal of Law and the Biosciences, 2(1), 69–78. https://doi.org/10.1093/jlb/lsu031