2023 SNFBA Course Materials

Required

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. DHEW Publication OS 78–0012. 1978; reissued in the Federal Register, 1979.

Mastroianni A and Kahn J. “Swinging on the Pendulum: Shifting Views of Justice in Human Subjects Research.” The Hastings Center Report 31, no. 3 (2001): 21–28. https://doi.org/10.2307/3527551.

Optional

Sherwin S. “Belmont Revisited through a Feminist Lens,” in James F. Childress, Eric M. Meslin, and Harold T. Shapiro, eds. Belmont Revisited: Ethical Principles for Research with Human Subjects, Washington, DC: Georgetown University Press, 2005.

Kahn JP, Mastroianni AC, Sugarman J, eds. Beyond Consent: Seeking Justice in Research, New York: Oxford University Press, 2018.

Case Discussion #1

Required

Sugarman J. “Ethics in the design and conduct of clinical trials.” Epidemiol Rev. 2002; 24(1):54-8. doi: 10.1093/epirev/24.1.54. PMID: 12119856.

Optional

Califf RM, Sugarman J. “Exploring the ethical and regulatory issues in pragmatic clinical trials.” Clin Trials 2015; 12: 436-441. doi: 10.1177/1740774515598334. PMID: 26374676.

Emanuel EJ, Wendler D, Grady C. “What makes clinical research ethical?” JAMA. 2000 May 24-31; 283(20):2701-11. doi: 10.1001/jama.283.20.2701. PMID: 10819955.

Required

Andorno, R. “Regulatory discrepancies between the Council of Europe and the EU regarding biomedical research”. Human Rights and Biomedicine. Antwerpen: Maklu, 2010; (André den Exter), pp. 117-133.

F.K. Dankar et al., “Informed Consent in Biomedical Research“, Computational and Structural Biotechnology Journal 17 (2019) 463–474.

Council of Europe, “Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research.”

Council of Europe, “Explanatory Report to the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research.”

Optional

Gytis A, Sprumont D. “The Importance of National Laws in the Implementation of European Legislation of Biomedical Research,” European Journal of Health Law, 2005, Volume 12: Issue 3 pp. 245–267.

Case Discussion #2

Required

Kass NE. “An Ethics Framework for Public Health.” Am J Public Health. 2001; 91:1776-1782.

Childress J, Faden R, Gaare R, Gostin L, Kahn J, Bonnie R, Kass N, Mastroianni A, Moreno J, Nieburg P. “Public Health Ethics: Mapping the Terrain.” Journal of Law, Medicine, and Ethics 2002; 30(2): pp. 170-178.

Taylor, HA. “Framing Public Health Research Ethics.” Oxford Handbook of Public Health Ethics, 2019.

Henri SC, Goren A, Chabris CF, Meyer MN. “Effect of Targeted Behavioral Science Messages on COVID-19 Vaccination Registration Among Employees of a Large Health System.” JAMA Network Open. 2021;4(7):e2118702. doi:10.1001/jamanetworkopen.2021.18702.

Required

Emanuel EJ, Wendler D, Killen J, Grady C. “What makes clinical research in developing countries ethical? The benchmarks of ethical research.” The Journal of Infectious Diseases. 2004 Mar 1;189(5):930-7.

Ijsselmuiden CB, Kass NE, Sewankambo KN, Lavery JV. “Evolving values in ethics and global health research.” Global Public Health. 2010 Mar 1;5(2):154-63. 

Parker M, Kingori P. “Good and bad research collaborations: researchers’ views on science and ethics in global health research.” PloS one. 2016 Oct 13;11(10):e0163579.

Optional

Tackett S, Jenn Ng C, Sugarman J, Daniel EG, Gopalan N, Tivyashinee, Kamarulzaman A, Ali J. “A Competency Framework for Health Research Ethics Educational Programs: Results from a Stakeholder‐Driven Mixed‐Method Process.” Ethics & Human Research. 2023 May;45(3):29-39.

Case Discussion #3

Required

Lyerly AD, Little MO, Faden R. “The second wave: Toward responsible inclusion of pregnant women in research.” Int J Fem Approaches Bioeth. 2008 Fall;1(2):5-22. doi: 10.1353/ijf.0.0047. PMID: 19774226; PMCID: PMC2747530.

Saenz C, Cheah PY, van der Graaf R, Henry LM, Mastroianni AC. “Ethics, regulation, and beyond: the landscape of research with pregnant women.” Reproductive Health. 2017 Dec;14(3):9-14.

Optional

Mastroianni AC, Henry LM, Robinson D, Bailey T, Faden RR, Little MO, Lyerly AD. “Research with Pregnant Women: New Insights on Legal Decision-Making.” Hastings Cent Rep. 2017 May;47(3):38-45. doi: 10.1002/hast.706. PMID: 28543423; PMCID: PMC5533594.

Required

Bombard Y, Brothers KB, Fitzgerald-Butt S, et al. “The Responsibility to Recontact Research Participants after Reinterpretation of Genetic and Genomic Research Results.” American Journal of Human Genetics. 2019 Apr;104(4):578-595. DOI: 10.1016/j.ajhg.2019.02.025. PMID: 30951675; PMCID: PMC6451731.

Gainotti S, Turner C, Woods S, et al. “Improving the informed consent process in international collaborative rare disease research: effective consent for effective research.” Eur J Hum Genet 24, 1248–1254 (2016). https://doi.org/10.1038/ejhg.2016.2

Vears DF, Hallowell N, Bentzen HB, Ellul B, Nøst TH, Kerasidou A, Kerr SM, Th Mayrhofer M, Mežinska S, Ormondroyd E, Solberg B, Sand BW, Budin-Ljøsne I. “A practical checklist for return of results from genomic research in the European context.” Eur J Hum Genet. 2023 Mar 22. doi: 10.1038/s41431-023-01328-6. Epub ahead of print. PMID: 36949262.

Optional

Atutornu J, Milne R, Costa A, Patch C, Middleton A. “Towards equitable and trustworthy genomics research.” EBioMedicine. 2022 Feb;76:103879. doi: 10.1016/j.ebiom.2022.103879.

Juengst ET, Van Rie A. “Transparency, trust, and community welfare: towards a precision public health ethics framework for the genomics era“. Genome Med. 2020;12(1):98. Published 2020 Nov 20. doi:10.1186/s13073-020-00800-y.

Vogel G. “Privacy concerns sparked by human DNA accidentally collected in studies of other species.” Science 15 May 2023 doi: 10.1126/science.adi7378.

Case Discussion #4

Required

Martinez-Martin N, Insel TR, Dagum P, Greely HT, and Cho MK. “Data mining for health: staking out the ethical territory of digital phenotyping.” NPJ digital medicine, 2018; 1(1), pp.1-5

Nuffield Council on Bioethics. “The collection, linking and use of data in biomedical research and health care: ethical issues.” London: The Nuffield Council on Bioethics, 2015. Executive summary.

Vayena E, Blasimme A, and Sugarman J. “Decentralised clinical trials: ethical opportunities and challenges.” The Lancet Digital Health. 2023.

Vayena E, Blasimme A, Cohen IG. “Machine learning in medicine: addressing ethical challenges.” PLoS medicine. 2018; 15(11): e1002689.

Van Dis EA, Bollen J, Zuidema W, van Rooij R, and Bockting CL. “ChatGPT: five priorities for research.” Nature, 2023; 614(7947), pp.224-226.

Optional

Vayena E, Haeusermann T, Adjekum A, and Blasimme A. “Digital health: meeting the ethical and policy challenges.” Swiss Medical Weekly. 2018. 148, p.w14571.

Blasimme A, Vayena E. “The ethics of AI in biomedical research, patient care and public health.” Patient Care and Public Health. Oxford Handbook of Ethics of Artificial Intelligence. Oxford University Press. 2019; Ch. 37.

Nuffield Council on Bioethics. “The collection, linking and use of data in biomedical research and health care: ethical issues.” London: The Nuffield Council on Bioethics, 2015.

Gostin LO, Cohen IG, Shaw J. “Digital Health Passes in the Age of COVID-19: Are “Vaccine Passports” Lawful and Ethical?” JAMA. 2021; 325(19), pp.1933–1934. doi:10.1001/jama.2021.5283

Aicardi C, Del Savio L, Dove ES, Lucivero F, Tempini N, and Prainsack B. “Emerging ethical issues regarding digital health data. On the world medical association draft declaration on ethical considerations regarding health databases and biobanks.” Croatian Medical Journal, 2016; 57(2), p.207.

Amann J, Blasimme A, Vayena E, Frey D, Madai VI. “Explainability for artificial intelligence in healthcare: a multidisciplinary perspective.” BMC Medical Informatics and Decision Making. 2020; 20, p.310.

Novelli C, Casolari F, Rotolo A, Taddeo M, and Floridi L. “Taking AI Risks Seriously: A Proposal for the AI Act,” SSRN. 2023. Available at SSRN: https://ssrn.com/abstract=4447964 or http://dx.doi.org/10.2139/ssrn.4447964

[paper written by ChatGPT!] King MR. “The future of AI in medicine: a perspective from a Chatbot.” Annals of Biomedical Engineering. 2023; 51(2), pp.291-295.

[podcast] “Can ChatGPT Support Biomedical Research?” https://www.feinberg.northwestern.edu/research/podcast/2023/chatgpt-gao-luo.html

Required

Vayena E, Blasimme A*, Sugarman J. “Decentralised clinical trials: ethical opportunities and challenges.” Lancet Digital Health. 2023; 5: e390–94. https://doi.org/10.1016/ S2589-7500(23)00052-3.

Case Discussion #5