2022 SNFBA Course Materials

Required

Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 8th Ed. Oxford University Press; 2021:chap. 1.

Gordon JS, Rauprich O, Vollman J, Applying the Four-Principle Approach. Bioethics. 2011; 25:293–300, with a reply by Beauchamp T. Making Principlism Practical: A Commentary on Gordon, Rauprich, and Vollmann. Bioethics. 2011; 25: 301–03.

Suggested

Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 8th Ed. Oxford University Press. 2021:especially chaps. 2, 10.

DeGrazia D, Beauchamp T. Philosophical Methods. in Sulmasy D, Sugarman J. Methods of Bioethics. 2nd Ed. Georgetown University Press. 2010:37-53.

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.

Rauprich O. Common Morality: Comment on Beauchamp and Childress. Theoretical Medicine and Bioethics. 2008; 29:43-71.

Discussion Case Number One

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.

Suggested

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

Beauchamp TL, Faden RR. Meaning and elements of informed consent. Bioethics. 4th edition. New York: Macmillan Reference USA, 2014, pp. 1682-87.

Suggested

Sugarman J, Barker RA, Charo RA. A Professional standard for informed consent for stem cell therapies. JAMA. 2019 Nov 5;322(17):1651-1652. doi: 10.1001/jama.2019.11290. PMID: 31403653.

Lavori P, Wilt T, Sugarman J. Quality assurance questionnaire for professionals fails to improve the quality of informed consent. Clin Trials 2007; 4: 638-649. PMID: 18042573.

Case Discussion #2

Required

• Sheehan M. “Can Broad Consent be Informed Consent?” Public Health Ethics. 2011 Nov;4(3):226-235. doi: 10.1093/phe/phr020. Epub 2011 Aug 3. PMID: 22102849; PMCID: PMC3218673.
• 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.
• Blasimme A, Brall C, Vayena E. “Reporting Genetic Findings to Individual Research Participants: Guidelines From the Swiss Personalized Health Network Front.” Genet., 11 December 2020 | https://doi.org/10.3389/fgene.2020.585820
• 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

Optional

• Leila Jamal, Jill O. Robinson, Kurt D. Christensen, Jennifer Blumenthal-Barby, Melody J. Slashinski, Denise Lautenbach Perry, Jason L. Vassy, Julia Wycliff, Robert C. Green & Amy L. McGuire (2017) “When bins blur: Patient perspectives on categories of results from clinical whole genome sequencing,” AJOB Empirical Bioethics, 8:2, 82-88, DOI: 1080/23294515.2017.1287786

Case: Genetics research and minorities

Readings

• Lipphardt, Veronika, Mihai Surdu, Nils Ellebrecht, Peter Pfaffelhuber, Matthias Wienroth, and Gudrun A. Rappold. “Europe’s Roma people are vulnerable to poor practice in genetics.” (2021): 368-371. 

Optional readings:

• The DNA of Roma People Has Long Been Misused, Scientists Reveal, The New York Times

Questions:

The paper sheds light on ethical and political quandaries around the collection and use of biological samples (and DNA) from ethnic minorities.

A broad array of ethically controversial issues can be highlighted.

1) AIMS:

Collection and analysis on DNA samples is not limited to the study of genetics. The DNA of ethnic minorities can also be used to exert political control on a given minority. For instance, DNA can be used to identify individual members of a minority group in police operation (including customs), for forensic purposes, to track the movement of such groups within a country or across borders, or to attribute membership to that or another social group, or to ascribe/deny citizenship, residence and related rights.

Is  it always possible/feasible to draw a sharp demarcation between the legitimate scientific use of DNA and the use of science for political purposes? Should this demarcation be made publicly visible – and if so, how?

Are there any uses of human DNA for genetics related analysis that are flat-out not compatible with the purposes of science and the notion of scientific integrity?

2) PROCESS:

Consent is a cornerstone of ethically sound scientific research, including genetics. But practices for the collection of informed consent vary greatly depending on institutional settings, and the relationship (including power relationship) between research subjects and researchers.

What challenges exist in the collection of DNA from ethnic minorities? To which extent and in what ways can such challenges undermine the validity of informed consent from minority groups?

Can you think of any specific case in which it could be ethically acceptable to use DNA samples from ethnic minorities for research purposes without consent? If so, what criteria should be followed? What conditions should be in place?

3) LEGACY:

Ethically controversial DNA-based research on ethnic minorities often involves social groups that have historically been dominated, exploited or discriminated by state authorities and/or Western settlers.

How should we take into account the legacy of such historical past in the conduct of scientific research involving the DNA of such minority groups? Can science (scientific practices) play a role in redressing/compensating for such past injustices? In what ways can researchers at least recognize the reality of such historical injustice?

4) CONTROL:

While consent is a key-precondition for ethically sound research, consent alone does not guarantee that research participants can exert meaningful control over the use of their DNA.

What degree of control over the use of DNA should be granted to research participants? What interests and rights are at stake? What risks ensue from insufficient levels of control over the use of DNA on the part of research subjects?

When it comes to DNA research control over the use of samples is not a merely individual matter, as it involves also the control that a given group/community can exert over their DNA as a whole.

How do such consideration apply to individual control vis-à-vis group control?

What additional processes can be in place to ensure ethically meaningful degrees of control over research use of DNA from ethnic minorities?

5) BENEFIT:

DNA research has uncontested scientific value. Who can and should benefit directly from the scientific use of DNA however is not straightforward.

What kinds of benefit can be associated with the research use of DNA? Who is more likely to benefit from it? Are some of these advantages/disadvantages unfair?

Do current scientific practices around human DNA fairly and adequately distribute the benefits of DNA research? Should researchers take care of sharing benefits of scientific research with research participants? If so, how and to which extent?

6) HARM:

The ethics of research pays special attention to the risk of harm for research participants. What scientific uses of DNA from ethnic minorities can lead to harm? What sort of harm can result from ethically dubitable uses of DNA from ethnic minorities? What about individual vs group-related harm? How can such harm be minimized or compensated for?

Scientific reputation can also be harmed in the case of unethical uses of DNA. How does that apply to research with DNA from minorities?

7) IDENTITY:

DNA research targeting specific ethnic groups presupposes a classificatory practices distinguishing one ethnic group from another and defining criteria for membership to a given ethnic group. Such classificatory practices are however contested: they often rely on scientifically dubious categories (e.g. race); they embody prejudices; they can result from histories of domination and discrimination. Even in the case of self-attributed membership (i.e. people who define themselves as “x”), such historical patterns can have a strong impact of ethnic identification. This is why many commentators say that scientific research can have reifying effects, that is, it can make socially imposed categories/classifications appear real – it can confirm such systems of classification as valid or objective, whereas they are the result of intentional efforts to keep certain people/groups separated from others.

How should scientists consider their role in relation to this issue?

What safeguards could/should be in place to minimize the risk that genetic research perpetuates unjust systems of social classifications?

8) INCLUSION:

Genetic research databases do not represent different social groups equally. As a matter of fact DNA from members of minority and indigenous groups is difficult to access and analyze for research purposes. This tendency reflects sedimented patterns of social exclusion and discrimination. Targeting minority and indigenous population for DNA studies is a prima facie legitimate strategy to redress such unbalance.

However, as the presented case shows, DNA collection practices from such groups can be problematic.

What specific vulnerabilities should be taken into account in the collection of DNA from minority/indigenous groups?

How could we balance the need to have DNA from minority/indigenous groups accessible for scientific research with the need to protect the members of such groups from risks such as stigmatization and discrimination?

How should cultural specificities be taken into account?

Do disadvantaged socio-economic conditions pose additional ethical demands onto researchers who want to study the DNA of minority/indigenous groups?

Required

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

Optional

Ethics and Public Health Research – discussion case (pdf)

Vayena Reading

Doroshow JH, Prindiville S, McCaskill-Stevens W, Mooney M, Loehrer PJ. COVID-19, Social Justice, and Clinical Cancer Research. J Natl Cancer Inst. 2021 Oct 1;113(10):1281-1284. doi: 10.1093/jnci/djaa162. PMID: 33057660; PMCID: PMC7665692.

Blasimme Readings (optional)

Timimi, S. and Taylor, E., 2004. ADHD is best understood as a cultural construct. The British Journal of Psychiatry, 184(1), pp.8-9.

van Os, J. and Kohne, A.C., 2021. It is not enough to sing its praises: The very foundations of precision psychiatry may be scientifically unsound and require examination. Psychological Medicine, 51(9), pp.1415-1417.

Kahn Readings (optional)

Jamrozik E, Littler K, Bull S, et al. Key criteria for the ethical acceptability of COVID-19 human challenge studies: report of a WHO Working Group. Vaccine 2021;39:633-640.

Eyal N, Lipsitch M, Smith PG. Human challenge studies to accelerate coronavirus vaccine licensure. J Infect Dis 2020;221:1752-1756.

Kahn JP, Henry LM, Mastroianni AC, Chen WH, Macklin R. Opinion: For now, it’s unethical to use human challenge studies for SARS-CoV-2 vaccine development. Proc Natl Acad Sci U S A. 2020 Nov 17;117(46):28538-28542.

Sugarman reading (optional)

Lovell-Badge R, Anthony E, Barker RA, Bubela T, Brivanlou AH, Carpenter M, Charo RA, Clark A, Clayton E, Cong Y, Daley GQ, Fu J, Fujita M, Greenfield A, Goldman SA, Hill L, Hyun I, Isasi R, Kahn J, Kato K, Kim JS, Kimmelman J, Knoblich JA, Mathews D, Montserrat N, Mosher J, Munsie M, Nakauchi H, Naldini L, Naughton G, Niakan K, Ogbogu U, Pedersen R, Rivron N, Rooke H, Rossant J, Round J, Saitou M, Sipp D, Steffann J, Sugarman J, Surani A, Takahashi J, Tang F, Turner L, Zettler PJ, Zhai X. ISSCR guidelines for stem cell research and clinical translation: The 2021 update. Stem Cell Reports 2021. doi: 10.1016/j.stemcr.2021.05.012.