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Preventing Group Harms in Genomic Research

Title

Speaker Name

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Agenda

• Welcome (Yann)
• Definitions, ethical arguments, and potential routes to promote consideration (Anna)
• Lack of institutional ethical oversight (Vaso)
• A shared responsibility (Yann)
• Brainstorm (All - led by Yann)
• Aligning on logistics (All - led by Yann)
• Wrap up

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What are group harms?

• Nature Publishing Group: Harms to “humans who do not participate directly in the research”

Research must do no harm: new guidance addresses all studies relating to people. Nature 606, 434 (2022)

Science must respect the dignity and rights of all humans. Nature Human Behavior 6, 1029–1031 (2022)

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What are group harms?

• The British Sociology Association: Harms to interested parties (except direct participants) who are affected by the work

British Sociological Association. Statement of Ethical Practice https://www.britsoc.co.uk/media/24310/bsa_statement_of_ethical_practice.pdf (2017).

• Fleischman et al. : “Unintended but foreseeable harms to the community from which the participants are drawn, broader populations, and society in general”

Fleischman, A., Levine, C., Eckenwiler, L., Grady, C., Hammerschmidt, D. E., & Sugarman, J. (2011). Dealing with the long-term social implications of research. The American Journal of Bioethics, 11(5), 5-9.

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What are group harms?

• Joan McGregor: “Harm for third parties or groups”

McGregor, Joan. "Racial, ethnic, and tribal classifications in biomedical research with biological and group harm." The American Journal of Bioethics 10.9 (2010): 23-24.

• Tangible harm: Stereotyping or stigmatizing – loss of social, economic, or political opportunities or even loss of face in the society
• Dignity harm: “Perceived value or worth” of a group are undermined. Members, their cultural beliefs, and traditions are treated as inferior, disparaged, or not taken seriously.

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Ethical reasoning to support consideration of these harms

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How could consideration of group harms be promoted?

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How could consideration of group harms be promoted?

Funders

Research Ethics Committees

Data custodians

Publishers

Communities impacted by research

Professional societies

Educators

Restrict funding to projects at risk of group harms or prioritize funding for projects with lower risks

Could insist on aspects of study design, e.g. consent docs

Limit who can access the data and for what uses

See e.g. Nature publishing group, urging “authors, reviewers and editors to respect the dignity and rights of groups of people”

Community consent, though it can be impractical. Other mechanisms?

Can define standards of practice, see British Sociological Association and American Sociological Association

Educational efforts targeted at scientists to help researchers identify and consider group

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How could consideration of group harms be promoted?

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In US Context, The Common Rule (45 C.F.R.) says IRBs should not consider the “long-range effects of applying knowledge gained in the research” (46.111).

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Integration into consent documents

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Integration into consent documents

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How could consideration of group harms be promoted?

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Institutional governance and oversight

Image credit: JISC

Points of ethics oversight on the research data lifecycle

IRB

DAC

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Challenges of existing oversight models

IRB

DAC

Timing

Too upstream of data collection to oversee ethical data re/use

Too downstream of data collection to oversee ethical data procurement and contextualize permissions

Effectiveness

Scope

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Challenges of existing oversight models

IRB

DAC

Timing

Too upstream of data collection to oversee ethical data re/use

Too downstream of data collection to oversee ethical data procurement and contextualize permissions

Scope

Prohibited from considering potential societal harms/benefits

Atypical to review ethical issues as a condition of data access

Effectiveness

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Challenges of existing oversight models

IRB

DAC

Timing

Too upstream of data collection to oversee ethical data re/use

Too downstream of data collection to oversee ethical data procurement and contextualize permissions

Scope

Prohibited from considering potential societal harms/benefits

Atypical to review ethical issues as a condition of data access

Effectiveness

Lack of membership expertise in data privacy, security & IT

Organized principally as a compliance body, not an ethics oversight body

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The ‘ping pong’ effect

Deferral to DAC on issues of data re/use, storage and management

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The ‘ping pong’ effect

Deferral to IRB on issues of ethical data collection, consent, and study purpose

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Gaps in oversight

Group harms

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Coherence between consent permissions and unique data access requests

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Accountability for data misuse

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Tracking of when and where genomic data end up

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Questions for further discussion

• What have we missed in this discussion on group harms? What questions remain and what effective approaches have we not considered for addressing group harm?
• Who should be accountable for following up on demonstrated instances of group harm?
• Should this responsibility be subsumed under existing ethics oversight bodies, or a new layer of oversight should be introduced

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