Hostname: page-component-8448b6f56d-sxzjt Total loading time: 0 Render date: 2024-04-16T11:02:49.909Z Has data issue: false hasContentIssue false

Incidental Findings from Deep Phenotyping Research in Psychiatry: Legal and Ethical Considerations

Published online by Cambridge University Press:  18 November 2022

Amanda Kim
Affiliation:
Department of Psychiatry, Brigham and Women’s Hospital, Boston, Massachusetts 02115, USA
Michael Hsu
Affiliation:
Department of Psychiatry, Brigham and Women’s Hospital, Boston, Massachusetts 02115, USA
Amanda Koire
Affiliation:
Department of Psychiatry, Brigham and Women’s Hospital, Boston, Massachusetts 02115, USA
Matthew L. Baum*
Affiliation:
Department of Psychiatry, Brigham and Women’s Hospital, Boston, Massachusetts 02115, USA
*
*Corresponding author. Email: mbaum@bwh.harvard.edu

Abstract

Substantial advancement in the diagnosis and treatment of psychiatric disorders may come from assembling diverse data streams from clinical notes, neuroimaging, genetics, and real-time digital footprints from smartphones and wearable devices. This is called “deep phenotyping” and often involves machine learning. We argue that incidental findings arising in deep phenotyping research have certain special, morally and legally salient features: They are specific, actionable, numerous, and probabilistic. We consider ethical and legal implications of these features and propose a practical ethics strategy for managing them.

Type
Research Article
Copyright
© The Author(s), 2022. Published by Cambridge University Press

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Footnotes

A.K. and M.L.B. contributed equally to this work.

This article is adapted from a blog piece (Kim A, Hsu M, Koire A, Baum ML. Incidental findings in deep phenotyping research: Legal and ethical considerations. Bill of Health, the Blog of Petrie-Flom Center at Harvard Law School, as Part of the Ethical, Legal, and Social Implications of Deep Phenotyping Symposium; 2021 Feb 10; available at https://blog.petrieflom.law.harvard.edu/2021/02/10/incidental-findings-deep-phenotyping/ [last accessed 1 Mar 2022]).

References

Notes

1. Baker J, Rauch S. Robust predictors of mania and psychosis U1 grant. NIH Grantome; 2018; available at https://grantome.com/grant/NIH/U01-MH116925-01 (last accessed 1 Mar 2022).

2. MindStrong Press Release. Mindstrong announces $100M funding round. Mind Strong Website; 2020 May 21; available at https://mindstrong.com/press-releases/mindstrong-announces-100m-funding-round/ (last accessed 1 Mar 2022).

3. President’s Commission on Bioethical Issues. Anticipate and communicate: Ethical management of incidental and secondary findings in the clinical, research, and direct-to-consumer contexts. Report of the Presidents Commission on Bioethical Issues; 2013 Dec.

4. Green, R, Berg, J, Grody, W, Kalia, S, Korf, B, Martin, C, et al. ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genetics in Medicine 2013;15:565–74CrossRefGoogle ScholarPubMed.

5. Illes, J, Desmond, JE, Huang, LF, Raffin, TA, Atlas, SW. Ethical and practical considerations in managing incidental findings in functional magnetic resonance imaging. Brain and Cognition 2002;50(3):358–65CrossRefGoogle ScholarPubMed.

6. Guttmacher Institute. Substance use during pregnancy. Guttmacher Institute; 2022 Feb 1; available at https://www.guttmacher.org/state-policy/explore/substance-use-during-pregnancy (last accessed 1 Mar 2022).

7. McGuire, AL, Knoppers, BM, Zawati, MH, Clayton, EW. Can I be sued for that? Liability risk and the disclosure of clinically significant genetic research findings. Genome Research 2014;24(5):719–23CrossRefGoogle ScholarPubMed.

8. Koplin, JJ, Turner, MR, Savulescu, J. The duty to look for incidental findings in imaging research. Ethics & Human Research 2020;42:212 CrossRefGoogle Scholar.

9. Hallowell, N, Parker, M, Nellåker, C. Big data phenotyping in rare diseases: Some ethical issues. Genetics in Medicine 2019;21:272–4CrossRefGoogle ScholarPubMed.

10. Grady, C, Eckstein, L, Berkman, B, Brock, D, Cook-Deegan, R, Fullerton, SM, et al. Broad consent for research with biological samples: Workshop conclusions. American Journal of Bioethics 2015;15(9):3442 CrossRefGoogle ScholarPubMed.

11. See note 4, Greenberg et al. 2013, at 565–74.

12. Pike, ER, Rothenberg, KH, Berkman, BE. Finding fault? Exploring legal duties to return incidental findings in genomic research. Georgetown Law Journal 2014;102:795843 Google ScholarPubMed.

13. See note 12, Pike et al. 2014, at 795–843.