The Concept of Vulnerability in Mental Health Research: A Mixed Methods Study on Researcher Perspectives

Abstract

The concept of vulnerability plays a central role in research ethics in signaling that certain research participants warrant more careful consideration because their risk of harm is heightened due to their participation in research. Despite scholarly debates, the descriptive and normative meanings ascribed to the concept have remained disengaged from the perspective of users of the concept and those concerned by its use. In this study, we report a survey- and interview-based investigation of mental health researcher perspectives on vulnerability. We found that autonomy-based understandings of vulnerability were predominant but that other understandings coexisted, reflecting considerable pluralism. A wide range of challenges were associated with this concept, and further training was recommended by researchers.

Keywords

vulnerability bioethics mental health pragmatism feminism researchers survey interviews

Get full access to this article

View all access options for this article.

References

American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). American Psychiatric Publishing.

Bell

Racine

Chiasson

Dufourcq-Brana

M. B.

Dunn

Fins

J. J.

Mathews

D. J. H.

(2014). Beyond consent in research: Revisiting vulnerability in deep brain stimulation for psychiatric disorders. Cambridge Quarterly of Healthcare Ethics, 23(3), 361–368.

Bracken-Roche

Bell

Macdonald

M. E.

Racine

(2017). The concept of “vulnerability” in research ethics: An in-depth analysis of policies and guidelines. Health Research Policy and Systems, 15(1), 8. https://doi.org/10.1186/s12961-016-0164-6

Bracken-Roche

Bell

Racine

(2016). The “vulnerability” of psychiatric research participants: Why this research ethics concept needs to be revisited. The Canadian Journal of Psychiatry, 61(6), 335–339.

Dillman

D. A.

(2007). Mail and internet surveys: The tailored design method (2nd ed.). John Wiley.

Emmanuel

E. J.

Wendler

Grady

(2000). What makes clinical research ethical? The Journal of the American Medical Association, 283(20), 2701–2710.

Fiester

A. M.

(2015). Weaponizing principles: Clinical ethics consultations & the plight of the morally vulnerable. Bioethics, 29(5), 309–315. https://doi.org/10.1111/bioe.12115

Forsyth

Lessler

J. T.

(1991). Cognitive laboratory methods: A taxonomy. In Biemer

R. G. P.

Lyberg

Mathiowetz

Sudman

(Ed.), Measurement errors in surveys. John Wiley.

Hurst

S. A.

(2008). Vulnerability in research and health care; describing the elephant in the room? Bioethics, 22(4), 191–202. https://doi.org/10.1111/j.1467-8519.2008.00631.x

10.

Kipnis

(2001). Vulnerability in research subjects: A bioethical taxonomy. Ethical and Policy Issues in Research Involving Human Participants, 2, 209–221.

11.

Kipnis

(2003). Seven vulnerabilities in the pediatric research subject. Theoretical Medicine, 24(2), 107–120.

12.

Levine

Faden

Grady

Hammerschmidt

Eckenwiler

Sugarman

(2004). The limitations of “vulnerability” as a protection for human research participants. The American Journal of Bioethics, 4(3), 44–49.

13.

Luna

(2009). Elucidating the concept of vulnerability. Inter-national Journal of Feminist Approaches to Bioethics, 2(1), 121–139.

14.

Luna

(2018). Identifying and evaluating layers of vulnerability: A way forward. Developing World Bioethics, 19(2), 86–95.

15.

Mackenzie

Rogers

Dodds

(2013). The importance of relational autonomy and capabilities for an ethics of vulnerability. Oxford Scholarship Online. https://www.oxfordscholarship.com/view/10.1093/acprof:oso/9780199316649.001.0001/acprof-9780199316649-chapter-2

16.

Mackenzie

Stoljar

(2000). Relational autonomy: Feminist perspective on autonomy, agency, and the social self. Oxford University Press.

17.

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

18.

Nickel

P. J.

(2006). Vulnerable populations in research: The case of the seriously ill. Theoretical Medicine and Bioethics, 27(3), 245–264. https://doi.org/10.1007/s11017-006-9000-2

19.

The Power of Health Research. (2017). www.cihr-irsc.gc.ca/e/50476.html

20.

Racine

Bracken-Roche

(2019). Enriching the concept of vulnerability in research ethics: An integrative and functional account, Bioethics, 33(1), 19–34. https://doi.org/10.1111/bioe.12471

21.

Racine

Cascio

M. A.

Bogossian

(2017). Instrumentalist analyses of the functions of health ethics concepts and principles: Methodological guideposts. American Journal of Bioethics, 17(12), 16–18.

22.

Racine

Cascio

M. A.

Montreuil

Bogossian

(2019). Instrumentalist analyses of the functions of ethics concept-principles: a proposal for synergetic empirical and conceptual enrichment. Theoretical Medicine and Bioethics, 40(4), 253–278.

23.

Schroeder

Gefenas

(2009). Vulnerability: Too vague and too broad? Cambridge Quarterly of Healthcare Ethics, 18(2), 113–121.

24.

Sengupta

Strauss

R. P.

Eron

Gifford

A. L.

(2010). How researchers define vulnerable populations in HIV/AIDS clinical trials. AIDS Behavior, 14(6), 1313–1319. https://doi.org/10.1007/s10461-010-9785-x