Evaluating the Ability to Consent to Research: A Twenty-Year Track Record

Mikaela Matera-Vatnick; Katherine W Todman; Paul G Wakim; Haley K Sullivan; Carol Squires; Julie Brintnall-Karabelas; Samuel N Doernberg; Marion Danis

doi:10.1002/eahr.500119

Evaluating the Ability to Consent to Research: A Twenty-Year Track Record

Ethics Hum Res. 2022 Mar;44(2):2-17. doi: 10.1002/eahr.500119.

Authors

Mikaela Matera-Vatnick¹, Katherine W Todman², Paul G Wakim³, Haley K Sullivan⁴, Carol Squires⁵, Julie Brintnall-Karabelas⁶, Samuel N Doernberg⁷, Marion Danis⁸

Affiliations

¹ Postbaccalaureate fellow at the National Cancer Institute.
² Clinical social worker at the National Institute of Mental Health (NIMH).
³ Chief of the biostatistics and clinical epidemiology service at the National Institutes of Health Clinical Center (NIH CC).
⁴ PhD student in health policy at Harvard University and was a fellow in the Department of Bioethics at the NIH CC at the time of participating in this research.
⁵ Licensed certified social worker at the NIMH.
⁶ Licensed clinical social worker at the NIMH.
⁷ Fourth-year medical student at Harvard Medical School and was a fellow in the Department of Bioethics at the NIH CC at the time of participating in this research.
⁸ Chief of the Bioethics Consultation Service at the NIH CC.

Abstract

Occasionally, the ability of prospective research participants to consent may be uncertain. Yet standardized capacity-assessment tools may not suffice to determine the ability to consent to a particular research protocol. This study consisted of a retrospective review of the outcomes of an alternative approach used by the Ability to Consent Assessment Team at the National Institutes of Health. Of 944 individuals evaluated over 20 years (1999-2019), 70.1% were determined to have capacity to consent to participate in research. Of those who lacked capacity to consent and were subsequently evaluated for their ability to assign a surrogate, 86.0% had the ability to do so. The findings demonstrate that establishing a task-specific approach for assessing the capacity of potential participants to consent to a variety of research protocols can facilitate safe and ethically justifiable inclusion of individuals whose ability to consent is initially uncertain.

Keywords: decision-making capacity; human subjects research; informed consent; neurocognitive disorders; surrogate decision-making.

MeSH terms

Decision Making*
Humans
Informed Consent*
Prospective Studies
Retrospective Studies

Abstract

MeSH terms

Grants and funding