Involuntary Consent: Conditioning Access to Health Care on Participation in Clinical Trials
Posted: 21 May 2016 Last revised: 28 Jun 2017
Date Written: May 19, 2016
Although the controversy over the lack of consent in fetal-tissue clinical trials is relatively new, history is replete with instances of medical researchers who have conducted clinical trials with minorities and the economically disadvantaged without their consent. Traditionally, American bioethics has served as a safety net for the rich and powerful (for they are not forced to act as research subjects to obtain access to health care for themselves or their children) while failing to protect the vulnerable, which includes minorities and the economically disadvantaged. Without access to health care, minorities and the economically disadvantaged are unduly influenced to participate in clinical trials that promise access to health care.
The “respect for persons” principle requires that “individuals be treated as autonomous agents” by obtaining their informed consent before they participate in clinical trials. In order for the consent to be valid, it must be free of undue influence, which includes inducements such as promises of access to health care. Promises of access to health care invalidate the voluntariness of consent because it leaves potential research subjects without choice, especially when the very institutions that are denying minorities and the economically disadvantaged access to health care are conducting the clinical trial. Without any meaningful choice to access health care other than participation in clinical trials, minorities and the economically disadvantaged are induced into consenting.
In this paper, I discuss how race and class biases are central to the bioethical debate about informed consent, why these biases prevent access to health care, and thus, must be addressed to ensure that research subjects are not being unduly influenced into participating in clinical trials to attain access to health care. To measure whether consent is voluntary, federal agencies such as the U.S. Department of Health and Human Services (HHS) should require researchers to use the Vulnerability and Equity Impact Assessment tool, which I have created based on the Health Equity Impact Assessment tool, to determine whether minorities and the economically disadvantaged are being unduly influenced into participating in clinical trials in violation of the “respect for persons” principle.
Keywords: informed consent, access to health care, bioethics, racial bias, class bias, Affordable Care Act
JEL Classification: K32, K40
Suggested Citation: Suggested Citation