Vulnerable Subjects: Why Does Informed Consent Matter?

11 Pages Posted: 28 Apr 2017

See all articles by Michele Goodwin

Michele Goodwin

University of California, Irvine School of Law

Date Written: September 2016


Most literature captures human experiments as either acceptable or unacceptable; good or bad; ethical or non-ethical. However, might there be finer degrees to distinguish medical experimentation from either being permissible or utterly unethical? Does informed consent convey different meanings depending on who invokes the term and the status of the human research subjects? When do researchers really know that consent is informed? Is a signature enough? This Essay unpacks important questions and concerns, including considering what human research subjects are entitled to know before, during, and after agreeing to participate in clinical trials. These matters gain further urgency in the wake of controversies involving the use of fetal tissue in human research. What can policymakers, lawyers, researchers, and doctors learn from the past to inform ethical research and medical practices in the wake of demands for fetal tissue research and the historic exploitation of vulnerable populations, including racial minorities, children, and the elderly in medical research?

This Essay makes three contributions. First, it offers a historical analysis and descriptive account of medical experiments conducted on individuals without informed consent of the human research subjects.

Second, through the case studies highlighted, it illuminates how race, class, and status continue to impact decision-making with regard to unethical research. That is, the status of the research subject too often plays a role or influences whether the patient will be treated with dignity, respected, and able to give informed consent. Too frequently if a human research subject is a child, ethnic minority, or poor, she is more likely to be violated in a research study. As the case studies demonstrated, often vulnerable subjects are denied clear medical information and unable to grant informed consent. Third, this Essay queries the role of law and ethics to bring about change.

Suggested Citation

Goodwin, Michele, Vulnerable Subjects: Why Does Informed Consent Matter? (September 2016). Journal of Law, Medicine and Ethics, Vol. 44, Fall 2016; UC Irvine School of Law Research Paper No. 2017-21. Available at SSRN:

Michele Goodwin (Contact Author)

University of California, Irvine School of Law ( email )

401 E. Peltason Dr.
Ste. 1000
Irvine, CA 92697-1000
United States

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