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Module 5 - Home

CONSENT AND RESEARCH

Modular Learning Outcomes

Upon successful completion of this module, the student will be able to satisfy the following outcomes:

· Case

· Examine the ethical implications of "consent."

· SLP

· Select a national healthcare agency and discuss the ethical standards that apply to experimentation and research.

· Discussion

· Discuss whether healthcare personnel should be involved in assisted suicide from an ethical perspective.

Module Overview

Human Experimentation

The Nuremberg Code of 1946 was the first publicly written international document providing a code of ethics relating to research on human subjects. The Code represented an absolute commitment to the doctrine of informed consent. "The voluntary consent of the human subject is absolutely essential." Also, the duty and responsibility for ascertaining the quality of consent rests "upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity." Trials of War Criminals before the Nuremberg Military Tribunal under Control Council Law No. 10 (Vol. 2) (Washington, D.C.,: U.S. Government Printing Office, 1949).

While the Nuremberg Code focused on the responsibility of the individual engaging in research activities, the United States Federal Government has placed responsibility on institutions as well as the individual. By 1970, the first federal guidelines designed to protect human research subjects were issued by what is now the Department of Health and Human Services. Federal regulations now require that all research projects funded by the DHHS be reviewed by local institutional review boards (IRB). The IRB is said to be the central mechanism through which the regulatory goal of protecting the rights and welfare of subjects of research is carried out.

Informed Consent

Medical procedures and experimentation required the expressed written consent of patients and participants. Consent sometimes called informed consent involves obtaining permission to proceed with procedures or experimentation after the patient/participant was informed of the risks, procedures, benefits, and safeguards that are in place to protect the best interest of the patient/participant.

The matter of consent can raise legal and ethical challenges if the patient/participant is mentally handicapped or otherwise incapacitated. Those lacking the cognitive faculties to understand the information may rely upon caretakers.

End-of-life

End-of-life decisions can be difficult for family members of those incapacitated and not expected to recover. When does life end? Who should decide when life should end? Should medical professionals rely on the subjective opinions of family members in making the decision?

Codes of Ethics

National organizations that serve individuals working in the human services or health-related fields offer codes of ethics for their members. The codes of ethics typically build on common virtues that promote the best interests of clients and patients. The virtues can be reduced to “Do no harm.” The codes cover the scope of practice and include guidelines for consent and for end-of-life decisions. The codes of ethics can be obtained on organizational websites.

Click for a PowerPoint presentation on federal regulations regarding  consent forms .

Module 5 - Background

CONSENT AND RESEARCH

Required Reading

Atac, A., et al. (2005). A Study of the Opinions and Behaviors of Physicians with Regard to Informed Consent and Refusing Treatment. Military Medicine, 170(7), 566-71.

Brudney, D. (2009, Mar./Apr.). Choosing for another: beyond autonomy and best interests. The Hastings Center Report. 39(2), 31-38.

Dickman, R. L. (2000, March). Bending the rules to get a medication. American Family Physician 61 (5), 1563.  http://www.aafp.org/afp/2000/0301/p1563.html

Erlen, J. A. (2010). Informed consent: Revisiting the issues. Orthopaedic Nursing, 29(4), 276-80. Retrieved from

Lambert, V., & Glacken, M. (2011). Engaging with children in research: Theoretical and practical implications of negotiating informed consent/assent. Nursing Ethics, 18(6), 781-801. doi: http://dx.doi.org/10.1177/0969733011401122

Miller, F. G., & Wertheimer, A. (2011). The fair transaction model of informed consent: An alternative to autonomous authorization. Kennedy Institute of Ethics Journal, 21(3), 201-18. Retrieved from Waller, B. N., & Repko, R. A. (2008). Informed consent: Good medicine, dangerous side effects.Cambridge Quarterly of Healthcare Ethics, 17(1), 66-74.

Websites

GAO Highlights (2005). Un-compensated Care. Retrieved from http://www.gao.gov/new.items/d05743t.pdf .