A History of Informed Consent
Madeleine M. Jester, RN, JD

Abstract

In today's medical environment, a health practitioner or clinical trial sponsor would (or at least should) never consider performing a surgical or diagnostic procedure on a patient, or putting that individual in a clinical trial, without first obtaining informed consent. This is not only important from a risk management perspective, but is basic to the proper practice of medicine.

What follows is an overview of some of the milestones that have been reached in the still developing field of medical ethics and consent. Looking at how the concept of obtaining consent has developed over the years provides a rationale for current practice that in most cases requires investigators to obtain consent from clinical trial participants. As new therapies are discovered and are the subject of research, issues unique to future testing methodologies will emerge and need to be addressed. Risk managers must keep in mind that there is no place within an ethical management scheme for research that is done or contemplated without considering how best to protect the interests of the research subject.

Early History

The concept of consent to treatment is a relatively new phenomenon. In ancient times during the Greek, Roman and Egyptian civilizations, there was no such thing as patient informed consent to medical treatment.¹ Since those days, however, as social trends changed and mankind as a whole became more focused on human rights, the concept of consent became the subject of case law both within and outside of the United States. In eighteenth century England, for example, a man brought a lawsuit against two doctors who were treating his fractured leg. Instead of continuing to monitor the healing process, which was proceeding without incident, they chose to re-break his leg and put it into an experimental device designed to straighten and lengthen the leg. The treatment was unsuccessful and the patient sued the physicians for malpractice; not just for using an investigational device, but for doing so without his consent.²

In the United States the concept of informed consent was not the subject of much legal action prior to the twentieth century. ³ However, that changed in the early twentieth century because of a landmark case tried before Justice Benjamin Cardozo.⁴ In this case, a woman had consented to an abdominal examination under anesthesia, but had not consented to any operation. In spite of this, the doctor removed a tumor and the patient sued. Justice Cardozo's opinion expressed what has become one of the most basic elements in the whole concept of informed consent development, that an individual has the right of bodily self-determination.⁵

Twentieth Century Developments

Notwithstanding the expression of this most important principle in the early years of this century, abuses of patients' rights, especially of human subjects involved in research, continued to occur. The most infamous transgressions were the experiments performed by Nazi doctors in Germany on concentration camp prisoners during the second world war. These prisoners were subjected to the most horrendous tortures in the name of medical experimentation, including poisoning and immersion in both freezing and boiling water.⁶

Even in the United States, a number of violations of research ethics occurred within this century. Beginning during World War II and continuing into the Cold-War era, U.S. physicians injected hospital patients with radioactive substances to learn the effects on the body. In another case, the Tuskegee Institute conducted a 40-year study on black men with syphilis during which treatment was withheld. ^7,8,9

Some Guidelines Emerge

Over the years a number of guidelines have been developed that have addressed the ethical issues presented by these events. During the 1947 trial of the doctors who performed the experiments in Germany, the Neuremberg Code came into being. This document, developed by the presiding judges at that trial, contained ten basic principles regarding safeguard of the fundamental dignity of subjects involved in research. These principles included the concepts that voluntary consent to participate in research by a legally competent individual is essential, that the research itself should be conducted by competent investigators with skill and care, and that the benefits to the participant should be commensurate with the risks.¹⁰

The tenets of this code have formed the basis for a number of other human rights philosophies developed over the years, among which is the well-known Declaration of Helsinki put forth by the World Medical Association in 1964. This document focuses on the obligations of investigators to research subjects.¹¹ Some companies doing global research require that studies conducted outside of the United States conform to the principles of the Declaration of Helsinki.

The rights of research subjects have been the subject of a number of initiatives within the United States as well. In the wake of the 1962 thalidomide disaster, a Consumer Bill of Rights was proclaimed by President John F. Kennedy. This rights declaration included the right to safety, the right to be informed, the right to choose and the right to be heard.¹²

In 1974, the National Research Act was passed and the Department of Health, Education and Welfare promulgated regulations for the protection of human subjects. The act also established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research,¹³ and in1979 the Commission issued The Belmont Report. This report summarized the basic principles underlying the ethical issues surrounding the conduct of human subject research. The report consisted of an introductory discussion of the boundaries between medical practice and research. It also reiterated the basic ethical principles of respect for persons, beneficence or efforts to secure well-being, and justice or fairness in terms of not restricting the availability of new treatments. It then discussed the application of these principles in the areas of informed consent, assessment of risks and benefits, and selection of research subjects.¹⁴

Current Regulations for Human Subject Protection

In July, 1981 the regulations governing the requirements for informed consent of human subjects became effective. These regulations instruct researchers on the general requirements for informed consent, as well as the basic elements that consent forms must contain. ¹⁵ These consent documents, along with the research plans and protocols from which they are derived, are reviewed by committees called Institutional Review Boards . These boards , established in the communities where the research will take place, are charged with the obligation to protect human subjects involved in biomedical research.

Over the years, much has been done to secure protection for participants in clinical research. However, as new therapies are discovered and are the subject of research, issues unique to future testing methodologies will emerge and need to be addressed. Risk managers must keep in mind that there is no place within an ethical management scheme for research that is done or contemplated without considering how best to protect the interests of the research subject.

See also The Basic Requirements of Informed Consent, Some Exceptions to Informed Consent, A Case Study on Informed Consent

References

1. Abstract: Kour; NW, Rauff, A, Informed Patient Consent - Historical Perspective and a Clinician's View, Singapore Medical Journal, 1992 Feb; 33(1), Medline (R)Advanced

2. Curran, W.; Hall, M; Kaye, D, Health Care Law, Forensic Science, and Public Policy, citing Slater v. Baker and Stapleton, 95 Eng. Rep. 860 (K.B. 1767); Fourth Edition,1990 p 256

3. Christianson, W; Sherman, M., The History of Patient Consent in the United States, Regulatory Affairs, 2, 400 (1990)

4. Supra 2, citing Schoendorff v. Society of New York Hospital, 106 N.E. 93 (N.Y. 1914); p 304

5. Supra 3, p 400

6. Supra 3, p 402

7. Letter Report to the Ranking Minority Member, Committee on Governmental Affairs, U.S. Senate, Scientific Research: Continued Vigilance Critical to Protecting Human Subjects, 3/8/96, GAO/HEHS-96-72, p 2

8. Abstract: Kaufman,SR, The World War II Plutonium Experiments: Contested Stories and Their Lessons for Medical Research and Informed Consent, Cult. Medicine and Psychiatry, 1997 Jun; 21(2), Medline (R )Advanced

9. Abstract: Dowd, S.B.; Wilson, B., Informed Patient Consent: A Historical Perspective, Radiologic Technology, 1995 Nov-Dec; 67 (2), Medline (R) Advanced

10. Shuster, E., Fifty Years Later: The Significance of the Neuremberg Code, The New England Journal of Medicine, 337(20), p 1436

11. Id., p 1440

12. FDA Backgrounder, Milestones in U.S. Food and Drug Law History, FDA web site, http://www.fda.gov, 1997

13. Supra 7, p 2

14. The Belmont Report, Ethical Principles and Guidelines for the Protection of Human Subjects of Research, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Department of Health, Education and Welfare, April 18, 1979

15. Code of Federal Regulations at 21 CFR part 50