April 18, 1997

Ethics debate centers on informed consent

Ethics debate centers on informed consent

Rules and regulations governing informed consent for research are designed to serve as a sort of protective blanket, covering and safeguarding the rights and well being of patients.

Both within Vanderbilt University Medical Center, in the form of the medical center's Institutional Review Board, and externally through federal regulations regarding informed consent, the protection of patients' rights is a complex issue in the often complicated world of medical science and research.

This relationship was at the heart of last week's Ethics Spring Grand Rounds, titled "Informed Consent for Research: Who Needs It? From Nuremberg to Now." The program was sponsored by VUMC's Ethics Committee, and drew a large and diverse crowd to Light Hall to hear presentations on informed consent. The event, moderated by Dr. Frank H. Boehm, professor of Obstetrics and Gynecology and director of Maternal/Fetal Medicine, also included a lengthy question and answer period.

George J. Flynn, an investigator with the U.S. Food and Drug Administration, presented a detailed history of informed consent and the rights of research subjects.

"There has been a long historical concern for the rights of research subjects. Some say it goes all the way back to the Hippocratic Oath, but the real concept of informed consent truly began in the 20th Century," Flynn said.

The mid-20th Century to be exact. Modern guidelines governing informed consent for research were born out of the Nuremburg trials following World War II. There, Nazi war criminals were tried for, among other things, unspeakable acts of human cruelty disguised as scientific research experiments.

During the next 50 years, rules and regulations regarding informed consent for research subjects went through numerous changes and revisions to respond to incidents such as the Tuskeegee syphilis study, where 300 African-American men, without their knowledge or consent, were infected with syphilis, then tracked for 30 years.

"It's a constantly evolving process," the FDA's Flynn said. "It's not a narrow concept. Like due process under the law, informed consent for research subjects is intended to cover everyone."

New federal regulations recently handed down expand informed consent to include ‹ in certain narrowly defined cases ‹ the use of experimental drugs or devices without the informed consent of the patient involved, said Virginia Wiley, R.N., director of VUMC's Institutional Review Board.

"The goal, with all informed consent procedures, is to ensure that patients have adequate knowledge and understanding of the relevant information to assure that the rights and welfare of research subjects are protected," Wiley said.

"We strive to minimize intended or unintended undue influence by researchers on potential research subjects."

According to Wiley, the following information must be conveyed to potential research subjects in instances warranting informed consent for research:

€ A description of the study, including its projected duration;

€ A description of procedures to be used;

€ A description of potential risks and benefits to the patient;

€ A description of alternative procedure that could be used;

€ A statement regarding confidentiality;

€ A description of compensation or treatment if injury occurs;

€ Information about who to contact for more information;

€ The fact that participation is voluntary.

Also participating in the Spring Grand Rounds were Dr. Gordon R. Bernard, professor of Medicine; Dr. Stephen P. Raffanti, associate professor of Medicine; and Dr. Barbara A. Murphy, assistant professor of Medicine.