IU Mini Medical School
Bioethics: Science With Conscience In Human Research

INDIANAPOLIS - Human participation in biomedical research is vital in helping scientists understand and ultimately treat disease, but much more needs to be done to ensure participants fully understand the risks and their rights.

Regulations governing human participation in federally funded research exist, but they do not apply to all research studies conducted in the United States. Less than 20 of the nearly 80 federal agencies and departments follow a single set of regulations called the "Common Rule." Institutions that are not federally funded do not have to follow these rules.

"We have a set of regulations but we do not have a federal system that guarantees the best possible protection for humans, and that should be the foremost concern in research," said Eric M. Meslin, Ph.D., director of the Indiana University Center for Bioethics, speaking to those gathered for the first of a six-week series of Mini Medical School presentations at the IU School of Medicine.

The assistant dean for bioethics and a professor of medicine and philosophy has an up-front perspective on the effectiveness of human research regulations before coming to the IU Center for Bioethics, he was executive director of the National Bioethics Advisory Commission. The commission, established in 1995 but recently disbanded, probed ethical issues related to the human participation in research and made recommendations to the president and the government on issues ranging from federal funding of embryonic stem-cell research to research conducted in developing countries.

Dr. Meslin cited controversial examples of past research where patients' safety was seriously jeopardized or were devoid of ethical considerations. Among the better known cases are Nazi experiments on concentration camp prisoners in World War II Germany and revealed in the subsequent Nuremberg trials; Tuskegee Syphilis Study, an observational research project from 1932 to 1972 of 600 African American males who were misled to believe they were being treated, and government ionizing radiation experiments on servicepersons, prisoners and unwitting civilians between 1944 and 1974.

Ethical questions also have surfaced in more recent research such as the 1997 U.S.-funded studies of maternal-fetal transmission of HIV conducted in Africa, a preventive drug trial that drew fire because it used placebos as the control instead of current accepted therapy, and the lack of continuing treatment at the conclusion of the trial.

"Why design a study that shows people can benefit from treatment and yet deny them access to it?" Dr. Meslin asked. "Clearly, this points to what obligations are due to humans once research is complete."

Society often views biomedical research with what Dr. Meslin described as the "therapeutic misconception," the belief that participation in research or a clinical trial is going to directly benefit their health. "While in fact this might occur, research is about gathering facts, weighing the evidence and finding answers."

It's important to note that a distinction exists between research ethics and medical ethics, Dr. Meslin noted. The former primarily is the scientific search for "truth and knowledge." The latter is the moral obligation physicians have to meet the total needs of the people they serve.

Whatever present or future challenges loom before society and science, never before have there been greater opportunities for progress. "Thousands of studies in the United States are conducted ethically and safely each year," Dr. Meslin said. "We live in exciting times in research and people can benefit from what is occurring and what lies ahead."

Mini Medical School is partly funded with an educational grant from Pfizer. IU Medical Group and Indianapolis radio station WIBC sponsor Mini Medical School, which is offered by the Indiana University School of Medicine Faculty Community Relations Committee through the IUPUI Division of Continuing Studies.

Related Sites

IU School of Medicine Mini Medical School
www.medicine.indiana.edu/mini_med/index.html

Indiana University Center for Bioethics
www.bioethics.iu.edu

Clinical Trials at the IU School of Medicine
http://medicine.iupui.edu/ctp

National Institutes of Health
www.clinicaltrials.gov

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Media Contact: Joe Stuteville
Tel: (317)274-7722
Email: jstutevi@iupui.edu

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