MEDICAL RESEARCH

Medical Research on Human Beings

Medical Research on Human Being

Medical Research Involving Human Beings

In recent years, stunning advances in biomedical research have made headline news. Such research allows scientists to determine whether new medications or procedures are effective and safe treatments. Progress in the treatment of diseases such as cancer and AIDS (acquired immune deficiency syndrome) has prompted many people who suffer from those diseases to clamor for a chance to be included in experimental drug trials. Researchers and patients alike have heralded the lightning speed at which medical research seems to be advancing; the Food and Drug Administration (FDA) approved a record 121 new drugs in 1997, an increase from just 69 drugs approved in 1987 (Angell, 1997, 847).

Those same advances, however, have caused ethicists and policy makers to question whether current experimentation, drug-approval and patient-protection regulations are strong enough for the booming medical research industry. Is it ethical to test medications or treatments on human subjects when their effects and possible dangers are still unknown? Conversely, is it right to withhold promising, and in some cases life-saving, treatments from the general public simply because the required research is not yet complete? Furthermore, do members of minority groups, people who are economically disadvantaged, children and mentally disabled people need special protection from research abuses? Should health insurers pay for experimental treatments that have not been proven effective? Are there any circumstances under which it is appropriate to enroll patients in research without their permission?

Although ethicists and lawmakers have long struggled with such questions, leading experts say the recent rise in medical research means that the current mechanisms for reviewing the ethics of medical experiments are overburdened. While experts disagree about how existing safeguards should be changed, most agree that some research abuses can occur under the current system. Research protections for human subjects are typically reviewed by local panels of experts who receive little supervision, guidance or compensation for their work. Although most policy makers contend that the system is generally effective, they admit that several weaknesses and loopholes in current regulations can create opportunities for abuse (Okie, 1997, 3).

However, federal agencies and lawmakers have so far failed to devise a better system. In 1997, Sen. John Glenn (D, Ohio) sponsored a bill that would tighten safety protections for research participants and increase supervision of research by scientific and ethical review boards. But the bill, the Human Research Subjects Protections Act, has languished in Congress. And despite a 1994 order from President Clinton (D) for all federal agencies to comply with tougher rules regulating human research, not a single agency not already compliant with the rules adopted them in the years that followed.

The Development of Research Protections

For centuries, doctors around the world have taken the Hippocratic oath, which requires that physicians act for the good of their patients and cause them no harm. However, medical experimentation is not regulated under international law. The drive to improve medical care has often resulted in abuses of research ...