Clinical Trials & Dangers

A clinical trial is a medical or health-related study that uses human participants as research subjects. Clinical trials investigate a range of research subjects, including experimental treatments, drugs and medical devices, and behavioral therapies. Clinical trials are regulated by legal and ethical standards that minimize possible harms to research participants; however, there are some dangers entailed in certain types of clinical research.

Background

• Although medical research makes important contributions to society, historically clinical trials have not always been conducted in an ethical manner. However, to regulate potential dangers in clinical trials, governments and institutions have created legal standards for protecting research subjects. The Nuremberg Code of 1949 proposes ethical standards for medical and scientific experiments. The document was drafted in response to the medical crimes committed against concentration camp prisoners during the World War II. In 1979, the U.S. Department of Health and Human Services adopted the recommendations of the Belmont Report, which established clear rules for protecting the rights and well-being of participants in clinical trials. All clinical trials in the U.S. are legally and ethically obliged to uphold the Belmont Report standards to minimize possible dangers.

Protection from Dangers

• Clinical trials adhere to three basic ethical principles to protect research subjects. The principle of respect for persons maintains that research subjects are autonomous individuals with the right to make decisions about what happens in their lives and to their own bodies. For populations with limited autonomy, such as children and those who are comatose, protections should be in place to uphold their rights. The principle of beneficence obliges medical researchers to do no harm, while also maximizing benefits to participants. The principle of justice pertains to who benefits from and who bears the burden of medical research, and guides investigators to make sure that the populations in which experiments are conducted also gain from the outcomes of research.

Possible Dangers

• Although clinical trials uphold standards for protecting research participants, dangers do exist. As clinical trials often investigate the merits of experimental therapies, there are no guarantees that the treatments offered will be effective for all patients. Additionally, some clinical trials pose risks for discomfort or even life-threatening conditions.

Unregulated Dangers

• In the U.S. clinical trials follow strict protocols for protecting human subjects; medical research conducted in foreign settings, especially developing countries, do not necessarily uphold the same standards. For instance, certain countries do not have the same standards of care as the U.S., and thus research participants have fewer resources to protect their health and rights. Additionally, critics point out that international clinical trials often violate the principle of justice by conducting experiments on foreign populations who then do not receive the benefits of the research findings. As the National Bioethics Advisory Commission explains in its 2001 report, this unequal distribution of benefits poses dangers to experimental populations, because they undertake medical risks in the absence of being able to access future benefits and without appropriate follow-up care.