Clinical Trials & Ethics

A clinical trial is a biomedical or health-related research study that uses human subjects. The purpose of clinical trials is to investigate new treatments, medicines, medical devices or behavioral therapies. Clinical trials can be either observational or intervention-based. Ethics play a crucial role in clinical trials in protecting the rights and well-being of research participants, and clear ethical and legal codes exist to regulate the conduct of medical research.

Background

• Historically, biomedical research has made substantial contributions to society. However, studies using human subjects have not always been conducted in an ethical manner. The Nuremberg Code of 1949 was the first piece of legislation governing how doctors and scientists could experiment on humans. It was drafted in response to the medical crimes committed against concentration camp prisoners in World War II. The ethical violations in the Tuskegee Syphilis Experiment conducted by the government in the southern United States subsequently prompted the creation of the Belmont Report. This document was published in 1979 by the Department of Health and Human Services under the title of "Ethical Principles and Guidelines for the Protection of Human Subjects of Research." The Belmont Report is the standard for ethics in clinical trials, and its provisions are legally required of all clinical trials in the United States.

Key Ethical Principles

• Protocol for clinical trials upholds three basic ethical principles in human subject research. Respect for persons says that individuals should be treated as autonomous agents with the ability to decide what happens to their bodies. For populations that are not capable of making autonomous decisions, such as young children, mentally handicapped individuals and those who are comatose, protections need to be in place to uphold their rights. The principle of beneficence obliges doctors and researchers to do no harm, and to maximize possible benefits while minimizing risks. The principle of justice pertains to who benefits from or bears the burden of medical research, and how gains and resources are distributed.

Upholding Ethics

• Clinical trials uphold ethical principles by following the guidelines and restrictions of an institutional review board, or IRB. An IRB oversees the research protocol and checks to make sure that the study commits no violations of ethical standards. The process of informed consent is the central ethical assurance in clinical trials, and provides research participants with clear information on the purpose of the research study and its risks and benefits. Informed consent takes place for the duration of the study, and participants can withdraw at any time.

International Ethics

• Although clinical trials in the United States are obliged to maintain strict ethical standards, research undertaken in international settings does not always follow the same regulations. In an article published in the "British Medical Journal" in 2000, researchers describe the ethical problems of conducting clinical trials in countries where there is a lower standard of care and fewer resources in place to protect the rights of patients. They additionally call attention to the problem of experimenting on populations who will not necessarily receive direct benefits from the findings.