What are the ethical guidelines for a human research subject?

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For centuries, man has used his brothers and sisters in research experiments. These experiments ended with varying degrees of success, sometimes finding a solution and sometimes causing more harm than good. It was only in modern times that professionals began following a code of ethics and instituting ethical guidelines to prevent harm to the humans involved in the projects.

Human subject research is often used in medical research. Many times it works by using volunteers that want to be part of the project. These volunteers take part in clinical trials, but aren’t paid for their services. In a small number of cases such as those involving drug trials, the participants may be paid by the drug company. Psychologists also used human subject research to study behaviors and issues relating to an individual’s mind.

Ethical guidelines came about after centuries of testing and experimentation that harmed the participants. For example Edward Jenner used smallpox vaccines on children in his area, by first infecting those kids with the disease. There was also the famous Tuskegee Study where African Americans were infected with syphilis to test vaccines and their reaction to the disease.

Human subject research is now guided by certain ethics outlined in laws and the Nuremberg Code. These codes state that the participant must be informed of the risks prior to the study and that the study must first be done on animals. The researcher must also show that the benefits of the study outweigh any risks and that suffering shouldn’t occur. Only trained medical staff should take part in the study is another part of this Code. These were incorporated into the Declaration of Helsinki in 1964, which also called for an Institutional Review Board to oversee the guidelines.

The United States also has the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. In addition, the US also has specific codes in place regarding the ethical treatment of participants. Title 45 defines the Institutional Review Board and ensures that all guidelines created under the Nuremberg Code are followed. The Department of Defense has their own rules and guidelines in place.

The Human Subject Research page at Wikipedia is one of the best resources for those new to the topic. This encyclopedia type entry covers the basic of human research, a history of the subject, and the guidelines used by professionals.

Different groups list their ethics on their homepages. For the Department of Defense regulations, see their Standards of Conduct Office. The American Psychological Association lists their guidelines at APA Ethics Office.

The Office for Human Research Protections is another excellent resource, as is the Policy Guidance found on that same website. These regulations and forms that must be followed prior to the implementation of the study and the guidelines during the study.

The Human Research Protections page of the APA website lists the acts and state laws that relate to the topic. They also list a copy of the Institutional Review Board’s policies and guidebook. Those who would like to see examples of current studies and trials should look to the Clinical Trials page, which contains all current studies.

A history of some more recent studies that tested the limits of ethics are listed in the Human Experiments Redrawing the Ethical Boundaries article. There’s also the Journal of Empirical Research on Human Research Ethics and the Ethical Standards page of the World Health Organization.