Who Should and Who Should Not be a Research Subject in a Clinical Trial

It is important to stress that a Research Subject is a volunteer. Volunteers in a clinical trial are often attracted to those trials because of some special interest in a disease or simply a desire to help advance medical knowledge. These are acceptable motives. However, if any circumstance forces an individual to participate in a clinical trial that he or she would not have willingly considered, then that individual is not truly a volunteer. For example, offering large sums of money might entice some persons to take risks they would otherwise not consider. Also, if misleading statements imply that an experimental drug, whose real value is unknown, holds great promise to cure a volunteer's illness then that person would not be a true volunteer. Therefore, at least two conditions must be met before a person becomes a Research Subject. First, the potential volunteer must be honest about the reasons that he or she wishes to be a participant. Second, the Principal Investigator must be honest and complete about the information given to potential volunteers. This interaction between the PI and the potential Research Subject, known as the informed consent process, includes exploring motivation, sharing information, providing education, and making a full disclosure.

However, even when all conditions appear right, the PI may reject some potential volunteers for specific reasons. When a research study is designed, it is necessary to control all factors that might affect the results. For that reason, the PI must include in the design of the research, the inclusion/exclusion criteria that will explain who should and who should not be included. These criteria may refer to age, gender, weight, race, existing diseases, allergy to medications, illness, and many others. However, the general rules for clinical research make clear that every effort is made to include representatives of groups that might benefit i.e. both men and women, all races and ethnic groups and all socio-economic levels. Even pregnant women can be included unless there is a specific reason not to do so. However, an interested volunteer might be refused the opportunity because of a specific inclusion or exclusion criterion.