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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.
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