<< Previous Section | < Previous Page | Next Page > | Next Section >> Selection of Subject Populations Selection of the appropriate participant population plays a critical role in the experimental design. They must be selected and dealt with on the basis of the three principles of Human Research, Autonomy, Beneficence and Justice. Autonomy Autonomy is understood to mean that becoming a research subject is a totally voluntary act. Individuals must be solicited without coercion or even implied coercion. Individuals must be fully informed and understand what they are signing up for. IRBs require that the prospective participants understand a long list of things before they can sign a consent document. If the study requires a vulnerable population to be studied, (children, cognitively impaired) then a surrogate who, presumably, has their best interests at heart (parent for child, relative for the patient with Alzheimer's disease) must sign for the participant. Individuals under the age of 18 are given special protections; so many studies pertain to adults only. The rule of autonomy requires that individuals are able to provide informed consent. Those who can't are afforded increased protections. When possible therefore, consenting adults are used. Age, degree of severity of the condition, life expectancy, ability to reach the study location and other factors may be included. Carrying out research on special populations It is essential to be able to conduct research on people who for one reason or another are vulnerable. This includes children who react differently to drugs than adults and for whom much too little research is carried out. This is due both to restrictive laws that limit the risks of research on children, parental fears for their children's well being and the need for written assent on the part of children over the age of 10 in addition to parental consent. The Pediatric Community needs to come together to decide what procedures carry minimal risk for children. Participation of patients with serious emotional or mental problems in research related to their conditions is essential to bringing about therapeutic improvement. Tests have been developed to help determine whether an individual with such a problem is capable of providing informed consent. Beneficence Beneficence means that the intention of the research is for good. Beneficence is demonstrated in the risk-benefit analysis carried out by the PI and by the IRB. Of course many studies offer no personal benefit to the participants, and for these, great care must be taken that the risks are minimized. Justice Justice relates to access to research of all relevant populations specifically including age, ethnicity, gender and preexisting conditions. The federal government has made it clear that studies should try to include ethnic groups and women in proportion to the population in the community unless there is a good scientific reason not to (for example studying hypertension in African Americans). Issues that must be considered in justice determinations include: Socioeconomic Status Gender Race Age Existing medical conditions Vulnerable populations (as noted above) Determining ability to consent Ensuring understanding of protocol Appropriate surrogate for consent Coercive nature of relationship (prisoners) The need to use such populations must be justified << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 3 Quick Links Ethics and Study Design Introductory Ethics Design Appropriate Risk to Benefit Ratio Selection of Subject Populations Cases Bibliography Chapter 3 Download (PDF)