...compromised. Justice demands the basic rights of all human subjects, especially the disadvantaged, be carefully protected and that researchers not involve these volunteers' only because of administrative convenience. Clinical and community- based investigators must assure that human subjects re always fully informed about the true nature and intent of study protocols.

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The 1979 Belmont Report clearly articulates the desired outcome of informed consent. Research Subjects (volunteers), regardless of background, should be provided information, understand the information, and based on their comprehension of the information, make a voluntary decision to participate in a research study. However, there is still little evidence about how well informed consent works to assure researchers that participants fully comprehend the "what and why" of the research activities for which they have volunteered.

Psychological research on biases and heuristics identifies cognitive biases in information processing (choices and interpretation of risks and benefits) that have implications for improving the informing process. A growing literature on patient decision aids provides evidence for the feasibility of more effectively informing volunteers, and includes examples of "de-biasing" procedures to improve information comprehension and consent. Informing and consenting involve conceptually different challenges when comparing effectiveness versus values. Both include social and individual values and require techniques that de-bias the process as needed. Over the years, many public health education methods and strategies have been tested and used to determine effectiveness in informing volunteers for community-based research. Many researchers are of the opinion that appealing to an individuals' sense of compassion and altruism may increase research participation among the underserved, and does not necessarily violate the voluntary nature of informed consent. (NIH, 1993; Holmes-Rovner, 2002; Tobias and Souhami R.L., 1993; Sharp and Strauss et al., 1992; NCPHSBBR, 1979).

In many cases, the goals, objectives and methodologies included in a research protocol can be hard to explain, thus making comprehension for some individuals difficult at best. In many cases, individuals from many disadvantaged population groups who volunteer for research projects may feel incompetent to make independent decisions. In some cases, they will "opt out" choosing not to be fully informed of the project, abnegating their civil rights and allowing investigators to make choices for them. This is especially true in the case of "proxy consent" (NCPHSBBR, 1979).

Many times research volunteers give their full trust and confidence to the investigator or research staff member, trusting solely in their skills and competencies. Such freedom of trust can be especially likely when members of the research team are of the same cultural group as the volunteer. Some investigators espouse that efforts should not be made at all to inform disadvantaged volunteers about the research in order to avoid stress and confusion on the part of the volunteer. To the contrary, however, most individuals, regardless of socio-economic status, seek more information, not less, about what is happening to them regardless of risk level. (Nuremberg Code, 1949; Levine, 1986; Kim, 2002).

Low literacy levels can also play a major role in how volunteers are able to comprehend information presented to them by researchers. Although the average reading level of adults in the United States is between the eighth and ninth grades, most health care instructions are written at or above the ninth-grade reading level (Doak and Doak et al., 1996). Several researchers have found that the reading levels of educational materials and the intended readers' literacy levels seldom match (Estey and Musseau et. al., 1994; Overland and Hoskins, et. al., 1993).

JUSTICE AND INFORMED CONSENT

Justice is relevant to the selection, informing and consenting of subjects for research at two critical levels: the Individual and the Social. Individual Justice requires that researcher's exhibit fairness; thus, they should not offer information or potentially beneficial research only to those individuals who are in their favor, nor should they select only disparate and vulnerable persons for risky research (NCPHSBBR, 1979).

Social Justice requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on the potential volunteer. Therefore, it can be considered a matter of social justice that there is an order of preference in the selection of classes of subjects, and that some classes of potential subjects may be involved as research subjects, based on certain criteria. (NIH, 1993).

Social Injustices, however, arise from social, racial, educational, economic, sexual and cultural biases institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and although individual institutions or investigators may not be able to resolve a problem that is pervasive in their social setting, they...

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