Researchers should understand that the process of Informed Consent may be seen as an "institutional function," an activity of the IRB. The person receiving formal documents and representations is likely to believe that these have been approved by the IRB, and in fact, they must have! While they are written as a direct communications between the researcher and the potential or participating subject, informed consent documents actually bear the authority of the IRB under the institutional Assurance.
At the same time, it is important that the potential or participating human subject be aware of the qualifications and expertise of the researcher. In both these areas the personal autonomy of the individual is affected by the researcher. It is assumed by the subject that what he sees of and hears from the researcher is approved process. Since researchers' personalities differ in many ways, the actual interaction between researcher and subject will be subject to many variables. It is the obligation of the researcher to keep these variables within accepted tolerances. Professionalism should pervade the informed consent process.
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