Certainly the most difficult single element for researchers is to envision and state is the full range of risk that reasonably attends participation in their research. Researchers are caught by the need to have enough subjects to provide a statistically significant study, on the one hand, and by the need to make a full and honest disclosure of the research risks, on the other hand. No responsible IRB is going to permit an error on the side of disclosing risk.
There are three basic kinds of risk:
Obviously, in the first two types of risk, the desire for confidentiality or anonymity will have no effect on the potential for risk. This does not mean that confidentiality is of no concern. The outcomes of research are hypothesized, but not actually known in advance. Because of this, it is necessary to achieve and maintain as complete as possible confidentiality of processes and records for all three categories of risk.
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