The IRB cannot approve any research with human subjects in which the risks remaining after measures taken to reduce or eliminate them outweigh the benefits which can reasonably be expected. This means that risks inherent to the research can often be addressed and reduced to achieve the positive and desirable balance.
Risk reduction is accomplished by several means, one of which is providing complete, succinct, and accessible information to the subjects about the research. When the risk of participation is limited to persons with certain kinds of predispositions, infirmities, medical conditions etc., informing these potential or participating subjects of their special risk due to their potentiality for risk generally causes them to remove themselves (and the risk) from the research. This is the only way information reduces risk.
In making its analyses, the IRB looks to the researcher for evidence that the researcher understands the relationship between information and risk.
| Back | Next |
