Bioethics Blogs

NRC Report: Assess Risk Empirically

One theme running throughout the NRC report is the need to replace the worthless gut reactions decried by Ezekiel Emanuel with a system that would base its judgments on the latest empirical evidence. But the report does not present a clear set of reforms that would effect this change without scrapping the current system of local IRB review.

Inexpert, Subjective Judgments

The NRC report notes the problem of subjective assessment of protocols:

To avoid subjectivity and enhance continuity within and across institutions, IRBs could draw on established scientific and professional knowledge in their determination of the probability and magnitude of research harms in daily life and in routine medical, psychological, or educational examinations, tests, or procedures of the general population. However, care is needed to avoid confusing evidence-based probability estimates with the subjective possibility that harms and discomforts of high magnitude are likely to be produced by the research. For example, IRBs could consider adopting procedures that appropriately balance the probability and magnitude of research harms, in order to avoid subjectively judging research as having a greater than minimal risk in cases where there is a very small probability that the research may produce harm of high magnitude or where there is a high probability that research may produce harms or discomfort of small magnitude.

Research Needed: To build a stronger evidence base, research is needed for identifying the probability and magnitude of harms and discomfort in daily life and the nature of age- indexed, routine medical, psychological, or educational examinations, tests, or procedures of the general population.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.