A statement about the frequency and severity of a possible harm. The risk of causing a serious rash is 1 in 100.
The SR/NSR decision is based on a risk evaluation. But which risks? All of the risks in the study? All of the risks of the device? All of the risks of the device as it is to be used in the context of the particular study?
First it is important to identify the risks.
Next it is important to identify the source of the risks.
Then it is important to decide which risks must be evaluated.
Finally, it is important to evaluate those risks.
A simple grid can help. Using the FDA’s example from the September 1998 Guidance on SR/NSR Decisions, a slightly altered pacemaker (B) is to be used in a patient who requires a pacemaker and who would usually have received pacemaker A. The Pacemaker B study includes some additional monitoring procedures during added visits. The risks of pacemaker A are substantial; the difference between A and B is miniscule.
Where you put the possible harms and which possible harms are to be included in the NSR decision is a matter of IRB policy. The decision is much easier if the possibilities are clear.
|Last Updated ( Friday, 07 April 2017 09:36 )|