MANAGEMENT MISC EVALUATING RISKS AND BENEFITS QUIZ

1. When reviewing a protocol RECs should consider: • whether risks of harm have been minimized • the magnitude of the potential harm as well as the risk it will occur • whether the potential benefits of the research outweigh the potential risks • whether the population bearing the risk of research is also likely to benefit from any knowledge gained in the research • all of the above 2. Risk/benefit assessments should take into account how research will affect communities and health systems as well as individual research participants. • True • False 3. When research is conducted with participants who are not competent to give informed consent: (select all that apply) • if the research is not expected to directly benefit participants then risks should be minimal (such as those no greater that would normally be posed by routine medical or psychological examination of such persons) Your correct answer • if the research poses more than minimal risk, there must be a justification for why the research is being conducted in this population • a significant amount of risk may be acceptable, even in research that is not expected to directly benefit participants, if the expected benefits to society in terms of generalizable knowledge are sufficient • if the research is expected to directly benefit the participants, a minor increase above minimal risk may be considered acceptable by RECs