What elements should I consider in my risk and benefit analysis?
An IRB must judge whether the anticipated benefit justifies the risks to the potential research subject. This evaluation is the major ethical judgement in reviewing research applications. In analyzing the risks and benefits of proposed research, the IRBs consider the following questions:
Frequently Asked Question
- What are the risks of participating in this protocol as compared to the risks of standard of therapy or everyday life?
- Are the risks adequately described in the application and protocol?
- Are there risks that might be different for children or other vulnerable populations and are these adequately described?
- If deception is used, is it adequately justified and is the debriefing plan adequate?
- Are risks minimized to the extent possible? Risks may be minimized by appropriate eligibility criteria, measures to make study procedures as comfortable as possible, study-wide monitoring of safety and data integrity, good study design, plans to handle adverse effects, using research personnel who are qualified to perform their duties, and having adequate levels of supervision.
- What will the research subject experience through study participation (number and length of study visits, procedures involved, etc.)?
- Are subjects told about the study in a way they can understand, so the participants can make an informed choice about taking part?
- Are provisions in place to maintain the privacy of the subjects and confidentiality of the data and research records?
- What are the expected benefits?
- Are risks of the research reasonable in relation to the benefits?