It is the policy of the Organization that human subject research protocols should employ sound research principles and minimize risks associated with participation. In minimizing risks, the IRB should consider physical, psychological, legal, economic and social risks. To this end, it is the Organization’s policy that investigators should be aware of the risks associated with study procedures and consider the following issues:
- Risks to subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk. For example:
- Substituting less risky procedures for riskier procedures when adequate to answer the study question
- Use of the minimal number of procedures to answer the study question
- Enrollment of the minimum number of subjects needed to answer the study question
- Modification of inclusion/exclusion criteria to exclude participants who might be at increased risk if they undergo the research procedures, or include participants who might be at less risk if they undergo the research procedures
- Risks to subjects are minimized whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.