It is the policy of the Organization that human subjects research (HSR) protocols must employ sound research principles and minimize the risks associated with participation. In determining whether the risks to participants have been minimized, the JHM IRBs must consider physical, psychological, legal, economic, and social risks. To this end, investigators must be aware of the risks associated with study procedures and consider the following issues in designing or agreeing to conduct HSR:
- Whether the 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
- Using the minimal number of procedures to answer the study question
- Enrolling of the minimum number of subjects needed to answer the study question
- Modifying 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
- Whether the risks to subjects are minimized whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes as part of clinical care.
Determinations by a convened IRB with respect to whether the risks to participants are minimized will be documented in the IRB’s meeting minutes. Determinations by an expedited reviewer for research reviewed under an expedited process will be documented in the reviewer form.