Greater than Minimal Risk With Direct Benefits:

If a project offers the child subject greater than minimal risk but also offers the prospect that the intervention or procedure will hold a direct benefit for the subject, CRP may approve it if it meets three conditions:

a. the risk must be justified by the anticipated benefits to the subject;

b. the relationship of the anticipated benefit to the risk is at least as favorable as that presented by available alternative approaches; and 

c. the project makes adequate provision to solicit the child’s assent and permission of parents or guardians.

Examples of research that fall into this category might include experimental behavioral treatment programs for autistic or other special children and experimental medical treatments for a childhood disease or condition.  The key idea in this category is that the intervention or procedure must provide a reasonable prospect for direct benefit to the child, not merely incidental benefit from having participated in a research activity. 




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