45 CFR

Question 1

45 CFR 46.409

Answer 1

When research involves greater than minimal risk with no direct benefit to subjects, the research must either be related to the children’s status as words or be conducted in the setting where the majority of children are not involved in words

Question 2

45 CFR 46.116(a)

Answer 2

IRB determines that the requirements for obtaining informed consent may be waived.

• research involves no more than minimal risk
• waiver or alteration will not adverse effect subjects
• subjects will be provided additional info as appropriate

Question 3

45 CFR 46.406

Answer 3

For children: the intervention or procedure is likely to yield generalizable knowledge for the understanding or treatment of the subjects disorder or conditions

Question 4

45 CFR 46.407

Answer 4

For children: research that is not otherwise approvable but presents opportunity to understand, prevent or alleviate a serious problem affecting the health or welfare of children
-also be done with sound ethics

Question 5

45 CFR 46.405

Answer 5

For children: the relationship of risk to benefit is at least favorable as any available alternative approach

Question 6

45 CFR 46.404

Answer 6

For children: research not involving greater than minimal risk

Question 7

45 CFR 46 sub part D

Answer 7

Required assent and permission are obtained in accordance for children who are pregnant.
-describes regulations to protect children participating in clinical research

Question 8

45 CFR sub part B

Answer 8

Describes regulations for participation of pregnant women or fetuses in trials

Question 9

45 CFR 46 sub part A

Answer 9

Required informed consent provisions