[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2007]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR50.52]

[Page 288-289]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION,

DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 50_PROTECTION OF HUMAN SUBJECTS--Table of Contents

Subpart D_Additional Safeguards for Children in Clinical Investigations

Sec. 50.52 Clinical investigations involving greater than minimal risk but

presenting the prospect of direct benefit to individual subjects.

Any clinical investigation within the scope described in Sec. Sec.

50.1 and 56.101 of this chapter in which more than minimal risk to

children is presented by an intervention or procedure that holds

[[Page 289]]

out the prospect of direct benefit for the individual subject, or by a

monitoring procedure that is likely to contribute to the subject's well-

being, may involve children as subjects only if the IRB finds and

documents that:

(a) The risk is justified by the anticipated benefit to the

subjects;

(b) The relation of the anticipated benefit to the risk is at least

as favorable to the subjects as that presented by available alternative

approaches; and

children and permission of their parents or guardians as set forth in

Sec. 50.55.

http://a257.g.akamaitech.net/7/257/2422/26mar20071500/edocket.access.

gpo.gov/cfr_2007/aprqtr/21cfr50.52.htm

Some of our shots are flat out deadly. They're going to kill you unless by sheer luck, you have a genetic fluke of some kind that will prevent your liver from turning into bleeding pudding. Obviously, we can hardly wait to inject your child with this because it really gets us off. There's no conceivable need for doing this in fact, there are probably much safer, tried and effective things to do instead.

Not doing anything is just as good a choice if your child's life is what we're worrying about. But it's not what we're worrying about, we just want to see what happens when we inject Drano into her veins. But you see, on the off chance that the shots don't kill your kid, and if by amazing dumb luck the damn thing even helps her, then that benefit would be so great as to make this worth the 90% risk that she'll croak shortly after we inject her. Don't worry, there's lots more kids coming in tomorrow from some orphanage in New Orleans. But please, you're responsible for getting rid of the body and don't even think about asking us for funeral costs. We're doctors man, we're trying to help. Ingrate.