[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: 21CFR50.55]

[Page 289-290]

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. 50.55 Requirements for permission by parents or guardians and for

assent by children.

(a) In addition to the determinations required under other

applicable sections of this subpart D, the IRB must determine that

adequate provisions are made for soliciting the assent of the children

when in the judgment of the IRB the children are capable of providing

assent.

(b) In determining whether children are capable of providing assent,

the IRB must take into account the ages, maturity, and psychological

state of

[[Page 290]]

the children involved. This judgment may be made for all children to be

involved in clinical investigations under a particular protocol, or for

each child, as the IRB deems appropriate.

proceeding with the clinical investigation if the IRB determines:

(1) That the capability of some or all of the children is so limited

that they cannot reasonably be consulted, or

(2) That the intervention or procedure involved in the clinical

investigation holds out a prospect of direct benefit that is important

to the health or well-being of the children and is available only in the

context of the clinical investigation.

(d) Even where the IRB determines that the subjects are capable of

assenting, the IRB may still waive the assent requirement if it finds

and documents that:

(1) The clinical investigation involves no more than minimal risk to

the subjects;

(2) The waiver will not adversely affect the rights and welfare of

the subjects;

(3) The clinical investigation could not practicably be carried out

without the waiver; and

(4) Whenever appropriate, the subjects will be provided with

additional pertinent information after participation.

(e) In addition to the determinations required under other

applicable sections of this subpart D, the IRB must determine that the

permission of each child's parents or guardian is granted.

(1) Where parental permission is to be obtained, the IRB may find

that the permission of one parent is sufficient, if consistent with

State law, for clinical investigations to be conducted under Sec. 50.51

or Sec. 50.52.

(2) Where clinical investigations are covered by Sec. 50.53 or

Sec. 50.54 and permission is to be obtained from parents, both parents

must give their permission unless one parent is deceased, unknown,

incompetent, or not reasonably available, or when only one parent has

legal responsibility for the care and custody of the child if consistent

with State law.

(f) Permission by parents or guardians must be documented in

accordance with and to the extent required by Sec. 50.27.

(g) When the IRB determines that assent is required, it must also

determine whether and how assent must be documented.

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

gpo.gov/cfr_2007/aprqtr/21cfr50.55.htm

"At our own sole discretion, we will decide when some little kid is able to comprehend who we are, what we want to do to him, and what the likely outcome will mean to him in a real way; i.e. it could kill him. Almost all little kids think of doctors as good guys who should always be trusted, and heck, so do their naive parents. Obviously, as long as any little kid, or any group of kids thinks of doctors as good guys, getting them to go along with what we want to do will be a piece of cake.

However every now and then we get one that's wise to us and he doesn't trust us or believe us. In those cases we reserve the right to over rule the little shit and do whatever we want anyway. Don't worry, we'll just lie to him, he'll never know what hit him. Hey man, it's in the name of science all right? What other possible thing exists out there that would let us get away with the atrocities you all think of as "medical care"? Let me tell you, there's not much out there, so shut up and trust us. We know what's best. For us. We'll need a payment today too please."

This is astonishing. Aren't children people? Do they not get a say over their own lives? Not according to the FDA. These people are not our friends.

Be clear on this, it's not everyone at the FDA who is a corrupt, inhumane, money-grubbing back-stabber. It's just the people at the top, the ones in critical power positions who can push through these corrupt rules under the shield of law and authority. The decision makers with all the authority in the world amount to a very few individuals in critical positions. Just a handful of crooks infiltrating literally every federal department can turn our entire system inside out, and ruin everything. That's what they're doing.

There are plenty of normal, real, caring people at the FDA who find all this just as upsetting as the rest of us. The problem is, when we allow individuals to have power instead of being accountable to us, the first thing they do is lock the public out of their own business. No one can force these crooks and psychopaths to listen to reason or consider human rights or decency. Those things are just in the way of rampant experimentation and big profits.

If we don't put a stop to this, it will go as far as they want to take it, and trying to stop them at that point may even be illegal.