[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: 21CFR50.23]

[Page 282-285]

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 B_Informed Consent of Human Subjects

Sec. 50.23 Exception from general requirements.

(a) The obtaining of informed consent shall be deemed feasible

unless, before use of the test article (except as provided in paragraph

(b) of this section), both the investigator and a physician who is not

otherwise participating in the clinical investigation certify in writing

all of the following:

(1) The human subject is confronted by a life-threatening situation

necessitating the use of the test article.

(2) Informed consent cannot be obtained from the subject because of

an inability to communicate with, or obtain legally effective consent

from, the subject.

(3) Time is not sufficient to obtain consent from the subject's

legal representative.

(4) There is available no alternative method of approved or

generally recognized therapy that provides an equal or greater

likelihood of saving the life of the subject.

(b) If immediate use of the test article is, in the investigator's

opinion, required to preserve the life of the subject, and time is not

sufficient to obtain the independent determination required in paragraph

(a) of this section in advance of using the test article, the

determinations of the clinical investigator shall be made and, within 5

working days after the use of the article, be reviewed and evaluated in

writing by a physician who is not participating in the clinical

investigation.

section shall be submitted to the IRB within 5 working days after the

use of the test article.

(d)(1) Under 10 U.S.C. 1107(f) the President may waive the prior

consent requirement for the administration of an investigational new

drug to a member of the armed forces in connection with the member's

participation in a particular military operation. The statute specifies

that only the President may waive informed consent in this connection

and the President may grant such a waiver only if the President

determines in writing that obtaining consent: Is not feasible; is

contrary to the best interests of the military member; or is not in the

interests of national security. The statute further provides that in

making a determination to waive prior informed consent on the ground

that it is not feasible or the ground that it is contrary to the best

interests of the military members involved, the President shall apply

the standards and criteria that are set forth in the relevant FDA

regulations for a waiver of the prior informed consent requirements of

section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

355(i)(4)). Before such a

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determination may be made that obtaining informed consent from military

personnel prior to the use of an investigational drug (including an

antibiotic or biological product) in a specific protocol under an

investigational new drug application (IND) sponsored by the Department

of Defense (DOD) and limited to specific military personnel involved in

a particular military operation is not feasible or is contrary to the

best interests of the military members involved the Secretary of Defense

must first request such a determination from the President, and certify

and document to the President that the following standards and criteria

contained in paragraphs (d)(1) through (d)(4) of this section have been

met.

(i) The extent and strength of evidence of the safety and

effectiveness of the investigational new drug in relation to the medical

risk that could be encountered during the military operation supports

the drug's administration under an IND.

(ii) The military operation presents a substantial risk that

military personnel may be subject to a chemical, biological, nuclear, or

other exposure likely to produce death or serious or life-threatening

injury or illness.

(iii) There is no available satisfactory alternative therapeutic or

preventive treatment in relation to the intended use of the

investigational new drug.

(iv) Conditioning use of the investigational new drug on the

voluntary participation of each member could significantly risk the

safety and health of any individual member who would decline its use,

the safety of other military personnel, and the accomplishment of the

military mission.

(v) A duly constituted institutional review board (IRB) established

and operated in accordance with the requirements of paragraphs (d)(2)

and (d)(3) of this section, responsible for review of the study, has

reviewed and approved the investigational new drug protocol and the

administration of the investigational new drug without informed consent.

DOD's request is to include the documentation required by Sec.

56.115(a)(2) of this chapter.

(vi) DOD has explained:

(A) The context in which the investigational drug will be

administered, e.g., the setting or whether it will be self-administered

or it will be administered by a health professional;

(B) The nature of the disease or condition for which the preventive

or therapeutic treatment is intended; and

information on conditions that could alter the effects of the

investigational drug.

(vii) DOD's recordkeeping system is capable of tracking and will be

used to track the proposed treatment from supplier to the individual

recipient.

(viii) Each member involved in the military operation will be given,

prior to the administration of the investigational new drug, a specific

written information sheet (including information required by 10 U.S.C.

1107(d)) concerning the investigational new drug, the risks and benefits

of its use, potential side effects, and other pertinent information

about the appropriate use of the product.

(ix) Medical records of members involved in the military operation

will accurately document the receipt by members of the notification

required by paragraph (d)(1)(viii) of this section.

(x) Medical records of members involved in the military operation

will accurately document the receipt by members of any investigational

new drugs in accordance with FDA regulations including part 312 of this

chapter.

(xi) DOD will provide adequate followup to assess whether there are

beneficial or adverse health consequences that result from the use of

the investigational product.

(xii) DOD is pursuing drug development, including a time line, and

marketing approval with due diligence.

(xiii) FDA has concluded that the investigational new drug protocol

may proceed subject to a decision by the President on the informed

consent waiver request.

(xiv) DOD will provide training to the appropriate medical personnel

and potential recipients on the specific investigational new drug to be

administered prior to its use.

(xv) DOD has stated and justified the time period for which the

waiver is needed, not to exceed one year, unless

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separately renewed under these standards and criteria.

(xvi) DOD shall have a continuing obligation to report to the FDA

and to the President any changed circumstances relating to these

standards and criteria (including the time period referred to in

paragraph (d)(1)(xv) of this section) or that otherwise might affect the

determination to use an investigational new drug without informed

consent.

(xvii) DOD is to provide public notice as soon as practicable and

consistent with classification requirements through notice in the

Federal Register describing each waiver of informed consent

determination, a summary of the most updated scientific information on

the products used, and other pertinent information.

(xviii) Use of the investigational drug without informed consent

otherwise conforms with applicable law.

(2) The duly constituted institutional review board, described in

paragraph (d)(1)(v) of this section, must include at least 3

nonaffiliated members who shall not be employees or officers of the

Federal Government (other than for purposes of membership on the IRB)

and shall be required to obtain any necessary security clearances. This

IRB shall review the proposed IND protocol at a convened meeting at

which a majority of the members are present including at least one

member whose primary concerns are in nonscientific areas and, if

feasible, including a majority of the nonaffiliated members. The

information required by Sec. 56.115(a)(2) of this chapter is to be

provided to the Secretary of Defense for further review.

(3) The duly constituted institutional review board, described in

paragraph (d)(1)(v) of this section, must review and approve:

(i) The required information sheet;

(ii) The adequacy of the plan to disseminate information, including

distribution of the information sheet to potential recipients, on the

investigational product (e.g., in forms other than written);

(iii) The adequacy of the information and plans for its

dissemination to health care providers, including potential side

effects, contraindications, potential interactions, and other pertinent

considerations; and

(iv) An informed consent form as required by part 50 of this

chapter, in those circumstances in which DOD determines that informed

consent may be obtained from some or all personnel involved.

(4) DOD is to submit to FDA summaries of institutional review board

meetings at which the proposed protocol has been reviewed.

(5) Nothing in these criteria or standards is intended to preempt or

limit FDA's and DOD's authority or obligations under applicable statutes

and regulations.

(e)(1) Obtaining informed consent for investigational in vitro

diagnostic devices used to identify chemical, biological, radiological,

or nuclear agents will be deemed feasible unless, before use of the test

article, both the investigator (e.g., clinical laboratory director or

other responsible individual) and a physician who is not otherwise

participating in the clinical investigation make the determinations and

later certify in writing all of the following:

(i) The human subject is confronted by a life-threatening situation

necessitating the use of the investigational in vitro diagnostic device

to identify a chemical, biological, radiological, or nuclear agent that

would suggest a terrorism event or other public health emergency.

(ii) Informed consent cannot be obtained from the subject because:

(A) There was no reasonable way for the person directing that the

specimen be collected to know, at the time the specimen was collected,

that there would be a need to use the investigational in vitro

diagnostic device on that subject's specimen; and

(B) Time is not sufficient to obtain consent from the subject

without risking the life of the subject.

(iii) Time is not sufficient to obtain consent from the subject's

legally authorized representative.

(iv) There is no cleared or approved available alternative method of

diagnosis, to identify the chemical, biological, radiological, or

nuclear agent that provides an equal or greater likelihood of saving the

life of the subject.

[[Page 285]]

(2) If use of the investigational device is, in the opinion of the

investigator (e.g., clinical laboratory director or other responsible

person), required to preserve the life of the subject, and time is not

sufficient to obtain the independent determination required in paragraph

(e)(1) of this section in advance of using the investigational device,

the determinations of the investigator shall be made and, within 5

working days after the use of the device, be reviewed and evaluated in

writing by a physician who is not participating in the clinical

investigation.

(3) The investigator must submit the documentation required in

paragraph (e)(1) or (e)(2) of this section to the IRB within 5 working

days after the use of the device.

(4) An investigator must disclose the investigational status of the

in vitro diagnostic device and what is known about the performance

characteristics of the device in the report to the subject's health care

provider and in any report to public health authorities. The

investigator must provide the IRB with the information required in Sec.

50.25 (except for the information described in Sec. 50.25(a)(8)) and

the procedures that will be used to provide this information to each

subject or the subject's legally authorized representative at the time

the test results are provided to the subject's health care provider and

public health authorities.

(5) The IRB is responsible for ensuring the adequacy of the

information required in section 50.25 (except for the information

described in Sec. 50.25(a)(8)) and for ensuring that procedures are in

place to provide this information to each subject or the subject's

legally authorized representative.

(6) No State or political subdivision of a State may establish or

continue in effect any law, rule, regulation or other requirement that

informed consent be obtained before an investigational in vitro

diagnostic device may be used to identify chemical, biological,

radiological, or nuclear agent in suspected terrorism events and other

potential public health emergencies that is different from, or in

addition to, the requirements of this regulation.

[46 FR 8951, Jan. 27, 1981, as amended at 55 FR 52817, Dec. 21, 1990; 64

FR 399, Jan. 5, 1999; 64 FR 54188, Oct. 5, 1999; 71 FR 32833, June 7,

2006]

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

gpo.gov/cfr_2007/aprqtr/21cfr50.23.htm

Why is the DOD developing, testing and patenting drugs?

It might be worth asking yourself what the department of defense, DOD has to do with the safety of your medical treatment. It might also be worth asking yourself how or why the president would be in this picture too.

But it may not require much digging when you understand that the human beings referred to in this federal regulation as "subjects" are none other than our fellow citizens who enlist to serve in our military.

The topic being discussed has nothing whatsoever to do with protecting any human beings. In fact, it's exactly the opposite.

What is being laid down here is under what circumstances can an enlisted person's best interests be deemed irrelevant so that pharmaceutical companies may use them as human lab rats, without their knowledge or consent, without fear of law suits or backlash, regardless of the damage done to, or the death of, any of the human "subjects" their latest inventions are being tested on.

The president has taken it upon himself to be the sole owner of all the rights of all of the people. He has interpreted the constitution to read, "The people are here for the benefit of corporations and will be available at all times to submit to any and all testing utilizing their bodies, or to perform in any capacity in which the corporation(s) deems they may be useful, productive, or otherwise likely to produce profits for the board of directors. It is wholly the right of the president to decide who's life matters and who's doesn't and no one may have an opinion about it. There is no legal recourse available to the citizens because they have no rights under this law. Their bodily flesh and life itself is the sole property of the president of the United States and may be used as he deems.

I'd say this is a pretty substantive loophole. You'd have to expect everything after the satisfaction guarantee to be loophole material. After all, if it was all about ensuring the safety of the people who consent to test new drugs, we wouldn't need all this legal stuff would we?

If any human subjects sicken or die, the DOD will take a keen interest as they will want to know immediately if the substance can be adapted for use in military warfare. Some may say that's not a fair statement, that in fact the military is trying to develop battlefield medical techniques, that's where they're interest lies. To that I can only say, "Hooey". If it was life saving techniques they were after, why the need for secrecy? Why the need for obfuscating even the fact that they're doing experiments? No, the only need for clandestine measures is when you're doing something wrong and don't want to get found out.

The administrative board who oversees these projects will be made up of people of the whoever's choosing who are best qualified to determine how much profit can be made regardless of the outcome. This is the most important aspect of these "investigations".

The investigators don't have to worry, they will not run out of unwitting human test subjects, there are thousands of them out there who can and will and are being ordered to stand still and receive dozens of injections of which they will be told absolutely nothing. This is to ensure the safety of the board of directors who will not have to be bothered by a landslide of wrongful death and disability lawsuits, which would only slow down the process and interfere with profits.

For those who are squeamish about the ethics involved here it is hereby declared by law that the ever increasing inflow of profits to corporations is more important than the lives of the unwashed masses who will never amount to anything anyway. The least they can do is give their bodies over to science for use as human test subjects. By doing so they will be performing a noble and honorable service to corporations who, if forced to achieve new drug approvals the old way would be made to wait ages before profits could begin rolling in. All the protections and safety requirements make it almost impossible to flood the market with ever new and unnecessary drugs.

By allowing forced non-consentual testing, corporations can rapidly go through the motions of appearing to have conducted safety and efficacy trials, but since the data will be classified, they will never have to cough it up. No one will ever be able to find out just how very aware they were all along of the dangers of every last one of the drugs they're pushing. It's the perfect straight road to pure profit. What could be better than that? A few hundred thousand deaths and crippling disabilities each year are an insignificant price that should be borne by the masses, they believe. The masses pay for everything else why not this too? At least they can die knowing they did something to make their lives worthwhile instead of just being beer guzzling, ignorant pot bellied TV addicts, or, as we call them: useless eaters. We are providing the mutual service of eliminating as many of those as we can get our syringes into.

This regulation also provides for the safety of drug developers as follows: no entity, public, private or governmental may attempt to pass any laws to shut this down or make it illegal or try to sue us blind. You don't get to do anything about it. Why? Because it works better for us that way.

This is the law as of this 1st day of April 2007. You may not have an opinion about it. Now shut up and sit down and wait to be called. You're next.