The Common Rule applies to all federally funded research conducted both intra- and extramurally. The rule directs a research institution to assure the federal government that it will provide and enforce protections for human subjects of research conducted under its auspices. These institutional assurances constitute the basic framework within which federal protections are effected. Local research institutions remain largely responsible for carrying out the specific directives of the Common Rule. They must assess research proposals in terms of their risks to subjects and their potential benefits, and they must see that the Common Rule's requirements for selecting subjects and obtaining informed consent are met.
This brings me to the 2 topics that millions around the world are addressing... geoengineering of the atmosphere and genetic modification of the food supply. For the past several years researching the public accessible studies and weatherization/climate control projects currently deployed around the world I am increasingly concerned for all life on the planet and I've noticed something that is not really being addressed. (and please, by all and any means, if you have the missing data I'd really like for you to share it with us)
What I find missing in the reports I've seen to this point is the addressing of "health and/or benefit to humans" (or any life for that matter).
An example of this: The
DOE Openness: Human Radiation Experiments: Roadmap to the Project
ACHRE Report
Chapter 3: Footnotes
1 . For a discussion of the
development of the Common Rule, see
chapter 14.
2 . We relied particularly on Ruth R. Faden and Tom
L. Beauchamp,
A History and Theory of Informed Consent (New York: Oxford
University Press, 1986). Other excellent sources include Jay Katz,
Experimentation with Human Beings (New York: Russell Sage Foundation,
1972), and Robert Levine,
Ethics and Regulation of Clinical Research
(Baltimore: Urban and Schwarzenberg, 1981).
3 . U.S. Congress, The Select Committee to Study
Governmental Operations with Respect to Intelligence Activities,
Foreign and
Military Intelligence [Church Committee report], report no. 94-755, 94th
Cong., 2d Sess. (Washington, D.C.: GPO, 1976). Also, U.S. Army Inspector
General,
Use of Volunteers in Chemical Agent Research [Army IG report]
(Washington, D.C.: 1975).
4 . In dissenting opinions, four justices of the U.S.
Supreme Court (Brennan, Marshall, Stevens, and O'Connor) cited the Nuremberg
Code.
United States et al. v. Stanley, 483 U.S. 669, 687, 710 (1987).
5 . Thalidomide was only available in clinical trials
in the United States at that time, but was approved for use in a number of
other countries.
6 . Louis Lasagna, interview by Susan White-Junod and
Jon Harkness (ACHRE), transcript of audio recording, 13 December 1994 (ACHRE
Research Project Series, Interview Program Files, Ethics Oral History Project),
37-38. See also, Louis Lasagna, "1938-1968: The FDA, the Drug Industry, the
Medical Profession, and the Public," in
Safeguarding the Public: Historical
Aspects of Medicinal Drug Control, ed. John B. Blake (Baltimore: The Johns
Hopkins Press, 1970), 173.
7 . Food, Drug, and Cosmetic Act amendments,
21 U.S.C. [[section]] 355 (1962).
8 . Congressional Record, 87th Cong, 2d Sess.,
22042, as cited in an attached memorandum, C. Joseph Stetler, Pharmaceutical
Manufacturers Association, to James L. Goddard, M.D., Commissioner of Food and
Drugs, DHEW, 11 October 1966 ("Regarding Statement Appearing in August 30, 1966
Federal Register Concerning Clinical Investigation of Drugs") (ACHRE No.
HHS-090794-A).
9 . Keith Reemtsma et al., "Reversal of Early Graft
Rejection after Renal Heterotransplantation in Man,"
Journal of the American
Medical Association 187 (1964): 691-696.
10 . This research, conducted by Dr. Chester Southam
of Sloan-Kettering Institute and Dr. Emmanuel Mandel of the Jewish Chronic
Disease Hospital in 1963 and funded by the U.S. Public Health Service and the
American Cancer Society, raised concern within PHS and brought about an
investigation by the hospital. Drs. Mandel and Southam were subject to a
disciplinary hearing before the Board of Regents of the University of the State
of New York. The hospital's internal review and a suit against the hospital
prompted concern and debate at the NIH. Edward J. Rourke, Assistant General
Counsel, NIH, to Dr. Luther L. Terry, Surgeon General, 16 September 1965
("Research Grants--Clinical--PHS responsibility--
Fink v. Jewish Chronic
Disease Hospital [New York Supreme Court, Kings County]") (ACHRE No.
HHS-090794-A).
For a more thorough discussion
of this case, see Katz,
Experimentation with Human Beings, 9-65.
11 . In 1967 Dr. Southam was elected vice president
of the American Association for Cancer Research and became president the
following year. Katz,
Experimentation with Human Beings, 63 and 65.
12 . For a fuller discussion of the Law-Medicine
Research Institute, see
chapter 2.
13 . The development of the Declaration of Helsinki
is discussed briefly in
chapter 2.
14 . Robert B. Livingston, Associate Chief for
Program Development, Memorandum to the Director, NIH, 4 November 1964
("Progress Report on Survey of Moral and Ethical Aspects of Clinical
Investigation" [the Livingston report]) (ACHRE No. HHS-090795-A), 3.
15 . Ibid., 7.
16 . Ibid.
17 . Mark S. Frankel, "Public Policymaking for
Biomedical Research: The Case of Human Experimentation" (Ph.D. diss., George
Washington University, 9 May 1976), 50-51.
18 . The NAHC discussed the "general question of the
ethical, moral, and legal aspects of clinical investigation" at its meetings of
September and December 1965. Terry's interest in this was motivated in part by
the concern of Senator Jacob K. Javits that the informed consent provisions of
the 1962 Drug Amendments were not applicable to nondrug-related research. See
(a) draft letter to Senator Javits from the Surgeon General, 15 October 1965;
(b) Senator Javits to Luther L. Terry, Surgeon General, 15 June 1965; and (c)
Edward J. Rourke, Assistant General Counsel, to William H. Stewart, Surgeon
General, 26 October 1965. All in ACHRE No. HHS-090794-A.
19 . Transcript of the NAHC meeting, Washington,
D.C., 28 September 1965. See Faden and Beauchamp,
A History and Theory of
Informed Consent, 208.
20 . Ibid.
21 . Dr. S. John Reisman, the Executive Secretary,
NAHC, to Dr. James A. Shannon, 6 December 1965 ("Resolution of Council") (ACHRE
No. HHS-090794-A).
22 . Surgeon General, Public Health Service to the
Heads of the Institutions Conducting Research with Public Health Service
Grants, 8 February 1966 ("Clinical research and investigation involving human
beings") (ACHRE No. HHS-090794-A). This policy was distributed through Bureau
of Medical Services Circular no. 38, 23 June 1966 ("Clinical Investigations
Using Human Beings As Subjects") (ACHRE No. HHS-090794-A).
23 . In December 1966 the policy was expanded to
include behavioral as well as medical research. William H. Stewart, Surgeon
General, Public Health Service, to Heads of Institutions Receiving Public
Health Service Grants, 12 December 1966 ("Clarification of procedure on
clinical research and investigation involving human subjects") (ACHRE No.
HHS-072894-B), 2.
In 1967 the Public Health Service required
that intramural research, including that conducted at NIH, abide by similar
requirements. William H. Stewart, Surgeon General of the Public Health Service,
to List, 30 October 1967 ("PHS policy for intramural programs and for contracts
when investigations involving human subjects are included") (ACHRE No.
HHS-072894-B), 2.
24 . Frankel, "Public Policymaking for Biomedical
Research: The Case of Human Experimentation," 161.
25 . Ibid., 161-162.
26 . U.S. Department of Health, Education, and Welfare,
The
Institutional Guide to DHEW Policy on Protection of Human Subjects
(Washington, D.C.: GPO, 1971) (ACHRE No. HHS-090794-A).
27 . Ibid., 1-2.
28 . Beecher's criticism involved many aspects of
the research, including the risk assessment, usefulness of the research, and
the question of informed consent. On this last point, Beecher argued that
while consent was important, he disputed the belief that it was easily
obtainable. In his talk at Brook Lodge, Beecher questioned the "naive
assumption implicit in the Nuremberg Code," that consent was readily
obtainable. Beecher indicated the difficulty of obtaining truly informed
consent may have led many researchers to treat the provision cavalierly and
often to ignore it. Henry K. Beecher, "Ethics and the Explosion of Human
Experimentation," unpublished manuscript of paper presented 22 March 1965, "a,"
Beecher Papers, Countway Library (ACHRE No. IND-072595-A).
29 . Ibid.,"a" and "b."
30 . Ibid., 2a.
31 . Ibid., 2.
32 . H. K. Beecher, "Ethics and Clinical Research,"
New England
Journal of Medicine 274 (1966): 1354-1360.
33 . W. Goodman, "Doctors Must Experiment on
Humans--But What are Patients Rights?"
New York Times Magazine, 2 July
1965, 12-13, 29-33, as cited in Faden and Beauchamp,
A History and Theory of
Informed Consent, 188.
34 . J. Lear, "Do We Need New Rules for
Experimentation on People?"
Saturday Review, 5 February 1966, 61-70.
35 . Henry K. Beecher, "Consent in Clinical
Experimentation: Myth and
Reality,"
Journal of the American Medical Association 195 (1966):
34-35.
36 . J. Lear, "Experiments on People--The Growing
Debate,"
Saturday Review, 2 July 1966, 41-43.
37 . Both the
New York Times and the
Wall
Street Journal ran stories on 24 March 1971. See
Medical World
News, 15 October 1971, "Was Dr. Krugman Justified in Giving Children
Hepatitis?"
38 . Beecher,
Research and the Individual: Human
Studies (Boston: Little, Brown, and Company, 1970), 122-127.
39 . Paul Ramsey,
The Patient as Person:
Explorations in Medical Ethics (New Haven: Yale University Press, 1970),
51-55.
40 . In a letter to the
Lancet, Dr. Stephen
Goldby called the work "unjustifiable" and asked, "Is it right to perform an
experiment on a normal or mentally retarded child when no benefit can result to
the individual?" (S. Goldby, "Letters to the Editor,"
Lancet 7702
[1971]: 749). The
Lancet editors agreed with Goldby. On this side of
the Atlantic, however, the editors of
NEJM and
JAMA, among
others, defended Krugman's work.
41 . Armed Forces Epidemiological Board, minutes of
24 May 1957 (ACHRE No. NARA-032495-B).
42 . S. Krugman, "Ethical Practices in Human
Experimentation," text of lecture presented at the Fifth Annual Midwest Student
Medical Research Forum, 1 March 1974 (ACHRE No. IND-072895-A).
43 . Ibid., 3-4.
44 . Louis Goldman, "The Willowbrook Debate,"
World Medicine (September 1971 and November 1971): 23, 25.
45 . James H. Jones,
Bad Blood (New York:
Free Press, 1993 edition), 114.
46 . Jones,
Bad Blood (1981), 69-71; Levine,
Ethics and Regulation of Clinical Research, 70.
47 . Charles J. McDonald, "The Contribution of the
Tuskegee Study to Medical Knowledge,"
Journal of the National Medical
Association (January 1974): 1-11, as cited in Faden and Beauchamp,
A
History and Theory of Informed Consent, 194-195.
48 . Jean Heller, "Syphilis Victims in U.S. Study Went Untreated for 40
Years,"
New York Times (26 July 1972) 1, 8, as cited in Faden and
Beauchamp,
A History and Theory of Informed Consent, 195.
49 . U.S. Department of Health, Education, and
Welfare,
Final Report of the Tuskegee Syphilis Study Ad Hoc Panel
(Washington, D.C.: GPO, 1973), Jay Katz Concurring Opinion, 14.
50 . Ibid.
51 . Ibid., 21-32.
52 . Ibid., 23.
53 . Senator Jacob Javits introduced legislation
that would have made the DHEW policy a regulation backed by federal law. S.
878 and S. 974, 93d Cong., 1st Sess. (1973).
Senator Hubert Humphrey introduced a bill to
create a National Human Experimentation Standards Board--a separate federal
agency with authority over research similar to the Security and Exchange
Commission's authority over securities transactions. S. 934, 93d Cong., 1st
Sess. (1973).
Also, Senator Walter Mondale introduced a resolution to provide for a "study
and evaluation of the ethical, social, and legal" aspects of biomedical
research. S.J. Res. 71, 93d Cong., 1st Sess. (1973).
54 . It is worth noting here that Senator Kennedy
had convened similar hearings two years previously, in 1971, to consider the
establishment of a national commission to examine "ethical, social, and legal
implications of advances in biomedical research." Among the topics mentioned
in this hearing was the total-body irradiation research sponsored by the
Department of Defense at the University of Cincinnati, which we discuss in
chapter 8.
55 . Jay Katz, "Human Experimentation: A Personal
Odyssey,"
IRB 9, no. 1 (January/February 1987): 1-6.
56 . Protection of Human Subjects, 39 Fed. Reg. 105, 18914-18920
(1974) (to be codified at 45 C.F.R. [[section]] 46).
57 . National Research Act of 1974. P.L.
348, 93d Cong., 2d Sess. (12 July 1974).
58 . U.S. Department of Health, Education, and
Welfare, Office for Protection from Research Risks, 18 April 1979, OPPR Reports
[
The Belmont Report] (ACHRE No. HHS-011795-A-2), 4-20.
59 . Interestingly, this committee included Henry
Beecher, who, as was discussed in part I,
chapter
3, had objected to the
imposition of these requirements to contract research in 1961. Beecher's
presence on the committee testifies to the common relationship between military
and private research during this time. Like many of the
60 . Department of the Army, Army Regulation 40-37,
12 August 1963 ("Radioisotope License Program [Human Use]").
61 . Department of the Army, AR 40-38, 23 February
1973 ("Medical Services--Clinical Investigation Program").
62 . Ibid.
63 . Ibid.
64 . Commanding Officer, Naval Medical Research
Institute, National Naval Medical Center, to Secretary of the Navy, 30 November
1964 ("Authorization to use human volunteers as subjects for study of effects
of hypoxia on the visual field; request for") (ACHRE No. DOD-091494-A), 2.
65 . Department of the Navy, "Manual of the Medical
Department," 20-8, Change 36, 7 March 1967 ("Use of Volunteers in Medical or
Other Hazardous Experiments") (ACHRE No. DOD-091494-A).
66 . Department of the Navy, SecNav Instruction
3900.39, 28 April 1969 ("Use of volunteers as subjects of research,
development, tests, and evaluation").
67 . Department of the Air Force, AFR 169-8, 8
October 1965 ("Medical Education and Research--Use of Volunteers in Aerospace
Research").
68 . Ibid.
69 . Ibid.
70 . National Aeronautics and Space Administration,
Manned Spacecraft Center, MSCI 1860.2, 12 May 1966 ("Establishment of MSC
Radiological Control Manual and Radiological Control Committee") (ACHRE No.
NASA-022895-A), 3.
National Aeronautics and Space Administration, "Ames Management Manual 7170-1,"
15 January 1968 ("Human Research Planning and Approval") (ACHRE No.
NASA-120894-A), 3.
71 . Ames required the voluntary, written informed
consent of the subject and stipulated that consent be informed by an
explanation to the subject in language understandable to him
. . . [including]
the nature, duration, and purpose of the human research; the manner in which it
will be conducted; and all foreseeable risks, inconveniences and
discomforts.
"Ames Management Manual 7170-1," 15 January 1968, 3.
72 . The Ames director was authorized to waive the
consent requirements (a) when the requirements would "not be necessary to
protect the subject"; (b) when the research uses "classes of trained persons
who knowingly follow a specialized calling or occupation which is generally
recognized as hazardous," including "test pilots and astronauts"; and (c) when
the research "would be seriously hampered" by compliance. "Ames Management
Manual 7170-1," 15 January 1968, 3.
73 . For example, one review from this group
recommended changes in a consent form to include
[T]he part of the procedure you are consenting to which principally benefits
the research program and is not part
of your treatment is known as arterial puncture. . . . These risks will be
explained to you in detail if you so desire. The entire procedure, including
the diagnostic radioscan, takes about an hour.
Although this proposed consent form does not delineate the medical risks posed
by the procedure, its statement that the patient's participation is incidental
to treatment may provide a greater opportunity for the patient to make an
informed decision about participation. George A. Rathert, Jr., Chairman, Human
Research Experiments Review Board, ARC, to Director, 20 January 1969 ("Proposed
Investigation entitled 'Measurement of Cerebral Blood Flow in Man by an
Isotopic Technique Employing External Counting,' by Dr. Leo Sapierstein,
Stanford University") (ACHRE No. NASA-022895-A), 4.
At MSC, the instruction establishing the Medical Uses Subcommittee was
rescinded in 1968. In 1969, formal combination of the medical operations and
medical research functions at MSC led to the reestablishment of the instruction
as the Medical Isotopes Subcommittee at MSC. No evidence suggests what
factors, other than risk, were considered in this form of prior review is
available currently. National Aeronautics and Space Administration, Manned
Spacecraft Center, MSCI 1860.2, 12 May 1966 ("Establishment of MSC Radiological
Control Manual and Radiological Control Committee"); and National Aeronautics
and Space Administration, NMI 1156.19, 28 August 1969 ("Medical Isotopes
Subcommittee of the MSC Radiation Safety Committee") (ACHRE
No. NASA-022895-A).
74 . National Aeronautics and Space Administration,
NMI 71008.9, 2 February 1972 ("Human Research Policy and Procedures") (ACHRE
No. NASA-022895-A). See also, National Aeronautics and Space Administration,
NMI 7100.9 ("Power and Authority -- To Authorize Human Research and to Grant
Certain Related Exceptions and Waivers") (ACHRE No. NASA-022895-A).
75 . Commission on CIA Activities within the United
States,
Report to the President, (Washington, D.C.: GPO, 1975).
76 . U.S. Congress, The Select Committee to Study
Governmental Operations with Respect to Intelligence Activities,
Foreign and
Military Intelligence [Church Committee report], report no. 94-755, 94th
Cong., 2d Sess. (Washington, D.C.: GPO, 1976), 394.
77 . For general information on the CIA program,
see the Church Committee report, 385-422, and J. Marks,
The Search for the
"Manchurian Candidate": The CIA and Mind Control (New York: Times Books,
1978).
78 . Church Committee report, book 1, 389.
79 . Church Committee report, book 1, 400, 402. In
1963 the CIA inspector general (IG) recommended that unwitting testing be
terminated, but Deputy Director for Plans Richard Helms (who later became
director of Central Intelligence) continued to advocate covert testing on the
ground that "positive operational capability to use drugs is diminishing, owing
to a lack of realistic testing. With increasing knowledge of the state of the
art, we are less capable of staying up with the Soviet advances in this field."
The Church Committee noted that "Helms attributed the cessation of the
unwitting testing to the high risk of embarrassment to the Agency as well as
the 'moral problem.' He noted that no better covert situation had been devised
than that which had been used, and that
80 . Ibid., 402.
81 . Executive Order 11905 (19 February 1976).
82 . Executive Order 12036, section 2-301
(26 January 1978) and Executive Order 12333, section 2.10 (4 December 1981).
83 . U.S. Army Inspector General,
Use of
Volunteers in Chemical Agent Research [Army IG report] (Washington, D.C.:
GPO, 1975), 2.
84 . One noted exception involved using LSD as an
interrogation devise on ten foreign intelligence agents, and one U.S. citizen
suspected of stealing classified documents. Army IG report, 143.
85 . Army IG report, 87.
86 . Ibid.
87 . The CIA paid death benefits to the Olson
family after Frank Olson's death, and the Army secretly paid half of an $18,000
settlement that the Blauer family negotiated with the state of New York in
1955. The state ran the psychiatric institute that administered the drugs, but
which never disclosed the Army's involvement. Both agencies feared that the
resulting embarrassment and adverse publicity might undermine their ability to
continue their secret research programs.
Barrett v. United States, 6660
F. Supp. 1291 (E. D. N.Y., 1987).
88 . Feres v. United States, 340 U.S. 146
(1950).
89 . United States v. Stanley, 483 U.S. 669
(1987).
90 . 483 U.S. 669, 682.
91 . 483 U.S. 669, 687-88.
92 . 483 U.S. 669, 709-10.
93 . George Annas, a scholar of human
experimentation and biomedical ethics, has traced the history of the Nuremberg
Code in the U.S. courts. The first express reference in a majority opinion,
Annas found, was in a 1973 decision in the Circuit Court in Wayne County,
Michigan. The decisions in which the Code has since been cited, Annas
concluded, reflect the proposition that the Nuremberg Code is a "document
fundamentally about nontherapeutic experimentation." Thus, the "types of
experiments that U.S. judges have found the Nuremberg Code useful for setting
standards have involved nontherapeutic experiments often conducted without
consent. . . . Many of these experiments were justified by national security
considerations and the cold war." George J. Annas, "The Nuremberg Code in U.S.
Courts: Ethics versus Expediency," in George J. Annas and Michael A. Grodin,
eds.,
The Nazi Doctors and the Nuremberg Code: Human Rights in Human
Experimentation (New York: Oxford University Press, 1992), 218.
SOURCE:
http://www.hss.doe.gov/healthsafety/ohre/roadmap/achre/chap3_fn.html#fn80
1. The IRS is not a U.S. Government Agency.
It is an Agency of the IMF. (Diversified Metal Products v. IRS et al.
CV-93-405E-EJE U.S.D.C.D.I., Public Law 94-564, Senate Report 94-1148
pg. 5967, Reorganization Plan No. 26, Public Law 102-391.)
200
years of operating under bankruptcy its finally over. (Executive
Order 12803) Do not personate one of the creditors or share holders or
you will go to Prison.18 U.S.C. 914
7. Social Security Numbers are issued by the UN through the IMF.
The Application for a Social Security Number is the SS5 form. The
Department of the Treasury (IMF) issues the SS5 not the Social
Security Administration. The new SS5 forms do not state who or what
publishes them, the earlier SS5 forms state that they are Department
of the Treasury forms. You can get a copy of the SS5 you filled out by
sending form SSA-L996 to the SS Administration. (20 CFR chapter 111,
subpart B 42 2.103 (b) (2) (2) Read the cites above)
12. The UN is a One World Super Government. 
18. The most powerful court in America is not the United States Supreme Court but, the Supreme Court of Pennsylvania. (42 Pa.C.S.A. 502)
war. (Treaty at Versailles July 16, 1782, Treaty of Peace 8 Stat 80)
father of George HW Bush and grandfather of George W. Bush, funded both sides of World War II. The Bush family have been traitors to the American citizens for decades. 
Society
for Propagating the Gospel, &c. V. New Haven 8 Wheat 464, Treaty
of Peace 8 Stat 80, IRS Publication 6209, Articles of Association
October 20, 1774.)
53-54)
pg 99. Websters 1828 dictionary for definition of Estate.)
