Transcript Chaplains & IRBs: A Great Combination!

IRBs & Chaplains:
A Great Match!
A Presentation at the 2007 Conference of the
Association of Professional Chaplains
David B. Plummer, M.Div., CIM, BCC, BCCC
[email protected]
Sentara CarePlex Hospital
Hampton, Virginia
757.736.1201
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Institutional Review Boards
 Why the Need?
 History
 Nazi “Experiments”/ War Crimes (1946)
 Tuskegee (1932-1973)
 Thalidomide (Late 1950s – 1962)
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IRBs: Why the Need?
 History
 Nazi “Experiments”/ War Crimes (1946)
* High-Altitude Experiments
to investigate the limits of human endurance and
existence at extremely high altitudes. The victims were
placed in the low-pressure chamber and thereafter the
simulated altitude therein was raised. Many victims died
as a result of these experiments and others suffered
grave injury, torture, and ill-treatment.
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IRBs: Why the Need?
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IRBs: Why the Need?
 History
 Nazi “Experiments”/ War Crimes (1946)
* Incendiary Bomb Experiments
to test the effect of various pharmaceutical preparations
on phosphorous burns. These burns were inflicted on the
victims with phosphorous matter taken from incendiary
bombs, and caused severe pain, suffering, and serious
bodily injury.
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IRBs: Why the Need?
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IRBs: Why the Need?
 History
 Nazi “Experiments”/ War Crimes (1946)
* Freezing Experiments
to investigate the most effective means of treating
persons who had been severely chilled or frozen. The
victims were forced to remain in a tank of ice water for up
to 3 hours. Extreme rigor developed in a short time.
Numerous victims died in the course of these
experiments. After the survivors were severely chilled,
rewarming was attempted by various means. In another
series of experiments, the victims were kept naked
outdoors for many hours at temperatures below freezing.
The victims screamed with pain as their bodies froze.
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IRBs: Why the Need?
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IRBs: Why the Need?
 History

Nazi “Experiments”/ War Crimes (1946)
* Sea-water Experiments
to study various methods of making sea water drinkable. The
victims were deprived of all food and given only chemically
processed sea water. Such experiments caused great pain and
suffering and resulted in serious bodily injury to the victims.
* Malaria Experiments
to investigate immunization for and treatment of malaria. The
victims were infected by mosquitoes or by injections of extracts
of the mucous glands of mosquitoes. After having contracted
malaria the victims were treated with various drugs to test their
relative efficacy. Over 1,000 victims were used in these
experiments. Many died and others suffered severe pain and
permanent disability.
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IRBs: Why the Need?
 History

Nazi “Experiments”/ War Crimes (1946)
* Mustard Gas Experiments
to investigate the most effective treatment of wounds caused
by Mustard gas. Wounds deliberately inflicted on the victims
were infected with Mustard gas. Some of the victims died as a
result of these experiments and others suffered intense pain
and injury.
* Sulfanilamide Experiments
to investigate the effectiveness of sulfanilamide. Wounds
deliberately inflicted on the victims were infected with bacteria
such as streptococcus, gas gangrene, and tetanus. Circulation
of blood was interrupted by tying off blood vessels at both
ends of the wound to create a condition similar to that of a
battlefield wound. Infection was aggravated by forcing wood
shavings and ground glass into the wounds. The infection was
treated with sulfanilamide and other drugs to determine their
effectiveness. Many victims died as a result of these
experiments and others suffered serious injury and intense
agony.
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IRBs: Why the Need?
 History

Nazi “Experiments”/ War Crimes (1946)
* Spotted Fever (Typhus) Experiments
to investigate the effectiveness of spotted fever and other
vaccines. Numerous victims were deliberately infected with
spotted fever virus in order to keep the virus alive - over 90
percent of the victims died as a result.
* Experiments with Poison
to investigate the effect of various poisons upon human beings.
The poisons were secretly administered to the victims in their
food. The victims died as a result of the poison or were killed
immediately in order to permit autopsies. In or about
September 1944 the victims were shot with poison bullets and
suffered torture and death.
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IRBs: Why the Need?
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IRBs: Why the Need?
 History
 Nazi “Experiments”/ War Crimes (1946)
The resulting Trial in Nuremburg, Germany
resulted in the conviction of 16 of the 23
physician defendants, seven of whom
were sentenced to death.
The principles used by the prosecutors
created the Nuremburg Code:
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To be ethical, research must have
Informed Consent & Minimized
Harm! David B. Plummer, CIM, BCC
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IRBs: Why the Need?
 History

Tuskegee (1932-1973)
* For forty years between 1932 and 1972, the U.S. Public Health
Service (PHS) conducted an experiment on 399 black men in
the late stages of syphilis. These men, for the most part
illiterate sharecroppers from one of the poorest counties in
Alabama, were never told what disease they were suffering
from or of its seriousness. Informed that they were being
treated for “bad blood,”1 their doctors had no intention of curing
them of syphilis at all. The data for the experiment was to be
collected from autopsies of the men, and they were thus
deliberately left to degenerate under the ravages of tertiary
syphilis—which can include tumors, heart disease, paralysis,
blindness, insanity, and death. “As I see it,” one of the doctors
involved explained, “we have no further interest in these
patients until they die.”
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IRBs: Why the Need?
 History

Tuskegee
(1932-1973)
* By the end of the
experiment, 28 of the
men had died directly
of syphilis, 100 were
dead of related
complications, 40 of
their wives had been
infected, and 19 of
their children had
been born with
congenital syphilis.
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IRBs: Why the Need?
 History

Tuskegee
(1932-1973)
• Charlie Pollard
receives an apology.
• NPR Clip
(Alex Chadwick’ s report as a National
Public Radio clip featuring President Clinton
apologizing for the Federal Government’s
sponsorship of the Tuskegee Experiment
can be found at
http://www.npr.org/ramfiles/me/20020725.m
e.14.ram . )
20020725.me.14.ram
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IRBs: Why the Need?
 History

Thalidomide (Late 1950s – 1962)
In the late 1950s, pregnant women in Europe, Canada,
and the United States were given thalidomide, an
experimental drug prescribed to control nausea.
Thalidomide caused severe birth defects in the fetus that
resulted in more than 12,000 deformed and limbless
infants. Expectant mothers were not informed of the
risks associated with thalidomide or that it was an
experimental drug. Additionally, patients did not volunteer
nor did they give consent to participate in the research.
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IRBs: Why the Need?
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IRBs: Why the Need?
 History
 Thalidomide (Late 1950s – 1962)
Once again, the Nuremberg principles of informed
consent and minimizing harm were not applied to
research practice. In response, the Kefauver-Harris Bill
was passed in 1962 to ensure greater drug testing safety.
The Kefauver-Harris Bill requires researchers to
inform all subjects about potential risks and benefits
of experimental drugs and to obtain consent from
participants prior to taking part in the study.
Written consent was not required, until 1981.
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Institutional Review Boards
 Why the Need?
 Present
 Pediatric AIDS Studies
(Late 1980s – Present)
– In 2005 The Associated Press (AP) released an investigative
report that:
Experiments were conducted in "at least seven states -Illinois, Louisiana, Maryland, New York, North Carolina,
Colorado and Texas -- and involved more than four dozen
different studies. “
– AP's investigation found that 13,878 children had been enrolled
in pediatric AIDS studies funded by the government since the
late 1980s. Their age ranged from infants to late teens.
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Institutional Review Boards
 Why the Need?
 Present
 Pediatric AIDS Studies
(Late 1980s – Present)
–
"More than two dozen Illinois foster children remain in
studies today." (May 2005)
– Those who conducted the experiments in violation of federal
regulations, are supported by taxpayers -- thus they have a
public responsibility which they violated. The children who were
targeted to serve as human drug testing subjects -- mostly poor
children of color -- were not afforded the protection of a
personal advocate -- as is mandated by federal regulations. (45
Code of Federal Regulations 46.409)
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Institutional Review Boards
 Why the Need?
 Present
 Pediatric AIDS Studies
(Late 1980s – Present)
– New York’s HIV Experiment deserves special attention:
Guinea Pig Kids on BBC
– http://news.bbc.co.uk/2/hi/programmes/this_world/4038375.stm
can N-O-W be downloaded at
– http://www.guineapigkids.com/
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Guinea Pig Kids
A BBC documentary exposes how the
city of New York has been forcing HIV
positive children under its supervision
to be used as human guinea pigs in
tests for experimental AIDS drug trials.
All of the children in the program were
under the legal guidance of the city's
child welfare department, the
Administration for Children's Services.
Most live in foster care or independent
homes run on behalf of the local
authorities and almost all the children
are believed to be African-American or
Latino. The BBC identified
pharmaceutical giant GlaxoSmithKline
as one of the companies that provided
the experimental drugs for the tests. In
the documentary, parents or guardians
who refused to consent to the trials
claim that children were removed by
ACS and placed in foster families or
children's homes. Then, acting over
their objections, ACS authorized the
drug trials. Not for the faint of heart; be
prepared to cry for these children.
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“Big Pharma’s Shameful Secret”
• Published as a special report in Bloomberg Markets,
December 2005, by David Evans, Michael Smith and Liz
Willen.
• Highlights:
*In the US, there have been 3.7 million human
research subjects.
*More than 75% of all clinical trials paid for by
pharmaceuticals are done in offices and private centers.
*Consent forms are often in technical language and
not understood by subjects.
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Institutional Review Boards
 Why the Present Need to Utilize Them?
 Regulatory


US & International Law.
JCAHO: RI.2.180 as described in 2007 Hospital
Accreditation Standards:
“RI 2.180 The hospital protects research subjects and
respects their rights during research, investigation and
clinical trials involving human subjects.”
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Institutional Review Boards
 Why the Present Need to Utilize Them?
 To Give Guidance to and Protection of
the Future of Humanity
 Washington Post Review (May 15, 2005) of Radical
Evolution by Joel Garreau:
“Inventing Our Evolution: We’re almost able to build better
human beings. But are we ready?“
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Institutional Review Boards
 Why the Present Need to Utilize Them?
 To Give Guidance to and Protection of
the Future of Humanity
 Testing in Third-World Countries:
Quote by Francis Fukuyama, Former Member of the
President’s Council on Bioethics
 2005 Movie: The Constant Gardener
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Institutional Review Boards
 Chaplains Are Ideal “Non-Scientist” Members!
 FDA Regulations require IRBs to have a nonscientist present or no business can take place.
Period! [Educational opportunities only.]
 Hopefully Objective. No ulterior motives.
Hopefully, chaplains are “travelers on the moral
high road.” In the end, healthcare facilities need
IRBs to protect patients and themselves!
 Cost-effective.
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Institutional Review Boards
How Can One Prepare for Service on an IRB?
 Via Self-Study

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For FDA Guidance (Non-Federal studies), read
and become familiar with
www.fda.gov/oc/ohrt/irbs .
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Institutional Review Boards
How Can One Prepare for Service on an IRB?
 Via Self-Study
 For OHRP Guidance (Federally-sponsored
studies), read and become familiar with
http://www.hhs.gov/ohrp/.
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Institutional Review Boards
How Can One Prepare for Service on an IRB?
 Via Training Conferences / Certification

National Association of IRB Managers offers Certified
IRB Manager training, credentialing, and continuing
education. www.NAIM.org
 Public Responsibility In Medicine & Research offers
Certified IRB Professional training, credentialing, and
continuing education. www.PRIMR.org
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IRBs & Chaplains:
A Great Match!
Questions and Concerns??
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Miscellaneous Credits
• The information on the history of the Nazi
“experiments/war crimes” can be found at The Nazi
Doctors Medical Experiments section of
www.DeathCamps.info . Additionally most of the
photographs used in that section of this presentation
came from that website. These photographs are in
excess of 50 years of age and are being used here with
“fair use” intent and for no financial profit.
• The photographs used regarding the Military Tribunal at
Nuremburg came from the website of the United States
Holocaust Memorial Museum at http://www.ushmm.org .
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Miscellaneous Credits
•
The information on the history of the Tuskegee Syphilis Experiment came
from an article by Borgna Brunner entitled, “The Tuskegee Syphilis
Experiment: The U.S. government's 40-year experiment on black men with
syphilis.” It can be found at
http://www.infoplease.com/spot/bhmtuskegee1.html .
•
Alex Chadwick’ s report as a National Public Radio clip featuring President
Clinton apologizing for the Federal Government’s sponsorship of the
Tuskegee Experiment can be found at
http://www.npr.org/ramfiles/me/20020725.me.14.ram . The clip reports that
it was copyrighted 2002, but that “There are no rights or restrictions
associated with this clip.”
•
The photo of the Tuskegee Study victim being treated is from the NPR
website at
http://www.npr.org/programs/morning/features/2002/jul/tuskegee/index.html
and is reportedly a courtesy from the National Archives. The photograph of
Charlie Pollard found at the same site is reportedly a Photo courtesy Joan
Echtenkamp Klein.
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Miscellaneous Credits
• The information on the history of the Thalidomide
Experiment came from an article posted by the National
Center for Juvenile Justice, “The Juvenile Justice
Professional Guide to Human Subjects Protection and
the IRB Process History” at
http://ncjj.servehttp.com/irb/History.asp .
• In the Thalidomide presentation, the photographs shown
came from the BBC (Mandy Masters) at
http://www.bbc.co.uk/radio4/factual/thalidomide.shtml ,
the Catholic University of American at
http://engineering.cua.edu/biomedical/faculty/kirtley/syne
rgy , and Maverick Television at
http://www.mavericktv.co.uk/default.php?id=1003 .
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Miscellaneous Credits
• “Big Pharma’s Shameful Secret” may be
found and downloaded as a PDF at
http://www.bloomberg.com/specialreport/p
harma.pdf .
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