2007david b. plummer, cim, bcc1 irbs & chaplains: a great match! a presentation at the 2007...

2007 David B. Plummer, CIM, BCC 1

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, Virginia757.736.1201


Institutional Review Boards

Why the Need?

History

Nazi “Experiments”/ War Crimes (1946)

Tuskegee (1932-1973)

Thalidomide (Late 1950s – 1962)


IRBs: Why the Need?

History


* High-Altitude Experimentsto 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.


IRBs: Why the Need?


IRBs: Why the Need?

History


* Incendiary Bomb Experimentsto 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.


IRBs: Why the Need?


IRBs: Why the Need?

History


* Freezing Experimentsto 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.


IRBs: Why the Need?


IRBs: Why the Need? History


* Sea-water Experimentsto 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 Experimentsto 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.




* Mustard Gas Experimentsto 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 Experimentsto 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.




* Spotted Fever (Typhus) Experimentsto 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 Poisonto 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.


IRBs: Why the Need?


IRBs: Why the Need?

History


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:

To be ethical, research must have Informed Consent & Minimized Harm!




* 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.”


IRBs: Why the Need?

History


* 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.


IRBs: Why the Need?

History


• 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.me.14.ram . )

20020725.me.14.ram


IRBs: Why the Need?

History


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.


IRBs: Why the Need?


IRBs: Why the Need?

History


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.



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.



Why the Need?

Present


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)



Why the Need?

Present


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.stmcan N-O-W be downloaded at

– http://www.guineapigkids.com/


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.

http://videosonaids.libsyn.com/index.php?post_id=175764


“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.



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.”




To Give Guidance to and Protection of

the Future of HumanityWashington 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? “




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



Chaplains Are Ideal “Non-Scientist” Members!

FDA Regulations require IRBs to have a non-scientist 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.



How Can One Prepare for Service on an IRB?

Via Self-Study

For FDA Guidance (Non-Federal studies), read and become familiar with www.fda.gov/oc/ohrt/irbs .




Via Self-Study

For OHRP Guidance (Federally-sponsored studies), read and become familiar with http://www.hhs.gov/ohrp/.




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


IRBs & Chaplains:A Great Match!

Questions and Concerns??


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 .


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.



• 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/synergy , and Maverick Television at http://www.mavericktv.co.uk/default.php?id=1003 .



• “Big Pharma’s Shameful Secret” may be found and downloaded as a PDF at http://www.bloomberg.com/specialreport/pharma.pdf .

2007david b. plummer, cim, bcc1 irbs & chaplains: a great match! a presentation at the 2007...

Documents

malaria experiments

sulfanilamide experiments

freezing experiments

highaltitude experiments

series of experiments

seawater experiments

mustard gas experiments

numerous victims