Historical Background Flashcards
(23 cards)
Nuremberg Code - Historical Context and Date of Enactment
The Nuremberg Trails (1945-1946); End of World War II; Nazi’s did experiments on Civilian prisoners, basically using them as guinea pigs;
1947, Code was the starting point for ethical standards in research.
Nuremberg Code - The Basic Elements (3)
Voluntary and Informed Consent;
Favorable Risk/Benefit Scale;
Right to Withdraw Without Penalty;
Wichita Jury Study
University of Chicago Researchers;
1955 Study looking at Juror decision-making, specifically due to concern of attorney showmanship;
Juror’s were recorded without their knowledge;
Whole thing was given national attention.
Thalidomide Experiment - Historical Context
Thalidomide was used for a variety of symptoms connected to pregnancy in the 1950s. Without notifying subjects that it was investigational (not a common practice at the time),
Pregnant Women that were treated with the Drug gave birth to babies with growth deformities.
Thalidomide Experiment - Historical Impact
Led to regulations that required informed consent prior to using investigational medicine on subjects;
First time federal agency regulations established specific ethical standards for research;
Declaration of Helsinki - Basic Elements
Essentially the Nuremberg Code, Plus:
- Individual subject interest/safety is above society’s.
- Best known Treatment for each subject.
Henry Beecher - Historical Impact
Wrote an article in 1966 about how 22 studies that were recently published were unethical despite the praise they received. I guess it was unprecedented due to its length and depth of the critique.
Congressional Hearings on the Quality of Health Care and Human Experimentation - Historical Context
- Lots of concerns from other studies (like the ones I’ve made flashcards for) led to this hearing, although the tipping point seems to be the Tuskegee Syphilis Experiment. This hearing led to the National Research act of 1974 / the establishment of the modern day IRB system.
Willowbrook Hepatitis Studies
1950s; Children had to drink other kids poops so they would get hepatitis, the disease they were studying at Willowbrook. The parents of these children were told their children would not be cared for unless the kids had hepatitis. Best example of coercion I’ve read. Poop for Pediatric Care.
Jewish Chronic Disease Hospital Studies
1960s; Patients were injected with live cancer cells without informed consent being obtained; The purpose of this was to see how a weakened immune system affected the spread of cancer. I could not find anything on how the patients reacted to the live cancer cells.
Milgram Studies of Obedience to Authority
1960s, Aftermath of World Ware II, dude was trying to understand the holocaust and why people would listen to authority figures when told to do horrific things. This is that electric shock one where subjects pushed a button to shock a person, but in reality they weren’t shocking anyone.
San Antonio Contraception Study
1970s; The purpose of the study was to compare the effectiveness of different contraceptive pills. Women who were receiving contraception were not told they were in a study where they may receive a placebo; lots of unplanned babies occurred.
‘Tearoom’ Trade Study
1970s; The study looked at homosexual encounters in public restrooms. The PI recording identifying information from the people involved didn’t tell them they were a part of research, and later went to their homes for interviews, where it was revealed to many of the families for the first time that the person was gay. Many of them were also identified in later published reports of the study.
Tuskegee Syphilis Study - Historical Context
1932-1972 (40 years); U.S. Public Health Service funded study looking at the natural progression of untreated syphilis, given that there wasn’t really a good treatment at the time. Problem was, the subject population, 300 uneducated African American sharecroppers from Macon County, Alabama, thought they were being treated, but in fact were essentially just being watched, but with the added bonus of receiving painful spinal taps and other procedures that were done solely for research purposes and not treatment. Even after Penicillin was discovered to be beneficial and widely available, the subjects continued to not receive treatment.
Tuskegee Syphilis Study - Historical Impact
This was funded by the federal government over the course of 40 years and stained the public’s look at medical research. It’s the main reason why the principle of Justice was developed in the Belmont Report and was the catalyst for the National Research Act of 1974.
Jesse Gelsinger
18 year old who died in 1999 while taking part in a gene transfer study at the University of Pennsylvania. Essentially the oversight of this study was horrid and an example of what not to do in research. The consent form, for example, failed to appropriately disclose the risks in joining.
Havasupai Tribe Blood Samples
Researchers collected blood samples in the 1990s from Havasupai tribe (Grand Canyon) members for use in studies on type 2 diabetes. These samples ended up being used in other research without the tribes knowledge until they found out about it in 2005. The resulting research however just made said results specific to the tribe and not to people in general.
Henrietta Lacks
Her cervical cancer cells continued to divide and are still in use for research today. Led to discussions on the collection and subsequent use of samples in research given her unique outcome.
The National Commission for Protection of Human Subjects of Biomedical and Behavioral Research.
Commission that was established through the National Research Act of 1974. The Commission issued many reports establishing the ethical framework used today, including the Belmont Report in 1978.
HHS regulations at 45 CFR 46 (Title 45, Part 46 of the Code of Federal Regulations)
Referred to as the Common Rule, as they are common to most federal agencies. These are the main IRB regulations and were enacted in 1981, though revised in 2018.
2018 Common Rule Revision
Mostly required institutions to revise internal operating procedures. Also introduced Broad Consent.
What’s the main difference between the Guatemala Syphilis Experiements and the Tuskegee Syphillis study?
Guatemala = Deliberately infected to study treatment
Tuskegee = observed without treatment to study natural progression
Guatemala Syphilis Experiments
Around 1300 individuals (including prisoners, sex workers, psychiatric patients, and soldiers in Guatemala) were intentionally infected with syphilis, gonorrhea, or chancroid without informed consent to study penicillin. Happened in the 1940s but not uncovered until 2010.
