One of the commenters on yesterday’s post concerning the possibility that the uBiome project has commenced human subjects research without any IRB oversight did some nice research on the ethical and legal foundations of IRB oversight of human subjects research. His name is Gregory Gadow, and his home page and blogge are here.
The rest of this post is his work and expresses his opinion:
A Brief History of Medical Research Ethics in the United States
Comradde PhysioProffe has asked me to expand on this comment a bit and provide links.
First off, I’m on the Community Advisory Board (CAB) for the Seattle HIV Vaccine Trials Unit. CABs are found mostly in the context of HIV research but they are spreading to other areas; while an institutional review board (IRB) works to cover the collective ass of the researchers and make sure they are following federal law and world ethical standards, CABs work to protect the rights of study participants and to represent the voice of communities affected by human medical research. I’ve also been a participant in three different studies involving HIV vaccines; I mention this so folks will understand where my passion for the topic comes from.
During the war crimes trials in Nuremberg, the extent and depravity of Nazi human experientation came to light. As they were prosecuting these experiments as war crimes, the Council for War Crimes in 1947 set forth the Nuremberg Code. These ten points defined legitimate medical research and required, among other things, that it be done for the good of society, avoid unnecessary physical and mental suffering, be conducted only by scientifically qualified persons and always — ALWAYS — have the informed, voluntary consent of the test subjects without any element of force, fraud, deceit, duress or coersion.
While it was originally intended as a guideline for the trials, it became the basis for the Declaration of Helsinki, written by the World Medical Association and adopted in June, 1964. The Declaration has been revised several six times, most recently in October, 2008, and typically in response to major crises: the first, in 1975, was in response to the US’ own horrific research abuses (more on that below) while the fourth (1996) and fifth (2000) were in response to studies involving HIV/AIDS. The Declaration serves as the model for laws governing human medical experimentation in many countries.
The US dragged its heels on adopting the Declaration. Then in 1972, a scandal erupted over the Tuskegee syphilis experiment. This study, started in 1932 by the US Public Health Service, recruited 600 poor African-American tenant farmers in Macon County, Alabama: 201 of them were healthy and 399 had syphilis, which at the time was incurable. The purpose of the study was to try out treatments on what even the US government admitted to be a powerless, desperate demographic. Neither the men nor their partners were told that they had a terminal STD; instead, the sick men were told they had “bad blood” — a folk term with no basis in science — and that they would get free medical care for themselves and their families, plus burial insurance (i.e., a grave plot, casket and funeral), for helping to find a cure.
When penicillin was discovered, and found in 1947 to be a total cure for syphilis, the focus of the study changed from trying to find a cure to documenting the progress of the disease from its early stages through termination. The men and their partners were not given penicillin, as that would interfere with the new purpose: instead, the government watched them die a slow, horrific death as they developed tumors and the spirochete destroyed their brains and central nervous system. Those who wanted out of the study, or who had heard of this new miracle drug and wanted it, were told that dropping out meant paying back the cost of decades of medical care, a sum that was far beyond anything a sharecropper could come up with.
With the publicity surrounding the Declaration of Helsinki in 1964, people involved in the study began to question the ethical standards they were using. The passage of the Freedom of Information Act in 1966 allowed them and others to demand — and get — answers from the US government. The story made national headlines when the Washington Star published an expose on July 25, 1972, and the study was officially ended on November 6 of that year. In response to the scandal, the National Research Act of 1974 was passed, which made the institutional review board (IRB) a mandatory part of medical research in the US. The Act also created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to study the ethical and legal issues and make recommendations. The Commission’s final report was the Belmont Report of 1978 (text here), which was adopted by the Department of Health and Human Services as the Federal Policy for the Protection of Human Subjects, informally known as the Common Rule (because it is the set of rules common to all human experimentation in the United States.) The US government did not officially apologize until May 16, 1997, when President Clinton addressed five of the eight surviving study participants at a White House ceremony,
What was done cannot be undone. But we can end the silence. We can stop turning our heads away. We can look at you in the eye and finally say on behalf of the American people, what the United States government did was shameful, and I am sorry … To our African American citizens, I am sorry that your federal government orchestrated a study so clearly racist.
In summary, there are damned good reasons why IRBs are required in this country. Any and all efforts to avoid independent oversight should be viewed with very deep suspicion. At best, it is unethical; at worst…. Surely, I don’t need to elaborate on that. The Food and Drug Administration has a list of information sheets regarding IRBs.
I’m no lawyer, but it seems that uBiome’s own comments about keeping data and using it for research purposes puts it firmly in the arena of human medical research. This would be true even if they are just collecting data for the use of other researchers. Because federal law requires that information about a research group’s IRB be public, and because uBiome has been so cagey about releasing this information, is highly suspect.
Maybe it is time for the FDA and other appropriate federal agencies to get involved.
Regarding CABs, they appeared in the early 1990s in response to activism by groups such as ACT-UP!. The idea was to make sure that, despite the law, the gay community would not become the next group of Tuskegee sharecroppers. Today, most HIV research organizations around the world require that every unit involved in the research have a board of local laypeople to represent the community in the research process.