Is The uBiome Project Performing Human Subjects Research Without IRB Approval? (UPDATED AGAIN) »« uBiome Has Made A Public Statement About IRB Compliance Of Their Human Subjects Research

The Ethical And Legal Foundations Of Institution Review Board Oversight Of Human Subjects Research

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
Gregory Gadow

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.

Comments

  1. Mattir, Another One With Boltcutters says

    So as one with a doctorate in a social sciences field, but unaffiliated with either an educational or research institution, where precisely would I obtain IRB approval for a research project that I wished to pursue? I fully appreciate the importance of IRBs, but the requirement for IRB approval does seem like quite a barrier to entry for a researcher who works outside of the traditional academic setting.

  2. DrugMonkey says

    Makes you sick, thinking what was done doesn’t it? There are reasons for IRB “red tape” people. And good ones too. Stop stamping your crowdfund, hipster, generationally frustrated adolescent feet and wise up.

  3. Mattir, Another One With Boltcutters says

    After some poking around, I see that there are commercial IRBs, so IRB approval could easily be added to the crowdfunding effort, especially for something as large as the uBiome project.

    But it really bothers me to see those within academia (with automatic access to in-house IRB resources) whining about those researchers who are outside the academic research world instead of helping them find the resources to get IRB approval. And for the record, commercial IRB approval can be VERY expensive – in the thousands to tens of thousands of dollars. Which essentially means that I will never do any research on the impact of nature education programs on inner city children, since I would have to pay out of my own pocket for IRB approval and IRB approval would consume 15-20% of my annual income.

    Yes, research abuses were sickening. But that doesn’t mean that only the well-funded (including crowd-funded) and/or academically-affiliated should have access to IRB resources.

  4. says

    Comradde, thanks for letting me post this to your blog.

    Mattir, the point of IRBs is to make sure that the human rights violations and willful disregard that have marked so much of the medical research done in and by the United States — not just the Tuskegee study, but also the nuclear “down wind” tests, and the experimentation done on US service members, and the recently disclosed study the US did in Guatamala where prostitutes were DELIBERATELY infected with syphilis to create the test subjects needed to prove the efficacy of penicillin against the disease — do not happen again.

    IRBs are not fly-by-night groups of ill-educated laypeople: they are typically professional ethicists and lawyers and researchers. It can be difficult to assemble the necessary range of skills, and there is a lot of work involved in approving a study, which is why they cost a lot. The alternative is to go back to the bad old days, which I hope you are not proposing. IRB approval is the law, so it is a necessary cost of doing research. If you have a problem with this, take it up with the Republicans: I’m sure they’d be happy to remove the financial barriers to using your grandparents or daughters as guinea pigs.

  5. Reverend PJ says

    But it really bothers me to see those within academia (with automatic access to in-house IRB resources) whining about those researchers who are outside the academic research world instead of helping them find the resources to get IRB approval.

    Just out of curiosity, have you ever been through the IRB process as an investigator at a university? Do you understand that damage the uBiome could do to public engagement in science? Have you thought about the risks they’re taking? My complaint with uBiome is not that they’re non-academics (several of the team are in fact academics) but rather that their evasion of the question of about their IRB makes me very concerned about their attention to detail, compliance with the law, and if they can be trusted to follow through with their obligations.

    Yes, research abuses were sickening. But that doesn’t mean that only the well-funded (including crowd-funded) and/or academically-affiliated should have access to IRB resources.

    You’re absolutely correct, and what exactly do you propose to do to change the situation with regards to cost? You could collaborate with someone at an educational institution. You could apply for a grant to cover the costs. You could lobby for subsidies for independent researchers. If you think your research is valuable enough to conduct then show some adaptability in how you’re going to get the work done.

  6. Mattir, Another One With Boltcutters says

    Yes, I have had experience with IRBs – I worked as a graduate student on a couple of different research projects, one of which was funded by a largish multi-year federal research grant, and my own dissertation research (which wasn’t part of a professor’s larger research project) went through an IRB. I am not arguing that uBiome should not go through an IRB, or that IRBs aren’t incredibly valuable. Weaseling about whether one’s research has been through an IRB is unethical and potentially very harmful.

    I am arguing that there are structural issues in the culture of human subject research that exclude researchers without institutional affiliations and that this might not be a good thing.

  7. Mattir, Another One With Boltcutters says

    I also saw several patients who had been part of the VA’s infamous antipsychotic dose-reduction study and experienced lasting harm as a result. So yes, I know why IRBs are important and that they are required by law.

  8. Reverend PJ says

    I am arguing that there are structural issues in the culture of human subject research that exclude researchers without institutional affiliations and that this might not be a good thing.

    Then work to change them. If you are working to change the structural problems, then great.

  9. says

    Jessica:

    Maybe you are thinking of this comment that you posted not on this thread, but on another one on my blogge?

    Hello it’s Jessica from uBiome. I just wanted to point everyone to our new FAQ on this subject on completed indiegogo page at http://www.indiegogo.com/ubiome. I apologize for the confusion on this so far, but we have of course considered the ethical and legal issues involved. Although IRB approval is not required for us to provide our primary service of microbiome compositional analysis and interpretation for private parties, we have planned to do so once our crowdfunding campaign ended, which occurred two days ago.

    I appreciate the dialog here on this blog. Although I think the tone of the original blog post is unnecessarily combative, we are glad for the focus on ethical oversight, and share the goal that citizen science be conducted in a thoughtful, privacy-aware, and ethical manner.

Trackbacks

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>