In the 1960s, as the US biomedical research establishment was starting to rev its engines, bioethicists called attention to a dark side to research, the abuse of human beings as subjects of research studies. The poster child for this was the "Tuskegee Study of Untreated Syphilis in the Negro Male," a study to see what happens to people when you don't treat them for a treatable disease. Like many such things, it started off with reasonable intentions. At its outset syphilis treatments were toxic with many adverse side effects. It wasn't obvious patients wouldn't be better off, on average, without treatment. But by 1947 a safe effective treatment for syphilis was available, penicillin. But the study didn't stop. It continued until 1972, only halted when details leaked to the press. The study is arguably the most notorious example of research subject abuse in US medical history.
But it wasn't the only one and it didn't take long for the government to require formal safeguards for research funded by tax dollars. Independent oversight boards were set up at each institution receiving federal research funds. These boards, called Institutional Review Boards or IRBs, must approve research protocols involving human subjects before the work can begin. Failure to comply can result in serious consequences for the institution. I have lived with the IRB requirements for most of my career. I won't say it has been fun. Often IRB decisions seem uninformed and capricious or both. But they serve a purpose and we learn to live with them. You can get used to anything, even a stone in your shoe. I also have no doubt we are all better off for having them. Like any member of a regulated community is chafe under the constraints.
But what constitutes human subject research? People in the social sciences and humanities also deal with human beings in their research, gathering information from them. Should they be subject to IRBs?
Oral history should not be subject to approval by institutional review boards, according to dozens of comments submitted by historians and others to the federal Office for Human Research Protections, which announced last October that it would amend the rules governing what kinds of research qualify for expedited review by the boards.
Some researchers and some boards, commonly known as IRBs, have interpreted the existing rules to mean that oral history is exempt from such oversight altogether. The boards were originally set up to monitor scientific research involving human subjects, but their scope has since expanded to include any studies of human beings, no matter what the field.
IRB oversight has been a sore spot for many scholars in the humanities and social sciences. Oral historians have been especially vocal about why they believe their work should be exempt from such review.
The American Historical Association weighed in with a letter to the research-protections office in late December expressing ?deep concern? about the proposed changes. ?We fear that, if implemented, the changes would severely limit our ability to collect information about the present and recent past for historians in the future,? the group said. (Chronicle of Higher Education)
I have no dog in this fight, as Mike Huckabee might say. I don't do oral history and it is clear all my research is appropriately subject to IRB approval. But I have a good deal of sympathy for my colleagues on the liberal arts campuses. Requiring IRB approval for oral history projects or most research in history that requires gathering information from people is, well, stupid.
I guess that almost guarantees they are going to require it.
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Why isn't FBI and CIA research covered by IRBs? That certainly has a lot of potential to harm the subjects. Not a small number of them have died during the process.
It's fucking ridiculous to have IRB oversight on nothing more than conversation between two people. If some nefarious social scientist thinks up a 21st Century variant on the Milgram obedience experiment, the participants can sue them for intentional infliction of emotional distress.
I'm currently reading through Alston Chase's Harvard And The Unabomber and if even half the misdeeds of the CIA Bluebird/MK-ULTRA program are true, our country has a deeply horrifying history of destructive human research. By that yardstick Tuskeege would be "an example of" and not even the worst one. Same for the Milgram experiments. The scale of those programs, like the concept of giving LSD-25 to a mentally handicapped 5-year-old, blows my mind.
Years ago I helped out as photographer for a local historian during interviews in elderly minority subjects' homes and from what I saw, they were really glad to be telling their stories and thrilled when they appeared in print. What sort of abuses should we be watching out for?
BTW-Federal Regulations STILL say that its okay to experiment on US citizens after notifying public health officials. IRB's only apply if and when there is an overriding need to involve the public. If they invoke the National Security Act, they can inform the public health officials, brief them on the experimentation, and then keep them from speaking out on it because of the act. That was put into place in the 1940's.
Pretty damned stupid if you ask me. Better to spray it in Russia or China from a B2. But thats just me.
Decrepit...check this out....http://www.newswithviews.com/Devvy/kidd257.htm
And of course we all remember those Hepatitis B experiments in 1978-1981 that introduced HIV with less than honourable intentions. This was a product of the War on Cancer. Of course, it is not the official history of today and has been trashed as a "conspiracy theory".
Today we are all being subjected to human experimentation. That GM food has not been adequately tested, and we are guinea pigs. This is not really discussed in the Homeland even though it is happening today and is a concern outside of the US.
So why are we puzzled about attempts to control oral history ?. What do you expect from the Ministry of Truth?. As Orwell said, control the present and you control the past, control the past and you control the future.
The news of today which becomes tommorows history is being controlled by the corporate media, and written history of yesterday is being controlled by publishers and in universities by government grants and the same tax free foundations who have funded Eugenics research from the 20's which has continued even today.
The American Eugenics Society was renamed as the Population Council in 1950's but it's mission is the same.
George Bush was asked a while back how he thought history would judge him. He said with a smirk on his face, "Well, I guess that depends on who writes the history."
Fifty years from now and the "Tuskegee Study of Untreated Syphilis in the Negro Male" may be erased from the history books. It is only came to be in our history of today due to the Ministry of Truth was far less powerful 40 years ago and those who remember the news of the day in 1972 still are alive. Once we pass on, so will this blemish.
http://www.newyorker.com/reporting/2008/01/07/080107fa_fact_elliott
The failure of the IRB system to stop what it was meant to stop can be found in a recent New Yorker article called "Guinea Pigging." The abstract [yes, the New Yorker calls it an abstract]can be found at the URL above.
Randy: IRBs apply for institutions doing research with federal funds and ALL NIH funded work. No public health officials are involved. All university research requires IRBs and IRB approval for biomedical research with human subjects.
I don't know, Randolph; contrails have enough well-known reasons to be considered bad without invoking conspiracy. There's stratospheric deposition of their CO2, their anti-icing and anti-biofilming additives, their nitrogen compounds and particulate emissions. It could just be ordinary military/industrial stupidity.
The most recent case of IRB stupidity I have heard was where a hospital had a procedure to reduce infections when setting IVs and other procedures, - worked - and they were forced to stop because it constituted an "experiment" but I can't find the reference now.
The problem with IRBs and many areas research center around "minimal risk" research, which would probably subsume a lot of oral history and other non-invasive research, that doesn't get into personal areas. IRBs have become laothe to apply these criteria because there are no good standards for it.
Biomedical research is not the only type of research currently subject to IRB approval. For example, psychological research is also subject to IRB. This applies to everything from social psychology experiments (like the Milgram or Zimbardo studies), cognitive psychology experiments (perception studies, etc.), and even personality research - most of which only consists of personality inventories (such as the Myers-Brig test, or the Block's CAQ) and interviews.
I'm not sure if personality research is also covered merely because it's just lumped in with the rest of psych research, or if there are concerns with the possibly detrimental effects of self-discovery, or concerns with confidentiality, or some combination of all of the above. However, how is this different from "oral histories"? If personality research is covered by IRBs, why not other social sciences?
Tasha: Pscych research is covered -- sometimes. Many liberal arts campuses don't submit there stuff to IRBs while medical campuses and big research universities mostly do. But there is lso political science and history and liguistics and much else that have not traditionally been covered by IRBs although to be entirely (and foolishly) consistent they would be. The reason not to do it is that it is a waste of time and effort to require IRB time and paperwork for oral histories, political science surveys, etc., etc. There is a point where quantitative differences in degree become differences in kind. I'm not arguing for myself. My work is appropriately and definitely covered by IRB rules. But my humanities colleagues on the liberal arts campus? Waste of time for everyone involved.
Psych research is definitely covered. At research universities and med schools, just about everything does get submitted to IRB. Journals routinely ask for human subjects review. If research is "exempt", e.g., minimal risk, disease surveillance, this determination needs to be made by an IRB or authorized official and that does not excuse proplr from providing informed consent.
Rich: That was always my impression but I am on a med campus where everything goes to the IRB. But I have been told that on the liberal arts campus there are pschology studies -- e.g., those done as student projects -- that don't get IRB approval and I think this is more common than most of us believed. Even student projects here have to get IRB approval. As you point out, "exempt" just means exempt from full Board review. It is still reviewed by someone on the IRB.