Tuskegee experiments hold valuable lessons
Tuskegee experiments hold valuable lessons
Training module offers lessons from the past
Most learned people know something about the experiments done on black men in Tuskegee, AL, in the early part of the 20th century: Syphilitic men were enrolled in a study without adequate consent or understanding, and ultimately refused effective treatment in the name of science. Such things, most assume, could never happen again. And yet, there are cases reported every year about patients in research projects who die needlessly.
In 2001, the world renowned Fred Hutchinson Cancer Research Center in Seattle was the subject of investigation over its Protocol 126 in which researchers were trying to find out if eliminating T-cells in donor bone marrow prior to transplant would eradicate graft-vs.-host disease. The patients, said a whistle-blower in the case, were treated as "laboratory rats."
"The issue is that the people in Tuskegee weren’t monsters. They didn’t start off to hurt people, rather they were trying to help people," says Kenneth D. Pimple, PhD, director of teaching research ethics programs at the Poynter Center for the Study of Ethics and American Institutions at Indiana University in Bloomington.
Pimple and his colleagues have created a learning tool about research ethics that focuses on the Tuskegee experiments. Called "The Least of My Brothers", it aims to show users how good people can end up doing bad things. "Most evil in the world isn’t perpetrated by evil people," he says. "It is done by ordinary folks who aren’t paying quite enough attention, who aren’t being careful enough."
Simply saying you were following orders or rules isn’t an excuse, either, he continues. "It is always your responsibility to speak up when you see bad things happen. The responsibility isn’t devolved to your superiors."
The program, available on-line at http://poynter.indiana.edu/sas/lb, costs $100 for the first 15 users at an institution and $15 for each additional one. The program groups users together into teams and includes on-line forums for discussion, Internet bulletin boards, and names and e-mail addresses of other users. Users are guided through the story of the Tuskegee experiments from the time of their inception in the early part of the 20th century until the exposure of the experiments in the 1970s.
The module includes letters, documents, pictures, and recreations of meetings so that the learners can see how what started out as a group of people interested in helping syphilitic African-American men degenerated in something that in the end was equated with Nazi medical experimentation. There are three episodes in the program, each with eight to 10 scenes. Many of the scenes conclude with an activity, such as a survey or participation in a bulletin-board forum online with other users.
The goals, according to the web site, include creating a general awareness of the history of the Public Health Service Syphilis Study at Tuskegee, an awareness of the ethical issues involved in the study, and an awareness and appreciation of the ethical complexity of the study.
Complex case still raises questions
Pimple, who has immersed himself in the study to create The Least of My Brothers program, still can’t understand how the Tuskegee study degenerated so badly. "Up until the time penicillin became known as a cure for syphilis, I can understand how these people made the choices they did. Until that point, I can’t say that the researchers were awful people." They weren’t lynchers, he adds, or cross burners. "They were the kind of racists that ordinary Americans were. They thought that blacks were inferior. They didn’t want to associate with them. They had a condescending and patronizing attitude. In a sense, they had an attitude like a farmer would towards livestock: the herd has a problem, let’s solve it for them, not with them."
Pimple says he wants the complexity of the case understood. "The beauty of this case is that it was terrible. It makes a real point about research ethics. But I want people to come away with more than a sense that Tuskegee was bad. I want them to have a good appreciation of the moral ambiguity and complexity. I want people to see it is complicated."
For those who design and run experiments that involve human research subjects, Pimple says he hopes they gain knowledge that they have blind spots and that it is useful, if not imperative, to get someone from outside the process and outside the expertise of clinical research to look at what they are doing. "There is no way this experiment could have gone on if there was annual outside review," says Pimple. "Institutional Review Boards don’t solve all problems, but one could have stopped this."
The program’s strength is that it lays out the myriad of influences on research that uses human subjects, says Jim Vander Putten, chairman of the Institution Review Board (IRB) at the University of Arkansas at Little Rock. "Most educated people have an idea of what happened at Tuskegee," he says. "But this program does a great job of providing specifics and delving into the decision making processes surrounding human subject research."
Vander Putten used the program for his own professional development. He was impressed enough that this fall he is going to provide the program for the members of the IRB as a training program. Shelling out the registration fee seems a cheap yet useful and educational perk for committee members who are lucky if they get a pizza provided during a meeting.
Pimple approves of such a use, hoping that IRBs would use it as a way to spur discussion.
Given that most researchers are aware of the horrors of the Tuskegee experiments, some may ask why bother. But Vander Putten says there are two reasons. "First, if you don’t know your history, you are bound to repeat it. I think it is vital to cultivate a deeper awareness so we don’t make the same mistakes of the past. More importantly, the web site requires users to engage in the scholarship of application. I think ethical principals are great to help you get into the ballpark for ethical decision-making. But this effectively gives you the real substance for putting ethical principals into practice."
The federal government recently required all faculty staff and students who use human subjects to complete mandatory training programs. They don’t say what the training should include. However, Vander Putten thinks this training module would be useful for many as a way of meeting that obligation. "Anyone interested in clinical trials could get something valuable out of this," he says.
The past revisited
Pimple says that in a time of national insecurity over national security, it is particularly important to be aware of the ethical pitfalls and pratfalls of researchers who went before. "I think this could definitely happen again," he says. "If the Department of Homeland Security wants to do something in secrecy, outside the oversight of an IRB, something really ugly could be undertaken and go on for a while."
You don’t even need to wait for something secret, says John Pesando, MD, PhD, the whistleblower in the Fred Hutchinson case in Seattle. Such things can, and do, happen now. "There is a strong conviction among many researchers that what they are doing is good for humanity," says Pesando. "They believe that mankind will be better off in the end, and the ends justify the means."
While Pesando acknowledges that human medical research is essential for the progress of medicine, and that human subjects are, to a degree, always lab rats, researchers must be sure and thus must ask themselves — if the research subject would be better off with conventional treatment than with the experimental one. "What we do can’t subject them to a worse outcome," he says.
Even with IRB oversight, something bad could continue for several years, says Pimple. "If the system works properly, something bad would be stopped within five years. It wouldn’t go on for 10 years, let alone the 40 that Tuskegee lasted. But if someone lies to the IRB, it can go on longer."
That, Pimple adds, is why it is important for every person involved in human subject research to understand the past and their personal responsibility for not repeating it.
IRBs themselves may be part of the problem, says Pesando. "The lay people on the committees usually defer to the medical people. They are also selected by the institutions and there may be some implicit understanding they will follow the institutional line." As for the medical and scientific people on IRBs, they are being asked to police their peers and superiors. "And we know how well that works," Pesando says.
"I assume that research administrators are very courageous and doing important work. But research protocols have to be scrutinized because medical research can do both good and harm," Pimple says. "I believe that researchers want to do good science, in an ethical manner. But I also believe they are pro-research, pro their institution’s researchers, and pro their institution."
People become overly protective of their relationships with research, researchers, and their particular institution, he continues. "Considering they have daily reminders about all three of those relationships, I think occasionally it is in the best interest of science and those who are involved in it to see the bigger picture and be reminded of the things that can go wrong. Thinking morally is just like any other skill. It has to be exercised to keep it sharp."
Sources
- Kenneth D. Pimple, PhD, Director of Teaching Research Ethics Programs, Poynter Center for the Study of Ethics and American Institutions, Indiana University, 618 E. Third St., Bloomington IN 47405-3602. Telephone: (812) 856-4986.
- Jim Vander Putten, Chairman, Institutional Review Board, University of Arkansas, Little Rock, Department of Educational Leadership, 2801 S. University Ave., Little Rock, AR 72204. Telephone: (501) 569-3572.
- John Pesando, MD, PhD, Consultant, 1066 E. Blain St., Seattle, WA 98102. Telephone: (206) 323-3977.
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