The question was simple, the answers not.
At the Presidential Commission for the Study of Bioethical Issues today, Commission Chair Dr. Amy Gutmann, president of the University of Pennsylvania, asked a panel of international experts on bioethics whether the so-called Guatemala incident could happen again. In Guatemala, from 1946 to 1948, a U.S.-funded research experiment deliberately infected people in a trial with sexually transmitted diseases and in some cases did not treat them.
“Of the many things that happened there, no, it could not happen again because of informed consent,” said Dafna Feinholz, chief of the Bioethics Section, Division of Ethics and Science and Technology, Sector for Social and Human Sciences, United Nations Educational, Scientific and Cultural Organization.
But she said there was great room for improvement in the current sets of regulations guiding clinical trials. She specifically mentioned the area of “how to enter negotiations about research projects, about what is relevant, and why is it being conducted.”
Others on the panel agreed that human subjects in clinical trials remained vulnerable today.
Francis P. Crawley, executive director of the Good Clinical Practice Alliance in Europe, championed the need for more transparency around clinical trials. First, he thanked the panel and Susan Reverby, the Wellesley College professor whose research uncovered the Guatemala experiments last year, leading President Obama to ask the Commission to investigate that study as well as whether federal funded research adequately protected human subjects in trials.
“I think this work by Dr. Reverby was done in an exemplary way as a historian, ethicist, and a human being,” Crawley said. “One of the things Dr. Reverby has done is to bring something out of darkness. And that is really, really important to us.”
He continued: “We need to consider carefully what we do as ethicists. Are we protecting human subjects? Is that what we are about? Are we justifying research of subjects? Are we advancing health? How are we advancing health? What are our roles and what should be our principle objective here? I think our primary objective should be health.”
Crawley said now there was a “trust deficit” between researchers and possible subjects of trials. He said that the U.S government, European governments and the World Health Organization have all moved quickly to promote more transparency of the clinical research.
But Commission member Anita L. Allen, professor of law and philosophy at the University of Pennsylvania, questioned whether transparency was the main problem.
“It’s often said that African Americans’ distrust of clinical medicine is due to a belief if a group is low enough in social status, (abuses) can happen in broad daylight,” she said. “Slavery and the Holocaust happened in broad daylight. So is transparency the key? Or is human rights and equality really the key?”
“I agree with you entirely,” Crawley said. “ … Trust is really the key issue here. It’s very important we maintain trust in research. … Transparency is in and of itself insufficient. It will never be sufficient. It is a necessary condition, but it is not sufficient.”
Commission member Christine Grady, deputy chief of the Department of Bioethics at the National Institutes of Health Clinical Center, raised another thorny issue: Do the interests of people participating in a clinical trial trump everything else?
Gutmann asked Grady to answer her own question.
“Sometimes the interest, the immediate interest, especially the medical interest of the individual at hand are not the primary focus of what is going on,” Grady said. “… The sort of struggle that has occupied many people for many years is what level of risk do we allow people to take if they are able to make autonomous decisions in the interest of science, in the interest of developing new knowledge that will help other people. That is really a very tough question.”
Johannes J.M. van Delden, president of the Council for International Organizations of Medical Sciences, said that in many cases “clinical research cannot be beneficial for the participants. … Usually there will be procedures that are harmful, or certainly not beneficial.”
The real questions are:
Where are the Tuskegee and Guatemala experiments happening right now?
How many are happening right now?
To say as Dafna Feinholz did that it could not happen because of informed consent is naive and shocking. The statement does not give one much confidence in the likelihood of consistent oversight.
There is an easily accessible trove of information on very ethically challenged research projects going on right now in the U.S. and abroad.
Transparency and trust are important but not primary. What is primary is to realize that a certain percentage of past, current and future researchers will have overly strong ambitions, an inordinately strong desire for financial reward and a lack of empathy for the research subjects, etc.
Only if it is accepted that the bio-ethical problems will be ongoing can we institute an intelligent oversight system that will help the research community work on the correct side of the ethical line.
This is only in reference to clinical research. It appears that nonclinical, interventional, nontherapeutic, involuntary human behavioral and biomedical research is presumed to either be non existent or is covered up or worse, victims of such experimentation are intentionally mislead as to who is behind it, what the experimentation actually is and what is being used in the experimentation.
It seems to me that in cases of clinical experimentation, there is more opportunity for redress since a victim can point to a time, place and a physician. It is the nonclinical studies that are more troubling precisely because it is harder to get at who is directing the research. For those of us who have stonewalled cases of communications interception, the problem is even more worrisome. And worse still, the use of fakes and fake groups with misleading information make it difficult for victims to compare experiences, unite, be heard, or even be taken seriously. It is as offensive as the research itself.
The other issue of course is that there is no oversight for all human subject research in the US, there is no country-wide regulation that limits research that causes intentional harm to victims (regardless of funding) and the attempts at passing stricter legislation though Congress have simply been ignored. What’s the point? Before the US applauds itself for its human rights concerns it should do a bit more navel-gazing at its human rights violations in more recent history. What’s the point of having committees and commissions if nothing really changes anyway? What happened to the recommendations from the ACHRE committee? Why is there no mention of human subjects experimentation that led to regulations like the Common Rule?
Why isn’t there a regulation that prohibits nontherapeutic, involuntary human subjects experimentation that puts a victim at more than minimal risks? Who (person, agency, department, institution) believes that their research interests trump my human rights? I do not consent and my trust level is in the negative number range.
This is only in reference to clinical research. It appears that nonclinical, interventional, nontherapeutic, involuntary human behavioral and biomedical research is presumed to either be non existent or is covered up or worse.
I would hope this can not happen again.Hopefully we understand medicine alot more than we did in the late 40′s. This is a real horrible experiment that i wwish the us never did.
This is quite an ethical dilemma. I’m not sure it can be boiled down to only Who will be harmed versus Who will be helped.
This is only in reference to clinical research. It appears that nonclinical, interventional, nontherapeutic, involuntary human behavioral and biomedical research is presumed to either be non existent or is covered up or worse.
I would hope this can not happen again.Hopefully we understand medicine alot more than we did in the late 40′s. This is a real horrible experiment that i wwish the us never did.
At PAHO we have experience implementing recommendations such as those that came out from the report on Guatemala. The PDF of the reference provides links that illustrate this and the great opportunity there is for collaboration and for promoting consistent and synergic approaches to strengthen research governance.
SAENZ, Carla; SAXENA, Abha; CUERVO, Luis Gabriel and PERIAGO, Mirta Roses. Guatemala never again: progress and challenges in the protection of research subjects. Rev Panam Salud Publica [online]. 2011, vol.29, n.5 [cited 2011-09-03], pp. 380-381 . Available from: . ISSN 1020-4989. http://dx.doi.org/10.1590/S1020-49892011000500012.
(PDF version provides links)
KRLEžA-JERIC, Karmela et al. Prospective registration and results disclosure of clinical trials in the Americas: a roadmap toward transparency. Rev Panam Salud Publica [online]. 2011, vol.30, n.1 [cited 2011-09-03], pp. 87-96 . Available from: . ISSN 1020-4989.
“The question was simple, the answers not.”
Of course.
Where are the Tuskegee and Guatemala experiments happening right now?