The Problem Of Informed Consent
June 27th, 2007
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In American science and medicine, the concept of informed consent owes much to the infamous Tuskegee syphilis experiment in which more than 300 American blacks were treated as guinea pigs to study the long term of effects of untreated syphilis. Despite the fact that Penicillin was discovered in the 1940’s–the experiment–started in the 1932, continued till 1972, when Jean Heller of the Associated Press broke the story. The effect of this outrage were widespread: institutional review boards in universities for conducting experiments involving human subjects and the establishment of the concept of informed consent. However, despite its widespread adoptions over the years, informed consent remains a grey area as this New York Times story suggests,
As the Karitiana Indians remember it, the first researchers to draw their blood came here in the late 1970s, shortly after the Amazon tribe began sustained contact with the outside world. In 1996, another team visited, promising medicine if the Karitiana would just give more blood, so they dutifully lined up again…But that promise was never fulfilled, and since then the world has expanded again for the Karitiana through the arrival of the Internet. Now they have been enraged by a simple discovery: their blood and DNA collected during that first visit are being sold by an American concern to scientists around the world for $85 a sample.[link]
The scientists are claiming that they have followed all ethical standards, and there are no pecuniary benefitsto be derived from the project. The Amazon people on the other hand feel cheated as they think they have not benefited from contributing their blood–worse, promises made to them in the form of free drugs have not been kept.
I think there are two important issues here. First, it is doubtful whether the Amazon people could have given informed consent as it is commonly understood; for thousand of years they have lived in isolation (exactly why their blood is so valuable), and it is questionable whether scientists explained their research in terms they could understand. Second, regulatory environment in developing countries remains weak. With their biodiversity, many developing countries are prime targets for researchers. Though some like India do have stringent laws, are they really followed? Are there bodies to ensure that the rights of the human subjects are respected? With the increasing number of Randomized Control Trials being held in developing countries, this is the something their governments must look into urgently.
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2 Responses to “The Problem Of Informed Consent”
bongopondit June 27th, 2007 at 9:21 pm #
Informed consent is tricky even with the so-called educated public in developed nations. But in addition to informed consent, participants in trials are almost always paid in cash. The question is that was there other remunerations provided to the tribes other than promises of future medicine and benefits. The latter is extremely open ended - you may have to wait years for the researchers to make substantial findings.
Hilton Pereira da Silva August 17th, 2007 at 11:32 am #
Ethical Humanitarian Medical Work, Not Biopiracy
In several recent news releases published in Brazil and reproduced worldwide my name has appeared linked to a case of biopiracy even though I have never been called to talk with the journalists. The news deal with the sale of immortalized cell lines of Brazilian Indians by the US company Coriel Cell Repositories.
In August of 1996 I worked as the anthropologist consultant in a documentary film for the Discovery Channel about the Mapinguari, one of legendary creatures that are supposed to live in the Karitiana Indian territory in the State of Rondônia, Brazilian Amazon. Since I am also a trained physician, with a Master’s degree in public health and several years of work experience among rural Amazonian populations, upon arrival at the Karitiana village I perceived that their health situation was extremely precarious and, even though their health post received medications from the documentary team, several people in the village were at risk of dying of dysentery, dehydration, malaria, tuberculosis, flu etc. In a conversation during filming the Headman of the tribe asked, in the name of their Karitiana Indian Association, if I could stay a little longer after filming and help them with emergency medical care as, according to him and the tribe’s health agents, several months had passed since they were last visited by a physician from the Brazilian Indian Service (FUNAI). After the end of filming, and after the okay of the local FUNAI officer, I stayed for three more days during which I attended, as a physician, at the tribe’s health post, and also at the huts of those who could not go to the post. Overall I attended emergencially and for humanitarian reasons exclusively everyone who requested my professional medical assistance. In order to try to help improve the diagnosis of some illnesses such as malaria, hepatitis, tuberculosis, viral diseases, anemia and others for which I could not provide a diagnosis based on clinical evidence alone some blood samples were drawn, and taken to be analyzed at the Instituto Evandro Chagas/FNS, in Belém, Pará. Samples were only taken of the people I considered more severely ill or that I could not make a final clinical diagnosis. Since I did not have adequate storage equipment in the field (as I did not intend originally to provide medical care for a whole tribe and had only brought a basic emergency kit for myself and the TV team), the blood coagulated and, I was told at FNS, was no longer suitable for biochemical analysis. In order to try to recover any useful information from the samples, I took the material to the Federal University of Pará, where I deposited all the vials collected. I asked colleagues in the department of genetics, as a favor, that when possible they tried to see what kinds of diseases they could identify from the samples so we could report them to FUNAI and the Karitiana. As the news about the Coriel Repositories came out in the press in 1997, the material was never touched by anyone at the University, and the 54 vials were delivered to the Ministry of Justice of Rondônia upon their request, in 1998. All the blood samples collected during my emergency medical work for the Karitiana went to the University, they never left Brazil, and they never had any commercial purpose. To conduct research or commercialize any biological sample without proper consent of its donor is unethical and immoral, and it is against my principles and the principles of those with which I have worked throughout my life.
With the volunteer help of Denise, who is Brazilian, who is not my wife and who is not a health professional as some reports have indicated, and simply helped with complementary activities such as playing with the children as I attended their parents, I provided, at their request, lawful emergency humanitarian medical attention to the Karitiana, with the best of my knowledge. I did not promise them future medical services as this is the role of the Brazilian Health Ministry, and I did nothing to hurt the interests or the culture of the Karitiana or any other people with which I have worked in over fifteen years of anthropological and medical service in the Amazon. A complete report of my emergency medical activities in the village was sent to the Karitiana Association, to the FUNAI in Brasília and in Rondônia, to CIMI and to all State and Federal authorities that have sought information about the case.
Several scientific papers published in the 1980s and 1990s, show that the Native American biological material for sale by Coriel comes from the Stanford/Yale collection and was gathered in the 1980s by North American researchers led by Dr. Francis L. Black, a world renown geneticist. The material was already announced for sale in April of 1996 in the USA fully five months before my first and only stay among the Karitiana, hence it is impossible that I have anything to do with Coriel’s samples. I never had any dealings with Coriel or any other commercial enterprise in the USA, and I have never been in any other Indigenous territory in Brazil. On February of 1997 I and other Brazilians tried to contact Coriel about their material and talked with Brazilian politicians about the need to investigate the legality of Coriel’s procedures. We received no answer. Since 1997 there have been dozens of reports published in newspapers and on the web presenting these facts in a distorted manner and indicating that I sold the Indian samples to Coriel, instead of acknowledging my clear and only intent which was to provide the Karitiana with emergency medical assistance. This irresponsible and wrong information published has generated a Federal Court case against me, and has seriously hampered attempts of other physicians and researchers to work among Indigenous populations, which is well known, are in extreme need of assistance. I have responded immediately to all news about this matter that come to my knowledge; however, the grotesque errors continue to be published.
Biopiracy, as all forms of piracy, is a matter to be seriously investigated and fought against by authorities, scientists, the public and the press worldwide. The commercial use of biological products without benefit to their donors is immoral, unethical and should also be illegal in all countries. As a Brazilian citizen, a health professional, an anthropologist and a scientist it is my duty to protect the best interest and well-being of the people I work with. This has been my practice all along my professional life. As a professional with dozens of publications and a faculty at the Universidade Federal do Rio de Janeiro all my contact information is easily accessible on the Internet, and I have always made myself available to anyone interested in knowing the truth about this horrible situation in which my name was involved. I have been accused of barbaric acts when in fact I only attended the emergency medical call of a native tribe in need and followed the mandate of the Brazilian Code of Medical Ethics, in its Articles 57 and 58. It is very unfortunate that instead of investigating the truth, reporters and news agencies care only for sensationalism, regardless of its costs to peoples’ lives.
Prof. Dr. Hilton Pereira da Silva, Department of Anthropology, Museu Nacional/UFRJ. ( hdasilva@acd.ufrj.br ).