The blog of the Presidential Commission for the Study of Bioethical Issues

In clinical trials, questions around community rights

At the final session today of the Presidential Commission for the Study of Bioethical Issues, one issue that rose repeatedly was the importance of involving the community in discussions around ethical issues in clinical trials.

“A lot of people talked about individual rights and community rights, but how do we take that into consideration and understand more about the community rights?” asked Commission member Dr. Raju Kucherlapati, the Paul C. Cabot Professor in the Harvard Medical School Department of Genetics. “How do you define the community? Is it the town or small city? Is it the country? The world? The implications on how you define this are very important.”

Dr. John R. Williams, a consultant with the World Medical Association, said it was a question that still confounds experts. “It’s an evolving concept,” he said. “It differs from one environment to another. .. In the African context, a tribe, or clan, is pretty well identified with a recognizable leadership. It’s more difficult in the U.S. and Canada where there are large immigrant populations.”

Commission Chair Dr. Amy Gutmann, president of the University of Pennsylvania, had a related question: How important were community rights? She brought up the case of the U.S.-funded Guatemala experiments from 1946-1948 during which investigators deliberately infected trial participants with sexually transmitted diseases and, with some, did not treat them.

“As far as we know in Guatemala, the Guatemalan government agreed to the experiment,” she said. “As we know today, getting the agreement of governments in many cases does not pose a high bar. Raj asked a very, very important question: What is the value you see in community consultation, and at what level is it important?”

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, said there were several benefits of community partipation.

“The added value is more involvement from the community and knowing better if this (research) is responding to what the needs are,” she said.

That only led to another question – again from Kucherlapati:

“When we think about benefits accruing to the community, how would we consider that? Do we consider only those regions in which trials are conducted, or do we consider the benefits to the world as a whole – drugs that benefit everybody?”

The Commission will be studying the issue of protecting human subjects in domestic and international trials throughout the year and is expected to make its recommendations to President Obama late in the year.

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6 Comments to In clinical trials, questions around community rights

  1. William Kidega's Gravatar William Kidega
    May 20, 2011 at 6:51 am | Permalink

    Very inciting debate. I have been specifically fascinated by Dr Raj’s questions i.e. “How to define the community” and it’s contextual variation, and “What is the value seen in community consultation and at what level it is important”

    Very useful questions to consider when conducting clinical trials.

  2. Dena S Davis's Gravatar Dena S Davis
    May 24, 2011 at 6:34 am | Permalink

    “Community” is like “dignity”: a warm and fuzzy word that is usually undefined and that can do a lot of damage if used carelessly. Some phrases, such as “the Jewish community,” are truly meaningless. If certain community organizations are useful conduits for strengthening the understanding and autonomy of the individuals who are being asked to participate in clinical trials, that is obviously a good thing. But “communities” can be authoritarian and can fail to represent all those whose interests are at stake, especially women and minorities. Self-appointed community spokespersons are often heavily invested in a particular narrative. I challenge the Commission to ask itself what “community” brings to the discussion, other than as an aggregate of individuals. Communities don’t have rights and interests–people do.

  3. Liliana Connor's Gravatar Liliana Connor
    May 31, 2011 at 12:32 am | Permalink

    On the subject of “Questions around community rights in clinical trials” Dr. Raju Kucherlapati asks “How do you define the community?” and whether that community is at the national or international level …

    So that the horrors of the Guatemala case are not repeated, if this country is responsible for experimenting nationally and/or internationally on non-consensual human subjects, then it should assume its full ethical responsibility by providing the community of human subjects — both nationally and internationally — with the ethical right of “informed consent” regarding the experiment they are being subjected to. This ethical, human right, of “informed consent” should be an inalienable right for the community of human subjects. The most ethical behavior should be to inform this community of subjects to be experimented upon — prior to the beginning of the study — that they have been selected for a certain experiment, and what this experiment consists of, and that “if you agree to participate you should provide us with your written consent”. If the most ethical behavior of informing the community of subjects prior to the study in order to obtain their “informed consent” has not dutifully taken place, then an emergency measure should immediately be enacted to remedy this serious lack of ethical behavior on those responsible for conducting the experiment. The Guatemala scenario should not be continually repeated where the community of human subjects are only able to find out about the details of the experiment after years of physical damage that may not be reverted. This type of repeated scenario only gives rise to the same kind of consequences as the Guatemala case: serious liability on the part of the government toward the community of human subjects at the national and/or international levels, and continuous exposure of the government — both nationally and internationally — as an entity that has no concern for, or interest in, responsible ethical behavior towards the community of human subjects of experimentation and their fundamental human right of “informed consent”. To avoid this undesirable situation that continually repeats itself, the best option for the government would be to announce that it will cease, from this day forward, all non-consensual human experimentation and that it will strictly enforce total compliance from all parts of government –at the federal, state and local levels– with providing the right of “informed consent” to all human subjects of experimentation. Included in this full compliance, provision must be made for the government to also warn any private entities performing non-consensual studies — such as private contractors, universities, pharmaceutical labs and scientists — that it will use the full force of the law to prevent any future occurrence of non-consensual experimentation, which is a total violation of human rights that will never again be repeated. By instituting such important and necessary measures which have been outstanding in this day and age, “another Guatemala case” would never happen again.

  4. Ignacio Mastroleo's Gravatar Ignacio Mastroleo
    July 16, 2011 at 3:21 pm | Permalink

    I believe that to address the question about community rights there should be incorporated an analysis of the moral and political responsibility of the host society of research. This is somewhat captured by the concept of “administrative division” or “subnational entity”:

    “An administrative division (or subnational entity) is a portion of a country or political jurisdiction, established for the purpose of government. Administrative divisions are each granted a certain degree of autonomy, and are required to manage themselves through their own local governments. Countries are divided up into these smaller units to make managing their land and the affairs of their people easier. For example, a country may be divided into provinces, which in turn are divided into counties, which in turn may be divided in whole or in part into municipalities.” http://en.wikipedia.org/wiki/Administrative_division

    Quoting Dr. Raju Kucherlapati “How do you define the community? Is it the town or small city? Is it the country? The world? The implications on how you define this are very important.” As it might be implied in Dr. Kucherlapati’s words, administrative or political divisions have particular implications with regard to the moral obligations of the researchers and sponsors of research trials. As Dr. Amy Gutmann stated “As far as we know in Guatemala, the Guatemalan government agreed to the experiment”. If this proves to be true, the different chain of Guatemalan political officials involved in localizing the syphilis study in their own territory have a special moral responsibility because of the special relationship they have with the research subjects as their political and administrative representatives. In an abstract level, this is the same moral responsibility American political officials have towards their citizens and citizens abroad in virtue of the conduct of Dr. John Cutler, a U.S. Public Health Service medical officer.

  5. July 28, 2011 at 3:00 pm | Permalink

    Very interesting debate indeed. As a medical professional (physical therapist and physical therapy marketing practitioner) I understand the need for clinical trials. But I also believe that the people that will be affected by the tests should be well aware of what’s happening.

  6. August 25, 2011 at 9:38 am | Permalink

    Yes, this is a very interesting debate and I am sure it will go on forever. Research has always been a tricky thing and will always be that way. some people feel that you should be allowed to do whatever research you want and others say you must stay within certain guidelines. to me it boils down to generalization of the study. if you only took a small group of rural people in a far away land you can not generalize their behavior to the whole world.

  1. By on July 28, 2011 at 10:05 pm

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