When an subject is controversial, one cannot hope to tell the truth. One can only show how one came to hold whatever opinion one does hold. One can only give one's audience the the chance of drawing their own conclusions as they observe the limitations, the predjudices, the idiosyncracies of the speaker.

- Virginia Woolf

Wednesday, March 14, 2007

Opinion : Research on vulnerable populations

Submitted for a grade as part of my medical ethics class:

Medical research in the western world (supposedly everywhere) is bound by local laws to adhere to a set of human rights protection guidelines modeled after the Nuremberg code. (Murray 792) In the United States, these ethics laws are also supplemented with rules to prevent egregious cases of misconduct such as the Tuskegee trials. (London 790) The general aim of these laws is that the researchers should always minimize the harm to potential subjects. (Friedman et. al 805) The problem is that these laws are too restrictive and can get in the way of beneficial research. This becomes an issue when a small amount of potential harm can bring a large amount of potential good, a classic "the ends justify the means" problem.
The first group of vulnerable subjects is children. It is clearly necessary to determine the effects of medicine or treatments on children before it is given to them, but to determine these effects, clinical trials are needed. Clinical trials all carry some level of risk, and therefore the trial can be generally defined as child endangerment. This line of reasoning however leads to the absurd view that it is not ethical to give any medical treatment to children, yet of course, it is not ethical to let them suffer either. Edward Jenner's vaccine experiments on local children would now be considered a serious ethical violation, yet that violation has saved millions of lives. The key to vulnerable populations who are mentally incapable of consenting themselves (children, mentally handicapped), is who should be allowed to consent for them. (Murray 794) The clear answer should be someone who has the child's best interests in mind. This can be the parents, government social workers, or an independent counsel appointed on behalf of the child. It should not be someone who has a financial stake in the outcome of the trial, however. The problem is that parents may second-guess themselves (as in the KKI trial) and an independent advocate should see little reason to put a child in a potentially risk experiment. When the researchers pay the family on behalf of the children, this just further complicates the issue. A possible solution to this problem is to pay the child with a deferred annuity (maturing when the child turns 18 or so) so that the financial incentive is for the subject and the guardian's actions are forced to be altruistic.
Another population of vulnerable subjects is prisoners. This is different from children in two key ways: first, the prisoners do have the ability to consent, but second, their personal freedom is restricted. The freedom restriction gives the researchers a greater level of control, even if that control is only perceived. Unlike the children, the prisoners cannot simply walk away from the experiments, and their level of personal responsibility is diminished. On the other hand, prisoners have other civil rights restricted, such as the rights of privacy, freedom, voting, and in some cases life. As society already considers prisoners less "human" than the general population, it may be justifiable to use this population for particularly high-risk trials. The only way to justify any clinical trial, or any action that can cause harm for that matter, is that the outcome will be of a greater good. In this light, the intentions of the researcher must be benevolent. The intent or the researcher is how a trial should ultimately be judged. If unexpected side effects occur, if mistakes are made, if the treatment does not work, or even if a vulnerable population was exploited, this is the inevitable consequences of scientific-medical progress. As long as the mistakes and exploitation was not driven by greed or anger, then the researchers should take note and not be held liable.


Disclaimer: I am currently NIH certified in human clinical trials and have helped to conduct trials in children

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