i doubt it will be very much
i doubt it will be very much different from how they are conducted at present. http://www.technologyreview.com/printer_friendly_article.aspx?id=16815This article has observations about drug trials in India. In “A Nation of Guinea Pigs,” Kahn describes the uncomfortable fact: that economic disparity between investigators and subjects in human research creates possibilities for abuse and coercion — possibilities that we do not really know how to manage. Kahn worries that payments to hospitals and doctors, which are meant to cover the costs of running and overseeing a trial, sometimes serve as bribes, encouraging improper human experimentation. She questions whether trials in remote areas receive proper oversight, from either the Indian government or foreign institutions. (Indeed, pharmaceutical trials that do not receive government funding are overseen by commercial institutional review boards, which are paid by the companies they are supposed to be monitoring — an obvious conflict of interest.) Kahn does not demonstrate specific wrongdoing or scandal. But she clearly explains the perverse incentives that might encourage unethical behavior.There are, however, very strong medical, scientific, and economic arguments for conducting clinical trials in the poor world. The drugs tested might be intended for the population testing them; the trials might benefit from genetic diversity; or the trials, usually the most expensive part of the drug development process, might be cheaper. Given that clinical trials will be conducted in the poor world, what would be a better system?The ethical requirements for human research were established by international agreements such as the 1964 Helsinki declaration. [ The Nuremberg Trials of medical experimentation crimes and then later in America the Belmont Report laid down guidelines.] They include various commonsense rules: for instance, physicians ought to consider the health and well-being of subjects above other considerations; any adverse effects that occur during the course of a study should be scrupulously monitored, reported, and treated; researchers must fully communicate potential risks and benefits; and subjects must not be coerced into participating. Most importantly, the subjects of a trial should bene-fit personally from the results of the research (that is, they should not be induced to participate in a trial for solely economic reasons).But obvious difficulties arise in interpreting these principles and applying them in impoverished settings. A common dilemma is, Just what constitutes excessive inducement? If researchers pay for their subjects’ transportation and lunch, or reimburse them for missing a day of work, is that a bribe? What if they offer direct payments?Informed consent is particularly elusive in places where patients are not well educated and where doctors’ authority looms large. Informed-consent agreements are lengthy, bureaucratic documents. One recent improvement is to supplement documents with -visual aids and require patients to answer a brief quiz to ensure they have really comprehended the nature and terms of the transaction. It is important that patients understand they may leave the trial whenever they wish and will -neither be punished nor lose their primary health care.Among the most vexing questions is, Who should oversee the people who oversee clinical trials? A variety of promising initiatives, sponsored by international bodies like the World Health Organization (WHO), may help these groups to grow stronger. WHO is funding projects that teach ethics and provide infrastructure. This sounds sane: American and European private and public institutions cannot provide the oversight required for ethical clinical trials in the poor world, particularly when American and European pharmaceutical companies are involved. Helsinki Agreementhttp://www.wma.net/en/30publications/10policies/b3/index.html Belmont Reporthttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html