Another rationale we heard was cost. It can be less expensive to do research in a developing country than in the United States. However, we also heard the argument made that, sometimes, not counting some of the ancillary costs of research makes it appear that research abroad is cheaper. If researchers addressed all the social and medical needs of a population — their underlying, more holistic health concerns — then we might realize that research in these countries is more expensive than it seems. But people are looking for cost-effective places in which to do this very expensive research.
Unfortunately, to some extent it is also a lack of regard for the human rights of people in developing countries that may have prompted some researchers to seek out these domains for this research. We heard a combination of reasons.
TR: Now that you have this information, what is the commission doing next?
ALA: Our commission has been asked, with specific respect to the Guatemala incident, to look at the circumstances under which that research took place. In that study we will be looking at the underlying causes and context of past atrocities.
We are also looking prospectively at how contemporary regulations and laws in the United States might prevent such things from happening again. The commission will be looking toward ensuring that, from a policy point of view, we have in place the rules and standards we need to make it unlikely that federally funded research would ever be used for a horrific purpose in the future.
TR: What are the current policies that are designed for this purpose?
ALA: There are federal ethical standards today that have been in place since Guatemala happened. Those standards apply to all federally funded research, no matter where it takes place. Those standards also apply to all human-subject research in the United States, whether it’s federally funded or not.
One important standard is informed consent. That means that the researcher is obligated to disclose the risks and benefits of the research, and then to get the person’s permission to, in light of those risks and benefits, go forward.
A second important condition is that the privacy and confidentiality be protected. Third, there’s a requirement for an institutional review board. This requires that there be a group of people convened whose purpose it is to examine the research protocol and to ensure that the safety and rights of the research subjects are protected in the course of the research.
TR: In terms of clinical trials in the United States, studies continue to be done on volunteers in the federal prison population. What kind of research is this exactly?