Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues

National Academies Press: "Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues"

This new report from the National Research Council is drawing press attention today.

Currently U.S. standards for pesticide dosages are 100 to 1000 times less than the toxic level in animals, as determined from animal testing. Were the pesticides to be tested in humans, a safety factor of ten -- imposed for possible response differences between species -- could be reduced or eliminated. This reduction could make it possible to use some pesticides in some applications that are unacceptable under current regulations. The question is, is testing in humans ever justified for pesticides.

This seems to me to be a K4D-related ethical question. Is it ethically acceptable to obtain certain kinds of knowledge that may be useful for development if doing so puts volunteers at risk, and if those volunteers will not personally benefit substantially and directly from the knowledge gained.

Certainly there are far too many historical examples of researchers, carried away with their enthusiasm for their work, imposing on or allowing research subjects to undergo undue risks. Regulation plays an important role in protecting against such excesses.

The real question in this case, however, is whether people with free will fully informed of the risks that they will undergo, who volunteer to be subjects to such research should be allowed to do so. Protection could clearly be provided against undue influence on such people (such as monetary enticements for the poor, or job pressures for employees of companies selling or testing the pesticides).

One important criterion for the ethical conduct of research is that the potential benefits to the persons tested should be commensurate with the risks that the person is asked to take. Thus it is considered unethical to test new drugs on poor African populations who would not be able to afford them, in order to obtain data to use in licensing the drugs for sale to patients in rich countries. With pesticide testing, there is some question as to what the benefits might be.

I would suggest that many people are altruistic. They feel good doing something that benefits others. I can well imagine people I know volunteering to test safety levels for pesticides that could help in the control of Tsetse flies or the carriers of river blindness, simply because they would like to help reduce the disease burden in Africa and help open lands to productive agriculture. Do the benefits from acting altruistically count?