Following the revelation that the U.S. Public Health Service conducted unethical research on STDs in Guatemala in the 1940s, President Obama charged the Presidential Commission for the Study of Bioethical Issues to conduct “a thorough review of human subjects protection to determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal government.”
In response, the Commission has spent a great deal of time considering the degree to which regulations can be amended or augmented to improve the safety of research subjects and to guide researchers. However, as has been pointed out in previous meetings of the Commission, it is important to recognize that regulations are still limited in the degree to which they can protect subjects. Although federally funded research must comply with federal regulations, and drug trials for therapies that will be marketed in the United States must comply with FDA requirements, there are still gaps where government regulations do not apply. In these cases, dependence on private industry standards of practice and professional guidelines may be the only line of ethical defense and human subject protection.
This morning the Commission heard from representatives of the Biotechnology Industry Organization (BIO) and the Pharmaceuticals Manufacturing Association (PhRMA) about the professional guidelines that each group has adopted. The professional guidelines adopted by BIO and PhRMA illuminate current best practices in the industry and ethical norms that may provide some helpful insight when considering engagement with researchers beyond the limited scope of governmental regulation.
Of particular interest to the Commission this morning were the views of industry on compensation of human subjects in clinical research. At present, the U.S. Government has no requirements for compensation of research subjects harmed in clinical trials. Dr. Russell M. Medford, speaking on behalf of BIO, told the Commission that the industry standard for members of BIO was clinical trial insurance that would cover either all the medical costs of harm associated with participation in the trial or those costs above and beyond the expenses that a trial participant’s private insurance would cover. Dr. Medford described these compensation practices as “required from a fiduciary standpoint and from an ethical standpoint.”
Mr. Jeffrey K. Francer, speaking on behalf of PhRMA agreed that similar practices were observed by PhRMA members, who felt a similar obligation to participants in their trials, and went on to suggest that this is certainly an area where the government could learn from industry.
Harmonization of protections was another concern of both Commission members and the speakers. Dr. Medford, said that it’s a misperception that international research trials are carried out in developing countries simply to avoid regulation. In fact, he said, administration of trials performed abroad can be more complicated because of differing regulations. Drawing an analogy, Dr. Medford described the conduct of international research as trying to ship goods on an interstate train system where on no one has agreed on the gauge of the tracks – requiring shipping companies to unload each car at state lines and reload on a new train.
Concluding the session, Francer pointed out that pharmaceutical companies make medicines that are used globally.
“Is it ethical to test them only in the United States?” he asked.