In the 1940s, research funded by the federal government resulted in thousands of Guatemalans being exposed to sexually transmitted diseases without their consent. The Presidential Commission for the Study of Bioethical Issues published its report today that examines safeguards and protections for human volunteers in medical research.

The report entitled: “Moral Science: Protecting Participants in Human Subjects Research,” recommends 14 changes to current practices to increase protection of research subjects. It also called on the federal government to improve its tracking of research programs supported with taxpayer dollars.

President Obama gave the Bioethics Commission two main tasks :

  • Firstly : To oversee a thorough fact-finding investigation into the specifics of the studies.
  • Secondly : To insure that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally.

Commission Chair, Amy Gutmann, Ph.D. said :

“The Commission is confident that what happened in Guatemala in the 1940s could not happen today …

However, it is also clear that improvements can be made to protect human subjects going forward. With the Commission’s recommendations, society will continue to benefit from advances in quality of life made possible by human subjects research and ensure respect for the inherent dignity of individual research volunteers.”

Commission Vice Chair, James W. Wagner, Ph.D. confirmed :

“Many of the most important advances today are driven by research that involves human participants …

We must ensure that the way we conduct research involving human subjects protects, encourages, and makes fruitful the selfless practice of allowing oneself to become the subject of a medical or social study intended for the benefit of another.”

The report’s central finding, states that :

“U.S. system provides substantial protections for the health, rights, and welfare of research subjects.”

However, the commission also pointed out that during their investigation they requested information from 18 different agencies that account for most of the federally funded research on human subjects, but many of the agencies could not provide specific details about the projects they support.

The Pentagon, for example, required more than seven months to prepare information on specific studies supported by the Department of Defense. In its report, the Commission found that the federal government supported more than 55,000 projects involving human subjects around the globe in Fiscal Year 2010, mostly in health-related research, but also in other fields such as education, engineering and social science.

Dr. Gutmann stated that immediate changes can be made to increase accountability of the individual agencies and safeguard ethical standards and treatment of volunteers. The Commission recommended that each federal department or agency supporting research with human subjects maintain a core set of data for their research programs that includes the title and lead investigator of each project, the location of each study, and the amount appropriated for the research.

The Commission stated that every branch of the government involved in this area of research should aid public accountability by developing or improving publicly available electronic systems or releasing information through a government-wide system.

Dr.Gutmann said :

“Immediate changes can be made to increase accountability and thereby reduce the likelihood of harm or unethical treatment …

When federal agencies lack the internal mechanisms to provide needed data about research they fund, you have a limited basis on which to answer the President’s charge about research protections …

It is clear that nothing like what happened in Guatemala would be permitted under today’s robust system for human subjects protection … the system today is vastly improved from what it was … but there still is a need for more transparency and public access to information about federally supported human subjects research.”

As well as putting forward ways to enhance accountability, the Commission also looked at other areas where improvements can be made, including implementing methods for compensating people who are injured during research.

The commission pointed out that the benefits of research help to improve all society, thus individual participants who are injured during studies should not be forced to personally bear the costs of treating their injuries.

The Commission noted that most other developed nations have instituted policies to require researchers or sponsors to provide treatment, or compensation for treatment, for injuries suffered by research subjects.

While there is no way to eradicate all risk of harm, particularly in some types of medical and translational research. Dr. Gutmann concluded that:

“Our nation vigorously and rigorously protects people who volunteer for research studies. However, the Guatemala experiments remind us never to take ethics for granted. We must never confuse ethical principles with burdensome obstacles to be overcome or evaded. Good science requires good ethics, and vice versa.”

Written by Rupert Shepherd B.Sc