The current regulatory framework for federally sponsored research involving human volunteers in the US provides “substantial” protections for the health, rights and welfare of participants.

Nonetheless, there is room for improvement on a number of fronts to enhance accountability and responsibility in human-subjects research, as well as treatment and compensation for related industries; to drive equivalence in international standards for the protection of research participants; promote community engagement in federally funded research; justify study-site selection; and ensure that trials are ethically designed.

These were broadly the conclusions of a report issued by the Presidential Commission for the Study of Bioethical Issues, which made a total of 14 recommendations for changes to current practices in federally funded research that would help protect study participants more effectively.

At the same time, the Commission determined that “current regulations generally appear to protect people from avoidable harm or unethical treatment, insofar as is feasible given limited resources, no matter where US-supported research occurs”.

That conclusion, the report added, was “fully consistent with, and also qualified by, the large yet incomplete set of information made available to the Commission in the time available to carry out its charge”.

The report also called on the federal government to improve its tracking of research programmes supported by taxpayer dollars, having found that “many federal departments and agencies have no ready means to identify basic information about the research they support (e.g., location of study sites) or link funding information with study-level data”.

Guatemala revelations

The Commission, which convened a panel of experts in bioethics and biomedical research from Argentina, Belgium, Brazil, China, Egypt, Guatemala, India, Russia, Uganda, and the United States to inform its discussions, was asked by US President Barack Obama to conduct a thorough review of current regulations and international standards to assess whether they adequately protected human subjects in federally supported scientific studies, regardless of study location.

This was in response to the revelations in October 2010 that the US Public Health Service supported research in Guatemala from 1946 to 1948 which involved intentionally exposing thousands of Guatemalans to sexually transmitted diseases without their consent.

The Presidential Commission for the Study of Bioethical Issues was given two assignments within a nine-month timespan: to oversee a fact-finding investigation into the specifics of the Guatemalan studies (the findings were documented in the report “Ethically Impossible” STD Research in Guatemala 1946 to 1948, released last September); and to ensure that current rules for research participants protected these subjects from harm or unethical treatment, both domestically and internationally.

Never again

“The Commission is confident that what happened in Guatemala in the 1940s could not happen today,” commented Amy Gutmann, chair of the bioethics commission.

“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.”

Among those recommendations were that:

•    To enhance public access to basic information about federally funded human-subjects research, each US department or agency supporting research of this kind should make publicly available a core set of data elements for their research programme – title, investigator, location, and funding – through their own systems or a trans-agency system.     

•    The federal government should support the development of systematic approaches to assessing the effectiveness of human-subject protections and should expand support for research related to the ethical and social implications of human-subject protection.                               

•    The government, through the Office of Science and Technology Policy or the Department of Health and Human Services, should “move expeditiously” to study the issue of research-related injuries and determine whether there is a need for a national system of compensation or treatment for those injuries.

•    It should also adopt or revise the 2003 Health and Human Services Equivalent Protections Working Group’s articulation of the protections afforded by the specific procedural requirements of the Common Rule – the ‘uniform regulatory floor’ for human-subjects research that applies to 18 federal departments and agencies.

    The federal government should then use these requirements to develop a process for evaluating requests from foreign governments and other non-US institutions so as to determine whether “their laws, regulations, and procedures can be recognised as providing equivalent protections to research subjects”.

While there is no way of eradicating all risk of harm from research, the US “vigorously and rigorously protects people who volunteer for research studies”, Gutmann said.  

“However, the Guatemala experiments remind us never to take ethics for granted,” she noted. “We must never confuse ethical principles with burdensome obstacles to be overcome or evaded. Good science requires good ethics, and vice versa.”