US ‘should be more open’ to other nations’ trial ethics

Clinical trials need to be tightly regulated to protect patients Copyright: Flickr/US Army Africa

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Long-standing principles that allow US scientists to use the clinical trial ethics of countries in which they do their research, rather than their own, have been mostly ignored, according to a US presidential commission.

US regulations governing the protection of humans in trials say that US departments and agencies can follow procedures from foreign countries that differ from those of the United States so long as they provide "equivalent protection" to the subjects.

But, in practice, US departments and agencies have "rarely, if ever, exercised the authority to accept any foreign country’s procedures as equivalent", according to the Presidential Commission for the Study of Bioethical Issues, which issued its findings last week (15 December).

"Instead they sometimes insist that all US procedural details must be met, in all cases, regardless of the effectiveness or similarity of foreign requirements," said the report, which added that this "insistence … fails to recognise or respect that many nations today have systems to protect human subjects that are as good, or perhaps more stringent than our own".

Moral Science: Protecting Participants in Human Subjects Research’was requested in November 2010, by US president Barack Obama, in response to revelations that the US Public Health Service intentionally exposed patients to sexually transmitted diseases without their consent in Guatemala between 1946 and 1948.

The commission concluded that such an abuse could not happen today because of the safeguards that have been built into the system since the 1960s.

It also found that "the current US system provides substantial protections for the health, rights … protect[ing] people from harm or unethical treatment".

But a sub-committee of the commission, known as the International Research Panel, charged with investigating bioethical issues in US-funded research abroad, found that the insistence on following the letter of US regulations was often unnecessary, could be disrespectful to the standards and practices of the local culture, and may be precluding research in countries where it could improve public health.

The Commission has recommended that the US federal government, through its Office of Human Research Protections, should develop a process for evaluating requests from foreign governments and other non-US institutions to determine if their laws, regulations and procedures can be recognised as providing equivalent protections to research subjects.

The panel’s research led it to conclude that, although rules and their interpretation vary across the globe, almost all codes, national laws and regulations governing research on humans "seem to promote the basic principles of respect for persons, beneficence and justice, and do agree specifically about certain fundamental requirements, such as minimising risk, obtaining informed consent and requiring independent view of research."

While it urged US researchers to be responsive and flexible in the face of local traditions (for example, a distrust of written informed consent that might be replaced by another, more acceptable form of documentation) it cautioned, however, that cultural standards should be followed only to the extent that they do not conflict with basic universally recognised human rights."

Dafna Feinholz, chief of the Bioethics Section at UNESCO’s Division of Ethics of Science and Technology and founder of the Latin American Forum of Ethics Committees in Health Research (FLACEIS), said that developing countries also share the responsibility to avoid unethical practices.  

As long as they have their research priorities clear, developing countries can "negotiate the terms of the research" with more powerful nations wanting to place studies in their territory. This in turn will help to build infrastructure and human capacity, train researchers and gain access to the trials’ benefits, she said.  

Despite the improvements in standards since the 1940s, Feinholz said that work was still needed to protect those most at risk from abuse. "Some communities are more vulnerable than others within the same country … evaluations by ethical committees are required where such committees don’t even exist," she added.

Link to full report by the Presidential Commission for the Study of Bioethical Issues [5.69MB]

Link to International Research Panel subcommittee report [11.6MB]