Beware FDA Changes to Guidelines

Change in FDA's ethical guidelines for clinical trials troubling: Lancet

The Lancet medical journal is reporting that the United States Food and Drug Administration is abandoning the Declaration of Helsinki as an ethical foundation for international clinical trials.

The declaration was drafted in 1964 by the World Medical Association to provide binding ethical standards for medical research involving humans.

Many basic patients' rights are enshrined in the declaration. Sections of it also govern business and environmental practices of the researchers.

The FDA is instead adopting the International Conference on Harmonization's Guideline for Good Clinical Practice (GCP), which allows less stringent ethical standards for overseas research.

In a commentary published in the Jan. 3 issue of the Lancet, medical research experts Jonathan Kimmelman of McGill University, Charles Weijer of the University of Western Ontario and Eric Meslin of the University of Indiana call the move "troubling."

The authors urge the incoming U.S. administration of president-elect Barack Obama to stick to the original declaration pending a review of the implications for American research overseas should the new guidelines be adopted.

"The FDA regulates the largest drug market in the world, and we worry that its replacement of the Declaration of Helsinki with a less morally authoritative document may cause others to follow suit, thereby undermining international ethical standards for research," they write.

In October 2008, the FDA formally stopped requiring that foreign clinical studies supporting applications for drug licensing comply with the declaration.

The authors point out several important requirements that the declaration contains but the GCP lacks, including:

* Investigators must disclose funding, sponsors and other potential conflicts of interest to both research ethics committees and study participants.
* Study design must be disclosed publicly (e.g., in clinical trial registries).
* Research, notably that in developing countries, must benefit and be responsive to health needs of populations in which it is done.

Source:CBC.ca