US shuts down Swedish trials

March 24, 2006

Medical research into brain-damaged HIV patients at Gothenburg University's world renowned Sahlgren Academy has been on hold since last autumn after the US National Institutes of Health suspended funding.

The Maryland-based Office for Human Research Protection (OHRP) revealed that checks to ensure the research followed ethical guidelines had not been carried out. US authorities stipulate that US-funded medical research must conform to US guidelines and be verified annually.

In Sweden, verification that ethical guidelines are being followed is required only once during a project, but as the project at the Sahlgren Academy and Sahlgren University Hospital is funded by the NIH, it is subject to US law.

The OHRP notified Gothenburg University in writing of its findings but when it did not receive sufficient assurances from the institution, funding was withdrawn. The research team was forced to cancel clinical trials and suspend the project.

Pam Fredman, dean of the Sahlgren Academy, has asked Sweden's Ministry of Education, Research and Culture to intervene Charlotte Hall, a ministry spokeswoman, said the incident could have serious ramifications.

"We're not sure what we can do, but the issue needs to be resolved," Ms Hall told Swedish daily Dagens Nyheter . "This could threaten a major part of all Swedish medical research."

Many of Sweden's leading medical research projects are funded by the NIH.

In the light of the Gothenburg episode, Sweden's medical research teams are expected to revise procedures to follow US guidelines.

But one senior researcher at Karolinska Institute in Stockholm said researchers felt they were being held hostage by US rules. "This is just interfering American bureaucracy. It's an example of how the Americans expect the world to follow American laws. In Sweden, if your research is approved by the regional ethical committee, that approval lasts for the duration of the research period. They don't have the resources to review every project annually."

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