Regulatory Focus™ > News Articles > After Flu Concerns, Regulators Look to Issue Guidelines on 'Dual Use' Preclinical Studies

After Flu Concerns, Regulators Look to Issue Guidelines on 'Dual Use' Preclinical Studies

Posted 12 April 2012 | By Alexander Gaffney, RAC 

International healthcare bodies are looking to issue guidelines on 'dual use' research on potentially hazardous materials and diseases after a researcher sent shockwaves through the medical community in 2012 for his re-engineering research on a potentially deadly strain of bird flu, reports The Financial Times.

"Washington has just issued new guidelines; the Royal Society, the British scientific organization, rushed to convene a high-level session last week on the topic; and the US Congress is gearing up for hearings this month that could strengthen controls over the funding and dissemination of such highly sensitive studies," reports The Times.

The guidelines would look to cover so-called 'dual use' research-in which research focusing on one topic may have another, equally important application-to make sure researchers don't inadvertently compromise health security by giving rogue researchers a blueprint for biological warfare.

While the risks of physical leaks and information leaks from rogue researchers remains an ever-present risk, a greater and growing threat exists as a result of the increase in biodefense dollars that have poured into funding hazardous biological materials research, says The Times.

Particularly troubling to some, including Nicolette Previsani, team leader for the World Health Organization's biorisk management team, is the incentive for countries to hide any leaks or mistakes in these biodefense programs.

"We would love to have more data," says Previsani, "but it's hard to ask countries to reveal this dark side. Whenever there are incidents, people tend to hide them because they are not proud of their mistakes."

Adding to the difficulties of adequately regulating the use of hazardous materials in preclinical testing is the significant overlap between regulatory authorities inside countries. As in the US, one agency may be responsible for regulating the use of the organism, while another may be responsible for general lab requirements, and still others responsible for occupational safety regulations.

Among different countries, the standards of biosecurity levels, including biosafety level (BSL)-rated facilities, may also be different. This can lead to gaps in protective measures, and leave hazardous materials vulnerable to leaks.

Read more:

Financial Times - The scramble to ensure scientific work can proceed without falling prey to accidental leaks or malevolent intent


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