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The government is slogging through week two of the federal shutdown with little progress. While both sides are pointing fingers with no budging in sight, IRBs and researchers at federal facilities are in a bind.
With the Office of Human Research Protections (OHRP) shut down, institutional review boards find themselves unable to renew Federalwide Assurance or IRB registrations. IRBs at HHS facilities will also not have OHRP oversight for ongoing research. OHRP has advised IRBs to defer to a non-federal IRB, or to suspend research, if possible. The office stated it will use decision-making flexibility when taking the situations into account. (You can find OHRP’s guidance on the matter here.)
National Institute of Health (NIH) trials are also hitting stumbling blocks. While trials are still being conducted with current patients, new patients are not being enrolled in existing trials. However, critically ill patients are being enrolled if they meet the criteria for a trial; about 12 new patients have been enrolled between Oct. 1 and Oct. 8, an NIH spokeswoman told the New York Times. Research at the Centers for Disease Control and Prevention is also currently on hold.
And while existing clinical trials are still running, approval for new ones has ground to a halt. Researchers are unable to get proposed trials off the ground. Members of the American Society for Cell Biology held a press conference this week on the effects the shutdown is having on research: Those who rely, at least in part, on NIH funding, are starting to sweat as the money runs low. Others say the shutdown only further strains the already-stressed funding needed for training future scientists and ongoing research.
The Food and Drug Administration (FDA) has also been hobbled, with 45% of its force furloughed and internal lab research shuttered. But while the agency postponed an advisory committee hearing, it still plans to go through with its October panel meetings.