Failure to even train staff could mean fines, suits.(Brief Article)

ANAHEIM, CA -- Failure to train clinical research staff could mean a loss of grant money, lawsuits or even jail time in an extreme case, an attorney told a recent Health Care Compliance Assn. conference here.

Kendra Dimond, an attorney with Arent, Fox, Kittner, Plotkin & Kahn in Washington, said some of the hazards include withholding of cash payments, suspension or termination of the award, a requirement for corrective action, imposition of special terms and conditions, or withdrawal of approval of key personnel.

Some of the more drastic outcomes might include triggering of the False Claim Act, a criminal investigation, private lawsuits by subjects and their families, or even a Congressional investigation.

The negative outcome might include institutional integrity agreements, debarment, …