Boundaries of Protection .

• Protects data maintained during any time the Certificate is in effect

• Protects those data in perpetuity

• Does not protect against voluntary disclosure:

  • child abuse
  • threat of harm to self or others
  • reportable communicable diseases
  • subject’s own disclosure

• Must disclose information about subjects for DHHS audit or program evaluation or if required by the Federal Food, Drug, and Cosmetic Act

Previous slide

Next slide

Back to first slide

View graphic version