IRB Open Library

1
IRB Open Library Whats New November 18,
2004Sheila Moore, CIP

• Reminder about Training see IRB website Check
  training status on the IRB website.
• Review of IRBs Revised Noncompliance Policy
• Examples of Serious Noncompliance
• Falsification of IRB documents
• Human subjects research conducted without IRB
  approval
• Deviation from the IRB approved consent process
• Modification of protocol without IRB prior
  approval
• Failure to maintain regulatory documents
• Examples of Continuing Noncompliance
• Missing Renewal Deadlines
• Use of Expired Consent Form
• Not Meeting Training Requirements
• Inaccurate document preparation
• Late Reporting of Serious Adverse Events
• Clinical Trial Registration required for
  publication? See www.clinicaltrials.gov for an
  example
• Electronic Submission
• Revised Forms/Revised Guidebook
• Accreditation for the IRB
• 200th Protocol Sent to WIRB