Changes to Consent Form May 2014

Changes to Consent Form May 2014

Institutional Review Board (IRB) News Changes to Consent Form May 2014

Changes to Consent Form May 2014

​The following are changes to the Sample Consent Form, version 05/29/14

  • Font has been changed to Calibri to comply with Institutional style guidelines.
  • Header:  The header has been updated to include Sponsor Protocol No., when applicable.
  • Risks and Discomforts:  Clarification to instructions in Randomization section and revisions to the example paragraph have been made.
  • Confidentiality:  
    • Change in language regarding publishing results of research
    • Updated Billing Compliance language
    • Addition of clinical trials indicator in medical records
  • Voluntary Participation and Withdrawal:  Instructions have been updated.
  • Cost of Participation:  Addition of sample language regarding Category B medical devices.
  • Signatures:  Several changes in the guidance.
  • HIPAA Authorization Form:  Revision to consent cancellation language.

Click here for a more detailed summary of the changes.

The sample consent form is available online by clicking this link.