March 13, 2014
Melissa Fink

IRB Releases Revised Informed Consent and Assent Templates

Investigators should begin using the new templates immediately. Older versions will not be accepted with new protocol submissions after Thursday, May 1.

The IRB has released new versions of the Biomedical, Behavioral and Social Sciences, Single Use, Humanitarian Use Device, Emergency Use and Addendum Informed Consent templates. New templates have a 3/2014 version date and are available on the IRB website Forms and Instructions page. Existing protocols need not transition to new versions.

Changes to the Informed Consent and Assent Templates include:

  1. General reformatting
  2. New University Injury language
  3. New Radiation Exposure Risk language
  4. Photo/audio/video imaging language
  5. Revised language for GINA, HIV Testing, Reporting of Communicable Disease Discovery, ClinCard payment methods and other minor changes

Note that the HIPAA Authorization template was not modified in this release as it is expected that a more significant revision of this document is forthcoming.

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