The Investigator Manual has been updated to describe consent guidelines for special populations that may require alternative consent processes, such as visually or hearing-impaired subjects.
Additionally, the process for obtaining IRB approval for a special consent process when such a subject is encountered unexpectedly has been updated:
- Submit a change of protocol application in ARROW for IRB review to include this subject population. This can be an expedited change, as long as there’s no increased risk and the change meets criteria in HRP-313 – Worksheet – Expedited Review for a minor modification to previously approved research. The change of protocol application and revised protocols/applications should describe safeguards and accommodations for the added population(s) as well as the consent process for the population.
- If the change is time-sensitive, please indicate this in the change workspace when submitting and email AsktheIRB@hsirb.wisc.edu to inform the IRB of the forthcoming time-sensitive submission.
Finally, a new Vietnamese translated short form is now available on our website! Remember, if you use the translated short forms posted on the IRB website or short forms translated by UWHC, you do not need to submit these forms for IRB approval.