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University of Wisconsin–Madison

HRPP Newsletter March 2023

Additional Translated Short Forms Now Available

Spanish and Vietnamese translated ‘short form’ consent documents are currently available on the IRB website.  Beginning this month, researchers needing other languages may access translation libraries of University of Utah as well as WCG As a reminder, the short form consent process requires IRB approval and is to be used when a non-English speaker is encountered unexpectedly and there is not time to translate the long form.  Continued enrollment of non-English speakers requires translation of the long form.  See HRP-091 for additional information on documentation of consent and the use of short forms. 

Accessing Part 11 Compliant DocuSign

There are new requirements for logging in to Part 11 compliant DocuSign using Single Sign On (SSO).  Users must now use the company login instead of entering a password on the DocuSign login page. This is an important change requiring users to login using their UW NetID and Duo Authentication to meet security guidelines.  DocuSign FAQs can be found here. 

In the Know

Justifying a waiver of informed consent

When you request a waiver or alteration of informed consent, be sure your request explains how the research activity meets regulatory requirements for a waiver. As part of the review and approval process, the IRB completes checklist HRP-410 Waiver or Alteration of Consent Process to make sure that all applicable regulatory criteria are met. The checklist asks for “protocol specific findings.” This means that the protocol (or non-protocol-based application) needs to show how the study meets each requirement. For example, why are the research risks minimal? Why is a waiver or alteration necessary for you to do the research? Why won’t the waiver have an adverse effect on participants’ rights and welfare? These explanations are essential to justify approval of a waiver or alteration. Simply asserting “this study is minimal risk” is not a justification.

Use checklist HRP-410 Waiver or Alteration of Consent Process for reference to identify the regulatory criteria relevant to your research and help you include adequate justifications in your protocol or application. Note that the criteria for approval vary slightly, depending on the nature of the study (e.g., if the study is FDA regulated). Questions? Contact asktheirb@hsirb.wisc.edu or (608) 263-2362 for the IRB analyst on call.

Previous editions of the HRPP Newsletter can be found here.