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Consent & Assent Information

Revised Human Subjects Regulations (Common Rule) Wednesday, June 20th 2018

The regulations that human subjects researchers must adhere to (referred to as the Common Rule Regulations) were established in 1991. In 2011, federal agencies began the long-awaited process to revise these regulations and, on January 18, 2017, the final revisions to the Common Rule (Final Rule) were posted in the federal register. The effective and implementation dates have recently changed. As posted in the federal register on June 18, 2018, the revised final Common Rule is both effective and to be implemented on January 21, 2019 with the option of implementing 3 burden-reducing provisions before January 21, 2019. Learn more about the regulations.

Below you will find information, checklists, and resources to create/improve your consent and assent documents.

Consent TypeDescription/Use
ReadabilityOnline training and resources to determine the readability level of your documents. Tools to help show you how to revise your documents to an appropriate reading level for your population.
PRISM Readability ToolkitA free, 81-page plain language handbook for researchers illustrating why health literacy is important and how to improve the readability of consent forms and other participant materials.
Consent FAQs from OHRPhttp://answers.hhs.gov/ohrp/categories/1566
Checklist: Consent FormUse this checklist to be sure that your consent document includes the required elements.
Checklist: General Waiver or Alteration of Consent [45 CFR 46.116(f)]Use this checklist to see if some or all elements of consent may be waived.
Checklist: Waiver of Documentation of Informed (signed) Consent (45 CFR 46.117)Use this checklist to see if you may be able to waive the requirement to obtain signed consent (e.g., use a cover letter or verbal script instead of the documented consent form)
Checklist: Parental Permission Wavier, 45 CFR 46.408(c)Use this checklist to see if you may be able to waive the requirement to obtain parental permission for participants who are <18 years old.