The Office of Research Protections has added, updated, or removed several documents on the IRB Forms and renamed Consent Guidance and Templates (previously the Consent Corner) pages of our website. Most importantly, we added new documents designed to help PIs create compliant, effective and efficient consent materials. These include:
- Standard Consent Template for Non-Exempt Research. This template should be used for designing consent materials for all non-exempt research projects with human subjects. This is a comprehensive template that replaces all previous consent templates for both social-behavioral and biomedical research, as well as the concise summary template (which is now contained within the single consent template). Note that after January 15, 2021, all initial applications for non-exempt research submitted for review by the full IRB, and new consent forms for non-exempt research in excess of 5 pages, must use this template for consent of adult subjects and/or parental permission.
- Consent Element Checklist and Example Language. This guidance document contains the basic elements for of consent and examples of each element that must be contained in consent documents.
- Procedures and Risk Language. This guidance document contains language for specific procedures, and the associated risks of those procedures, that has been approved by the IRB and can be used in consent forms. Several of the examples are also appropriate to use in the consent materials for exempt research.
In addition, IRB Forms and Consent Guidance and Templates pages were reorganized, and several documents that are no longer consistent with our current processes were removed.
For questions regarding the new documents, consent templates, and the requirement for using the new Standard Consent Template for Non-Exempt Research, contact Nat Krancus, Associate Director of Research Protections, at 828-262-4060 or email firstname.lastname@example.org.