Based on feedback from researchers, IRB members, and participants from the Informed Consent Workshops, we have made revisions to both the Medical and Nonmedical Informed Consent Template. The changes involve:

• Clarifications in instructions and simplification of the section describing storage and sharing for future secondary use. 
• Addition of collapsed sections the user can click to open and include if applicable.  If not related to the research, the user simply deletes the section. 
• Reducing appendix examples in the nonmedical template to one, as most nonmedical consents are sufficiently concise and not enhanced by appendices that merely duplicate information.  

Available now for new submissions:
The updated medical and nonmedical informed consent templates are available for use immediately.  Archive any saved versions of past templates, and use the current templates available in the “All Templates” menu option of your  E-IRB application, or the UK Template website for new submissions. The template updates have not prompted ORI to ask investigators to edit consents that already have IRB approval or are submitted for IRB review. 

Guides not carved in stone:
Templates are provided as guides to be customized to best meet the needs of the potential population and the context of the research.  We encourage researchers to use conversational style, lay terminology resources and “plain language” techniques to create a consent document that facilitates understanding.  After drafting, use the Consent Checklists to assess for regulatory compliance.

For more information on using consent templates, see the updated UK consent Form Template FAQ.

Background:
The UK ORI and IRB implemented a revised informed consent template December 2017, along with newsletter announcements, FAQs, and Informed Consent Workshop offerings. This transition occurred a year in advance of the January 2019 effective date of the new “Common Rule” regulations for protecting human subjects.  The revision has provided an opportunity for researchers and IRB members to become familiar with select requirements from the new rule.  In addition, the revised template included design and organization options for presenting information in a format intended to aid in understanding and help prospective subjects decide whether to participate in the research.