HS-IRBs News Special Edition - New Informed Consent Tools and Knowledge Base Rollout

Health Sciences and Minimal Risk IRBs, IRB News / Informed Consent Special Edition June 2017

The Health Sciences IRBs Office is excited to announce that newly developed Informed Consent Templates and Additional Model Language are now available on our updated Informed Consent Knowledge Base (KB) page. This newsletter provides an overview of the new materials, including when and how researchers submitting to the HS IRBs can use the documents.

What’s New?

Using the New Templates and Model Language

The HS IRBs Office encourages researchers to begin using these templates and model language when creating consent documents for new, investigator-initiated studies that will be reviewed by the Health Sciences or Minimal Risk IRBs.

Consent documents that do not use the new templates will still be accepted by the HS IRBs. Effective July 1, however, newly-submitted consent forms will need to incorporate new template language for compensation for injury and contact information.

Consent documents currently approved by the HS IRBs do not need to be revised to follow the new templates.

What’s Ahead?

Questions? Suggestions?

ICWG members are happy to answer questions about the new consent materials. We also welcome feedback and suggestions for model consent language and for consent-related guidance topics. Contact ICWG via AsktheIRB@medicine.wisc.edu, or call (608) 263-2362 (main HS IRBs phone line) and ask to speak to Jennifer, Jackie, Jake, or Sherry.

Our Thanks

ICWG would like to thank those who participated in our pilot of the consent templates and model language and provided helpful comments.

ICWG is especially grateful for the assistance of the Wisconsin Network for Research Support (WINRS) Community Advisors on Research Design and Strategies (CARDS)®. Much of our model language incorporates CARDS’ recommendations for enhancing clarity and readability. Information included in our consent templates also reflects CARDS’ insights on consent-related issues important to potential research participants.