Updated Social Behavioral Consent Templates

Dear Research Community,

The Social-Behavioral consent template (HRP-582) has been significantly revised to better fit social-behavioral research.  The revised version of HRP-582 contains instructions at the end on how to modify the final portion of the consent to fit verbal or online consent. There is now a separate Social-Behavioral consent template with HIPAA Authorization language (HRP-1721) for studies that plan to access the electronic medical record for recruitment, screening, and data analysis purposes. This will help minimize issues with HIPAA Authorization language being inadvertently included in the consent forms submitted to the IRB for studies where HIPAA does not apply. We have also created a Social-Behavioral Supplemental Consent Language Document (HRP-1722) which contains specific language to be inserted into the consent form for certain circumstances (e.g., studies using focus groups, studies with a Certificate of Confidentiality, studies using deception/incomplete disclosure).

You do NOT need to revise consent forms and scripts that have already been approved by the IRB to fit this new consent template – you can continue to use consent forms and scripts previously approved by the IRB.  For any new studies, the protocol templates and consent templates should be accessed by going to the Templates, Forms, & SOPs tab on the IRB website, rather than using protocol and consent forms from previous studies to create your documents. This will help prevent against using obsolete versions of the IRB templates.   

The IRB also has new guidance documents posted on the website on research participant payments, and research with children, parental permission, and child assent.  The guidance documents are available under the Policies tab on the IRB website.

Thank you,

Northwestern University IRB Office