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Monthly Website Update: September 2022

Dear Northwestern Research Community,

As a part of the Northwestern University IRB Office’s initiative to share timely resources and information with the research community, the following documents and webpages were created and/or updated on the website this past month:

New: Guidance on Suicidality in Human Research Protocols HRP-1915

Research studies that include assessments of suicidality require additional monitoring of participants’ responses.  This new guidance details what researcher responsibilities are when suicidal ideation/behaviors are identified and under what study settings, what information needs to be included in the protocol, and what consent language is required. The new form is now available on the Policies & Guidance Page.

Updated: Human Research Determination HRP-503

The IRB Office has made substantial changes to its Human Research Determination Form (HRP-503).  We are very excited to be sharing this new form with the Northwestern research community and anticipate that researchers will find it very user friendly. Use this form to help determine if and when a study involves human subjects research as defined by the federal regulations. The updated form is now available on the Protocol Templates & Forms Page.

Updated: Supplemental  Consent Language HRP-1722

Supplemental Consent Language (HRP-1722) was updated this month.  This document contains Social Behavioral research-focused suggested consent language that research teams can use as appropriate within their informed consent form.  Please find Supplemental Consent Language (HRP-1722) on the Biomedical & Social Behavioral Consent Templates Page.

Updated:  Consent & HIPAA Pages

Based on input from the Northwestern research community, the IRB Office updated its Consent and HIPAA pages, reformatting, improving, and condensing the content.  The new pages are titled Consent & Waiver of Consent, and HIPAA, PHI, & PII. We hope the Northwestern research community finds these two new webpages informative and easily digestible.

 

Thank you,

Northwestern IRB Office