IRB Documents for Research with Children

Dear Research Community,

We are pleased to announce that the IRB Office has updated the website to include several timely revisions to documents related to research with children. Notably, revisions do not reflect any changes in policy, practices or regulatory criteria, but are geared to improve readability/accessibility of documents. Changes are effective June 25, 2021 and include the following:

Guidance on Children as Research Participants, Parental Permission, and Child Assent- Revisions include: reorganization of content, added color contrast to improve readability, and highlighted considerations most applicable to NU research projects. (Link to Guidance Documents Webpage)

Social Behavioral Protocol Template (HRP-583)- Revisions include: encompassing the previous “Appendix A” into the protocol. All considerations specific to children as a vulnerable population should now be detailed within the protocol. (Link to Templates and Forms Webpage)

Parent Permission with Child Assent (HRP-1712) & Parent Consent and Permission with Child Assent (HRP-1711): Revisions include: reorganization of sections and information to better align with current IRB consent documents, and language that addresses the audience and use of PPRA (when applicable). (Link to Templates and Forms Webpage)

Assent to Participate in Research (HRP-1708)- This is a new document, replacing the previous Written Assent and Assent Script documents. This document includes: organization of sections and information to better align with current IRB consent/permission documents, and language that it is more developmentally appropriate for the target participant population (ages 7-`11). (Link to Templates and Forms Webpage)

*Note the above documents are specific to research applications reviewed by the Northwestern University IRB. If your research involves Lurie Children’s Hospital, please reference the website to determine the most appropriate IRB to review your research.

Thank you,

Institutional Review Board Office

Northwestern University