August 3, 2020
As part of its ongoing quality improvement process, Research Compliance Services made multiple revisions to Institutional Review Board policies in the Human Research Protection Program. The revisions include updated information and provide additional clarity for investigators.
- HRPP Policy #9.002: Development of the Informed Consent Document has been revised to include more information about readability relative to the participant population. It also clarifies that during an IRB review process, readability scores (i.e., SMOG, Flesch-Kincaid Grade Level, Flesch Ease) may be requested and revisions to the informed consent and/or assent may be required.
- HRPP Policy #5.005: Research Involving Persons with Impaired Decision-making Capacity has been revised to provide additional definitions and clarity as it pertains to legally authorized representatives and who can provide consent for human subjects research.
These policies and additional guidance are included in RCS’ Guidance Topics (A – Z) webpage. RCS has created a summary table including brief descriptions of all updates made to policies.
Review the UNL HRPP Policies to ensure your current and future human subjects research is in compliance, and use the RCS A-Z Guidance page for additional clarity on a variety of topics. RCS recommends bookmarking these pages for quick reference.
If you have further questions, contact the IRB at 402-472-6965.