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New and Updated Guidance

June 30, 2016

The IRB has released two new guidance documents: FERPA and Quality Improvement vs. Research.

The FERPA (which stands for Family Educational Rights and Privacy Act) guidance was written to offer investigators additional factors to consider when designing and conducting research involving students and student records. These factors originate from the federal law governing the access of educational information and records.

Quality Improvement vs. Research guidance is intended to assist investigators in making the determination whether a project represents a quality improvement initiative, or alternatively whether it constitutes research with human subjects and thus invokes IRB oversight.

Guidance on Informed Consent has been updated to include information regarding electronic consent options. Information regarding signature requirements and options for obtaining verified, electronic signature has been added. Specifically, the guidance allows subjects to provide verified signature in lieu of a physical, “wet” signature via encrypted digital signature, electronic signature pad, voice print, digital fingerprint, or signature made with a fingerprint on a touchscreen. Studies which do not plan to obtain wet or verified signature should consider requesting a waiver of documentation of consent.

All documents are located on the Policies and Guidance webpage.