Human Subject Research and JITs CAT SUTHERLAND ASSISTANT

Human Subject Research and JITs CAT SUTHERLAND ASSISTANT DIRECTOR, COMIRB

Topics Human Subject Research Exempt Categories Secondary Research JIT Process

Human Subject Research • a living person about whom an investigator obtains – data through intervention and/or interaction • e. g. , surveys, interviews, drug studies – identifiable private information • e. g. , medical record review

Exempt 1. Education Research Differences in curriculum, teaching styles, etc. 2. Surveys, interviews 3. Benign Behavioral Interventions Playing music during a computer test vs. no music 4. Secondary Research Study of previously collected data or samples Not collected for the purposes of this research

Secondary Research Gets tricky If an investigator on current grant was involved in initial data or sample collection, it is Human Subject Research. Ability to access identifiers – whether or not they intend to Exempt Category 4 If not involved, it might be non-Human Subject Research.

JIT Process Pre-award sends me an email with the grant and any IRB approvals that you have submitted to them I go into the Info. Ed submission and check that the grant is consistent and is part of the Info. Ed submission If it is, I confirm If it is not, I will likely email you for more information This is where we see lots of Secondary Research apps needed. Sometimes an amendment is needed to add the grant to the study.

Questions and Help COMIRB@ucdenver. edu 303 -724 -1055 Catherine. Sutherland@cuanschutz. edu