Human Subject Research Audrey Williams, PhD

Human Subjects Living subject Obtaining data through intervention or interaction Identifiable data Private information Reasonably expects no observation/recording Reasonably expects not be made public

Clinical Trial Human subject research Prospectively assigned to intervention Drug, device, procedure, delivery system (including interviews or telemedicine), etc. Strategies to change health behavior (diet, cognitive therapy, exercise, etc.) Health related or behavioral outcome Mood, reading comprehension, biological parameters, quality of life

Exempt Categories Category 1 – educational setting with normal education practices Category 2 – Educational tests, surveys, interviews unless identifiable AND poses a risk Cannot include children Category 4 – Data or samples previously collected with no identifiable data Existing at time of submission* Cannot be coded with a link to identifiers

Exempt Categories Category 3 – surveys of public officials (such as politicians) Category 5 – Public benefit of service programs Category 6 – Taste and food quality evaluation New Common Rule 1/21/2019 Category 7 – Storage or maintenance of samples or data for which broad consent is required Category 8 – Secondary research for which broad consent is required