1. Human Subject Research
Audrey Williams, PhD

2. 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

3. 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

4. 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

5. 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