Expedited Categories

Question 1

Expedited Category 1 - D’s

Answer 1

Drugs/Devices

Clinical studies of drugs/medical devices (Only if no FDA investigational new drug (IND) or device exemption (IDE) is required, or the device is already cleared/approved)

Question 2

Expedited Category 2 - Drip Drip

Answer 2

Blood collection

(From healthy adults or other subjects in safe amounts using standard methods)

Question 3

Expedited Category 3 - No Needles

Answer 3

Collecting Biological Specimens

(Noninvasive collection of biological specimens, like saliva, hair, nails, or urine — no surgery or needles into the body)

Question 4

Expedited Category 4 - Syllables

Answer 4

Noninvasive Procedures - Data Collecting

(Data collection using noninvasive procedures, such as MRIs, EKGs, ultrasound (not involving sedation or significant risk))

Question 5

Expedited Category 5 - exit signs

Answer 5

Research existing data/documents/records

(If the data were already collected and either publicly available or recorded to protect identity)

Question 6

Expedited Category 6 - bytes

Answer 6

Voice, video, digital, or image recordings

(Collected for research purposes (e.g., interviews, focus groups))

Question 7

Expedited Category 7 - Austin Powers

Answer 7

Behavioral research of individuals or group characteristics

(Includes surveys, interviews, or observations — as long as it’s minimal risk)

Question 8

Expedited Category 8 - UCI

Answer 8

Continuing review previously approved research

(When no more subjects are being enrolled or only long-term follow-up remains)

Question 9

Expedited Category 9 - Krillin

Answer 9

Review of small changes/modifications that don’t increase risk