Random Definitions

Question 1

Research

Answer 1

a systematic investigation designed to contribute to generalizable knowledge.

Question 2

Human subject

Answer 2

a living individual about whom an investigator conducting research obtains, uses, studies, or analyzes information or biospecimens from a subject

Question 3

Minimal risk

Answer 3

Research harm or discomfort <= daily living

Question 4

What is Subpart A of 45 CFR 46?

Answer 4

It’s the Common Rule — the core federal policy for protecting human subjects in research. The other subparts add extra protections to certain groups.

Question 5

Which groups get additional protections under Subparts B, C, and D under the common rule (45 CFR 46)?

Answer 5

B = pregnant women + Neonates (B = Baby)
C = Prisoners (C = Criminal)
D = Children (D = Dumb)

Question 6

What is ICH GCP in Layman terms?

Answer 6

The Common Rule’s international cousin

Question 7

Clinical equipoise

Answer 7

A genuine uncertainty within the expert medical community about whether a treatment or intervention is more effective than another. Justifies randomly assigning participants to different treatment arms, including placebo or standard of care. Otherwise, researchers would be intentionally giving subjects worse treatment.