Vulnerable populations

Question 1

What are the key protections for Pregnant Women, Fetuses, Neonates (Subpart B)?

Answer 1

• IRB must assess scientific and ethical justification
• Must minimize risk to fetus
• Consent may be needed from mother only or both parents, depending on viability and benefit

Question 2

What are the key protections for Prisoners (Subpart C)?

Answer 2

Prisoners must not be coerced or influenced by incarceration

IRB must include a prisoner representative

Only specific categories of research are allowed (e.g., conditions affecting prisoners)

Question 3

Who consents in research involving children

Answer 3

The parents/guardian, plus assent from the children when possible.

Question 4

Why are Students/employees considered a vulnerable population, and what is the safeguard for them?

Answer 4

Concern: Undue influence

Safeguard: Use third-party recruiters, stress voluntariness

Question 5

Why are the Cognitively impaired considered a vulnerable population, and what is the safeguard for them?

Answer 5

Concern: Lack of capacity to consent/understand

Safeguard: Use a legally authorized representative (LAR)

Question 6

Why are the Economically disadvantaged considered a vulnerable population, and what is the safeguard for them?

Answer 6

Concern: May feel pressured by incentives

Safeguard: Justify compensation structure carefully

Question 7

What is required when research involves children under Subpart D?

Answer 7

The IRB must categorize risk level and determine appropriate consent/assent.