Payments to Research Subjects

Question 1

Payments to research subjects should be based on:

a) Time and inconvenience
b) Risk and discomfort
c) Ensuring participation
d) Satisfying the needs of study participants

Answer 1

a) Time and inconvenience

Question 2

According to FDA guidance the payments to research subjects should be:

a) An upfront payment
b) A lump sum given at the end of the study
c) Should be prorated in accordance with the research related visits
d) ould be given as gift certificates only.

Answer 2

c) Should be prorated in accordance with the research related visits

Question 3

In a questionnaire study of homeless subjects the investigator wishes to pay each subject $10. The IRB could be concerned about this payment because:

a) The payment could be used to pay for drugs
b) The payment violates the principle of justice in the Belmont report because non study participants are not being paid
c) The payment may constitute undue influence
d) The payment may be too small in consideration of the principle of beneficence in the Belmont report

Answer 3

c) The payment may constitute undue influence

Question 4

In assessing the payments to subjects in light of the Belmont report the IRB should be concerned about:

a) Respect for persons
b) The principle of justice
c) The principle of beneficence
d) Loss of dignity

Answer 4

b) The principle of justice

Question 5

According to FDA guidance the payment of a completion bonus for a clinical trial is:

a) Undue influence
b) Constitutes coercion
c) Violates the principle of justice in the Belmont report
d) Permitted under the guidance.

Answer 5

d) Permitted under the guidance.

Question 6

According to the FDA guidance on payments which of the following applies:

a) May be viewed as a recruitment incentive or a benefit
b) It is not uncommon for subjects to be paid for their participation in research
c) May be considered as coercion
d) Is higher in Phase 1 studies.

Answer 6

b) It is not uncommon for subjects to be paid for their participation in research

Question 7

Payments to children for research participation:

a) Is prohibited under DHHS regulations
b) Should be given only to the parent
c) Must be in the form of a gift certificate
d) Is not addressed in the DHHS regulations

Answer 7

d) Is not addressed in the DHHS regulations

Question 8

Among the various models proposed for payments to research subjects the IRB is most likely to favor:

a) The Market model which suggests that payments be regulated by the laws of supply and demand
b) A wage payment model in which payment would be based on reimbursement for wages for time involved but close to the minimum wage.
c) Reimbursement model to cover a subject’s reasonable expenses
d) A benefit model which views the payment as a supplemented benefit.

Answer 8

c) Reimbursement model to cover a subject’s reasonable expenses

Question 9

When a subject voluntarily withdraws from participation in a research study:
a) Payments for past visits should be withheld
b) The rate of payment should be recalculated based on the completed visits
c) Payments should be made up to and including the latest visit.
d) Payments should be made for all visits regardless.

Answer 9

c) Payments should be made up to and including the latest visit.

Question 10

Payment in a lump sum at the beginning of the research study may be viewed as ——–, while payment in a lump sum at the end of the visit schedule may constitute ——–
a) Convenient; a late payment
b) Undue influence; coercion
c) Beneficence; disrespect for persons
d) Justice; maleficence

Answer 10

b) Undue influence; coercion

Question 11

According to FDA guidance information on payments to subjects
a) Need not be disclosed to the subjects until the first visit
b) Should be disclosed in detail in the consent form
c) May be verbally communicated to the subject
d) May be disclosed in general terms in the consent form without committing to a dollar amount

Answer 11

b) Should be disclosed in detail in the consent form