An IRB message – compensating research subjects

picture disc.Continuing education of the research community is a very important function of the UNMC Institutional Review Board (IRB). Once a month, topics of interest will appear in the UNMC Today. Today’s topic examines compensation for subjects enrolled in research studies.

Can subjects be compensated for participation in research studies?

Yes. Compensation may be offered but is not required. Keep in mind that payment cannot be seen as a “benefit,” when weighing the risks and benefits associated with the study.

How is the level of compensation determined?

Subject compensation should be calculated based on an hourly rate appropriate for unskilled but essential jobs. It should be based on the time spent in preparation for, participation in, and recovery from, a particular research intervention. This includes visits to a clinic or research setting, phone interviews, or surveys completed. If appropriate, hourly compensation may include all parties involved (for example, if a family member is required to be present to drive a research subject home after a procedure, his/her time may be compensated.)

Is there an hourly rate that is acceptable to the IRB?

Yes. The IRB has determined that a reasonable hourly rate is $10 per hour.

I want to pay the subject more than $10 per hour. What do I need to do?

Compensation above $10 per hour must be justified by the researcher in the IRB application. Final approval of a study may be dependent on modification of compensation to the subject.

Are there special instructions for providing the payment to the subject?

Subject compensation must be prorated. Payment cannot be dependent upon the subject completing the entire study. If the subject withdraws from the study, prorated payment must be made regardless of whether withdrawal is voluntary or involuntary (based on withdrawal criteria of the research protocol.)

Is there a limit to the total compensation for participation in a research study?

Yes. Total compensation for all visits should not exceed $1,000. Requests for compensation beyond this amount must be justified by the investigator and approved by the full IRB.

Should compensation be discussed in the consent form?

Yes. The IRB consent form templates have designated a spot to tell the subject about compensation – “Will you be paid for being in this research study?” The subject should be told the payment for each visit or intervention, but not include a total amount to be paid.

How do I provide compensation to children for participation in a study?

As a general rule, children should not be paid to participate in a research study. It may be appropriate to offer children some age-related token, such as a small toy or gift certificate. With appropriate justification, the IRB may approve a plan to compensate 16-18 year old subjects. Older children (16-18 years old) may receive compensation.