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3.8 Research Subject Compensation

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for, and limitations on, compensation of research subjects.

2.0 Policy

  • 2.1. It is the policy of the Organization that compensation for research subjects may be acceptable if: 1) the possibility of coercion or undue influence is minimized, and 2) the compensation is considered a reasonable incentive either for participation in the research and/or reimbursement for study-related travel and other expenses.
  • 2.2. It is the policy of the Organization that compensation in any form is not considered a benefit to be weighed against risks in the IRB’s assessment of the risk/benefit relationship of the research, and that compensation not be presented to the potential subject as a benefit in either the process of consent, or the potential benefits section of the consent form.

3.0 General Principles

  • 3.1. Compensation for participation in research is not a requirement.
  • 3.2. Participation in research should, if possible, not require any financial sacrifice on the part of the subject. Any additional costs to the subject that may result from participation in the research must be justified and disclosed in the consent form.
  • 3.3. The amount or type of compensation should not serve as undue inducement to potential subjects.
  • 3.4. Amount of compensation should reflect the amount of time required of the subject. The amount of compensation should not be tied to the degree of risk or discomfort associated with the study.
  • 3.5. The IRB will not consider compensation as a benefit to offset risks (either quantitative or qualitative) associated with the research.
  • 3.6. Since the risks associated with “minimal risk” research do not exceed those of daily life or routine physical or psychological examination, compensation is not an inducement to offset risk. Therefore, there is no restriction on compensation for minimal risk research.

4.0 Specific Requirements

  • 4.1. Compensation for research which involves greater than minimal risk should be based on a reasonable hourly wage for time spent in preparation for, participation in, and recovery from, research interventions. A reasonable hourly rate is $20.00 per hour.
  • 4.2. The IRB has the authority to review the level of compensation and, in appropriate circumstances, limit the total value.
  • 4.3. Interventions are understood to include such elements as procedures performed, visits to a clinic or research setting, phone interviews, or surveys completed. If appropriate, such hourly compensation should 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.
  • 4.4. Compensation above these levels must be specifically justified by the investigator, and must comply with the general principles described Section 3.0 of this policy.
  • 4.5. The terms of the compensation must be completely disclosed in the IRB application and in the informed consent process and ICF.
  • 4.6. Payments to subjects must be prorated based upon the duration of participation of the subject in the research. Any credit for payment should accrue as the study progresses and not be contingent upon the subject completing the entire study. Prorated payment should be made regardless of whether withdrawal was voluntary (subject decided to withdraw from the study) or involuntary (based on withdrawal criteria of the research protocol.). Prorated compensation should be provided, if possible, to subjects at defined intervals as opposed to at the end of a study.
  • 4.7. The amount of total compensation should not be emphasized during the process of consent or in the ICF.
  • 4.8. The IRB does not allow bonuses paid for completion of a study as it may offer undue influence to a subject to continue in a study when he/she would otherwise have chosen to withdraw.
  • 4.9. Compensation for participation in research may not include free sample(s) or coupon(s) good for a discount on the purchase price of the test product upon conclusion of the study. The IRB views this form of compensation to be an inappropriate marketing tool when associated with research participation.
  • 4.10. For studies where compensation is likely to total more than $600, the consent form must include a statement that an IRS form 1099 will be issued if the total compensation from participation in research reaches $600 in any given year.
  • 4.11. Records should be maintained at the department or other level that tracks all forms of compensation and their distributions. The amount and type of compensation must be able to be tracked to a corresponding recipient. If the accounting and/or payment office required the subject to provide their Social Security Number, this must be both justified and disclosed in the consent form.
  • 4.12. Payments for involvement of minors <16 years of age in research should not be made directly to the minor. It may be appropriate to offer children through their parents an age appropriate token for their participation, such as a small toy or gift certificate. With appropriate justification, 16-18 year olds may be directly compensated.
  • 4.13. The IRB will evaluate the type and amount of compensation on a case-by-case basis, and make a determination of its acceptability in consideration of the general principles described Section 3.0 of this policy and any justification provided by the PI for an exception.
  • 4.14. Due to the concerns relating to the potential subject’s overestimating the value of compensation the UNMC IRB will not allow the use of a lottery (or raffle) as a mechanism to provide compensation to subjects for participation in greater than minimal risk research.
  • 4.15. The IRB may allow use of a lottery (or raffle) as a mechanism to provide compensation to subjects for participation in minimal risk research on a case-by-case basis. This method of compensation must be approved by the IRB Executive Chair/designee.

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED MARCH 8, 2019

 REVISED JANUARY 26, 2018

 REVISED MAY 10, 2017

 INITIAL DECEMBER 28, 2015

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