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. Author manuscript; available in PMC: 2018 Jan 1.
Published in final edited form as: Yale J Health Policy Law Ethics. 2017 Winter;17(1):61–141.
Institution D Institution E Institution F
Policy Regarding Payment Yes Yes Yes
Discussion of Coercion, Undue Influence, or Exploitation - direct or indirect “The … IRB must determine that the following requirements are satisfied before it approves research: … There are appropriate additional safeguards included in the study to protect the rights and welfare of participants who are likely to be vulnerable to coercion or undue influence.” “The IRB shall review both the amount of payment and the proposed method and timing of disbursement to determine that neither are coercive nor present undue influence.” “The IRB reviews remuneration plans to assess whether the amount, schedule and type of any proposed compensation is fair for the participant, and to assess whether the payments could be considered coercive (i.e., by unduly inducing individuals to participate because compensation would difficult to refuse.”
Definitions of Key Terms Remuneration
Recognized Uses of Payment “Payment to research subjects for participation in studies is considered compensation for time and inconvenience rather than a benefit to subjects.” Compensation
Factors Influencing the Acceptability of Payment “In general, remuneration … should be comparable to other projects involving similar time, effort, and inconvenience.”
Amounts
Prorating “Payment(s) shall be made to the subject as the study progresses and shall not be contingent upon the subject completing the entire study. If, for example, payment is made for each appointment attended, the payment must be made after each appointment.” “In general, remuneration … [s]hould be pro-rated based on the number of procedures and study visits and should not be conditioned on completing the entire study, although a bonus for completing the study may be acceptable.”
Completion Bonuses “Any amount paid as a bonus for completion must be reasonable and not so large as to unduly induce participants to stay in the study who otherwise would have withdrawn.”
Informed Consent “[A] timetable for the payments themselves must be … presented to every subject as part of the Informed Consent process.”
“The Informed Consent Form must clearly establish how the subject is to be paid, i.e. cash, check, etc. A subject must sign a receipt for any cash payment, and this procedure must also be described as part of the Informed Consent process.”
“In general, remuneration … [s]pecifics (including the amount per visit and payment schedule) should be documented in the consent form under the “Compensation” section–but not under the “Benefits section.”
Advertising “Advertisements may state that subjects will be paid, but should not emphasize the payment or the amount of be paid, by such means as larger or bold type and compensation information should be added towards the bottom of the advertisement.” “Advertising materials shall not include the following: … an emphasis on the payment or the amount to be paid, by such means as larger or bold type. The IRB has authority to approve whether compensation shall be included in the advertisement.” “Recruitment materials should not emphasize remuneration for participation (e.g., larger or bold type).”
General Attitudes Toward Payment “Remuneration … ordinarily offered as a form of appreciation for the individual’s time and effort in the research project”