1. Annual IRB Member Training October 2010 Research Participant Compensation John Stillman Director Institutional Review Board University of Utah

2. Background - Regulations §46.111(a)(3) Criteria for IRB approval of research Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. §46.116(a)(6) For research involving more than minimal risk, an explanation as to whether any compensation…is available.

3. Background – Belmont Report One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their ready availability...for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition.

4. University of Utah Policy Implemented July 2002  Defines Payment  Requires consent document to inform subject of need to disclose name, SSN, address to University  Sets forth process for payment of human subjects Check request is preferred form of payment Petty cash may be dispersed if payment is less than $50 or “when confidentiality or anonymity is a prime consideration.” Limited Purchase orders and Purchasing card prohibited

5. University of Utah Policy Established four “Exceptions”  Vice President approval  Three Categories  Incidental Payments

6. Category One Subjects with little or no requirement for confidentiality should be required to provide their name, SSN, and address regardless of type of payment. The subject must be informed of the need to provide this information to the University. Subjects who do not provide this information can “waive receipt of any payment.”

7. Category Two For studies where the University must guarantee confidentiality, the University must protect confidentiality by obtaining informed consent from the prospective research subject with information related to the reason for the need to provide the University with their name, SSN, and address. Subjects have the option to waive receipt of payment.

8. Category Three Studies that require “total anonymity”  PI must indicate payment amount is “nominal”  Number of subjects and reason for anonymity at department level  Do not include names or “any other identifiers”  IRB authorizes payment Payments less than $100 may be made from petty cash as long they do not exceed $599 in a calendar year

9. Incidental Payments When payments are of such small amounts (e.g. $1 for answering a questionnaire) that it is not possible or reasonable to collect social security numbers or to process the payment through the University. In these instances, a synopsis of the study with PI/Responsible Person approval should be included with the petty cash reimbursement request.

10. Payments = “incidental” ($1) Payments > “incidental” ($1) No SSN SSN UNLESS… *Category 3 Exception* “anonymity” (not confidentiality) Policy in Summary

11. Concerns IRB does not routinely consider this policy as part of our review process Collection of SSN and other identifiable information for accounting increases risk of loss/breach of confidentiality Payment of participants becomes more complicated for study teams who may only provide nominal amounts Very few studies qualify for the Category Three exception due to interpretation of “anonymity”  Confidentiality and Anonymity are not the same Incidental Payments are not defined and very low - $1

12. Proposed Solution Define and raise the Incidental Payment to $100 or $599 Alter or add to the exceptions

13. Conclusion John Stillman Director Institutional Review Board (IRB) University of Utah (801) 587-9136 john.stillman@hsc.utah.edu