Approved by Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 161
AAHRPP Elements: II. 3.C.1
- The UIC IRB reviews proposed subject recruitment methods, advertising materials, and participant payment arrangement, and permits them when they are equitable, fair, honest, and appropriate.
- The IRB Chair, IRB member designee, or the convened IRB review the following to ensure the rights and welfare of the prospective subjects are protected:
- The information that will be contained in the advertisement.
- The mode of their communication. The final version of advertisements in any format; print, audio, video or internet.
- The information contained in the appropriate application form. The prorated reimbursement schedule based on the subjects’ participation.
- Recruitment Process. The IRB, IRB Chair, IRB member designee, or convened IRB reviews whether the proposed recruitment of faculty, students, and employees as are the targeted research population when making its determination for approval in accordance with the appropriate review guide.
- The IRB reviews the advertisements and other materials in accordance with 45 CFR 46 and 21 CFR 56 using the appropriate review guide. For additional information, refer to the UIC HSPP Investigator Guidance: Recruitment Materials.
- The PI is responsible for accurately disclosing all information as to payment and including a prorated schedule of payments, as applicable, in the protocol application and the informed consent document in the appropriate application.
- The PI must disclose any changes to the payment terms and submit changes to the IRB, IRB Chair, designee, or convened IRB through an amendment. The change in the payment terms must be approved and the PI must receive confirmation of approval before any changes in the payment terms can be implemented.
- The IRB reviews the payment plan in accordance with the appropriate review guide, i.e., UIC HSPP Tip Sheet #4.
- For additional information, refer to University policy Human Subject Payments.
- VA Research. The IRB, IRB Chair, or designee, must prohibit proposed payments to JBVAMC research subjects that are not in accordance with the payment requirements of VHA Handbook 1200.05 as listed in the appropriate review guide.
- The facility Director is responsible for ensuring that recruiting documents, flyers, and advertisements for non-VA research are not posted within or on the premises of a VA facility. Posting of such documents may give the Veteran or visitors to the VA facility the impression that the non-VA study is VA-approved research, the VA supports or endorses the research, or that VA will pay for the research expenses that are incurred. General guidance may be posted within VA indicating that Veterans may speak with their health care providers if they wish to participate in research and that information on clinical trials is available at: http://clinicaltrials.gov.
- Department of Defense sponsored research.
- Refer to UIC HSPP Policy Research Involving DoD-Components
- Bureau of Prisons
- Incentives may not be offered to help persuade inmate participants to participate.
- soft drinks and snacks to be consumed at the test setting may however be offered
- reasonable accommodations such as nominal monetary recompense for time and effort may be offered to non-confined research participants who are:
- no longer in Bureau of Prisons custody, and
- participating in authorized research being conducted by Bureau employees or contractors.
45 CFR 46.116
VHA Handbook 1200.05
, vs. 10/15/2010, para. 5, 59
28 CFR 52.111
DoD Instruction 3216.02, 2011
|Version (#, date)
||Replaces (#, date)
||Summary of changes
||Policy revised to clarify difference between recruitment process and recruitment materials.
||Added section VI, which provides Department of Defense sponsored research requirements as to recruitment.
||Updated DoD and VA sections and added Bureau of Prisons.