Clinical trial practitioners seeking direct U.S. Food and Drug Administration (FDA) input for specific questions can leverage an online service from the agency’s Office of Good Clinical Practice. While comprehensive, it is an often-overlooked and cumbersome data repository. In this occasional series, ACRP wades through the posted questions and answers and provides highlights some of the most interesting and important interactions between industry and regulators. Answers are generally provided by Doreen M. Kezer, MSN, Senior Health Policy Analyst, Office of Good Clinical Practice, Office of the Commissioner, though she often calls in specific FDA regulatory subject matter experts for additional analysis.
Q (edited): In clinical studies, the sponsor reimburses patients for their travel cost per visit. Normally, we pay a fixed amount from $20 to $30. In some cases, the actual travel cost is less than the amount. Practically, it’s difficult for us to pay according to the actual cost. It’s also prohibited to collect the subjects’ addresses due to privacy laws. The information will be included in the informed consent form. Local ethics committee and regulatory approvals are required. The subjects are aware of the compensation. In this circumstance, will it be considered as an incentive for the subjects from the inspection perspective? Is there any ethical concern from your view?
Kezer’s Response (edited): FDA recommends that the amount or schedule of compensation should not undermine a person’s capacity to exercise free and uncoerced choice to participate in the study.
The institutional review board (IRB) should determine that the risks to subjects are reasonable in relation to anticipated benefits, and that the consent document contains an adequate description of the study procedures as well as the risks and benefits. The amount and schedule of all benefits should be presented to the IRB at the time of initial review. The IRB should review both the amount of payment and the proposed method and timing of disbursement, to assure that neither are coercive not present undue influence.
Q (edited): Protocol requires subjects to have pre-existing condition for a specific amount of time (i.e., one year prior to inclusion in trial). However, prior medical records to serve as documentation are not required by protocol. Moreover, potential subjects have not authorized the release of past medical records to the site. Would a subject’s self-reported medical history suffice to meet inclusion criterion, or are past medical records necessary?
Kezer’s Reponse (edited): It depends. I suggest you consult with the sponsor of the study and, if the study is under an Investigational New Drug application, with the regulatory project manager at FDA to determine what documentation is needed or expected.
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Author: Michael Causey