Nearly nine years to the day the Food and Drug Administration (FDA) issued a draft “information sheet” on informed consent, the agency published a 66-page final guidance document on the topic—marking the first time since 1998 FDA has comprehensively addressed this bedrock of human subjects research.
The guidance addresses the basics of informed consent—such as the elements of the process—as well as the responsibilities of institutional review boards (IRBs), investigators and FDA. The guidance also includes 16 FAQs on an array of significant topics; electronic informed consent and the sharing of aggregate study results are among them. Unfortunately, the wait goes on for truly current guidance or regulations—to comport with the 2018 revised Common Rule and to offer more harmonization with other agencies that oversee federally funded research. The guidance also draws attention to a number of other rules FDA has not finalized—some of them equally significant.
As compliance officials know, guidance is not the same as regulations, and it is not legally binding, as FDA points out. Still, the guidance will be useful for those conducting or overseeing FDA-regulated drug and device trials, as it brings previous documents on aspects of informed consent together in one place.
FDA acknowledged in the guidance, published Aug. 16, that the 2018 revisions “include significant changes to the provisions regarding informed consent” and said the agency is “currently engaged in notice and comment rulemaking to harmonize its human subject protection.” FDA issued two proposed rules—a general one and another on cooperative research—on Sept. 28, 2022. It has not yet issued final rules.
“This guidance supersedes FDA’s guidance entitled ‘A Guide to Informed Consent,’ issued in September 1998, and finalizes FDA’s draft guidance entitled ‘Informed Consent Information Sheet,’ issued in July 2014,” FDA explained.
RRC asked FDA to highlight some of the changes from its 2014 informed consent information sheet. An official noted FDA “clarified our guidance regarding financial payments to clinical trial participants and the additional costs they may face due to participation.”
FDA: Payments Should Be ‘Just, Fair’
Regarding payment to subjects, FDA said, “paying research subjects in exchange for their participation is a common and, in general, acceptable practice,” although this is “not specifically addressed by FDA regulations [and] may, in some cases, raise difficult questions that should be addressed by IRBs.”
FDA recommended IRBs “address how much money research subjects should receive, and for what subjects should receive payment (e.g., their time, inconvenience, discomfort, or some other consideration).”
Moreover, FDA “does not consider reimbursement for reasonable travel expenses to and from the clinical trial site (e.g., airfare, gas, tolls), and associated costs, such as parking and lodging, to raise issues related to coercion or undue influence. Reimbursement for other expenses may be considered by an IRB on a case-by-case basis, and IRBs should consider whether the proposed remuneration could be an undue influence. Payment for participation in research should be just and fair.”
FDA’s statements on payment are generally in line with its 2018 information sheet on payment. The agency also addressed the possibility that research subjects may incur “additional expense” while in a trial. Informed consent documents “must explain the added costs” and whether they will be borne by subjects, their insurance “or other reimbursement mechanism.” If subjects are to be charged for the investigational drug or device, this also must be included in the informed consent process, FDA said.