This year the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) has approved two sets of recommendations in the context of payments in research.
The first set of recommendations, which were approved in July 2019, address concerns that arise when sponsors and investigators want to offer payments to research participants. SACHRP was asked to examine this issue following the January 2018 update to the FDA Information Sheet Payment and Reimbursement to Research Subjects in which the FDA clarified that reimbursement of expenses incurred due to research participation were acceptable and did not raise ethical concerns.
In their recommendations, SACHRP notes that payments to participants can take on many forms – reimbursement for out of pocket expenses, compensation, tokens of appreciation, and incentive – and that most of them should not present concerns of undue influence on participants.
In the context of incentive payments, where there is the potential for undue inducement, SACHRP recommends that the regulators “acknowledge that concerns about incentive payments that may be unduly influential can be managed without necessarily lowering or eliminating them.” The recommendation identify five considerations for IRBs when evaluating the acceptability of incentive payments:
- Their responsibility to approve research only when risks are reasonable in relation to benefits to participants and/or society;
- The possibility that incentive payments will compromise the informed consent process;
- Steps that can be taken to support autonomous decision-making in those contexts;
- Tradeoffs that may be associated with restricting incentive payments and how that may affect achieving adequate recruitment; and
- How similar payment might be viewed outside the research setting.
The second set of recommendations that were approved by SACHRP on October 16th examine research studies that ask potential research participants to bear some or all of the costs of the research. Anecdotally, IRBs are seeing an up-tick in the frequency of such submissions, with many of them being in the area of regenerative medicine. Earlier this year, the FDA targeted some of these studies and warned consumers to be wary of unproven therapies. While some of these are examples of investigator-initiated, unfunded research, there are also reports of entities using this mechanism to provide unproven therapies without having to market a product in a way that would require FDA oversight.
The recommendations also note that there is an increase in the use of crowd-funding mechanisms that have not been previously contemplated by IRBs or regulators. Although the FDA regulations do address charging participants for investigational drugs and biologics (21 CFR 312.8), and investigational devices (21 CFR 812.7), they did not contemplate a scenario where the ability to charge study participants might be exploited to take advantage of individuals who are both desperate for an effective therapy and have the ability to manage significant out of pocket costs.
SACHRP’s recommendations conclude with a list of questions that can serve as a starting point for prospective subjects who are contemplating such research, and also the IRBs that review proposals that require participants to pay for access to the experimental intervention. These questions include:
- Who has reviewed this research and said it is OK to do? Has there been ethical and scientific review of the research?
- Why do the researchers think that what is being tested might help people like me? What do they think it might do, if it works?
- Has it been tested before? If so, how many people has it been tested on?
- Why am I being asked to pay to join this research?
- How much will the researchers charge me to be in this research?
- What exactly will I be paying for (eg., diagnostic tests, the study intervention)?
- What are some reasons I might be willing to pay to join this research? What are some reasons I might not be willing to pay to join this research?
- Besides the people like me who join this research, are any other people or groups also paying for this research? If so, what exactly are they paying for?
- If I am injured, who will pay for the treatment of that injury?
- When will I be expected to pay? If paid in installments, what happens if a payment it missed?
- If I quit the research, will I get any of my money back?
- If the researchers make me leave the research, will I get any of my money back?
- What other costs might I have to pay if I join this research?
- Will being in this research affect my health insurance coverage? Will my health insurance cover any part of what I am being charged for this research?
Ultimately, IRBs need to proceed in a careful and deliberate manner when considering the intersection between research, payments and participants.