About four years ago, my 2012 Advancing Ethical Research Conference (AER12) poster titled Incentive Parameters for International Human Subjects Research was published on Ampersand. I was a brand new public health faculty member with big ideas on how having incentive parameters could change the way we do research—but with little insight into the methods of doing so and little understanding of why the topic would be important to NIH reviewers.
What I did know is that incentives—including money, gifts, and services—are a common and accepted component of human subjects research and often essential for enrolling and retaining participants. While some bioethicists do not believe incentives compromise ethical participation, more data on incentives are needed to understand their impact, as little attention has been given to defining what constitutes fair incentives and undue inducement. No public data exist on incentives provided, nor is there written guidance on the range, types, and amounts of incentives that one should provide in a study—not even in the IRB handbook or in the US Code of Federal Regulations. The absence of such guidance raises the question of how incentive decisions are made, and the fact that after four years there is still no public record of incentives/payment provided or specific guidance on what types and amounts of incentives/payment to provide in any study inspires my continued enthusiasm for pursuing the topic.
Going back to AER12, I utilized my poster presentation and conversations about the importance of an incentives database at the conference as a springboard to publish a more detailed version of the incentives database argument in the journal IRB: Ethics & Human Research titled A Global Public Incentive Database for Human Subjects Research.
My co-author and I came up with a list of potential parameters by which to study the issue of incentives, including the context (setting, income, major causes of disease, healthcare access) and research features (risks, condition under study, number of visits, invasiveness) that would be important when collecting information on study incentives. Still, before making a final argument of what incentive parameters would be appropriate going forward, I needed to learn more about the scope of incentives provided globally. I conducted a literature review of incentives in international research on a single disease focus area titled Using Financial Incentives for HIV Prevention Studies in Diverse Global Contexts following my oral presentation at the 2013 Biomedical HIV Prevention Forum. We found that the range of incentives provided in global HIV studies was broad ($2-$60 USD) and there was no standardized incentive amount provided, apart from regulations in South Africa. We also argued that prior to incentives being provided, they should be screened by community members and ethics committees to ensure their appropriateness.
This literature review also led me to think about what kind of monitoring occurs for studies conducted abroad but initiated in the US. To investigate this more, I brought together a group of experts with an interest in this issue for a publication, and again noted some concerns around incentives in a Journal of Bioethical Inquiry article titled Post-approval monitoring and oversight of US initiated human subjects research in resource-constrained countries. Ethical concerns related to participant incentives included lack of truly informed consent, limited consideration of local norms when providing compensation, therapeutic misconception, and post-trial access.
By July 2015, I had transitioned from my position in public health at UC Irvine to the Center for Healthy Communities at the UC Riverside School of Medicine and brought with me funding from the HIV Prevention Trials Network (HPTN) Scholars program. With a lower teaching load and protected time for research, I was able to refocus on the incentives topic.
In thinking about how to best tackle the issue, I began to consider the various stakeholders who are or might be involved in decision making for incentives in research. These included IRB members, researchers, study coordinators, behavioral economists, funding agencies, and of course, potential study participants from the community. Community is often overlooked and consulted after the fact. I spent some time at the Hastings Center in Garrison, New York as a visiting scholar and my discussions there with IRB members, ethicists, and scholars and fellows formed the basis for a research idea which I am pursuing with colleagues in the form of an NIH grant with support of the NRMN. My planned study would be a collaboration with the HPTN ethics working group to determine how different stakeholder groups view incentives and pilot test the database for incentives decision making on new protocols submitted to HPTN. An initial focus on HIV research for the incentives database makes sense, as the impact of incentives or payment to participate in research may be most ethically questionable in high-risk studies or studies with little potential benefit.
Of course, any project only improves with feedback from community members and knowledgeable academics, and with additional background research. In order to capture additional points of view and build my case, I presented a talk titled How much payment is too much in ethical research on my home campus at UC Riverside, and at IDRC with audiences of IRB members, study sponsors, community members, researchers, academic staff, and ethicists. I presented hypothetical scenarios of HIV studies (a clinical trial, a clinical trial with visits over 5 years, and a clinical trial with visits over 5 years where there was the possibility of death) where different incentive amounts were proposed ($0, $8000, $25,000), and I asked audience members if they agreed or disagreed with the amount. There was a diverse response of perceived appropriate incentive amounts, with many thinking 0 dollars was appropriate. Media coverage from these talks led to an interview on incentives in research which appears in IRB Advisor in which the lack of guidance and transparency on incentives provided in research was the main focus, as well as an agreement that the term ‘excessive’ incentive is difficult to define.
So what’s next? I hope to develop a user-friendly, publicly available, and transparent database of incentives provided in previous research which can aid decision making for incentives/payment to provide in future studies, empower participants to negotiate their participation in research, and to begin to develop a data-driven discussion on what incentives are appropriate and excessive.
Brandon Brown is Assistant Professor at the Center for Healthy Communities in the Department of Social Medicine and Population Health at the University of California, Riverside School of Medicine.
Brown is teaching Session A6 on Monday, November 14, at PRIM&R's AER16 conference: Examining Participant Perspectives on Social and Structural Constraints on Research Involving Vulnerable Populations