The purpose of the early-career research spotlight is two-fold. First, the aim is to bring attention to an early-career APA member who is doing some interesting research. Second, the hope is to generate discussion about the spotlighted work. Feel free to ask our spotlighted researcher questions pertaining to the work discussed in the post. Comments must conform to our community guidelines and comment policy.
This installment of the early-career research spotlight series looks at the work of Danielle Wenner. Wenner is an Assistant Professor of Philosophy at Carnegie Mellon University (CMU) and focuses on the intersection of global justice and bioethics. She received her Ph.D. from Rice University in 2011, and has since completed both a clinical ethics fellowship at the Cleveland Clinic and an Andrew W. Mellon Postdoctoral Fellowship at CMU. More recently, she has been appointed as an ethicist to the National Heart, Lung, and Blood Institute’s (NHLBI’s) Blood and Marrow Transplantation Clinical Trials Network Data Safety and Monitoring Board, and has joined the Efficacy Trials Working Group of the HIV Vaccine Trials Network. Her work has been featured in numerous journals, including Developing World Bioethics and the American Journal of Bioethics. Examples of her work discussing the proper way to conduct research in low- and middle-income countries (LMICs) can be found in her papers “Against Permitted Exploitation in Developing World Research Agreements” and “Discharging the Duty to Conduct International Clinical Research.”
Nathan: Thanks for agreeing to the interview, Danielle. In your work, you argue against the exploitation of research subjects in low- and middle-income countries (LMICs), saying that research in these parts of the world is not ethically justified unless the knowledge produced in such research is meant to improve these communities. In doing this, you refer to the “social value of knowledge.” Can you elaborate on what you mean by socially valuable knowledge? Does all knowledge have a social value, and how does one measure the value of knowledge?
Danielle: Thanks for inviting me to do this interview, Nathan. I’m grateful for the recent work the APA has done to increase exposure for young scholars in our field.
I think knowledge can be valuable in lots of ways, but what I’m trying to hit on in my work on international research ethics is how knowledge can be valuable to a society, and in particular, what kinds of knowledge-gains can justify the risks (both known and unknown) of harms (both known and unknown) that we subject human subjects to in clinical research. Although I don’t take a stand on whether knowledge can have intrinsic value, it seems that in order to justify experimenting on human subjects, the knowledge we’re expecting to gain has to be valuable in some instrumental way—that is, it needs to be of some benefit to someone. We might think that the knowledge should be of benefit to the research participants themselves, but this doesn’t sync well with how research works: the goal of clinical research is not to benefit the participants, but rather to generate knowledge that can be put to use in benefiting science and, via science, future patients. The whole reason we do research is because we’re uncertain whether new interventions will be of benefit to the trial participants, and often prioritizing benefits to research participants can undermine the goals of rigorous scientific investigation. So my account seeks to explain how to determine whether research-generated knowledge has instrumental value for society.
And really, my account isn’t a novel account of the value of knowledge so much as a novel application of an existing account of the value of information from the decision sciences. It says that we can assign value to information based on whether it’s likely to change our choice in some relevant decision we’re facing. In evaluating policy decisions, for example, a policy-maker might be faced with a range of options and think she has an approximate understanding of what different outcomes might be generated by any given choice and how likely each of those outcomes are. New information can change how likely she thinks different outcomes are, and in some instances change those likelihoods to a large enough extent that it changes her preferred choice. In those instances, we can say that the information was valuable in a practical sense: it informed social utility functions in a way that generated a decision that otherwise would have been made another way. This is, loosely, the sense of the social value of knowledge that I appeal to. When considering whether a particular trial is capable of producing socially valuable knowledge, the decision procedure is roughly to ask what piece of information this trial could produce that is most likely to cause a change in social decision-making (usually, in late-phase research, this will be a rejection of the null hypothesis), and then to ask: supposing this is the information that it produces, what impact might this information have on decisions that are facing stakeholders? This might involve decisions informing local health policy or resource allocation, future research priorities, or the funding priorities of NGOs and non-profits working to address health deficits.
Many research ethicists, as well as guidance documents governing human subjects research, posit that in order for research on human subjects to be ethical, it must be capable of producing socially valuable knowledge, but little work has been done to fill out what that means. So that’s one contribution I see this work doing. In the case of international research, there is also a concern about the frequency with which interventions are tested on members of low- and middle-income countries for the sake of health benefits that ultimately devolve only to members of high-income populations, as when new drugs are tested in places where they will never be marketed due to their high prices. These trials are often characterized as exploitative, and I argue that one way to reduce such exploitation is to require that clinical trials be conducted only where they will produce knowledge that is of local social value, so this is one application of the framework. I think the framework can also be usefully applied to other questions in research ethics though, like the demand for public access to study-generated data and persistent deficits in the publication of negative results.
All of that said, I also see this line of research as making an important methodological contribution: although other areas of applied ethics—and political philosophy more broadly—have made great inroads in bringing formal tools to bear on difficult questions, I haven’t seen much of that in research ethics. There is really a wealth of tools that have been developed in economics, math, and the decision sciences that can be incredibly valuable in bioethics, and I hope this work helps to highlight that and to encourage more people working in bioethics to see the value that can be gained by interaction with these other disciplines.
Nathan: It sounds as though you are advocating a form of consequentialism which looks for social value as the desired outcome (as opposed to justice or happiness). One of the objections I’ve often heard against consequentialist ethics is that what counts as a good outcome is relative to society, upbringing, or something else, and as a result it cannot be used as a yardstick for what is right. What would be your response to the claim that what counts as socially valuable knowledge cannot be determined in any meaningful sense?
Danielle: I’m not sure I’d agree with the dichotomy you present. First, I don’t think it’s very useful to talk about clinical research or its goals without talking about desired outcomes. When we use human subjects in experiments, we’re often asking them to submit to significant health risks. It’s not clear to me that this would be justifiable were there not some outcome we were seeking to promote—in this case, greater biomedical knowledge with which to improve the health and well-being of future patients. And second, I don’t see the requirement for social value in research to be opposed to accounts of justice, but rather as one part of an account of what justice in research requires. So, for example, you suggest that what counts as a good outcome may be relative to a society or some other context. But I see the account that I present as entirely able to accommodate that. Whether some clinical trial is likely to produce knowledge that is valuable within a particular social context can be determined by the social decisions being faced by that community. I don’t aim to give an account of what knowledge is valuable simpliciter, but rather what knowledge is instrumentally valuable to a particular community at a particular time in informing social decision-making. When thinking about what justice requires, then, what I suggest is that one necessary (but not sufficient) condition for ensuring that the benefits and burdens of clinical research are distributed in a just fashion is that the knowledge that is expected from a particular clinical trial can be made use of in informing decisions that are relevant to the community in which the trial will be conducted. This is just one standard out of many that are necessary to the prevention of exploitation—when construed as an unfair distribution of the benefits of interaction—in clinical research.
Nathan: While it looks like a lot of your work is focused on articulating the ethical principles owed to LMICs in which research is conducted, you often mention that there are important connections between your work and the field of social and political philosophy. What sociopolitical institutions, systems, or practices do you think work against the ethical treatment of LMICs, and why?
Danielle: That’s a big question, and so it’s not clear to me that the answer is terribly straightforward. One of the ideas that I’m interested in is that of threat advantage: when, in negotiating a trade or an agreement or a contract, one party’s willingness and ability to simply not transact is significantly greater than the other’s (due to the second party’s need, for instance). In such cases, the stronger party is often able to simply dictate the terms of the interaction, without regard for the interests or preferences of the weaker. This kind of threat advantage is prominent in a huge proportion of international interactions, whether between multinational research sponsors and the LMIC populations that host clinical research, or between states’ representatives in multilateral trade negotiations like TPP, or even the parties trying to negotiate a new climate deal at the COP21 meeting in Paris this past fall. The staggering difference in bargaining power between the parties in each of these kinds of interactions means that a few very powerful interests are well positioned to dictate large swaths of the policies governing international relations. And similarly, on a smaller transactional scale, those who are worst off are least empowered to direct their futures and the institutions that will impact them. It seems to me that this pervasive form of vulnerability is a major source of many of the problematic institutional structures and practices that govern interactions between high- and low- or middle-income populations. Of course, how to characterize this form of vulnerability, and in particular how to distinguish between instances when threat advantage undermines the legitimacy of the outcomes of interactions and when it doesn’t is incredibly difficult. The complexity of international institutions, trade regimes, and treaties only exacerbates these difficulties.
Nathan: Are there programs in place at Carnegie Mellon’s Center for Ethics and Policy (or other bio-ethics centers you know of) to advocate for the changes you suggest in your work? If so, can you elaborate on the type of work that they do?
Danielle: I think the biggest way I advocate for the changes I suggest in my work is through direct engagement with the medical research profession. As a discipline, philosophy often takes knocks for being disengaged or cut off from the realities of everyday life, but I don’t believe it has to be that way, and, frankly, I take the most pride in those parts of my work that actively inform practices in the clinic and impact the lives of real patients. For me this means not only publishing in medical and scientific outlets as well as philosophy journals, but also serving on boards and committees that actually oversee or direct ongoing research. Currently that includes working on an oversight board at the National Institutes of Health (NIH) that monitors ongoing clinical trials to ensure that risks are appropriately minimized and reasonable in relationship to the value of the research, as well as serving on a working group composed primarily of HIV researchers, statisticians, and community advocates whose mandate includes developing of strategic plans for the prioritization and implementation of efficacy trials for new HIV vaccines and considering the ethical and regulatory issues that are confronted in trial development, such as choosing the appropriate comparator, and ensuring the adequate protection of what are often socially vulnerable populations.
That said, there are a number of organizations—CIOMS (The Council for International Organizations of Medical Sciences), the World Health Organization, and large clinical trials networks such as HVTN (the HIV Vaccine Trials Network) and HPTN (the HIV Prevention Trials Network)—to name just a few—that convene regularly to consider the ethical implications of international research and to issue consensus guidance to researchers and research sponsors who will be working in LMICs or elsewhere. Many research ethicists contribute to these efforts, and so there is a very real sense in which this work has implications for real-world practice.
Nathan: Many thinkers who have spoken out against exploitation have argued that in order to prevent it from recurring it is important for the voices of the exploited to be included in decision-making processes. With research ethics, this poses an interesting dilemma, since research programs need to be designed by individuals who understand how they work. Do you think the problem of exploitation could be prevented by involving people from LMICs at some stage in the development of research projects? If so, what would that look like?
Danielle: I think it’s an interesting dilemma, but not an insurmountable one. Community engagement is considered by most to be a pillar of ethical research, and many of the guidance documents to which I referred earlier emphasize engagement with local stakeholders during the planning and conduct phases of clinical trials. Although there are a number of ways to unpack what constitutes sufficient engagement, who counts as the relevant community (or communities), and who should represent those communities, these are questions that have received a lot of attention among both researchers and research ethicists who want to ensure that research is as representative and transparent as possible. The HIV research community is a great example of this. HIV activists have played a huge role in shaping how research and treatment have developed since the 1980s, when it was activist pressure that really spurred more research investment into the disease and pushed for greater access to new drugs. I think researchers in this area now largely recognize that large-scale trials aren’t feasible without the buy-in and support of the HIV community. Community advisory boards (CABs) are usually involved from the very beginning of the planning stages for new HIV research, and members of CABs and other community representatives often attend conferences and meetings not only to learn about the scientific background motivating new studies, but also to consult on trial design and the specific challenges researchers face, provide feedback to researchers about issues researchers might not recognize, and voice community concerns about specific trials or research practices. The HIV research community makes a concerted effort to promote this kind of engagement, and although I don’t want to give the impression that everything is figured out and there are no problems, I think they provide a great example that researchers in other areas can look to for how to consciously and intentionally seek input from those who have the most at stake in a given research arena, including stakeholders from LMICs.
That said, while community involvement may be necessary for engaging in ethical research, it is certainly not a panacea for combating exploitation. Often, hosting clinical research can bring much-needed benefits to low-income populations in the form of access to basic healthcare, local infrastructure development, and training of medical personnel. Given the urgency of need that often characterizes such populations, we may think that even a very engaged local community might welcome the opportunity to host research in exchange for very minimal benefits. On its face, this sounds great: local communities can benefit from hosting research, while research sponsors, the medical-scientific community, and broader society benefit from the findings generated. But this leaves unaddressed whether those communities are receiving a fair share of the surplus value created by such interactions. If a multinational corporation develops a new drug by testing it on underprivileged people and turns that drug into millions of dollars of profit and huge gains in the form of reduced morbidity and mortality for its high-income consumers, while the communities that drug was tested on benefit in only small, incremental increases in local healthcare capacity, then it’s at least plausible that there’s an injustice in the resulting distribution and that the host communities deserved a greater share of the benefits. And given the disparity in bargaining position between host communities and research sponsors, an active and engaged local community is unlikely to be sufficient to ensure that this isn’t the outcome we see.
So while I would argue that community engagement and input are necessary to ensure that research is transparent and responsive to the needs of those who are most vulnerable, it is not sufficient to protect the vulnerable from exploitation or to ensure that research is ethical. For this, we need additional standards governing the conduct of clinical research that not only seek not to ensure that research is well-designed and consensual, but which also serve other important goals such as the ratcheting up of local standards of care, the promotion of more just distributions of the benefits of research, the preservation of social support of the clinical research enterprise, and the reduction of incentives that function to reinforce existing disparities in access to health and healthcare.
Nathan: It looks like your teaching complements your work, as you’ve recently taught classes on global justice, law, morality, and human rights. How receptive are your students to the ideas you discuss in your classes, especially those relating to moral obligations to the third world?
Danielle: There’s a pretty big divide, in my experience, actually. It’s often the case that talking about the structures that contribute to or maintain severe poverty in other parts of the world requires students to take a step back and reevaluate the way they live their own lives. Many students (and people more generally) are made very uncomfortable by the idea that they may not be entitled to all the things that they have, or to live at the level of consumption they’ve grown accustomed to. The same can be said when discussing, for example, global climate change. Some students seem more willing to take that step back than others, and to really examine behaviors they had previously taken for granted through the lens of what a deep commitment to equality or fairness or some other standard of global justice might imply. For this group, such questioning represents an opportunity to rethink behaviors they had previously thought were outside the realm of moral decision-making, and to either reason about how those behaviors ought to change or to grow more confident and comfortable that they have defensible reasons for not changing them. On the other hand, some students seem deeply resistant to this, seemingly unwilling to consider the possibility that behaviors they had considered to be at worst morally neutral may in fact be problematic. These students seem to struggle in particular with the idea that taking these considerations seriously may imply that they are, or have been, behaving immorally.
This is actually another place where I think it’s interesting to consider the value of knowledge, but in this case to think about how some knowledge can be particularly dis-valuable. When students (and people more generally) are made aware of reasons they might have for changing behaviors they had long thought morally neutral, it can be easy to think of that knowledge as harmful. It can negatively impact their ethical assessments of themselves, and when taken into account in future behavior, can have seriously costly implications. Thinking again about climate change, for example, it seems clear that if we as a society are going to attempt to address the level of greenhouse gas emissions we produce, then as individuals our levels of consumption have to be reduced as well. But when people are made to think about these things, there is both a natural tendency to want to cling to a way of life that is familiar, especially when contemplating the costs associated with change, and also a natural reluctance to accept a view that seems to imply that one is acting wrongly—immorally—insofar as one refuses to change. I take it that it is this discomfort to which Martha Nussbaum refers when she calls cosmopolitanism a “lonely” position and characterizes it as “exile from the comfort of local truths.”
Please feel free to ask Danielle questions about her work in the comment thread.
If you know of an early-career researcher doing interesting work, nominate them for our research spotlight series through the submission form here. Our goal is to cover early-career research from a broad array of philosophical areas and perspectives, reflecting the variety of work being done by APA members.