Distinguishing appropriate from inappropriate conditions on research participation.

Individuals do not have a right to participate in clinical trials. But, they do have a right against being denied participation for inappropriate reasons. Despite the widespread endorsement of these two claims, there has been little discussion regarding which conditions for participation in clinical trials are appropriate and which are inappropriate. The present manuscript attempts to address this gap in the literature. We first describe and then argue against the claim that conditions on enrollment or continued participation are appropriate only when they are needed to answer the scientific question(s) posed by the trial. We then offer an alternative view according to which the appropriateness of conditions depends on whether they help to satisfy the ethical requirements of clinical research. Because these requirements include social value, the present view implies that promoting social value is an acceptable reason to impose conditions on research participation. With this in mind, we explain why it is not coercive to require potential participants to accept conditions on enrollment that promote a trial's social value, even when the participants find those conditions unwelcome. We conclude by evaluating the present proposal's implications for the common practice of requiring participants to agree to the possible use of their leftover biospecimens in a broad range of future research. We argue, contra current regulatory policy, that this practice can be acceptable even when the present trial offers participants the prospect of clinical benefit and the samples are being reserved for future research that is unrelated to the present trial.

Payment is a benefit and why it matters for pediatric trials.

Alan Wertheimer has argued persuasively that research ethics committees should be willing to count payment as a benefit when evaluating studies' risk-benefit ratios. In this paper, I begin by first recapitulating his argument and adding my own, complementary one. I then do two further things. First, I explain why the practical implications of these arguments for studies enrolling competent adults are less than fully clear. Second, I explain why the practical implication for trials enrolling children are clear and significant. I argue that we should be comfortable paying children to compensate them for undergoing research risks. I propose we do so by putting money into accounts that the child gains access to upon attaining majority.

Reconceptualising risk-benefit analyses: the case of HIV cure research.

Modern antiretroviral therapies (ART) are capable of suppressing HIV in the bloodstream to undetectable levels. Nonetheless, people living with HIV must maintain lifelong adherence to ART to avoid the re-emergence of the infection. So despite the existence and efficacy of ART, there is still substantial interest in development of a cure. But HIV cure trials can be risky, their success is as of yet unlikely, and the medical gain of being cured is limited against a baseline of ART access. The medical prospect associated with participation in cure research thus look poor. Are the risks and burdens that HIV cure research places on participants so high that it is unethical, at present, to conduct it? In this paper, I answer 'no'. I start my argument by describing a foundational way of thinking about the ethical justification for regulatory limits on research risk; I then apply this way of thinking to HIV cure trials. In offering this analysis, I confine my attention to studies enrolling competent adults and I also do not consider risks research may pose to third parties or society. Rather, my concern is to engage with the thought that some trials are so risky that performing them is an ethically unacceptable way to treat the participants themselves. I reject this thought and instead argue that there is no level of risk, no matter how high, that inherently mistreats a participant.

Why continuing uncertainties are no reason to postpone challenge trials for coronavirus vaccines.

To counter the pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), some have proposed accelerating SARS-CoV-2 vaccine development through controlled human infection (or 'challenge') trials. These trials would involve the deliberate exposure of relatively few young, healthy volunteers to SARS-CoV-2. We defend this proposal against the charge that there is still too much uncertainty surrounding the risks of COVID-19 to responsibly run such a trial.

Compulsory Research in Learning Health Care: Against a Minimal Risk Limit.

Existing calls to implement learning health care systems have tended to stipulate a minimal or near-minimal risk limit for compulsory learning activities. I argue to the contrary that such a limit cannot be defended. So long as the way in which patients are compelled to participate in learning activities is solely through the withholding of nonresearch options for receiving care, compelling participation does not violate any individual's rights and can be both efficient and adequately fair. Because the decision to compel participation in this way is relevantly similar to the decision to ration care, theories of justice in cost-effectiveness rationing can be used to further specify when it is appropriate to use this method to compel research participation. When applied, these theories will not support a minimal risk limit for compulsory research.

The development of a multidimensional measure of job market cognitions: the Employment Opportunity Index (EOI).

The purpose of this research was to develop a multidimensional measure of job market perceptions based on a meta-analysis. Item sets were developed to operationally define the dimensions and were tested among 3 samples. Results of a series of exploratory and confirmatory factor analyses in 3 samples indicated that the 5 scales have satisfactory psychometric properties, construct, and criterion-related validity. The 5 dimensions accounted for significant and relatively large amounts of turnover variance, even after a number of standard turnover predictors had been taken into account. The results suggest the presence of job search microprocesses in the employee turnover process. These microprocesses are described and integrated into current thinking about the turnover process.