It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for participants. There is evidence that such a competition is a predictor of low study accrual, with increased competition tied to increased recruitment shortfalls. But there is no consensus on what steps, if any, institutions should take to approach this issue. In this article, we argue (...) that an institutional policy that prioritises some trials for recruitment ahead of others is ethically permissible and indeed prima facie preferable to alternative means of addressing recruitment competition. We motivate this view by appeal to the ethical importance of minimising the number of studies that begin but do not complete, thereby exposing their participants to unnecessary risks and burdens in the process. We then argue that a policy of prioritisation can be fair to relevant stakeholders, including participants, investigators and funders. Finally, by way of encouraging and helping to frame future debate, we propose some questions that would need to be addressed when identifying substantive ethical criteria for prioritising between studies. (shrink)
The view that research with competent adults requires valid consent to be ethical perhaps finds its clearest expression in the Nuremberg Code, whose famous first principle asserts that “the voluntary consent of the human subject is absolutely essential.” In a similar vein, the United Nations International Covenant on Civil and Political Rights states that “no one shall be subjected without his free consent to medical or scientific experimentation.” Yet although some formulations of the consent principle allow no exceptions, others hold (...) that informed consent is not always strictly necessary for ethical research. The U.S. federal regulations known as the “Common Rule,” which govern research with human subjects, lists several conditions for waiving consent. However, neither guidance documents on the ethics of clinical research nor the literature in bioethics contains a general justification of research without consent. The purpose of this paper is to advance a justificatory framework that will explain why research without consent is permissible in paradigmatic cases and that can be useful in analyzing cases about which there is disagreement. We argue that research without consent can be justified on two grounds: if it stands to infringe no right of the participants and obtaining consent is impracticable, or if the gravity of the rights infringement is minor and outweighed by the expected social value of the research and obtaining consent is impracticable. (shrink)
I examine different strategies involved in stating anti-theistic arguments from natural evil, and consider some theistic replies. There are, traditionally, two main types of arguments from natural evil: those that purport to deduce a contradiction between the existence of natural evil and the existence of God, and those that claim that the existence of certain types or quantities of natural evil significantly lowers the probability that theism is true. After considering peripheral replies, I state four prominent theistic rebutting strategies: skeptical (...) theism; Richard Swinburne's view that moral knowledge entails natural evil; the soul-making theodicy; and the natural law theodicy. (shrink)
The modern ethical framework demands informed consent for research participation that includes disclosure of material information, as well as alternatives. The severe acute respiratory syndrome coronavirus 2 pandemic results in illness that often involves rapid deterioration. Despite the urgent need to find therapy, obtaining informed consent for COVID-19 research is needed. The current pandemic presents three types of challenges for investigators faced with obtaining informed consent for research participation: uncertainty over key information to informed consent, time and pressure constraints, and (...) obligations regarding disclosure of new alternative therapies and re-consent. To mitigate consenting challenges, primary investigators need to work together to jointly promote urgent care and research into COVID-19. Actions they can take include prior plan addressing ways to incorporate clinical research into clinical practice in emergency, consider patients vulnerable with early deliberation on the consent process, seek Legally Authorized Representatives, create a collaborative research teams, aim to consent once, despite evolving information during the pandemic, and aim to match patients to a trial that will most benefit them. The COVID-19 pandemic both exacerbates existing challenges and raises unique obstacles for consent that require forethought and mindfulness to overcome. While research teams and clinician-investigators will need to be sensitive to their own contexts and adapt solutions accordingly, they can meet the challenge of obtaining genuinely informed consent during the current pandemic. (shrink)
I consider two views that combine different elements of general theistic replies to natural evil, those of Peter van Inwagen and William Hasker. I end with a Hasker-style defense – one that, unlike Hasker's, denies the existence of pointless natural evils – and some brief observations on the direction of future debate.
Significant attention has been given both to the ethics of Controlled Human Infection Model research and the ethics of payment for research participation. However, comparatively little attention has been given to the ethics of paying for participation specifically in CHIM research. Grimwade et al should be commended for thoughtfully addressing this topic and especially for the empirical data collection informing their work, which is too often lacking in discussions of payment for research participation. In what follows I will discuss three (...) relatively subtle factors that, I believe, make a difference to the ethical analysis of paying for research participation and raise what I intend to be constructive questions about the extent to which the survey instrument employed by the authors captures them. The authors focus on payment for risk in CHIM research. They correctly stress that compensating participants for risk is controversial and that “many general guidelines warn against paying for the risk in medical research”. While not all guidance documents share this scepticism,1 compensating for risk raises thorny issues and uncertainty over the topic among IRBs and regulatory bodies is likely to hinder the practice. Part of the difficulty in assessing payment for research risks stems from the way in which subtle variances in background assumptions influence the ethical assessment, which also complicates empirical attempts to measure attitudes on the topic. Most importantly, it is crucial to be precise about background assumptions concerning whether participants are protected from bearing the financial burdens of research risks that eventuate in actual harms. Protective mechanisms …. (shrink)
Recently Jason Hanna has argued that a particular type of susceptibility to framing effects—namely, the tendency to reverse one’s choice between certain logically equivalent frames—invalidates actual tokens of consent. Here I argue that this claim is false: proneness to choice-reversal per se between the relevant types of frames does not invalidate consent.
Ensuring that clinical trials, once launched, successfully complete and generate useful knowledge is an important and indeed ethically imperative goal, given the risks and burdens borne by research participants. Since there are insufficient willing research participants to power all the trials that are currently undertaken,1 addressing underenrolment will require prioritisation decisions that reduce the number of trials competing for participants. While there are multiple levels at which research priority-setting can and does take place, competition between trials often plays out in (...) real time at the institutional or site level, where complex decisions must be made about how to manage overlapping trials in ways that balance different considerations, including the risk of non-completion. We sought to explore what research institutions in particular might ethically do to mitigate the risk that competition between trials will contribute to recruitment shortfalls. Against this backdrop, we appreciate the thoughtful replies to our article and are especially encouraged that all three respondents acknowledge the importance and indeed necessity of setting research priorities in ways that respect the rights and interests of various parties. The key question raised by the commentaries primarily concerns not whether research prioritisation should take place but rather how it is best accomplished. In what follows, we clarify our argument in the original article, and then focus on several points raised in the commentaries regarding the role of institutions in research priority-setting. Our approach is animated by the risk that competition between clinical trials for the same population of participants can be a cause of underenrolment when there are insufficient participants to meet the statistical needs of all open studies. In such situations, one or more of the competing studies will fail to meet recruitment targets, reducing their statistical ability to answer the research question. There are strong ethical reasons to avoid …. (shrink)