Luke Gelinas
Harvard University
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Publication
Featured researches published by Luke Gelinas.
American Journal of Bioethics | 2017
Luke Gelinas; Robin Pierce; Sabune J. Winkler; I. Glenn Cohen; Holly Fernandez Lynch; Barbara E. Bierer
The use of social media as a recruitment tool for research with humans is increasing, and likely to continue to grow. Despite this, to date there has been no specific regulatory guidance and there has been little in the bioethics literature to guide investigators and institutional review boards (IRBs) faced with navigating the ethical issues such use raises. We begin to fill this gap by first defending a nonexceptionalist methodology for assessing social media recruitment; second, examining respect for privacy and investigator transparency as key norms governing social media recruitment; and, finally, analyzing three relatively novel aspects of social media recruitment: (i) the ethical significance of compliance with website “terms of use”; (ii) the ethics of recruiting from the online networks of research participants; and (iii) the ethical implications of online communication from and between participants. Two checklists aimed at guiding investigators and IRBs through the ethical issues are included as appendices.
Hastings Center Report | 2016
Luke Gelinas; Alan Wertheimer; Franklin G. Miller
The purpose of consent is to let a person waive her rights of control over some aspects of her life. But becoming part of a research study does not always seriously undermine ones control.
The New England Journal of Medicine | 2018
Luke Gelinas; Emily A. Largent; I. Glenn Cohen; Susan Kornetsky; Barbara E. Bierer; Holly Fernandez Lynch
Ethical Payment to Research Participants The authors propose a framework for evaluating the appropriateness of payments to research participants. They distinguish three acceptable rationales for pa...
Journal of Medical Ethics | 2017
Luke Gelinas; Holly Fernandez Lynch; Barbara E. Bierer; I. Glenn Cohen
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.
Therapeutic Innovation & Regulatory Science | 2018
Luke Gelinas; Holly Fernandez Lynch; Emily A. Largent; Carmel Shachar; I. Glenn Cohen; Barbara E. Bierer
The practice of paying research participants has received significant attention in the bioethics literature, but the focus has been almost exclusively on consideration of factors relevant to determining acceptable payment amounts. Surprisingly little attention has been paid to what happens once the payment amount is set. What are the ethical parameters around how offers of payment may be advertised to prospective participants? This article seeks to answer this question, focusing on the ethical and practical issues associated with disclosing information about payment, and payment amounts in particular, in recruitment materials. We argue that it is permissible—and indeed typically ethically desirable—for recruitment materials to disclose the amount that participants will be paid. Further, we seek to clarify the regulatory guidance on “emphasizing” payment in a way that can facilitate design and review of recruitment materials.
Journal of Medical Ethics | 2017
Luke Gelinas; Holly Fernandez Lynch; Barbara E. Bierer; I. Glenn Cohen
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 …
Archive | 2016
Bruce D. White; Luke Gelinas
While there are real dangers involved with surgical innovation, calling for vigilance in safeguarding patient well-being and autonomy, it is important not to overplay the dangers of innovation or underplay its benefits. One only needs to consider the history of surgical innovation to understand this point (Science 200:937–941, 1978). That history suggests that physicians should—to the degree possible—consider, suggest, and provide insightful, studied, and cogent innovative treatments that are peer-acknowledged—accepted, or—reviewed, while taking care to balance their obligation to respect patient autonomy and benefit their patients. To achieve this balance, it is essential for innovative practitioners to be thoroughly embedded in, and engaged with, their peers in the medical community. Certainly it would be awkward, if not almost impossible, for a reasonably prudent, competent physician to offer an unproven treatment as a lone wolf, acting in a manner radically afield from similarly situated practitioners, without some collegial involvement and support.
Annals of Internal Medicine | 2018
Luke Gelinas; Joel S. Weissman; Holly Fernandez Lynch; Avni Gupta; Ronen Rozenblum; Emily A. Largent; I. Glenn Cohen
American Journal of Bioethics | 2018
Luke Gelinas; Holly Fernandez Lynch; Barbara E. Bierer; I. Glenn Cohen
American Journal of Bioethics | 2016
Luke Gelinas