-
11Devil in the Details: Physician Duties and Expanded AccessJournal of Law, Medicine and Ethics 51 (1): 181-184. 2023.Vermeulen et al. suggest a moral duty exists for physicians to inform patients of “relevant opportunities” for Expanded Access. Such a duty is likely both too broad, leading to important practical challenges, and too narrow, without further steps to promote patient access. However, physicians should be expected to be aware of the EA pathway, disclose it to eligible patients, and support the pursuit of EA options reasonably likely to help.
-
23Confronting Biospecimen Exceptionalism in Proposed Revisions to the Common RuleHastings Center Report 46 (1): 4-5. 2016.On September 8, 2015, the Department of Health and Human Services issued a Notice of Proposed Rule Making to revise the Federal Policy for the Protection of Human Subjects, widely known as the “Common Rule.” The NPRM proposes several changes to the current system, including a dramatic shift in the approach to secondary research using biospecimens and data. Under the current rules, it is relatively easy to use biospecimens and data for secondary research. This approach systematically facilitates …Read more
-
18Adding Insult to Injury: Reluctance to Engage in Clinical Research with At-Risk Groups Further Disenfranchises These PopulationsAmerican Journal of Bioethics 9 (11): 62-64. 2009.
-
30A Functional Approach to Assessing Consent for Biospecimen ResearchAmerican Journal of Bioethics 17 (12): 20-23. 2017.
-
35Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committeesJournal of Medical Ethics 42 (4): 229-234. 2016.
-
24Patient‐Engaged Research: Choosing the “Right” Patients to Avoid PitfallsHastings Center Report 48 (5): 26-34. 2018.To ensure that the information resulting from research is relevant to patients, the Patient‐Centered Outcomes Research Institute eschews the “traditional health research” paradigm, in which investigators drive all aspects of research, in favor of one in which patients assume the role of research partner. If we accept the premise that patient engagement can offer fresh perspectives that shape research in valuable ways, then at least two important sets of questions present themselves. First, how a…Read more
-
15Patient‐Centered Outcomes Research: Stakeholder Perspectives and Ethical and Regulatory Oversight IssuesIRB: Ethics & Human Research 40 (1): 7-17. 2018.
-
17Prescription Requirements and Patient Autonomy: Considering an Over‐the‐Counter DefaultHastings Center Report 50 (6): 15-26. 2020.When new drugs are approved by the Food and Drug Administration, the default assumption is that they will be available by prescription only, safe for use exclusively under clinical supervision. The paternalism underlying this default must be interrogated in order to ensure appropriate respect for patient autonomy. Upon closer inspection, prescription requirements are justified when nonprescription status would risk harm to third parties and when a large segment of the population would struggle t…Read more
-
16INTRODUCTION Health Law and Anti-Racism: Reckoning and ResponseJournal of Law, Medicine and Ethics 50 (1): 10-14. 2022.Law and racism are intertwined, with legal tools bearing the potential to serve as instruments of oppression or equity. This Special Issue explores this dual nature of health law, with attention to policing in the context of mental health, schools, and substance use disorders; industry and the environment in the context of food advertising, tobacco regulation, worker safety, and environmental racism; health care and research in the context of infant mortality, bias in medical applications of AI,…Read more
-
22When clinical trials compete: prioritising study recruitmentJournal of Medical Ethics 43 (12): 803-809. 2017.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,…Read more
-
75Using Social Media as a Research Recruitment Tool: Ethical Issues and RecommendationsAmerican Journal of Bioethics 17 (3): 3-14. 2017.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 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…Read more
-
32Nonexceptionalism, Research Risks, and Social Media: Response to Open Peer Commentaries on “Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations”American Journal of Bioethics 17 (5): 1-3. 2017.
-
33Institutions as an ethical locus of research prioritisationJournal of Medical Ethics 43 (12): 816-818. 2017.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 researc…Read more
-
14Plumbing the Depths of Ethical Payment for Research ParticipationAmerican Journal of Bioethics 21 (5). 2021.The peer commentaries on our Target Article, “Promoting Ethical Payment in Human Infection Challenge Studies,” offer a number of insights that will help advance the co...
-
19Compensating for research risk: permissible but not obligatoryJournal of Medical Ethics 46 (12): 827-828. 2020.When payment is offered for controlled human infection model research, ethical concerns may be heightened due to unfamiliarity with this study design as well as perceptions—and misperceptions—regarding risk. Against this backdrop, we commend Grimwade et al 1 for their careful handling of the relevant issues, coupling empirical and conceptual approaches. We agree with foundational elements of the authors’ analysis, including the acceptability of payment for research risk.1 However, in our view, i…Read more
-
29A Response to CommentariesHastings Center Report 46 (S2): 45-48. 2016.Our article “NFL Player Health Care: Addressing Club Doctors’ Conflicts of Interests and Promoting Player Trust” focused on an inherent structural conflict that faces club doctors in the National Football League. The conflict stems from club doctors’ dual role of providing medical care to players and providing strategic advice to clubs. We recommended assigning these roles to different individuals, with the medical staff members who are responsible for providing player care being chosen and subj…Read more
-
4Human Subjects Research Regulation: Perspectives on the Future (edited book)MIT Press. 2014.Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects.