800 Boylston Street Boston,
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The use of social media in clinical research carries many potential benefits—for example, it enables the creation of valuable support and communication networks for research participants. However, it also carries potential risks, including the possibility that participants may share information online in ways that permit themselves, other participants, and/or the research team to be unblinded to key aspects of the research data. These potential risks, as well as the practical approaches by which they may be mitigated, were the topic of the January 22nd meeting of the Bioethics Collaborative.
800 Boylston Street Boston,
Massachusetts
02199United States
The widespread use of mobile smart devices and wearables has the potential to change how clinical research is conceptualized and conducted. Participants’ data may now be leveraged for a variety of health purposes, including the development of remote screening and diagnostic tools, early intervention programs, and the promotion of public health. While these developments can make research participation less burdensome, they also raise ethical and regulatory challenges around acceptable levels of privacy risk, necessary precautions for safeguarding participants’ confidentiality, and the optimal approach to risk mitigation. The promises and potential barriers to integrating mobile devices and wearable technologies in clinical trial workflows was the focus of the May 2, 2019, meeting of the MRCT Center Bioethics Collaborative. View Summary >
800 Boylston Street Boston,
Massachusetts
02199United States
Adaptive and platform trials may promise greater efficiency and scientific sophistication, but they also raise ethical questions about the principles of informed consent, clinical equipoise, and justice, in addition to practical challenges. Attendees engaged and expanded upon these ethical issues and considered strategies for addressing the theoretical and practical challenges they raise for investigators, sponsors, IRBs, participants, and other stakeholders.
800 Boylston Street Boston,
Massachusetts
02199United States
Pragmatic clinical trials (PCTs) compare or assess interventions in real-world practice settings, hoping to deliver data on effectiveness and safety that more closely resembles clinical care than explanatory clinical trials that focus on demonstrating efficacy in a highly controlled setting. PCTs obscure the distinction between research and clinical care more than traditional randomized control trials (RCTs), which in turn raises novel ethical questions concerning informed consent, data privacy, incidental findings, and other issues.
The COVID-19 pandemic has raised novel ethical issues and intensified existing ones in clinical research. From the abundance of ethical issues, the MRCT Center identified 3 topics to initiate discussion at the June 1st Bioethics Collaborative: 1) clinical equipoise and the standard-of-care for COVID-19 research, 2) clinical trial prioritization amidst a scarcity of resources, and 3) the role of the Institutional Review Board in COVID-19 research. Attendees guided discussion beyond these issues over the course of the Bioethics Collaborative.
Ethical questions relating to the work of patient advocates in clinical research have been given insufficient attention. What experience and training must a person have to participate in patient engagement in clinical research? What does it mean for an advocate to be representative, and to what extent are advocates expected to represent the full range of perspectives of patients with the condition or that may be impacted by the proposed research? Are there conflicts of interest (financial and otherwise) that affect patient engagement in clinical research, and if so, how can they be managed?
AI technologies may be used to facilitate certain aspects of clinical trials, or AI may be the intervention under investigation in a clinical trial or an observational study. Both applications raise questions about data privacy, the risks of non-representative and/or biased data, and the appropriate oversight mechanisms for AI in clinical research.
Decentralized clinical trials (DCTs) are clinical trials that are executed in part or in whole through remote modalities, such as telemedicine, healthcare providers who travel to participants’ homes, smart phone applications, and mobile health wearables, inter alia. Bioethics Collaborative attendees will discuss questions of justice and access, privacy, oversight for research participant safety, and the changing roles and responsibilities of various stakeholders in the research process, among other ethical challenges raised by DCTs.
Despite the potential benefits of community engagement (CE), the rigor, quality, and impact of CE are difficult to assess, in part due to the lack of a standardized understanding of what is meant by CE. Relatedly, it can be challenging to define ‘community’ in the abstract, and any decision about how to specify the relevant community will be ethically and politically significant. Other ethical challenges are connected to practical issues, such as identifying individuals who can speak on behalf of a community and/or marginalized populations within a community; engaging individuals without taxing their time or services too much; and how to ensure that there is sufficient reciprocity to the interactions. Finally, it is often difficult for sponsors, sites, and investigators and their study teams to know whether they have achieved representativeness, that is, whether they have heard from an adequate range of perspectives in a community.
Limited English proficiency (LEP) refers to a limited ability to read, speak, write, and/or understand English. The exclusion of individuals with LEP from research is a significant issue, and this exclusion raises issues of justice. Strategies to accommodate individuals with LEP in research must include consideration of the principles of autonomy and beneficence/non-maleficence; safeguards may be added to ensure that the consent and participation of individuals with LEP is informed and voluntary, and furthermore, that the safety and well-being of individuals with LEP can be maintained throughout their research participation. These ethical considerations must be weighed against the expense and delay of translation and interpreter services.
