Ethics & human research最新文献

Autism research frequently seeks to evaluate interventions or inform their development. Unfortunately, researchers often assume that autism intervention should reduce autistic traits, effectively setting as a goal of treatment that autistic people attempt to “pass” as nonautistic. A growing body of evidence highlights serious potential harms from passing demands. We discuss why it is important for institutional review boards (IRBs) to scrutinize autism research for clinical passing demands, and we document the existence of such demands in outcome measures commonly employed in autism research. We propose an ethical framework for IRBs and others to make use of in evaluating the ethical appropriateness of particular treatment goals in autism intervention or intervention-adjacent research, emphasizing that treatment goals should be in pursuit of a beneficial nonpassing purpose and be the least burdensome means of accomplishing such a purpose. We also highlight potential promising practices for IRBs, investigators, and other stakeholders seeking to address these issues in autism research.

Over the past 30 years, progress has been made in increasing women's representation in clinical research. However, women continue to be underrepresented in phase I clinical trials—those trials that test the safety and tolerability of investigational drugs, often on healthy individuals. As sex-based differences in adverse drug reactions are often linked to drug dose, pivotal safety information in phase I trials is often insufficiently—and inequitably—captured for females. Yet there has been little attention to how clinical investigators and those charged with overseeing the ethical conduct of these trials perceive the barriers to women's inclusion in phase I trials. To address this gap, we report on 22 interviews with U.S. phase I investigators and institutional review board (IRB) members. Our findings indicate that although these investigators and IRB members acknowledged the importance of including women in clinical trials, they justified women's exclusion from phase I trials by citing the need to manage their reproductive potential. In particular, we identified four key themes that informants used to warrant women's exclusion from phase I trials: the structure of the drug-development system itself, fears about risks to potential fetuses, distrust of women to prevent pregnancy, and concerns about risks and burdens to institutions from resulting pregnancies. We argue that these rationales reflect structural and cultural barriers to women's inclusion in clinical research that ultimately fail to respect female research participants as persons, highlighting the need for broad-based solutions.

Generative artificial intelligence (AI) has the potential to transform many aspects of scholarly publishing. Authors, peer reviewers, and editors might use AI in a variety of ways, and those uses might augment their existing work or might instead be intended to replace it. We are editors of bioethics and humanities journals who have been contemplating the implications of this ongoing transformation. We believe that generative AI may pose a threat to the goals that animate our work but could also be valuable for achieving those goals. In the interests of fostering a wider conversation about how generative AI may be used, we have developed a preliminary set of recommendations for its use in scholarly publishing. We hope that the recommendations and rationales set out here will help the scholarly community navigate toward a deeper understanding of the strengths, limits, and challenges of AI for responsible scholarly work.

Impactful translational research requires new approaches to computational analysis and bioethics, both of which have been advanced by adoption of community-engagement strategies. Community knowledge and experience will hone data collection, research, and insights and accelerate the impact of derived translational applications to improve individual health, medical decision-making, and public health policy. In the context of translational research with big health data, meaningful community-researcher engagement will require developing and deploying coengagement tools across the research life cycle and developing approaches for novel coproduction.

To be ethical, clinical trials must exhibit a favorable risk-benefit balance at the time of their initiation. However, in some cases, the expected value of a study decreases while the study is ongoing, due to developments outside of the study itself, such as findings from other studies or an otherwise shifting evidence base. While such situations are acknowledged in the research community, they have not received sufficient attention, given the high costs of uninformative studies, both in material and human capital. In addition, the Covid-19 pandemic has exposed serious shortcomings with current approaches to monitoring studies for continued relevance and value. In this article, with reference to a case study from the Covid-19 pandemic, we identify and describe the importance and challenge of ensuring that clinical trials continue to exhibit scientific relevance and value once initiated. We explore the ethical dynamics of these situations and identify unresolved issues. While more empirical work is needed to ensure that proposed solutions to the issues are evidence based, we offer some provisional considerations that amount to a framework for approaching these challenging situations.

The National Institutes of Health (NIH) requires use of a single institutional review board (sIRB) for multisite, nonexempt, NIH-funded research with human participants. The Clinical Trials Transformation Initiative (CTTI) conducted in-depth interviews with 34 stakeholders at two universities and in research administration leadership positions at multiple institutions about their experiences implementing the sIRB model, focusing on the NIH policy's goals soon after the policy was enacted. While some stakeholders suggested that using an sIRB has streamlined and reduced inefficiencies associated with the local IRB model, more stakeholders indicated that the sIRB model has not simplified the ethics review process and instead created new inefficiencies due to unclear roles and responsibilities for staff and institutions; a lack of systems and processes for implementing the sIRB model, including communication systems; and increased workloads. CTTI used these findings to propose a new framework for evaluating the NIH sIRB policy.

Over recent decades, adaptive trial designs have been used more and more often for clinical trials, including randomized controlled trials (RCTs). This rise in the use of adaptive RCTs has been accompanied by debates about whether such trials offer ethical and methodological advantages over traditional, fixed RCTs. This study examined how experts on clinical trial methods and ethics believe that adaptive RCTs, compared to fixed ones, affect the ethical character of clinical research. We conducted in-depth interviews with 17 researchers from bioethics, epidemiology, biostatistics, and/or medical backgrounds. While about half believed that adaptive trials are more complex and may thus threaten autonomy, these respondents also expressed that this challenge is not insurmountable. Most respondents expressed that efficiency and potential for participant benefit were the main justifications for adaptive trials. There was tension about whether adaptive randomization in response to increasing information disrupts clinical equipoise, with some respondents insisting that uncertainty still exists and therefore clinical equipoise is not disrupted. These findings suggest that further discussion is needed to increase the awareness and utility of these study designs.