Promoting Equity in Health Care through Human Flourishing, Justice, and Solidarity.

In this article, we develop a non-rights-based argument based on beneficence (i.e., the welfare of individuals and communities) and justice as the disposition to act justly to promote equity in health care resource allocation. To this end, we structured our analysis according to the following main sections. The first section examines the work of Amartya Sen and his equality of capabilities approach and outlines a framework of health care as a fundamental human need. In the subsequent section, we provide a definition of health equity based on the moral imperative to guarantee that every individual ought to have the freedom to pursue health goals and well-being. In the later part of the article, we outline a non-right approach to health care based on three pillars: (1) human flourishing, (2) justice as a disposition not a process, and (3) solidarity.

Easy-to-Read Informed Consent Form for Hematopoietic Cell Transplantation Clinical Trials: Results from the Blood and Marrow Transplant Clinical Trials Network 1205 Study.

Because of the complexity of hematopoietic cell transplant trial treatments, informed consent forms are often long and difficult to read. We evaluated a 2-column easy-to-read informed consent (ETRIC) form that incorporates elements of health literacy and readability in participants and centers participating in Blood and Marrow Transplant Clinical Trials Network (BMT CTN) clinical trials. In a randomized study 198 adult patients from 25 centers potentially eligible to participate in 4 BMT CTN interventional trials were randomized to the ETRIC form or a standard consent form for that trial. Both forms were written at no more than an eighth-grade reading level. The primary endpoint was objective comprehension score on the Quality of Informed Consent, part A (QuIC-A) instrument. In a parallel evaluation study, 2 moderators conducted semistructured interviews of 49 investigators, research staff, and institutional review board (IRB) members at 9 BMT CTN trial sites. The mean QuIC-A scores were comparable in 152 patients (77%) assessable for the primary endpoint (ETRIC form, 80.5; standard form, 81.8; P = .37). In regression analysis there was no significant association between the consent type and QuIC-A score. In the evaluation study dominant themes identified on qualitative analyses included general comfort and willingness to use the ETRIC template and that its formatting and layout enhancements would offer additional value to research participants, investigators, and IRBs. IRB language preferences and requirements, length, and prior experience with alternative consent formats were perceived as barriers. Among patients considering participation in BMT CTN clinical trials, the formatting enhancements of the ETRIC form did not alter comprehension of the trial. Despite local challenges to implementation, trial sites generally viewed the ETRIC form favorably and expressed willingness to use it over standard consent form.

The limits of traditional approaches to informed consent for genomic medicine.

This paper argues that it will be important for new genomic technologies to recognize the limits of traditional approaches to informed consent, so that other-regarding implications of genomic information can be properly contextualized and individual rights respected. Respect for individual autonomy will increasingly require dynamic consideration of the interrelated dimensions of individual and broader community interests, so that the interests of one do not undermine fundamental interests of the other. In this, protection of individual rights will be a complex interplay between individual and community concerns.

Navigating the perils and pitfalls throughout the consent process in hematopoietic cell transplantation.

Hematopoietic cell transplantation (HCT) is a complex treatment used in malignancies and some non-malignant diseases. The informed consent process for HCT can also be complex due to patient- and process-related barriers. The informed consent process needs to be a dynamic and ongoing process, not simply a checklist. As a result of the realities of HCT, we highlight some potential pitfalls to the informed consent process including uncertainty, sociocultural and communication barriers, and decisional regret. The purpose of this comprehensive review is to highlight unique situations which can result in failure of the informed consent process. We also offer potential solutions to these pitfalls, primarily making the informed consent more patient focused through dynamic and continuous processes to mitigate decisional regret.

Easy-to-read informed consent forms for hematopoietic cell transplantation clinical trials.

Informed consent is essential to ethical research and is requisite to participation in clinical research. Yet most hematopoietic cell transplantation (HCT) informed consent forms (ICFs) are written at reading levels that are above the ability of the average person in the United States (U.S.). The recent development of ICF templates by the National Cancer Institute, National Institutes of Health, and the National Heart Blood and Lung Institute have not resulted in increased patient comprehension of information. Barriers to creating Easy-to-Read ICFs that meet U.S. federal requirements and pass institutional review board (IRB) review are the result of multiple interconnected factors. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) formed an ad hoc review team to address concerns regarding the overall readability and length of ICFs used for BMT CTN trials. This paper summarizes recommendations of the review team for the development and formatting of Easy-to-Read ICFs for HCT multicenter clinical trials, the most novel of which is the use of a 2-column format. These recommendations intend to guide the ICF writing process, simplify local IRB review of the ICF, enhance patient comprehension, and improve patient satisfaction. The BMT CTN plans to evaluate the impact of the Easy-to-Read format compared with the traditional format on the informed consent process.

Pupillary Dilation in Research: More than Meets the Eye.

Purpose: Pupil dilation is a commonly used procedure in vision research. While often considered a minimal risk procedure, there is the potential for significant adverse effects. Methods: Currently, there is variance in practices and protocols among researchers and institutions, perhaps due to a lack of guidelines for safe pupil dilation practices in research settings. In this perspective, we explore variables that can increase the potential for adverse effects and provide suggestions to limit their impact. Prior to dilation, an investigator can assess an individual's medical status and drug regimen when deciding upon a mydriatic agent to be used. Results: Assessing the angle through a variety of methods (i.e. penlight test, van Herick slit lamp, optical coherence tomography, gonioscopy) can also prevent inappropriate dilation of pupils with concerning anatomical features. During dilation, an investigator should look to limit the potential of infection and use caution in repeat dosing of dilation-resistant pupils. Conclusions: Post-dilation, an investigator should closely monitor eyes with elevated risk factors and improve an individual's health literacy on angle closure complications. When combined with proper informed consent processes regarding adverse effects, the aforementioned can allow for risk mitigation in studies using pupil dilation.

The History of Human Subjects Research and Rationale for Institutional Review Board Oversight.

The history of human subjects research and the abuses that led to the creation of the United States' (US) regulatory schema for research, which includes institutional review boards (IRBs), is long and complex. However, when one understands the history, one can see direct links between those abuses and the regulations, as well as the ethical principles, contained in the Belmont Report. To that end, we provide a brief analysis of the history of human subjects research and its abuses, including a lesser known case (the atrocities committed by Nazi scientists and physicians during World War II) and infamous cases in the US (including the Tuskegee Syphilis Study and Willowbrook). With that history in hand, we will then seek to understand the regulations that govern human subjects research and the IRB by grounding them both in the ethical principles in the Belmont Report.

The rights (and responsibilities) of the public to advance health through research.

In this commentary we assert that the rights and responsibilities of the community at large as an important key stakeholder in the effort of advancing health through research and discovery have not been carefully examined and delineated. The time has come to investigate the nature of the rights and responsibilities of the public in advancing health through research and discovery. We argue that the public has the right not merely to participate in research and have their rights protected, but that they have a right to engage in and take ownership in research.

Characterizing Current Attitudes and Practices for Human Subject Safety in Studies Involving Pupil Dilation.

Standards in pupil dilation practices regarding the safety of human subjects are not present in vision research despite the potential for significant adverse effects. We developed two surveys to examine current practices around pupil dilation among vision researchers and individuals associated with oversight of human subjects research. While both groups note an absence of adverse events associated with pupil dilation, vision researcher practices differed with informed consent use and measures taken to minimize complications. For Institutional Review Boards, general risk assumption associated with dilation was not unanimous and there was a lack of specific guidance available to researchers for minimizing risk. These results uncover the need for standardized practices regarding pupil dilation in human subjects research.

Community-Based Participatory Research and its Potential Role in Supporting Diversity in Genomic Science.

OBJECTIVES: This paper seeks to understand why targeted efforts to recruit subjects from underrepresented communities have failed to meaningfully increase diversity of genomic reference data. APPROACH: We review a variety of mechanisms that have attempted to establish trust with communities underrepresented in genomic research, including sophisticated informed consent, broad consent, community consultation, and initiatives designed to diversify the scientific workforce. We also analyze the ability of deep community engagement of the type advanced by community-based participatory research (CBPR) to address deficiencies in previous strategies to build trust. CONCLUSION AND RECOMMENDATION: Previous strategies to build trust do not fully address key concerns related to the foundational aims and projects of scientific inquiry. The techniques of CBPR are well suited to address these concerns and thus build trust. Community engagement strategies show tremendous promise in supporting participation of underrepresented communities in genomic research.

Maximizing beneficence and autonomy. Ethical support for the use of nonpharmacological methods for managing dental anxiety.

This article examines advantages associated with nonpharmacological behavioral management techniques and suggests that there are benefits to their use (such as achieving a more lasting solution to the problem of dental anxiety) that are not realized with medication-based interventions. Analyses that use Kantian and existential viewpoints for exploring the use of medication versus behavioral interventions for managing life problems yield parallel conclusions: there are advantages gained by using behavioral interventions that are not always associated with medication-based interventions. These analyses, taken together with an understanding of the psychology of dental anxiety management, suggest that using nonpharmacological techniques for the management of dental anxiety can maximize adherence to the ethical principles of beneficence and patient autonomy. The authors discuss the barriers that make nonpharmacological interventions for anxiety management difficult for dentists to routinely use, and suggest that additional training in these methods and increased collaboration with mental health professionals are needed for dentists.

Bias in the Peer Review Process: Can We Do Better?

Peer review is the major method used by the scientific community to evaluate manuscripts and decide what is suitable for publication. However, this process in its current design is not bulletproof and is prone to reviewer and editorial bias. Its lack of objectivity and transparency raise concerns that manuscripts might be judged based on interests irrelevant to the content itself and not on merit alone. This commentary reviews some of the most common biases that could potentially affect objective evaluation of a manuscript and proposes alternatives to the current single-blind peer review process that is being used by most scientific journals, including Obstetrics & Gynecology. By rethinking and tackling the shortcomings of the current methodology for peer review, we hope to create a discussion that will eventually lead to improving research and, ultimately, patient care.