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.

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.

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 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.

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.

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.

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.

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.

The Real-Time IRB: A Collaborative Innovation to Decrease IRB Review Time.

Lengthy review times for institutional review boards (IRBs) are a well-known barrier to research. In response to numerous calls to reduce review times, we devised "Real-Time IRB," a process that drastically reduces IRB review time. In this, investigators and study staff attend the IRB meeting and make changes to the protocol while the IRB continues its meeting, so that final approval can be issued at the meeting. This achieved an overall reduction in time from submission to the IRB to final approval of 40%. While this process is time and resource intensive, and cannot address all delays in research, it shows great promise for increasing the pace by which research is translated to patient care.

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.

Piloting a nationally disseminated, interactive human subjects protection program for community partners: unexpected lessons learned from the field.

Funders, institutions, and research organizations are increasingly recognizing the need for human subjects protections training programs for those engaged in academic research. Current programs tend to be online and directed toward an audience of academic researchers. Research teams now include many nonacademic members, such as community partners, who are less likely to respond to either the method or the content of current online trainings. A team at the CTSA-supported Michigan Institute for Clinical and Health Research at the University of Michigan developed a pilot human subjects protection training program for community partners that is both locally implemented and adaptable to local contexts, yet nationally consistent and deliverable from a central administrative source. Here, the developers of the program and the collaborators who participated in the pilot across the United States describe 10 important lessons learned that align with four major themes: The distribution of the program, the implementation of the program, the involvement of community engagement in the program, and finally lessons regarding the content of the program. These lessons are relevant to anyone who anticipates developing or improving a training program that is developed in a central location and intended for local implementation.