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.

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.

Pupillary Dilation in Research: More than Meets the Eye.

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. 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.

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.

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).

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.

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.

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.

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.

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.

More than cheating: deception, IRB shopping, and the normative legitimacy of IRBs.

Deception, cheating, and loopholes within the IRB approval process have received significant attention in the past several years. Surveys of clinical researchers indicate common deception ranging from omitting information to outright lying, and controversy surrounding the FDA's decision not to ban "IRB shopping" (the practice of submitting protocols to multiple IRBs until one is found that will approve the protocol) has raised legitimate concerns about the integrity of the IRB process. While at first blush these practices seem to cast aspersions on the integrity of clinical researchers, the moral issues raised go deeper than the ethics of cheating.

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.