“Members of the Same Club”: Challenges and Decisions Faced by US IRBs in Identifying and Managing Conflicts of Interest

Conflicts of interest (COIs) in research have received increasing attention, but many questions arise about how Institutional Review Boards (IRBs) view and approach these. Methods: I conducted in-depth interviews of 2 hours each with 46 US IRB chairs, administrators, and members, exploring COI and other issues related to research integrity. I contacted leaders of 60 IRBs (every fourth one among the top 240 institutions by NIH funding), and interviewed IRB leaders from 34 of these institutions (response rate = 55%). Data were analyzed using standard qualitative methods, informed by Grounded Theory. Results: IRBs confront financial and non-financial COIs of PIs, institutions, and IRBs themselves. IRB members may seek to help, or compete with, principal investigators (PIs). Non-financial COI also often appear to be “indirect financial” conflicts based on gain (or loss) not to oneself, but to one's colleagues or larger institution. IRBs faced challenges identifying and managing these COI, and often felt that they could be more effective. IRBs' management of their own potential COI vary, and conflicted members may observe, participate, and/or vote in discussions. Individual IRB members frequently judge for themselves whether to recuse themselves. Challenges arise in addressing these issues, since institutions and PIs need funding, financial information is considered confidential, and COI can be unconscious. Conclusions: This study, the first to explore qualitatively how IRBs confront COIs and probe how IRBs confront non-financial COIs, suggests that IRBs face several types of financial and non-financial COIs, involving themselves, PIs, and institutions, and respond varyingly. These data have critical implications for practice and policy. Disclosure of indirect and non-financial COIs to subjects may not be feasible, partly since IRBs, not PIs, are conflicted. Needs exist to consider guidelines and clarifications concerning when and how, in protocol reviews, IRB members should recuse themselves from participating, observing, and/or voting

To Protect Human Subjects, Review What Was Done, Not Proposed

The Advance Notice of Proposed Rulemaking (ANPRM) released in 2011 by the U.S. Department of Health and Human Services (HHS) (1) recommends many important changes to federal regulations on protection of human research subjects. Perhaps most important, through the 74 questions it poses, it offers the opportunity to rethink approaches to research oversight. The current regulatory model of prospective review, based on what researchers say they plan to do, focuses the attention of Institutional Review Boards (IRBs, which must approve proposed research) and researchers on perfecting protocols and consent forms rather than interacting with subjects. Such a regulatory model may discourage innovation in human subjects protection. In contrast, we describe how a system based on retrospective, auditlike review of a subset of projects could stimulate assessment of the effectiveness of current approaches and the development of creative alternatives, with efficiencies for all concerned

Laminar flow of two miscible fluids in a simple network

When a fluid comprised of multiple phases or constituents flows through a network, non-linear phenomena such as multiple stable equilibrium states and spontaneous oscillations can occur. Such behavior has been observed or predicted in a number of networks including the flow of blood through the microcirculation, the flow of picoliter droplets through microfluidic devices, the flow of magma through lava tubes, and two-phase flow in refrigeration systems. While the existence of non-linear phenomena in a network with many inter-connections containing fluids with complex rheology may seem unsurprising, this paper demonstrates that even simple networks containing Newtonian fluids in laminar flow can demonstrate multiple equilibria. The paper describes a theoretical and experimental investigation of the laminar flow of two miscible Newtonian fluids of different density and viscosity through a simple network. The fluids stratify due to gravity and remain as nearly distinct phases with some mixing occurring only by diffusion. This fluid system has the advantage that it is easily controlled and modeled, yet contains the key ingredients for network non-linearities. Experiments and 3D simulations are first used to explore how phases distribute at a single T-junction. Once the phase separation at a single junction is known, a network model is developed which predicts multiple equilibria in the simplest of networks. The existence of multiple stable equilibria is confirmed experimentally and a criteria for their existence is developed. The network results are generic and could be applied to or found in different physical systems

Living with ‘melanoma’…for a day: a phenomenological analysis of medical students’ simulated experiences

Background Despite the rising incidence of melanoma, medical students have progressively fewer opportunities to encounter patients with this important condition. Curricula tend to attach the greatest value to intellectual forms of learning. Compared to intellectual learning, however, experiential learning affords students deep insights about a condition. Doctors who experience ill health are more empathic towards patients. However opportunities to learn about cancer experientially are limited. Temporary transfer tattoos can simulate the ill health associated with melanoma. We reasoned that, if doctors who have been sick are more empathic, temporarily ‘having’ melanoma might have a similar effect. Objectives Explore the impact of wearing a melanoma tattoo on medical students’ understanding of patienthood and attitudes towards patients with melanoma. Methods Ten fourth year medical students were recruited to a simulation. They wore a melanoma tattoo for 24 hours and listened to a patient’s account of receiving their diagnosis. Data were captured using audio-diaries and face-to-face interviews, transcribed, and analysed phenomenologically using the template analysis method. Results There were four themes: 1) Melanoma simulation: opening up new experiences; 2) Drawing upon past experiences; 3) A transformative introduction to patienthood; 4) Doctors in the making: seeing cancer patients in a new light. Conclusions By means of a novel simulation, medical students were introduced to lived experiences of having a melanoma. Such an inexpensive simulation can prompt students to reflect critically on the empathetic care of such patients in the future

Local IRBs vs. Federal Agencies: Shifting Dynamics, Systems, and Relationships

How IRBs relate to federal agencies, and the implications of these relationships, have received little, if any, systematic study. I interviewed 46 IRB chairs, directors, administrators, and members, contacting the leadership of 60 U.S. IRBs (every fourth one in the list of the top 240 institutions by NIH funding), interviewing IRB leaders from 34 (response rate=55%). IRBs describe complex direct and indirect relationships with federal agencies that affect IRBs through audits, guidance documents, and other communications, and can generate problems and challenges. Researchers often blame IRBs for frustrations, but IRBs often serve as the “local face” of federal regulations and agencies and are “stuck in the middle.” These data have critical implications for policy, practice, and research

Legal guardians understand how children with the human immunodeficiency virus perceive quality of life and stigma

AIM: This aim of this study was to describe how legal guardians assessed health-related quality of life and HIV-related stigma in children with the human immunodeficiency virus (HIV) compared to the children's own ratings. METHODS: A cross-sectional nationwide study was performed to compare how 37 children aged from eight to 16 years of age with perinatal HIV, and their legal guardians, assessed the children's health-related quality of life and HIV-related stigma. Data were collected using the 37-item DISABKIDS Chronic Generic Module and a short eight-item version of the HIV stigma scale. RESULTS: Intraclass correlations indicated concordance between the legal guardians' ratings and the children's own ratings of the child's health-related quality of life and HIV-related stigma. There were no statistically significant differences between the ratings of the two groups and gender did not have any impact on the results. Both groups indicated that the children had concerns about being open about their HIV status. CONCLUSION: The results of this study indicated that legal guardians understood how their children perceived their health-related quality of life and HIV-related stigma. The results also indicated the need for interventions to support both the children and legal guardians when it came to disclosing the child's HIV status

Misunderstandings Concerning Genetics Among Patients Confronting Genetic Disease

Critical questions arise about misunderstandings of genetics. We interviewed for 2 h each, 64 individuals who had or were at risk for Huntington's disease (HD), breast cancer or Alpha‐1 antitrypsin deficiency. These individuals revealed various misunderstandings that can affect coping, and testing, treatment and reproductive decisions. A therapeutic misconception about testing appeared: that testing would be helpful in and of itself. Many believed they could control genetic disorders (even HD), yet these beliefs were often incorrect, and could impede coping, testing, and treatment. Misunderstandings about statistics and genetics often fueled each other, and reflected denial, and desires for hope and control. Emotional needs can thus outweigh understandings of genetics and statistics, and providers’ input. Individuals often maintained non‐scientific beliefs, though embarrassed by these. These data have implications for care, and public and professional education. Misunderstandings’ persistence, despite realization of their inaccuracy, suggests that providers need to address not just cognitive facts, but underlying emotional issues

Attitudes and Practices Among Internists Concerning Genetic Testing

Many questions remain concerning whether, when, and how physicians order genetic tests, and what factors are involved in their decisions. We surveyed 220 internists from two academic medical centers about their utilization of genetic testing. Rates of genetic utilizations varied widely by disease. Respondents were most likely to have ordered tests for Factor V Leiden (16.8 %), followed by Breast/Ovarian Cancer (15.0 %). In the past 6 months, 65 % had counseled patients on genetic issues, 44 % had ordered genetic tests, 38.5 % had referred patients to a genetic counselor or geneticist, and 27.5 % had received ads from commercial labs for genetic testing. Only 4.5 % had tried to hide or disguise genetic information, and <2 % have had patients report genetic discrimination. Only 53.4 % knew of a geneticist/genetic counselor to whom to refer patients. Most rated their knowledge as very/somewhat poor concerning genetics (73.7 %) and guidelines for genetic testing (87.1 %). Most felt needs for more training on when to order tests (79 %), and how to counsel patients (82 %), interpret results (77.3 %), and maintain privacy (80.6 %). Physicians were more likely to have ordered a genetic test if patients inquired about genetic testing (p  < .001), and if physicians had a geneticist/genetic counselor to whom to refer patients (p  < .002), had referred patients to a geneticist/genetic counselor in the past 6 months, had more comfort counseling patients about testing (p  < .019), counseled patients about genetics, larger practices (p  < .032), fewer African‐American patients (p  < .027), and patients who had reported genetic discrimination (p  < .044). In a multiple logistic regression, ordering a genetic test was associated with patients inquiring about testing, having referred patients to a geneticist/genetic counselor and knowing how to order tests. These data suggest that physicians recognize their knowledge deficits, and are interested in training. These findings have important implications for future medical practice, research, and education