Voluntariness of Consent to Research: A Conceptual Model

A good deal of policy and practice in human subjects research aims to ensure that when subjects consent to research, they do so voluntarily. To date, however, voluntariness and its impairment have been poorly conceptualized and studied. The legal doctrine of informed consent could provide a useful model

“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

Disclosure of Information to Potential Subjects on Research Recruitment Web Sites

We examined systematically how a sample of Web sites that recruit participants for research on particular diseases present studies to potential subjects, exploring the presence of information about research benefits, risks, procedures, and incentives, including monetary incentives. Such data can elucidate the degree to which federal guidance is being followed and may have potential implications for policy, suggesting areas that IRBs, policy-makers, and regulators may want to consider further regarding online recruiting of research participant

Anticipating issues related to increasing preimplantation genetic diagnosis use: a research agenda

Increasing use of preimplantation genetic diagnosis (PGD) poses numerous clinical, social, psychological, ethical, legal and policy dilemmas, many of which have received little attention. Patients and providers are now considering and using PGD for a widening array of genetic disorders, and patients may increasingly seek ‘designer babies.’ In the USA, although governmental oversight policies have been discussed, few specific guidelines exist. Hence, increasingly, patients and providers will face challenging ethical and policy questions of when and for whom to use PGD, and how it should be financed. These issues should be better clarified and addressed through collection of data concerning the current use of PGD in the USA, including factors involved in decision making about PGD use, as well as the education of the various communities that are, and should be, involved in its implementation. Improved understanding of these issues will ultimately enhance the development and implementation of future clinical guidelines and policies

Editorial Commentary: Suspensory Fixation of Displaced Tibial Posterior Cruciate Ligament Avulsions: A Novel Application of a Familiar Technique

Isolated tibial posterior cruciate ligament avulsion fractures, although rare, are becoming increasingly common in regions of the world with frequent 2-wheel motor vehicle accidents. Arthroscopic-assisted suture fixation has become a popular fixation method for these injuries. Suspensory metal button fixation of tibial posterior cruciate ligament avulsion fractures, although commonly used for other applications, has until recently been limited to isolated reports of a few patients

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

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

Naming names: Perceptions of name-based HIV reporting, partner notification, and criminalization of non-disclosure among persons living with HIV

Policies of name-based HIV reporting, partner notification (PN), and criminalization of non-disclosure of HIV positive status to sexual partners remain controversial. The views of people living with HIV (PLH) are critical to the success of these three initiatives, but have been understudied. Thus, we interviewed 76 PLH about these policies. Themes arose of potential public health benefits (e.g., epidemiological surveillance and notification of possible exposure) and costs (e.g., deterrence of testing); threats to privacy, civil rights and relationships; government mistrust; and beliefs that prevention is an individual, not governmental responsibility. Misperceptions about the intent, content and scope of these policies, and past experiences of discrimination, shaped these attitudes. To enhance development and implementation of HIV prevention strategies, the views of PLH must be taken into account, and education campaigns need to address misperceptions and mistrust. These data shed light on difficulties in developing and implementing policies that may affect sexual behavior, and have critical implications for future research

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