Streamlining Ethical Review

The U.S. review system for human subjects research has been widely criticized in recent years for requirements that delay research without improving human subjects protections. Any major reformulation of regulations may take some time to implement. In the meantime, current regulations often allow for streamlined ethics review without jeopardizing—and possibly improving—protections for research participants. We discuss underutilized options, including research that need not be classified as “human subjects research,” categories of studies that can be exempt from ethical review, and studies that need only undergo expedited review by one IRB member. In addition, we consider ways to simplify review of multi-center research using one institution’s IRB. We speculate on multiple reasons for the underuse of these mechanisms, and exhort IRBs and researchers to take advantage of these important opportunities to improve the review process

Interactions of inert confiners with explosives

The deformation of an inert confiner by a steady detonation wave in an adjacent explosive is investigated for cases where the confiner is suciently strong (or the explosive suciently weak) such that the overall change in the sound speed of the inert is small. A coupling condition which relates the pressure to the deflection angle along the explosive-inert interface is determined. This includes its dependence on the thickness of the inert, for cases where the initial sound speed of the inert is less than or greater than the detonation speed in the explosive (supersonic and subsonic inert ows, respectively). The deformation of the inert is then solved by prescribing the pressure along the interface. In the supersonic case, the detonation drives a shock into the inert, subsequent to which the ow in the inert consists of alternating regions of compression and tension. In this case reverberations or `ringing' occurs along both the deflected interface and outer edge of the inert. For the subsonic case, the flow in the interior of the inert is smooth and shockless. The detonation in the explosive initially defl ects the smooth interface towards the explosive. For sufficiently thick inerts in such cases, it appears that the deflection of the confiner would either drive the detonation speed in the explosive up to the sound speed of the inert or drive a precursor wave ahead of the detonation in the explosive. Transonic cases, where the inert sound speed is close to the detonation speed, are also considered. It is shown that the confinement affect of the inert on the detonation is enhanced as sonic conditions are approached from either side

Single-Particle Green Functions in Exactly Solvable Models of Bose and Fermi Liquids

Based on a class of exactly solvable models of interacting bose and fermi liquids, we compute the single-particle propagators of these systems exactly for all wavelengths and energies and in any number of spatial dimensions. The field operators are expressed in terms of bose fields that correspond to displacements of the condensate in the bose case and displacements of the fermi sea in the fermi case. Unlike some of the previous attempts, the present attempt reduces the answer for the spectral function in any dimension in both fermi and bose systems to quadratures. It is shown that when only the lowest order sea-displacement terms are included, the random phase approximation in its many guises is recovered in the fermi case, and Bogoliubov's theory in the bose case. The momentum distribution is evaluated using two different approaches, exact diagonalisation and the equation of motion approach. The novelty being of course, the exact computation of single-particle properties including short wavelength behaviour.Comment: Latest version to be published in Phys. Rev. B. enlarged to around 40 page

Data and Safety Monitoring Boards: Some Enduring Questions

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/75571/1/j.1748-720X.2009.00410.x.pd

Self-Similar Random Processes and Infinite-Dimensional Configuration Spaces

We discuss various infinite-dimensional configuration spaces that carry measures quasiinvariant under compactly-supported diffeomorphisms of a manifold M corresponding to a physical space. Such measures allow the construction of unitary representations of the diffeomorphism group, which are important to nonrelativistic quantum statistical physics and to the quantum theory of extended objects in d-dimensional Euclidean space. Special attention is given to measurable structure and topology underlying measures on generalized configuration spaces obtained from self-similar random processes (both for d = 1 and d > 1), which describe infinite point configurations having accumulation points

How payment for research participation can be coercive

The idea that payment for research participation can be coercive appears widespread among research ethics committee members, researchers, and regulatory bodies. Yet analysis of the concept of coercion by philosophers and bioethicists has mostly concluded that payment does not coerce, because coercion necessarily involves threats, not offers. In this article we aim to resolve this disagreement by distinguishing between two distinct but overlapping concepts of coercion. Consent- undermining coercion marks out certain actions as impermissible and certain agreements as unenforceable. By contrast, coercion as subjection indicates a way in which someone’s interests can be partially set back in virtue of being subject to another’s foreign will. While offers of payment do not normally constitute consent-undermining coercion, they do sometimes constitute coercion as subjection. We offer an analysis of coercion as subjection and propose three possible practical responses to worries about the coerciveness of payment

“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

Protecting Clinical Trial Participants and Protecting Data Integrity: Are We Meeting the Challenges?

Susan Ellenberg discusses alternative approaches towards evaluating data as it accumulates in clinical trials, and to protecting the integrity and preventing undue risks to participants, as the trial continues