How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

<p>Abstract</p> <p>Background</p> <p>Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.</p> <p>Discussion</p> <p>Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.</p> <p>The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.</p> <p>Conclusion</p> <p>Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed?</p

Bumblebee foraging rhythms under the midnight sun measured with radiofrequency identification

<p>Abstract</p> <p>Background</p> <p>In the permanent daylight conditions north of the Arctic circle, there is a unique opportunity for bumblebee foragers to maximise intake, and therefore colony growth, by remaining active during the entire available 24-h period. We tested the foraging rhythms of bumblebee (<it>Bombus terrestris </it>and <it>B. pascuorum</it>) colonies in northern Finland during the summer, when the sun stays above the horizon for weeks. We used fully automatic radio-frequency identification to monitor the foraging activity of more than 1,000 workers and analysed their circadian foraging rhythms.</p> <p>Results</p> <p>Foragers did not use the available 24-h foraging period but exhibited robust diurnal rhythms instead. A mean of 95.2% of the tested <it>B. terrestris </it>workers showed robust diurnal rhythms with a mean period of 23.8 h. Foraging activity took place mainly between 08:00 and 23:00, with only low or almost no activity during the rest of the day. Activity levels increased steadily during the morning, reached a maximum around midday and decreased again during late afternoon and early evening. Foraging patterns of native <it>B. pascuorum </it>followed the same temporal organisation, with the foraging activity being restricted to the period between 06:00 and 22:00.</p> <p>Conclusions</p> <p>The results of the present study indicate that the circadian clock of the foragers must have been entrained by some external cue, the most prominent being daily cycles in light intensity and temperature. Daily fluctuations in the spectral composition of light, especially in the UV range, could also be responsible for synchronising the circadian clock of the foragers under continuous daylight conditions.</p

Turner syndrome and sexual differentiation of the brain: implications for understanding male-biased neurodevelopmental disorders

Turner syndrome (TS) is one of the most common sex chromosome abnormalities. Affected individuals often show a unique pattern of cognitive strengths and weaknesses and are at increased risk for a number of other neurodevelopmental conditions, many of which are more common in typical males than typical females (e.g., autism and attention-deficit hyperactivity disorder). This phenotype may reflect gonadal steroid deficiency, haploinsufficiency of X chromosome genes, failure to express parentally imprinted genes, and the uncovering of X chromosome mutations. Understanding the contribution of these different mechanisms to outcome has the potential to improve clinical care for individuals with TS and to better our understanding of the differential vulnerability to and expression of neurodevelopmental disorders in males and females. In this paper, we review what is currently known about cognition and brain development in individuals with TS, discuss underlying mechanisms and their relevance to understanding male-biased neurodevelopmental conditions, and suggest directions for future research

Medical Hope, Legal Pitfalls: Potential Legal Issues in the Emerging Field of Oncofertility

The article will begin its discussion by identifying the values at stake in the field of oncofertility. These values include the constitutional protection of the rights of women and minors to bear children and to use reproduction-assisting technologies, as well as the feminist critique of gendered expectations that may pressure women to use these technologies. Part III will focus on the medical options of oncofertility. It will also discuss some conditions that may lead otherwise fertile and young patients to lose their ability to bear children as a side-effect of necessary medical treatment. The article will then proceed to discuss briefly the current state of the art and the various medical options available to patients wishing to preserve fertility. After laying out both the medico-scientific and legal groundwork, the article will then address the potential legal questions that may emerge as the field of oncofertility develops. Can or must parents consent to a medically unnecessary surgery on behalf of a child to preserve her fertility? Who owns the excised tissue and the gametes contained within it? Additionally, legal issues that arise in conducting research on excised tissues for the purposes of future reproduction will be discussed. We avoid making definitive predictions of what the law relating to oncofertility will look like. Rather, our purpose is to suggest a framework based on the current state of the law which can help to answer these questions