Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We look at (...) what we know about IRB decision-making in relation to protecting and including “vulnerable” groups in research and examine the lack of regulatory guidance related to this dilemma, which encourages protection over inclusion within IRB practice. Finally, we offer recommendations related to how IRBs might strike a better balance between inclusion and protection in research ethics oversight. (shrink)

We are grateful to everyone who took the time to offer such insightful comments with regard to the protection–inclusion dilemma in research oversight. Nearly all respondents agreed that this dilemm...

1 Evidence-based policy requires researchers to provide the answers to ecological questions that are of interest to policy makers. To find out what those questions are in the UK, representatives from 28 organizations involved in policy, together with scientists from 10 academic institutions, were asked to generate a list of questions from their organizations. 2 During a 2-day workshop the initial list of 1003 questions generated from consulting at least 654 policy makers and academics was used as a basis for (...) generating a short list of 100 questions of significant policy relevance. Short-listing was decided on the basis of the preferences of the representatives from the policy-led organizations. 3 The areas covered included most major issues of environmental concern in the UK, including agriculture, marine fisheries, climate change, ecosystem function and land management. 4 The most striking outcome was the preference for general questions rather than narrow ones. The reason is that policy is driven by broad issues rather than specific ones. In contrast, scientists are frequently best equipped to answer specific questions. This means that it may be necessary to extract the underpinning specific question before researchers can proceed. 5 Synthesis and applications. Greater communication between policy makers and scientists is required in order to ensure that applied ecologists are dealing with issues in a way that can feed into policy. It is particularly important that applied ecologists emphasize the generic value of their work wherever possible. (shrink)

The essays in this volume, with the exception of Gary Ferngren's, derive from ancestral versions originally presented at a symposium, 'Conflicts with Newborns: Saving Lives, Scarce Resources, and Euthanasia: held May 10-12,1984, at the Mercer University School of Medicine, Macon, Georgia. We wish to express our gratitude to the Georgia Endowment for the Humanities for a generous grant for the symposium and to Mercer University and the Medical Center of Central Georgia for additional financial support. The vit:ws expressed in this (...) volume do not necessarily represent those of the Georgia Endowment for the Humani ties, Mercer University, or the Medical Center of Central Georgia. We have endeavored to bring together a group of individuals with contrast ing viewpoints to display some of the range of approaches to a major problem in public policy: medical decisions regarding the treatment of defective newborns. So many persons contributed to the symposium that acknowledg ment of each would be impossible. Although unnamed, we express our sincere appreciation to each. Three individuals, however, must be recognized: R. Kirby Godsey, President, Mercer University; William P. Bristol, Dean, Mercer University School of Medicine; and Kenneth C. Henderson, Medical Director and Director of Medical Education, Medical Center of Central Georgia. Without their support, the symposium could not have succeeded and this volume would not have been possible. We wish also to express our gratitude to S. G. M. (shrink)

The coming of bioethics to Singapore / W. Calvin Ho and Sylvia S.N. Lim -- The impact of the bioethics advisory committee on the research community in Singapore / Charmaine K.M. Chan and Edison T. Liu -- Engaging the public : the role of the media / Chang Ai-Lien and Judith Tan -- Confucian trust and the biomedical regulatory framework in Singapore / Anh Tuan Nuyen -- The clinician-researcher : a servant of two masters? / Alastair V. Campbell, Jacqueline Chin, (...) and Teck Chuan Voo -- The US model for oversight of human stem cell research / Lindsay Parham and Bernard Lo -- Genetics and stem cell research : models of international policy-making / Bartha Maria Knoppers, Emily Kirby and Rosario Isasi -- Public engagement and bioethics commissions / Thomas H. Murray and Ross S. White -- Norm-making on human-animal chimeras and hybrids in Singapore, the United Kingdom and the international domain / W. Calvin Ho and Martin Bobrow -- How will future bioethical issues engage Singapore? / John Elliott. (shrink)

An English language translation accompanies the original Greek text of Aristotle's book about the nature of the state, constitutions, revolutions, democracy, and oligarchy.

Transgenic plants are now being used to develop pharmaceutical and industrial products in addition to their use in crop improvement. Using confinement requirements, these transgenic plants are grown and processed under conditions that prevent intermixing with commodity crops. Regulatory agencies in the United States have provided guidance of zero tolerance of these new industrial crops with commodity crops. While this is a worthy goal, it is theoretically unattainable. In spite of the best containment practices, there is a potential risk using (...) any system of production due to unforeseen incidences including natural disasters or exposure to workers. The precautionary principle has been used for numerous regulated articles in addressing the potential risks of new products and technology based on a risk assessment in similar situations. We present here a risk assessment model that could be used as a start to develop an accepted model for the industry. The model is based on current risk models used for other regulated articles, but adapted for these types of products. This could be used to determine action levels in the event of an unintended exposure or to ensure that detection or confinement methods are adequate to avoid risks. As an example, aprotinin, a therapeutic protein now being produced in maize, was evaluated for potential risk to humans using this model. (shrink)

There is evidence for increase, followed by decline, in synaptic numbers during development. Dendrites do not function in isolation. A constructive neuronal process may underpin a selectionist cognitive process. The environment shapes both ontogeny and phylogeny. Phylogenetic natural selection and neural selection are compatible. Natural selection can yield both constructivist and selectionist solution to adaptuive problems.

Representation must be prior to communication in evolution. Wilkins & Wakefield's target article gives the impression that communicative pressures play a secondary role. We suggest that their evolutionary precursor is compatible with protolanguage rather than language itself. The difference between these two communicative systems should not be underestimated: only the former can be trivially reappropriated from a representational system.

Man (Islam); Islamic philosophy; Islamic ethics.

Philosophy; philosophical theology; philosophical anthropology; history.

al-majmūʻah 1. Kayfa naʻmal lil-Islām -- Muqawwimāt shakhṣīyat al-Muslim -- al-Tawāzun wa-al-iʻtidāl fī ḥayāt al-Muslim.