The legal ethics of pediatric research

Since the mid- to late 1990s, the scientific and medical research community has sought to increase its access to healthy children for research protocols that involve harm or a risk of harm. This move reverses longstanding policy within that community generally to exclude healthy children from such protocols on the grounds that the research as to them is non-therapeutic, that they are particularly vulnerable to research-related abuses, and that they are unable themselves to give informed consent to their participation. The research community's new posture has been supported by prominent pediatric bioethicists who have argued that unless healthy children are included as research subjects in harmful or risky research, the pediatric population will continue to suffer relative to the adult population in the extent to which it benefits from modern advances in science and medicine. In their view, it is possible for the research community to self-administer a rule that strikes a balance between protecting healthy children from research-related abuses and allowing their inclusion in cutting-edge pediatric research. In this scheme, parental consent is central to the research community's claims about child protection. This Article explores the flaws inherent in this ethics of pediatric research. Specifically, it challenges the view from ethics that the law permits parents to consent to their children's inclusion in harmful or risky research to the extent that related invasions would meet legal maltreatment standards. More broadly, it challenges the movement to increase access to healthy children for harmful and risky research on the ground that it risks two important regressions: First, in its willingness to risk harm to individual children in the interests of the group, it threatens the progress the law has made in its development of the concept of the child as an individual worthy of respect in his or her own right, a concept that imagines parents as fiduciaries and that includes strong protections against invasions of bodily integrity. Second, in its failure to assure that the burdens of non-therapeutic research are not placed disproportionately on children of lower socioeconomic and minority status, it violates the antidiscrimination principle, which has only begun to make good on its promise of equal treatment for all children. Ultimately, this Article argues that harmonization of the rules governing pediatric research with the law of child protection and parents' consent authority is the best way to assure that children are protected in the research setting in these respects and to the same extent they are otherwise in the society.     

The ethics of promulgating principles of research ethics: the problem of diversion effects

There is an important distinction between ethical standards for the conduct of research with human subjects and the ethics of promulgating principles of research ethics. Those who promulgate ethical standards for the conduct of research have an ethical responsibility to consider the consequences to which those promulgations give rise. In particular, they must consider whether their promulgations will give researchers incentives not to conduct research or not to conduct research in locales in which participants would benefit from participation. I first show how such ‘diversion effects’ are possible and then examine four principles of research ethics in that light. I then consider several objections to the argument that those who promulgate principles of research ethics should consider diversion effects.     

The conduct of socially sensitive research: sex offenders as participants

This article examines some extra-research variables inherent in conducting community-based research with child molesters and other sex offenders. These include such issues as informed consent with court-referred participants, confidentiality when interagency collaboration is necessary, and duty to take proper care. Methods for establishing the scientific credibility of the project, responding to client grievances, dealing with client crises, and protecting staff and the surrounding community also are addressed. Adopting procedures similar to those described here could be an important step in ensuring the viability of other socially sensitive research projects.     

Research ethics across the 49th parallel: the potential value of pilot testing "equivalent protections" in Canadian research institutions

Canada and the United States share the world's largest trade partnership and an increasing concern about divergent regulatory approaches to common industries. Canadian research institutes receive more research funding from the U.S. National Institutes of Health than any other country, much of it to fund multi-centre and collaborative research between the two countries. Because of these close economic and research ties, and the extensive similarities between the two countries in the review and oversight of ethics in human subjects research, we propose that Canada would be an ideal country for a pilot-test of the feasibility of "equivalent protections," a U.S. regulation that permits comparison of protections for human subjects between institutions in the two countries. The "equivalent protections" has been advocated by various bodies in the United States as a potentially beneficial mechanism for improving oversight of foreign trials. As well, we argue that "equivalent protections" could prove to be valuable for Canada in five specific ways: (1) by potentially reducing administrative burden on Canadian research institutions administering U.S. federal research funding; (2) by creating symbolic value of an explicit recognition by the United States that procedures normally followed for the protection of human subjects in Canadian research institutions are at least equivalent to those provided by the U.S. regulations; (3) by lowering the opportunity cost of investing in research in Canada; (4) by affording Canada an opportunity to enhance its leadership role in international research by offering an alternative to the U.S. regulatory model for the protection of human subjects; and (5) by providing a model for how the idea of equivalent protections might be addressed for research funded by Canadian agencies but conducted in other countries.     

Diversion effects,incentive effects,and the goals of research ethics promulgations

It was with great sadness that the philosophical and ethical communities noted the recent passing of Alan Wertheimer. It is not possible to engage in serious work regarding international research ethics (nor much of political philosophy more broadly) without encountering and wrestling with his careful contributions. He was welcoming of discussion and generous with his intellectual energies. Ongoing work in these areas will be so much the poorer for his absence.     

Legal liability and research ethics boards: the case of neuroimaging and incidental findings

Neuroimaging research covers a wide range of intriguing issues from revealing brain structures to investigating what happens in our brain when we lie. The field appears to be thriving, but skepticism and alertness to the various ethical, scientific, policy and philosophical challenges associated with it also appear to be on the rise. One particularly complex issue concerns what to do with incidental findings that emerge during the course of neuroimaging research. Research ethics boards (REBs) play a central role in research oversight. In this paper, we will consider some of the potential issues associated with REB liability in negligence in the context of incidental findings in neuroimaging research.     

构建公共服务型地方政府管理机制创新研究

当前,在构建公共服务型地方政府过程中,其管理机制存在一些突出问题.因此,必须深化行政管理体制和政府机构改革,加快经济主导型政府向公共服务型政府转变的步伐,重点是完善"六种机制"的创新,以期推进公共服务型地方政府建设.     

The current potential of forensic medical expertise of a local radiation injury

The present review concerns radiation injury, a most challenging problem facing modern forensic medical expertise. It is shown that its successful solution requires the combined application of all currently available relevant methods including radio- and biodosimetry, forensic histological examination, etc.