Ethical and Policy Issues in Research Involving Human Participants. Report and Recommendations of the National Bioethics Advisory Commission. This report on end-of-life decision-making in Canada was produced by an international expert panel and commissioned by the Royal Society of Canada. Solutions in Drug Plan Management enables communication between the benefits community and pharmacists in order to uncover innovative, health outcomes-based solutions. ![]() Research Ethics » The Canadian Bioethics Companion. INTRODUCTION AND PREAMBLEWe owe much in the modern world to scientific research. In the systematic search for knowledge the scientific method is fundamental to progress. But even the rational and calculating scientific methodology cannot elude moral and ethical considerations. The study of research ethics is a study of those ethical considerations that impinge on the scientific method, its players and its stakeholders. This chapter is an attempt at introducing and fostering a sharper understanding of research ethics in (and outside) Canada. The first broad topic in this chapter is a consideration of the evolution of research ethics. I.The Origin of Bioethics: a Brief Historical Overview. All activity within the sphere of health care, from time immemorial and in all cultures, has been imbued with. Chronic illness any disorder that persists over a long period and affects physical, emotional, intellectual, vocational, social, or spiritual functioning. The world confronted the transgression of research ethics in the atrocities of World War II. A formal and normative research ethics has been evolving ever since. We find ourselves in the new and exciting landscape of fresh and innovative technology, pondering questions that were inconceivable even a few decades ago. Canada and the world have responded to this situation with a series of broad and comprehensive documents and treatises that both describe where we have been and attempt to establish a way forward. While understanding the past is possible, and establishing a trajectory for the future is desirable, living in the present and simultaneously describing contemporary research ethics is a complicated affair. The second topic in this chapter is a survey and overview—a roadmap—of current rules, regulations, policy, and law pertaining to Canadian research ethics. Funds grants and financial concerns will be considered first, for it is here that, practically speaking, research begins. ![]() An overview of significant research guidelines and regulations will follow. With Health Canada as the government agency at the centre of oversight and policy formation, the departments and agencies that extend from here will be examined, and the ways and means of research oversight studied. This will include a necessary examination of some of the pitfalls of research ethics law and policy in Canada and the world. Research ethics boards (REBs) are central to regulation and oversight of research in Canada. ![]() LIVER AND BILIARY DISEASE Ed Friedlander, M.D., Pathologist scalpel. Ordinary e-mails are welcome. Grifols USA From Our Family to Your Family: A Heritage of Caring. Grifols is a global healthcare company whose mission is to improve the health and well being of. Almost all research is scrutinized by REBs so their composition, their mandate and their influence will be discussed. This section will end with an examination of some of the significant legal considerations that have shaped research ethics in Canada. The third major topic is research subjects. In contemplating ethical treatment of subjects, most considerations are for the ethics of research directly involving humans, and the Tri- council Policy Statement will be seen to be the first and final word on this account. This document, its guiding principles and its core policies, will be central to the discussion on research involving humans. But this section will not leave off without a description of some of the relevant guidelines for research involving animals—most animal research is, after all, not for the animals themselves, and proper treatment of animal subjects must be considered part of any comprehensive discussion about ethical scientific conduct. The fourth and most extensive topic is that of responsible conduct, a topic that focuses on the ethical behaviour of researchers, sponsors, and institutions. This topic will open with an examination of competing and conflicting interests. On the topic of conflicts in the scientific world, conflict of interest, per se, is the one that first springs to mind. A discussion of the genesis and the many manifestations of conflict of interest will be examined along with the role that each of the stakeholders plays in this broad area. Also discussed, will be the codes of ethics, legal instruments, and institutional policy that impact on prevention and remedy of conflict of interest. ![]() ![]() Other competing interests, such as conflict of commitment and conflict of conscience, will also be examined. In the research world, gathering information and generating knowledge and new technology are fundamental objectives. Raw data is not of value in and of itself, it is the interpretation and publication that gives it substance and value. Ethical considerations of publication will be discussed, and this will move into an examination of intellectual property and the ownership of research and the fruits that it bears. Any discussion of proper research conduct must include a consideration of misconduct, and this will be the final topic in this chapter. Misconduct will be defined, but more importantly, the mechanisms for investigating, and remedying misconduct will be considered and discussed in parallel with an assessment of an archetypal legal case. Examining the ramifications of this case will lead to a consideration of the changes that have transpired, and the means by which future ethical transgressions can be monitored and prevented. Lastly, a brief survey of liability—just who can and should be made liable for poor outcomes—will conclude the chapter. EVOLUTION OF RESEARCH ETHICS GUIDELINESCanada has evolved its research ethics guidelines from the common stock of the world’s research ethics foundations. This common stock includes, in a rough timeline, the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, the Council of International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines. While it is beyond the scope of this discussion to elaborate on the guidelines themselves and the ethical and moral underpinnings, it is important to recognize the reasons for their development, and the means by which they evolved, in order to understand the current relevant guidelines and oversight in Canada. What has commonly come to be known as the Nuremberg Code is in fact the third part of the decision at the military tribunal trying Nazi doctors after World War II. The world reacted with moral outrage at the experiments conducted on prisoners under the Nazi regime. The Nuremberg Code was the first code to explicitly outline ethical conduct in research involving human subjects, and it was the first formal attempt to explicate things that the scientific community previously did not deem worthy of formal explication. Hitherto, a reliance on common sense seemed to obviate such a formal code, but the absence of such a code represented a significant defence for the Nazi doctors on trial. Thus, the common sense principles of “respect for persons”, “beneficence” and “justice” found their way into the ten statements that make up the Code. The first statement is the clear and unequivocal requirement that willing and informed consent is paramount for any research conducted on humans. The further points go on to elaborate on the need for justification of the research, the requirement for ensuring safety and mitigating risks, and so on. The atrocities committed in the name of science under the Nazi regime represented, in a sense, a loss of innocence among the medical and research communities worldwide, and prompted an examination of practices among many international and national science foundations. The World Medical Association (WMA) began an examination of its practices that resulted in the first Declaration of Helsinki of 1. This document was an attempt at a codified research ethic that would build on Nuremberg and instead of a reaction to atrocities, was a proactive piece that addressed present and future concerns. It attempted to reconcile the absolute need for informed consent with the notion that substitute consent could sometimes be legitimately warranted where a subject may lack capacity (for example with children), and a recognition that research could, in fact, be therapeutic as well as investigational (and that a sensitivity to the differences between therapeutic and non- therapeutic must be held in mind by researchers). The Declaration of Helsinki (Do. H) has undergone several revisions and refinements that attempt to meet the challenges of research in the current socio- political climate. Currently, the latest iteration is derived from the 5. Congress of the World Medical Association held in Seoul Korea in 2. The Do. H continues to provide guidance for Canadian research and researchers. Another significant and evolving international set of guidelines relevant and influential in Canadian research is the International Ethical Guidelines for Biomedical Research Involving Human Subjects. This document was born of a twenty year partnership between the Council for International Organizations of Medical Sciences (CIOMS) and the World Health Organization. It represents a departure from other codes inasmuch as it is an attempt to address certain needs in the global community. While Nuremberg was a reactionary and bold first step, and the Do. H and the Belmont Report (see below) are more philosophical in their guidance, the International Ethical Guidelines represent an attempt at providing a practical means of oversight and regulatory advice in an uncertain and unequal global community. These guidelines also attempt to create an even playing field for all stakeholders in multinational research endeavours. Diverse socioeconomic concerns, and varied socio- political circumstances among developed and developing nations creates tremendous uncertainty and significant barriers in carrying out research across multiple nations or by developed nations inside developing nations (HIV research in Africa is perhaps the most important and common example of this). Different nations have different governance and public policy yet, among the global medical community there is an acknowledged value in striving for consensus on how to conduct international research—research which still respects sound bioethical principles such as respect for persons, justice and mutual benefit.
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