Lecture

Regulation of Biomedical Research with Human Participants

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Description

This lecture covers the general framework of regulations for biomedical research involving human subjects, focusing on the balance between innovation, medical progress, and subject protection. It explains the objectives of biomedical research, the distinction between research and medical practice, and the legal frameworks in Switzerland and other countries. The lecture also delves into the ethical considerations, international norms, and the authorization process for research projects involving human subjects. It discusses the types of research projects requiring authorization, the classification of risks, and the legal aspects of using biological material for research purposes. The lecture concludes with a reflection on the importance of progress in research while upholding ethical standards.

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Related concepts (32)

Ethics

Ethics or moral philosophy is a branch of philosophy that "involves systematizing, defending, and recommending concepts of right and wrong behavior". The field of ethics, along with aesthetics, concerns matters of value; these fields comprise the branch of philosophy called axiology. Ethics seeks to resolve questions of human morality by defining concepts such as good and evil, right and wrong, virtue and vice, justice and crime. As a field of intellectual inquiry, moral philosophy is related to the fields of moral psychology, descriptive ethics, and value theory.

Human subject research

Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question.

Outline of ethics

Ethics or moral philosophy is a branch of philosophy that involves systematizing, defending, and recommending concepts of right and wrong conduct. The field of ethics, along with aesthetics, concern matters of value, and thus comprise the branch of philosophy called axiology. The following outline is provided as an overview of and topical guide to ethics.

Virtue ethics

Virtue ethics (also aretaic ethics, from Greek ἀρετή [aretḗ]) is an approach to ethics that treats virtue as central. Virtue ethics is usually contrasted with two other major approaches in ethics, consequentialism and deontology, which make the goodness of outcomes of an action (consequentialism) and the concept of moral duty (deontology) central. While virtue ethics does not necessarily deny the importance to ethics of goodness of states of affairs or of moral duties, it emphasizes virtue, and sometimes other concepts, like eudaimonia, to an extent that other ethics theories do not.

Business ethics

Business ethics (also known as corporate ethics) is a form of applied ethics or professional ethics, that examines ethical principles and moral or ethical problems that can arise in a business environment. It applies to all aspects of business conduct and is relevant to the conduct of individuals and entire organizations. These ethics originate from individuals, organizational statements or the legal system. These norms, values, ethical, and unethical practices are the principles that guide a business.

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