Lecture

Introduction to Research Ethics and Compliance

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In course

BIO-455: Introduction to law and ethics

The aim of this course is to introduce students to the basic legal and ethical concepts relevant to research in the life sciences and its translational application, and to provide them with the essential tools to identify legal and ethical issues in their ...

Description

This lecture covers the ethical issues related to research on human beings, biological material, genome, and biobanks, emphasizing the importance of research ethics and compliance. It discusses the Nuremberg Code, the Belmont Report, and the principles of research ethics, such as respect for persons, beneficence, justice, and informed consent. The lecture also explores the challenges of human challenge trials, the ethical considerations of COVID-19 challenge trials, and the formal requirements for ethical evaluation in research. It delves into the concepts of social value, scientific rigor, fair subject selection, and the balance between risks and benefits in clinical research.

Official source

Ontological neighbourhood

Philosophy

Ethics: Topics in ethics

Related concepts (27)

Belmont Report

The Belmont Report is a 1978 report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report summarizes ethical principles and guidelines for human subject research.

Medical ethics

Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice. Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal.

Beneficence (ethics)

Beneficence is a concept in research ethics that states that researchers should have the welfare of the research participant as a goal of any clinical trial or other research study. The antonym of this term, maleficence, describes a practice that opposes the welfare of any research participant. According to the Belmont Report, researchers are required to follow two moral requirements in line with the principle of beneficence: do not harm and maximize possible benefits for research while minimizing any potential harm on others.

Nuremberg Code

The Nuremberg Code (Nürnberger Kodex) is a set of ethical research principles for human experimentation created by the court in U.S. v Brandt, one of the Subsequent Nuremberg trials that were held after the Second World War. Though it was articulated as part of the court's verdict in the trial, the Code would later become significant beyond its original context; in a review written on the 50th anniversary of the Brandt verdict, Jay Katz writes that "a careful reading of the judgment suggests that [the authors] wrote the Code for the practice of human experimentation whenever it is being conducted.

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.

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