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A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
The Declaration of Helsinki (DoH, Finnish: Helsingin julistus) is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). [1]
The ethics of therapy and the ethics of research are two distinct enterprises that are governed by different norms. They state, "The doctrine of clinical equipoise is intended to act as a bridge between therapy and research, allegedly making it possible to conduct RCTs without sacrificing the therapeutic obligation of physicians to provide ...
Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. [20] 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. [21]
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ethical. The main goal of IRB ...
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.
Research integrity or scientific integrity is an aspect of research ethics that deals with best practice or rules of professional practice of scientists. First introduced in the 19th century by Charles Babbage , the concept of research integrity came to the fore in the late 1970s.
Analogous to clinical ethics consultation, Research Ethics Consultation (REC) describes a formal way for researchers to solicit and receive expert ethical guidance related to biomedical research. The first REC service was established at the National Institutes of Health (NIH) Clinical Center in 1997. [ 1 ]