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Research ethics is a discipline within the study of applied ethics. Its scope ranges from general scientific integrity and misconduct to the treatment of human and animal subjects. The social responsibilities of scientists and researchers are not traditionally included and are less well defined.
The Common Rule is a 1991 rule of ethics (revised in 2018) [2] regarding biomedical and behavioral research involving human subjects in the United States.The regulations governing Institutional Review Boards for oversight of human research followed the 1975 revision of the Declaration of Helsinki, and are encapsulated in the 1991 revision to the U.S. Department of Health and Human Services ...
A ranking system used to describe the strength of the results measured in a clinical trial or research study. The design of the study (such as a case report for an individual patient or a randomized double-blinded controlled clinical trial) and the endpoints measured (such as survival or quality of life) affect the strength of the evidence.
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.
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.
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 ...
GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates.
This revision implies that in choosing a study design, developed-world standards of care should apply to any research conducted on human subjects, including those in developing countries. The wording of the fourth and fifth revisions reflect the position taken by Rothman and Michel [41] and Freedman et al., [42] known as 'active-control orthodoxy'.