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The ICMJE recommendations (full title, "Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals") are a set of guidelines produced by the International Committee of Medical Journal Editors for standardising the ethics, preparation and formatting of manuscripts submitted to biomedical journals for publication. [1]
The Council selects topics to examine through a horizon scanning programme, which aims to identify developments relevant to biological and medical research. Members of the Council meet quarterly to discuss and contribute to ongoing work, review recent advances in medical and biological research that raise ethical questions and choose topics for further exploration.
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 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 ...
Medical ethics tends to be understood narrowly as applied professional ethics; whereas bioethics has a more expansive application, touching upon the philosophy of science and issues of biotechnology. The two fields often overlap, and the distinction is more so a matter of style than professional consensus.
FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.
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An ethics committee in the European Union is a body responsible for oversight of medical or human research studies in EU member states. Local terms for a European ethics committee include: A Research Ethics Committee (REC) in the United Kingdom [1] A Medical Research Ethics Committee (MREC) in the Netherlands. [2]