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The artificial sweetener aspartame has been the subject of several controversies since its initial approval by the U.S. Food and Drug Administration (FDA) in 1974. The FDA approval of aspartame was highly contested, beginning with suspicions of its involvement in brain cancer, [1] alleging that the quality of the initial research supporting its safety was inadequate and flawed, and that ...
It is the violation of scientific integrity: violation of the scientific method and of research ethics in science, including in the design, conduct, and reporting of research. A Lancet review on Handling of Scientific Misconduct in Scandinavian countries provides the following sample definitions, [1] reproduced in The COPE report 1999: [2]
Although a 2005 FDA investigation appeared to clear the university, greater awareness of the case stemming from Elliott's 2010 article in the magazine Mother Jones resulted in a group of university faculty members sending a public letter to the Board of Regents urging an external investigation into Markingson's death. [40]
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 letters were intended to let manufacturers know how much work is needed on their applications. [1] Non-approval letters were rejections of a drug's application. [ 2 ] Approvable and non-approvable letters were covered under Title 21 of the Code of Federal Regulations , section 314.110.
Paolo Macchiarini (Sweden, Italy), a thoracic surgeon and researcher formerly at the Karolinska Institutet, was in 2017 found by an ethics review board to have committed research misconduct, including false claims of clinical success and falsely claiming ethical approval for his surgical interventions, in his work on the surgical implantation ...
In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. [1]
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.