Leg 500 Legal And Ethical Considerations

IntroductionA new U.S. law requires pharmaceuticals to be tracked and secured across the healthcare supply chain. Pharmaceutical supply chain leaders must re-evaluate their current and future track-and-trace strategies now. The ethics committee of clinical research or Institutional Review Board (IRB) is defined as an independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical/scientific professionals and nonmedical/nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. (Perez, 2010)The legal status, composition, function, operations, and regulatory requirements pertaining to IECs / IRBs may differ among countries, but should allow the IECs / IRBs to act in agreement with good clinical practice (GCP).EventOn 28 November 2013, U.S. President Barack Obama signed H.R. 3204 — the Drug Quality and Security Act (DQSA) — into law. The law calls for the U.S. Food and Drug