Search results
Results from the WOW.Com Content Network
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH).
Aside from the Pure Food and Drug Act of 1906 and the Harrison Act of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control ensuring the safety of new drugs. Thus the early calls for regulation of human experimentation concerned medicine, and in particular, testing of new pharmaceutical drugs and their release on ...
The NIH employs five broad decision criteria in its funding policy. First, ensure the highest quality of scientific research by employing an arduous peer review process. Second, seize opportunities that have the greatest potential to yield new knowledge and that will lead to better prevention and treatment of disease.
Some independent regulatory agencies perform investigations or audits, and other may fine the relevant parties and order certain measures. In a number of cases, in order for a company or organization to enter an industry, it must obtain a license to operate from the sector regulator. This license will set out the conditions by which the ...
Inspectors were appointed to employ oversight on those who were involved in the process of medicine creation and were given a lot of leeway to ensure compliance and punishments were stringent. [3] The first official 'act', the 'Apothecary Wares, Drugs and Stuffs' Act (also sometimes referred to as the 'Pharmacy Wares, Drugs and Stuffs' Act) was ...
Oversee the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market. Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products.
Executive Order 12866 describes OIRA's role in the rulemaking process and directs agencies to follow certain principles, such as consideration of alternatives and analysis of impacts, both benefits and costs. OIRA reviews draft regulations to ensure agency compliance with this executive order.
A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews case report forms (CRFs), and communicates with clinical research coordinators. [4] Clinical research associates also "ensure the protection of the rights, safety and well being of human study subjects."