Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 31

What is an AMC and why do they fit in this matrix? The answer in part is found in the definition developed by the University of Pennsylvania – At an academic medical center, education, research, and clinical care are combined to provide the best possible clinical care, that uses cutting‐edge technologies, resources and therapies other community hospitals may not have available [6]. AMCs are often affiliated with a college or university which pursues human clinical research through commercial sponsors via government agency grants or on their own as sponsors. Such institutions have established the infrastructure necessary to navigate the Federal, State and if needed foreign regulatory pathways to conduct human clinical trials in full compliance with national and local laws as well as meet all ethical expectations. A title for such a group at an AMC might be Office of Research Conduct and Compliance.

Since an AMC is a hospital environment patients receiving clinical care may also be recruited into clinical trials. Researchers, whether independent or affiliated directly with the AMC must abide by all applicable regulations, codes, and ethical review expectations in order to draw on the resources of the institution. In addition, the researcher must follow the internal procedures established by the institution many of which may be more rigorous above the baseline regulations imposed by the regulatory authority. AMCs also have a substantive measure of enforcement powers or sanctions which can be brought to bear swiftly if a researcher violates commitments made to the AMC and/or the regulator. For example revocation of medical privileges, economic sanctions, or being denied the ability to continue enrollment in a trial are the types of actions an AMC can take to address bad behavior by a clinical researcher.

AMCs also coordinate and support local IRB services in many cases so a researcher seeking to undertake a study can be directed to that resource. AMCs can be either nongovernmental or government affiliated. They wield important authority and impact in terms of ensuring that the Regulatory environment or matrix prevents uncontrolled human research study activity from occurring.