There is a clear lack of needed information geared towards investigators and other clinical trial professionals on the legal/regulatory aspects of clinical trials. While keeping up with regulatory changes related to clinical trials is challenging staying abreast of other areas of the law which do not immediately come to mind when thinking about clinical trials such as implication of potential criminal laws, for example, is particularly difficult for investigators and other professionals associated with clinical trials who do not have access to the resources or training to conduct legal research since there is no single source to consult for this information. This information is needed to not only reduce the risk of liability, ut to contribute to improved safety and quality of care. Legal aspects of clinical trials are a relatively new and rapidly evolving area of the law with a lot of ongoing activity, both in terms o statutes and regulations as well as case law. The innovative aspect of the product proposed is in fulfilling this unmet need. We propose to use the most up to date technologic methods available as a vehicle to provide access to information to clinical investigators and other professionals involved in clinical trials on legal aspects of clinical trials through development o ultimately an interactive website. The website proposed will address the informational gap described and will provide continuous up to date comprehensive resources designed for non-lawyer professionals involved with clinical trials to understand and stay abreast of the many different legal/regulatory changes related to clinical trials. The website will be designed for persons working in clinical research fields who have considerable competing demands for their time that prevent them from researching the topic themselves, and often do not have the legal training needed to investigate this particular topic. It is important to remember the intended audience, its needs and the importance of good synthesis of existing information in the dissemination of legal developments and scholarship. Accordingly, the two specific aims to be accomplished in Phase I am: 1) to conduct focus groups of the intended audiences to inform website content and presentation and 2) to develop a prototype of the website for potential users to test in phase II.
For almost a decade, it has been recognized that many elements necessary to support clinical research outside of medicine are missing. This is certainly the case with regard to health care professionals'and administrators'need for readily available information explaining the legal/regulatory aspects of clinical trials. A solid foundatio in medico-legal principles is not just self-serving for those seeking to reduce the risk of liabiliy, but can contribute to improved safety and quality of care. The intent of the proposed project is to address an un-met need in the clinical """"""""trialist"""""""" community by developing a website to provide up to date information on the legal developments and scholarship related to clinical trials. The website proposed is in response to the need for such compilations for persons working in clinical research fields who have considerable competing demands for their time that prevent them from researching the topic themselves, and often do not have the legal training or resources needed to stay abreast of and understand the implications of changes in laws, regulations, or rules that impact the conduct of clinical trials.
