Development of website devoted to legal issues associated with medical research

描述（由申请人提供）：在临床试验的法律的/监管方面，明显缺乏针对研究者和其他临床试验专业人员的所需信息。虽然跟上与临床试验相关的监管变化具有挑战性，但在考虑临床试验时不会立即想到的其他法律领域（例如潜在的刑法含义）对于研究人员和其他与临床试验相关的专业人员来说尤其困难，因为他们没有 获得进行法律的研究所需的资源或培训，因为没有单一的信息来源可供参考。需要这些信息不仅可以降低责任风险，而且有助于提高护理的安全性和质量。临床试验的法律的方面是一个相对较新的和快速发展的法律领域，有很多正在进行的活动，无论是在法规和条例以及判例法方面。所提出的产品的创新方面是满足这一未满足的需求。我们建议使用最新的技术方法，通过开发最终的交互式网站，为临床研究者和参与临床试验的其他专业人员提供有关临床试验法律的方面的信息。建议的网站将解决所描述的信息差距，并将提供持续的最新的综合资源，旨在为非律师专业人员参与临床试验，以了解和了解与临床试验相关的许多不同的法律的/监管变化。该网站将为在临床研究领域工作的人设计，他们对自己的时间有相当大的竞争需求，这阻止了他们自己研究这个主题，并且通常没有调查这个特定主题所需的法律的培训。重要的是要记住目标受众、他们的需要以及在传播法律的发展和学术方面对现有信息进行良好综合的重要性。因此，第一阶段要实现的两个具体目标是：（1）对预定受众进行重点小组讨论，以了解网站内容和介绍方式;（2）开发网站原型，供潜在用户在第二阶段测试。 公共卫生相关性：近十年来，人们已经认识到，支持医学以外的临床研究所需的许多要素都缺失了。医疗保健专业人员和管理人员需要随时可用的信息来解释临床试验的法律的/监管方面，这当然是这种情况。一个坚实的医学法律原则基础不仅仅是为那些寻求减少责任风险的人服务，而且有助于提高护理的安全性和质量。拟议项目的目的是 通过开发一个网站，提供与临床试验有关的法律的发展和学术方面的最新信息，解决临床“试验者”社区未满足的需求。建议的网站是为了满足在临床研究领域工作的人员对此类汇编的需求，这些人员对自己的时间有相当大的竞争需求，阻止他们自己研究该主题，并且通常没有所需的法律的培训或资源来了解影响临床试验进行的法律、法规或规则变化的影响。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: 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.