Development of website devoted to legal issues associated with medical research

开发专门讨论与医学研究相关的法律问题的网站

• 批准号: 8373948
• 负责人: PATRICIA Miller TERESKERZ
• 金额: $ 15.06万
• 依托单位: IP ADVANTAGE
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8373948
• 关键词: Access to Information; Address; Administrator; Area; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Design; Communities; Conduct Clinical Trials; Consult; Criminal Law; Development; Elements; Focus Groups; Goals; Health Professional; Laws; Legal; Medical Research; Medicine; Methods; Mind; Persons; Phase; Principles of law and justice; Quality of Care; Regulation; Research; Research Personnel; Resources; Risk; Safety; Scholarship; Solid; Source; Testing; Thinking; Time; Training; Work; design; improved; innovation; meetings; prevent; prototype; response; web site

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.

描述(由申请人提供)：在临床试验的法律/法规方面，明显缺乏针对研究人员和其他临床试验专业人员的必要信息。虽然跟上与临床试验相关的法规变化是一项挑战，但要与法律的其他领域保持同步，当考虑到临床试验时，例如潜在的刑法含义时，不会立即想到这些领域，对于调查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 获得进行法律研究的资源或培训，因为没有单一的资料来源可供参考。需要这些信息不仅是为了降低责任风险，而且是为了提高护理的安全性和质量。临床试验的法律方面是一个相对较新、发展迅速的法律领域，在法规和法规以及判例法方面都有许多持续的活动。该产品的创新之处在于满足了这一未得到满足的需求。我们建议使用现有的最新技术方法作为媒介，通过开发最终建立一个互动网站，为临床研究人员和参与临床试验的其他专业人员提供有关临床试验法律方面的信息。拟议的网站将解决所描述的信息差距，并将为参与临床试验的非律师专业人员提供持续最新的全面资源，以了解和了解与临床试验相关的许多不同的法律/法规变化。该网站将为在临床研究领域工作的人员设计，这些人对自己的时间有相当大的竞争要求，使他们无法自己研究该主题，而且通常没有接受过调查这一特定主题所需的法律培训。重要的是要记住目标受众、其需求以及在传播法律发展和学术知识时良好综合现有信息的重要性。因此，第一阶段要实现的两个具体目标是：1)对目标受众进行重点小组，告知网站内容和介绍情况；2)开发网站原型，供潜在用户在第二阶段进行测试。 与公共卫生相关：近十年来，人们已经认识到，缺乏支持医学以外的临床研究所需的许多要素。卫生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/法规方面，这当然是一种情况。对于那些寻求降低责任风险的人来说，坚实的法医学原则基础不仅是自私的，而且可以有助于提高安全性和护理质量。拟议项目的目的是 通过开发一个网站，提供与临床试验相关的法律发展和奖学金的最新信息，解决临床试验社区中未得到满足的需求。建议的网站是为了满足临床研究领域工作人员对此类汇编的需求，这些人对自己的时间有相当大的竞争要求，使他们无法自己研究主题，而且往往没有所需的法律培训或资源来了解影响临床试验进行的法律、法规或规则的变化的影响。