Leveraging accomplishments made under the current year's award, the Kaiser Foundation Research Institute (KFRI) proposes to use HSREP funds to support the following six initiatives. 1. Web-based IRB Member Orientation. This on-line training program will provide consistent information to the approximately 120 members of KP's 9 IRBs that support research conducted 8 geographic Regions. It will 1) summarize ethical principles and applicable federal regulations including the new Privacy Rule; 2) describe the authority of the IRB and the role of the IRB member; 3) describe KP's policies on conflicts of interest, confidentiality protection, education & training and other expectations of KP IRB members. 2. Web-based IRB Staff Orientation. The training program will address the important role of the IRB staff, including protecting confidentiality of private information and documents, avoiding conflicts of interest, communicating with investigators and IRB members, and meeting KP documentation and quality standards. It will address the IRB staff role in the preparation of key documents, including meeting agendas, meeting minutes, correspondence to investigators, etc. 3. Web-based Training: Research Integrity. Kaiser Permanente has recently revised its policies and procedures relating to the prevention of investigator conflicts of interest and addressing allegations of research misconduct. This on-line tutorial for KP investigators will communicate new standards and processes. 4. Web-based Training: Managing Investigational Drugs. Building on a new policies and procedures, KFRI proposes to develop an on-line tutorial designed to assure consistent practices on the management of investigational drugs across all KP Regions. This tutorial will address such topics as ordering, receiving, documenting, storing, preparing, dispensing, returning, and destroying investigational drugs. 5. Clinical Trial Site SOPs. KFRI proposes to develop a customizable series of standard operating procedures (SOPs) for clinical trial sites. The SOPs will address the areas of 1) subject management, 2) regulatory management, 3) data management, and 4) clinical research unit management. 6. Human Research Protections and Compliance Conference. KFRI will bring 100 research compliance leaders representing all member of the HMO Research network together in a two-day meeting to present and discuss the results of this and last year's HSREP initiatives.
