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Recently, substantial undisclosed financial Conflicts of Interest (COI) by researchers at academic medical centers have been discovered and reported in US Senate investigations, prompting large research institutions to take a close look at policies and procedures associated with the reporting and with the management of researcher COI. This article defines COI, reviews the background, describes the problems that arise, and offers solutions.

Law and the workplace: Occupational medicine. Jack W. Snyder & Julie E. Klees, Eds. (Hanley & Delfus, Inc., Philadelphia, Pennsylvania, 1996), 200 pages, $36.00.

Background/Aims This session will provide investigators, project teams, and organizational administrators with a basic understanding of the HMO Research Network’s (HMORN) structure and organization, as well as several key processes the HMORN has developed to streamline collaboration across sites. Those new to the Network, to multi-center research, or just needing a refresher will benefit from an overview of HMORN governance, the Virtual Data Warehouse (VDW), multi-site grant writing tools and resources, and the IRB ceding process.

Background/Aims The member institutions of the HMORN have long been concerned about their ability to conduct multi-site research in a timely and efficient manner. Frequently in the past, investigators in multi-site studies have felt constrained by the requirement of submitting proposed research to multiple IRBs. In June 2008, the HMORN Governing Board approved a Standard Operating Procedure (SOP) that streamlined this submission process for data-only studies (Version 1), and in September 2010, the SOP was revised (Version 2) to permit the inclusion of all HMORN multi- site research except clinical trials. Version 3 of the SOP was approved by the Governing Board in July 2011. IRB Administrators and Directors from around the HMORN meet regularly to discuss strategies for harmonizing review as well as establishing a Network-wide IRB Authorization Agreement for the conduct of HMORN multi-site research. In addition, the section on IRB in the HMORN Collaboratory submission provides a roadmap for future activities.

Background Psychosocial working conditions are likely to contribute to work-related musculoskeletal disorders (WRMSDs), but a lack of standardized measurement tools reflects both the theoretical and methodological limitations of current research. Methods An interdisciplinary team including biomedical, behavioral, and social science researchers used an iterative process to adapt existing instruments for an interviewer-administered questionnaire assessing psychosocial workplace exposure related to musculoskeletal disorders. Results The resulting questionnaire included measures of psychosocial workplace factors based on two theoretical models (the demand-control-support and the effort-reward imbalance models), supplemented by the additional constructs of “emotional demands,” and “experiences of discrimination.” Other psychosocial and physical measures selected for questionnaire inclusion address physical workload, sociodemographic and anthropometric characteristics, social relations and life events, health behaviors, and physical and psychological health. Conclusion Using an interdisciplinary approach facilitated the development of a comprehensive questionnaire inclusive of key measures of psychosocial factors that may play a role in the complex mechanisms leading to WRMSDs. Am. J. Ind. Med. 45:428–439, 2004. © 2004 Wiley-Liss, Inc.

Background/Aims The member institutions of the HMORN have long been concerned about their ability to conduct multi-site research in a timely and efficient manner. Frequently in the past, investigators in multi-site studies have felt constrained by the requirement of submitting proposed research to multiple IRBs. In June 2008, the HMORN Governing Board approved a Standard Operating Procedure (SOP) that streamlined this submission process for data-only studies (Version 1), and in September 2010, the SOP was revised (Version 2) to permit the inclusion of all HMORN multi-site research except clinical trials. IRB Administrators and Directors from around the HMORN met in December 2010 to discuss strategies for harmonizing clinical trials review as well as establishing a Network-wide IRB Authorization Agreement for the conduct of HMORN multi-site research.

Background/Aims All research institutions receiving federal funds must comply with new regulations regarding investigator COI. The adoption and implementation of these regulations has proven to be a challenge for many institutions and individual investigators. The purpose of this presentation is to explore what the new regulations actually mean, and to discuss best practices regarding their operationalization.

Background/Aims New regulations regarding researcher Conflicts of Interest (COI) for federally funded research have just been promulgated by the Federal Government. All investigators and institutions conducting such research are required to comply with these new COI rules by August 24, 2012. The aims of this presentation are to 1) familiarize investigators and research administrators with these new regulations, and 2) discuss what steps institutions need to take in order to be in compliance. In addition, specific rules dealing with institutional COI that exist nowhere else also are in place for the FDA Mini-Sentinel Project. These rules will be discussed in detail.

Background and Aims: In the era of ARRA, we are routinely confronted with compressed timelines and an accelerated pace of research. Concurrently, discussions have intensified over recent months about the HMORN’s capacity to conduct comparative effectiveness research on topics of national interest. Building on these unique challenges and opportunities, this interactive session will serve as a forum for conference attendees to discuss recent HMORN efforts to make multi-site IRB review as agile as possible. In particular, we will showcase the HMORN facilitated review process and discuss how it might be further improved or expanded. Methods: In early 2008, the HMORN ratified its first Standard Operating Procedure (SOP), which outlines procedures for inter-institutional IRB review of data-only studies. This SOP helped clarify what steps to take and who to contact, both in order to pursue ceding, and when multiple IRBs need to review the same study. This process has now been used in a majority of HMORN member institutions. As its use has increased, researchers and IRB administrators have become more familiar with the process. In September 2009, the HMORN Governing Board identified continuing such work to ensure IRB agility as a key 2010 priority for the HMORN. Results: In this session, we will review how to use the facilitated IRB review process outlined in the SOP and learn from attendees how we can further facilitate multi-site IRB review, along with attendant concerns such as HIPAA. In addition, we will give a snapshot of recent and upcoming developments across the Network sites, including human research protection program accreditation efforts and migration to electronic IRB systems. Conclusions: This session will enable research investigators, IRB administrators and HMORN leadership to engage in a constructive dialogue about the residual barriers to using the facilitated IRB process for data-only studies, and identify pathways to institutionalize this process in our Network’s routine research processes. This session will also introduce how the demands of IRB accreditation and the implementation of new electronic IRB systems may facilitate or impede our progress in this area.