URCLASerie) The Secretarial Panel for the Evaluation of Epidemiologic Research Activities In the summer of 1989, the DOE faced a major erosion of its credibility in epidemiologic research. Congress was considering transferring responsibility for such research from the DOEto an independent federal health agency. To counter growingcriticism, Energy Secretary Watkins formed the Secretarial Panelfor the Evaluation of Epidemiologic Research Activities of the Department of Energy (SPEERA). The Panel’s membership included academic experts in public and environmental health, state health officials, epidemiologists and legal experts. The SPEERA was charged with providing “an independentevaluation of the DOE’s epidemiology program and the appropriateness, effectiveness, and overall quality of DOE’s epidemiologic research ac- tivities.” °* It was asked to investigate many aspects of the DOE’s epidemiologic program, including: partment develop “an independentsystem for managing its analytic epidemiologic research.” ” This recommendation was based on the follow- _ing SPEERA findings: a The DOE has shown a continuing commitment to funding energy-related epidemiology. @ There are limits to how well an organization can study itself without facing conflict of interest issues. @ Most ofthe scientists conducting epidemiologic research for the Departmentare employeesofthe Department’s major long-term contractors. The Department, through its relationship with con- tractors, has madeit difficult for researchers outside of the system to conduct studies. w The Panel heard testimony accusing the Department and its contractors of attempting to @ the goals and objectives; @ the management and reporting structure; @ quality control mechanisms, including standards for data, archiving, and access; and w the utiliry and feasibility of transferring the epidemiologic research to another entity.” From September, 1989 through March, 1990, the SPEERA held a series of meetings, public hearings, and DOEsite visits. The SPEERA’s final report characterized DOE epidemiologic research program as lacking central coordination, and recommended consolidation of the research activities and opening up the research field to other federal health agencies, independent researchers, and the public. To achieve this, the SPEERA urged that the DOE’sscattered epidemiologic activities be unified in one office. It recommended that the DOE negotiate a Memorandum ofUnderstanding (MoV) with the Department of Health and Human Services (HHS), under which HHS would manage the DOE’s analytic epidemiologic research. It also urged standardization of the basic data and improvements in its quality and availability,®° and called for increasing the dissemination of data through the creation ofa Comprehensive Epidemiologic Data Repository (CEDR)*! open to independentscientists. The SPEERA’s Findings and Recommendations The Panelstressed that restoring public trust and assuring high scientific quality required that the De- influence epidemiologic findings inappropri- ately. The Panel also heard testimony from people whobelieve that there is a consciouseffort not to influence the studies. The Panel decided it was not in a position to judge; however, the fact that the question ofinfluence has arisen requires that it be addressed. w There has not been open competition for epidemiologic research projects. Open competition helps assure a strong research program. w In many cases the research interests of current primary contractors appear to set the epidemiologic research agenda. In its relation- ships with contractors, the Department’s epidemiology program appears to lack leadership.'” In light of these findings the Panel recommended the enactment of the MoU between the DOE and HHS. Inits view, such an MoU could include provisions for the DOEto continue to fund the studies taken over by HHS, and current grants and contracts would continue to be executed by the original parties. Thus, primary DOE epidemiology contractors would continue to carry out much of the research in progress. However, HHS would use “its usual methods to set the research agenda, provide for peer review of research proposals, provide quality assurance for research-in-progress and pro- vide access to data.” * (See page 55 for further discussion.) DEAD RECKONING RIA Agger yo eee & whee brute 23