Document v6K4NRB1kb2rRkBQbEb1K9RQb

From: Elsie Barbaza [Barbaza@api.org] Sent: Tuesday, May 15,2001 7:37 AM To: 'pmc1egg@shellus.com' Subject: Shell Chern ChecklBenzen Health Research Consortium Importance: High Lorraine Twerdok wishes to inform you that she received the check $15,000 for Benzene Health Research Consortium. Elsie Barbaza American Petroleum Institute Tel: 202-682-8329 Fax: 202-682-8270 Email: barbaza@api.org SH ELL-MCCLU RG-068073 Shanghai Health Study - Ethics Draft - July 1,2003 Assuring that medical, social and cultural ethical issues are addressed appropriately is a challenge for the Shanghai Health Study. The consortium has addressed ethical issues. The attached document provides a summary of the issues and the processes for addressing. Successfully managing ethical issues in China during the study will result in Individuals Good medical treatment for participants Participants compensated appropriately Participants understand and consent to be a part of the study Confidentiality for participants is maintained Workplace Benzene exposures are reduced in the workplace Monitoring technology is shared Community Laboratory is gifted to Fudon University Trained technicians remain Diagnostic tools For Shell, we will have Honored our commitment to HSE and Product Stewardship Proactively investigated the potential health effects of exposure to benzene Participated in a joint US-China project SH ELL-MCCLU RG-068074  Consortium Ethics Issue Paper Issue Resolution Scientific Validity of the Study Multiple review of protocols by an independent Scientific Review Panel Approval of protocols by US and Chinese Universities' Institutional Review Boards Future protocol changes to be approved by Scientific Review Panel Benefits to Participants Uniform, general understood diagnostic standards for hematopoietic disease Regular, defined follow-up after treatment Technology transfer for workplace monitoring Ensure patients with benzene toxicity have been removed from workplace as required by law Compensation for study participation Appropriateness of Compensation for participation based on level of Compensation to Participants participation and standard practice in China for similar procedures. Informed Consent Consent forms tailored to type of participation in the study and disease status, e.g., case or control. Forms were developed with Chinese clinicians and bioethicist. Confidentiality Separate password controlled databases for clinical and study-specific research data. Transfer of data between databases requires consent of participant. Results The investigators will have final control over content and interpretation of published or presented study data. Benefits to the General Worker Investigators are cooperating with government efforts to Population Exposed to lower benzene occupational exposures. Benzene Identification of more sensitive biological indicators of exposure to benzene Community Benefits Laboratory provides increased diagnostic capabilities State of the art diagnostic laboratory with trained laboratory technicians is available to medical community and will remain in Shanghai. Technology transfer from training oflocallaboratory technicians Possible increase in standards for diagnosis and follow-up care for hematopoietic disease Technology transfer of industrial hygiene monitoring technology & practices SH ELL-MCCLU RG-068075 SH ELL-MCCLU RG-068076 SH ELL-MCCLU RG-068077