Document pevGEan87Mmdb4gGdy3xx4anB

DRAFT - August 2,2001 Minutes Oversight Committee Benzene Health Research Consortium July 26, 2001 Issues Finances and Scheduling Rich Irons has secured a work on the project. Need to find out when the I Some payments on invoices sent out outstanding. Selection of a Chair for the Committee It was decided to rotate the chair among the companies on ann vice-chair would also be selected and would serve as ch .r in t BP will hold the chair, with Shell serving as vice-chao I basis, and that a Contract Issues Issue of contracting with the Consortium (incorporating the consortium and having a separate contract with API to manage the project) versus companies contracting with API Need for a more explicit statement that the Oversight Committee would negotiate contracts with other types of organizations. Remove references to China, throughout. Do not include any of the individual researchers in the contract, this also pertains to the Shanghai Medical University and/or Fudan University. New title should be: AGREEMENT FOR THE CONDUCT AND FUNDING OF A RESEARCH PROGRAM ON HEALTH RISK FROM BENZENE EXPOSURE Section 1 - BP has comments on re-writing this section Section 2 - Membership needs to be broader in scope Section 3 - Definition of company also needs to be broadened and re-worked for other types of organizations. 1 SH ELL-MCCLU RG-065682 DRAFT - August 2,2001 Section 5 - API Policies and Procedures will be used in administering the contract. Copies of the table of contents and selected policies relevant to the business of the consortium will be sent to the Oversight Committee members for review. Section 6 - Delete paragraphs (i) and (ii), then rework (iii) to not specify TSCA. Section 7 - Share Formula o May need some mechanism to negotiate variances to the funding structure (either for separate instances or for the overall structure) o Reimbursement I age/mechanism o Weight of vote on fun ing issues (Section 7) o Need a cap ritten into t e contract. o Potential gotiating a "lower than share" contribution and sociate" status with lower privileges, . I be developed by Patrick Beatty and uded as part of Section 7. Scientific Review API Responsibilities Documentation - need to accurately create a permanent transcription of p c API will facilitate setting up meetings an committee, if requested to do so. o The independent review panels (both ethics and sci option of hiring their own support. Panel Organization and Responsibilities The intent of each of the panels will need to be defined in some statement. The Oversight Committee will need to decide on the size of the Scientific Review panel, and 12 was discussed as a reasonable maximum number of members. Otherwise, the SRP will have complete control over their structure (number of members in each discipline and disciplines to be included). The Oversight Committee was given the recommendation of the Technical Committee on the initial composition of the SRP (discussed below). A process for developing an amendment to the protocol was discussed. Attachment A shows a draft document used to track a proposal to change the protocol and document approvals. Technical Committee Update (Refer to the Minutes of the July 23 Conference Call) The Communications Committee stated a desire to have the Technical Committee available as a source of expert opinion and to serve as a spokesman when necessary. 2 SH ELL-MCCLU RG-065683 DRAFT - August 2,2001 The decisions will be made by the Oversight Committee with advice from the Technical Committee The division of labor will be such that API will track the financial auditing of the project with the Technical Committee developing milestones with the investigators to track reasonable progress relative to the resources spent. This will be tracked by reports from each to the Oversight Committee. QAlQC concerns o How are they to b aranteed? o Lab is to be FD Certl ed e lab will certified by the College of American Pathologists bet een committees, the investigators, and the o orm targets for this solicitation effort, and muster resources to assist in the effo contributions). Bill Frick was suggested as the API person spearhead this Action Item: Distribute the list of targets identified from t Action Item: Provide nominations for this committee t 3 (all) Action Items ALL ACTION ITEMS ARE DUE FRIDAY, AUGUST 3, unless otherwise indicated. Consortium Agreement Issues: 1. JOHN WAGNER will write & distribute a one-pager listing the pros and cons for an agreement between companies and API vs incorporation of the consortium to include a contractual agreement between companies. 2. JOHN WAGNER will edit the exiting contract agreement based on comments from today's meeting. John will also list sections to be reworked by the consortium agreement workgroup. 3. OVERSIGHT COMMITTEE (OC) MEMBERS will send Lorraine and Paula nominations (minimum = 1 per company) for a consortium agreement workgroup to be staffed by JOHN WAGNER. 4. PATRICK BEATTY and the Technical Committee will develop a I-page scope of research work, referencing study protocols, to be added to consortium agreement. 3 SH ELL-MCCLU RG-065684 DRAFT - August 2,2001 5. LORRAINE TWERDOK will circulate relevant API Policies and Procedures to OC for review. nominations (due date to be eter 6. PATRICK BEATTY will c and Chinese IRB reviews, and als (purchase lab equipment; train technician , etc. approval is in place. Communications Committee Issues: 1. SUSAN HAHN of API will contract PR firm with CC guida ce ( timeline). 2. JOHN WAGNER will contract outside council for con determined). Ad Hoc Consortium Membership Committee - BILL FRICK will spearhead: 1. OVERSIGHT COMMITTEE MEMBERS will submit committee nominations (l/company) to Lorraine Twerdok. 2. GEORGE WOODALL will circulate to OC a list ofNGOs & foundations for potential consortium membership. 3. MEMBERSHIP COMMITTEE will develop a list of companies (refining, chemical, other business sectors) , associations, NGOs, Foundations, Agencies, etc, to target for membership "drive." Strategies for contacting the various organizations will be developed. (will be a continuing effort over at least the next few months). 4 SH ELL-MCCLU RG-065685 From: Lorraine Twerdok [twerdokl@api.org] Sent: Tuesday, October 02,2001 8:34 AM To: 'Benzene OC listserve' Cc: Bill Frick; 'Irons, Richard' Subject: WE HAVE A BENZENE CONSORTIUM Importance: High Want you all to be the FIRST to know that we have now received all five consortium agreement signatures, satisfying the conditions for consortium formation. Thanks to everyone for making this happen! Regards, Lorraine ****************************** Lorraine E. Twerdok, PhD., DABT Manager, Health Sciences American Petroleum Institute 1220 L Street, N.W. Washington, DC 20005 tel: 202-682-8344 fax: 202-682-8270 email: twerdokl@api.org SH ELL-MCCLU RG-065686