Document 33289JLnDrvVwMMaLGQXo3wE

American Petroleum Institute 1220 L Street, Northwest Washington, DC 20005-4070 Tel: (202) 682-8067 Fax: (202) 682-8031 E-mail: woodallg@api.org George M. Woodall, Ph.D. Senior Toxicologist Minutes Benzene Consortium Conference Call April 24, 2001 Participants: Barach Brody Bill Maseth Patrick Beatty Lorraine Twerdok Don Burnette John Depasquale Stuart Cagen Norm Zeiser Chris Roythorn Patsy Clegg Otto Wong Rob Schnatter Funding Status~um.nl~..y (Lofrai~el"'werdok) Myron Harrison Tom Armstrong Craig Parker Rich Herold Christy Quinn George Woodall Available Funds Itis unlik~ly th~t additioh~l A.PIOues ~udget funds would be provided without firtncommitments frohI mefupertompanies. API has provided approximately $700Kip s~~d fuoney for the p~oject6ver t4el~st). 5 years ($350K from specific Benzene Task F.orce pr6j~cts~.$185k reprogramm,ed from other Benzene Task Force projects, and.$165K re.program.med from rt&PS) ... $17K in comp~ny ~eedmon~y contrib4.ti6ris r~main fr6mlh~ original $85K promised (only $60K:was~ctually colle.cted,.another $25K inolltstanding commitments from 2couip~nies havenot been pa.id) .. / . $4,100 in API's Dues Budg~tin6hi~s re~,t"inJ.lncomrtiittedll.msp~nt Outstanding CommitmentslNeeds $2,500 to Chinese bioethicist $21K to EMBSI $25K to Dr. Fu of Fudan University for laboratory renovations (part of the exit strategy commitments, see below) Reviewers to review final protocols, estimated cost.of $75K Schedule for a Decision Funding in Irons lab for this work comes to an end on June 1, he needs a guarantee by May 15th or his staff positions will be terminated by the University. ACTION ITEMIDECISION (Member Companies): Letter of commitment from companies by May 1 (with contingencies) to Lorraine Twerdok. An e-mail followed up by a hard-copy letter is acceptable. Lorraine Twerdok American Petroleum Institute 1220 L Street, NW Washington, DC 20005 Twerdokl@api.org An equal opportunity employer SH ELL-MCCLU RG-065552 DRAFT - April 26, 2001 Minutes from April 24, 2001 Benzene Consortium Conference Call Page 2 Points needed for the commitment letter: Co. is committed to participate in the consortium pending enough companies contribute to create a critical mass of funding (see note below). Any contingencies upon which participation is based, e.g., review process, nonindustry stakeholder participation. Critical mass will be based upon number of shares represented by participating companies and will be determined by the consortium members on another conference call. Next conference call on May 3, 3:30 PM EDT Ethics Summary (BafJlch Brody - see handout) Dr. Brody feels that the prOtocols are in very good shape and the areas have been identified that need/to be finahzed with the Chinese investigators (e.g., the consent forms, etc.) . Benefits P~ymeIJ.ts to indivigU"als"~ may be in'cash, and may need to be linked to completing . the corisentforms a.sa form"ofdocumentation There is a ne~dt~ .consider the~ech~nics/logistics of payments in the protocol protectio~'~fC~~~d~~tialit~ ...> "qqq, / / ./ / / Four databa~es \Viill)~ us~d, with Hiniteq access to eacb, Only the finard~tab~se 'Yill re-rI{ain.afl:.er th~'studyis co;Uplete. It will be owned by the Chinese and will NOT contain~ny linkage~to individuals.. o~iy th6~~ dU~iri.1~~gepartThe costs for ethics review were liz of p;oposed to the substantial amount of work done by Otto W'onfi"& R...ich Irops to a.ddress the cqncerns raised by the ethics workgroup. . ' . . . . . . Consortium Formation Issues Concern about Spy Plane Incident ./ Dr. Fu is also concerned with this issue (The follQ~ingis an excerpt of an e-mail from Dr. Fu to Otto after the call): '. . "I was really glad to hear the good progress of the project from you. I am concerning and worry about the relationship of Sino-US. In my side it would not affect our collaboration anymore. So I am waiting for the final decision ... " Possibly discuss this with Chinese officials in DC Will be brought up and discussed on the May 3rd call. Other Issues: Otto met Dr. Xu (the Chinese bio-ethicist) last month, who has been helping with review of the consent forms. SH ELL-MCCLU RG-065553 DRAFT - April 26, 2001 Minutes from April 24, 2001 Benzene Consortium Conference Call Page 3 Patrick received confirmation from Dr. Xu on his acceptance of the proposal for compensation ($2,500). Protocol Review Good agreement that the protocols are being reviewed over again outside the development process It was proposed to get NCI, EPA and/or other regulatory agencies involved in the review; it will give the studies more weight with agencies ACTION ITEM (George Woodall): Need to get written comments from reviewers, response to comments etc. from 18t round. The previous reviewers were: Dick Albertini (OeQetic Toxicologist, U of Vermont); Nancy Mueller (Epidemiologist, Harvard); Richard Larson (Hematogist/Oncologist, U Chicago); Elizabeth pelZel (Epidel,1liologist Uof Alabama, Epidemiologist) ACTION "ITEM (George Woodall): Need to make sure to document this 2nd set of review~'~n~ pfov~de anffo~.9se.d ti~eline for .c~mpleti~n. .. .Imtial plaQ.for 2/ r9tmd IS to' have 4 ongmal reVIewers (world class sCIentIsts, rerriove(jfrom.theproc~s~) to db a review prior to IRB review by the Prinicpal Investigator:s otganizati04s .., . Six weeksapticipatedfoI'review / . Issueofgetiinggov'ttlgency to also rev:iew / Raises tl,leissqeofpropeflevel o.fiJarticipa,.,tion for NGOs & agencies (The model cif having.a stakeholder group>is 'Yell as the Qversight committee was discussed.)." // .. / .. //.ii ./ .... How to approach t4~.iss~e? Th~ycol}ld participate as aformal member of the committee, or provide th,em with a qlore .informal reyiewof t4e protocols prior to an IRB review... / .. . . . i .. i .. / ..,/ ........ Depends on proper discipliU"~ rept~sehted.by agerjey p~?sonnel a~d Qn how the organization will participate, i' // // './ / .. EfIt was suggested to approach A & WHO for possib..le parti2ipapts; IARC may also be a consideration (Patrici~ Buffler, Dean..ofthe..SchoolofPublic Health, UC Berkeley) /. . Need to determine how this review process wiUhe c.onstructed (parameters) prior to deciding on who to ask. Shell woul(rathe{have adverse comments early rather than late in the game. Responses to comments need to be handled by the PI's, but an issue of who has "final say." PI's need to take the comments into consideration, but do not need to accept all comments. ACTION ITEM (George WoodalllPatrick Beatty): Draft a proposed outline for the process steps for scientific review This outline should also be reviewed by the Ethics Review Workgroup Guidelines for reviewers: What is expected, how it will be processed, how it impacts the project SH ELL-MCCLU RG-065554 DRAFT - April 26, 2001 Minutes from April 24, 2001 Benzene Consortium Conference Call Page 4 Contract Issues ACTION ITEM (Member Companies): All companies should send comments on the draft contract to George Woodall by May 1 Consortium Administration What is API's role in Administrating the project?, concerns with document management and segregation of documents (not necessarily only attorney/client privilege) All documents should go through API's OGC or other counsel prior to release The cost for outside counsel would be part of the $lM communications budget. All funding man.agement, invoicing, budgets, legal review of documents (by API counsel), tracking and archiving documents, oversight and administrating, etc. would be c<:YV~red in the5% administrative charge in the proposed budget Questiollbn he.wIng API}as ad.lTIinistrator and also as a member of the consortium is a non-issue sihce two separate parts of API (Subscription Research and Benzene TaskForcc::( respectively) Will perform these functions. Legal reYiew L lawyer should l1ot change a document but needs to understand the . qocumertt contr91pr&ess ./ . Cost Control . ' Basic conce.rn of cOsts esd.Iat1~g in. th~ fu.ture/ The reason\he.ydid.escalilte bet-ween th~initi~l estimate and the final was that a lot of up front costs he.l:'Ve b~n inCluded. /ltlflation has"heen bui.1t into the estimate PI's needs to be are aw~re'that costs.~re fi~ed Put a "true ceiling" ~d~xpenditures in th~ contracJ:/It wassugges-ted to put a "not to exceed" percentage where a member c;lrt exit "witp.out pfejudice"if it is exceeded. /'/ ./ .// . . / > "/ It was mentioned that a proposalfdrNIH-type funding could be 4!:,ed foy/other beissues as they come up. Having anm-golng flow of datarnay ldoked upon favorably by the granting institution. .... . PI's have been very thorough in looking at the detailS of th~ costs Availability of Data The issue was sparked by Bill Moyers Special and concern that "burying information" not be a perception with this project "We expect open flows of information" which also works well with having agencies and NGO's as members on the oversight or a stakeholder committee Opposite side of coin is not to release data as they are being collected (interim findings), issues of confidentiality, incomplete data, etc. Paragraph 6 of draft contract (TSCA reporting) was seen as very appropriate SH ELL-MCCLU RG-065555 DRAFT - April 26, 2001 Minutes from April 24, 2001 Benzene Consortium Conference Call Page 5 Consortium Structure Draft document not on the web site Only those having a full share will have a vote ACTION ITEM (George Woodall): Provide the detailed draft document on the web site Exit Strategy Need to meet all financial obligations, including the 25K to Fudan University (see discussion above) The individual companies also need to honor their commitments to seed money contributions There is a cOlpmuni~ation issue on providing a reason "why the consortium did not go forward" ,if that is the case (done by the communication workgroup) Next confereric:~ail O~:MaY3,,.3:30 PM EDT SH ELL-MCCLU RG-065556