Document mpn2BkoXa59Qa4xQdVZ0nQxK0

From: Burnett, Donald M. [burnetdm@bp.com] Sent: Tuesday, February 18,2003 11:19 AM To: Patsy Clegg Subject: FW: Interactions with the Ethics and Scientific Review Panels Patsy, the e-mail communication below from Patrick Beatty to Richard Irons and Otto Wong is the "letter" which you and I just discussed. The attached Word document is referenced in the last paragraph of Patrick's e-mail and was sent to Irons and Otto to clarify the roles and responsibilities of the various consortium committees, including the SRP and ERP. Financial oversight of the project is an explicit responsibility of the Oversight Committee. Don -----Original Message----From: Beatty, Patrick (PatrickBeatty) [mailto:PatrickBeatty@ChevronTexaco.com] Sent: Thursday, January 30, 2003 6:03 PM To: Burnett, Donald M. Subject: FW: Interactions with the Ethics and Scientific Review Panels Don, Sorry that you did not get the original version of this message. I have two versions of your e-mail address in my computer address book, and I clicked on the wrong one. This is what I sent including the attachment. Patrick -----Original Message----- From: Beatty, Patrick (PatrickBeatty) Sent: Thursday, January 30, 2003 3:53 PM To: 'Richard.Irons@UCHSC.edu'; 'OttoWong@aol.com' Cc: 'Dr. Baruch Brody'; 'Jmricewas@aol.com'; 'Burnettdm@bp.com'; Beatty, Patrick (PatrickBeatty) Subject: Interactions with the Ethics and Scientific Review Panels Dear Richard and Otto, Because of recent events which have necessitated changes in the study protocols and informed consent documents, I feel the need to clarify from the perspective of the Benzene Health Research Consortium (BHRC) members our expectations for the roles of the Ethics Review and Scientific Review Panels. These panels have been established as part of the BHRC structure both to reassure the consortium members that the studies are being conducted in the highest ethical and scientific manner possible and to provide top-tier independent review. This review operates in conjunction with traditional and legally mandated reviews by IRBs affiliated with the principal investigators' parent institutions as well as relevant Chinese institutional and governmental reviews. The combined purpose of all of these reviews, including those of the ERP and the SRP, is enhanced scientific credibility and universal acceptance of the study. The BHRC members recognize that the relevant IRBs are the final arbiter of what is legally acceptable from a scientific or ethics perspective. However, this does not preclude either the SRP or the ERP from requiring additional conditions or wording that goes beyond the requirements of an IRB ruling. Because of this, protocol changes that need to be submitted for IRB review should be reviewed by the internal Review Panels prior to submittal to the IRB. For example, I am fairly confident that the scientific approaches as detailed in the protocols presented to the SRP in September of 2001 would have been approved by COMIRB and the AHS IRB. Prior review by the SRP identified additions to those protocols that should enhance the credibility of the resultant findings, and the resultant amended protocols were approved by the appropriate IRBs. IRB approval prior to submittal to the SRP would have necessitated resubmittal to the institutional review boards and unnecessary delay. Following are some guidelines for Ethics Review Panel Any proposed changes in wording to informed consent documents should be submitted to the Chairman of the ERP. The Chair will determine if the change: a.) requires no action by the ERP; b.) is insignificant enough to be approved by the Chair without full Panel action; or c.) is significant enough to be considered by the entire ERP for comment. Any changes in compensation or other terms of participation by subjects should be submitted to the Chairman of the ERP for similar review. Protocol changes that alter the degree or type of interaction with study participants should also be submitted to the SH ELL-MCCLU RG-067937 ERP Chairman. Minor proposed changes such as the details of an assay or other methods related changes would not normally have ethics implications and need not be submitted. Scientific Review Panel It is the intent of the Consortium that any proposed protocol changes that have the potential to affect the scientific conduct or validity of the study should be submitted to the Chairman of the SRP. As with the ERP, the SRP Chairman will determine if the change requires no approval, the Chairman's approval, or consideration by the entire Panel. In some cases, the Chairman may refer the proposed change to a member of the SRP with specialized knowledge for input without convening the entire SRP, e.g., changing the assay for a specific endpoint from one method to another without changing the endpoint itself. Any proposed protocol change requiring action by the full SRP will be communicated to the ERP Chairman for consideration. These procedures are not intended to hamper the conduct of the studies, and if proposed or anticipated changes are communicated in a timely manner, delays should be minimal. These procedures place a responsibility on the members of the review panels to act on submitted items as expeditiously as possible in order to avoid delaying ongoing research activities. If the Chairman of a Panel does not respond to, or acknowledge receipt of a request that is sent as an urgent matter, the vice-Chair will be contacted to keep the process moving. Otto and Richard, I hope that the above does not cause you undue concern, but the principles underlying this clarification have been part of this project from its inception. Independent review by the Ethics and Scientific Review Panels is an integral and indispensable part of ensuring ultimate acceptance and value of the results of this research program. The consortium realizes that as principal investigators you have the ability to report protocol changes or not. However, our expectation is that the internal review procedures will be honored in the best interest of the study. Patrick Beatty Chairman, Technical Oversight Committee I have attached below a document which is the official explanation of the roles and responsibilities of the committees that make up the formal structure of the Benzene Health Research Consortium. This document also lays out the roles of the Ethics Review Panel and the Scientific Review Panel as well as the expected interactions and communication channels between the Panels, the investigators and the Consortium. Although it was only finalized in December of last year. it was an oversight that we have not provided you with a copy of this earlier Shanghai Cmtte r&r 12-9-02.doc SH ELL-MCCLU RG-067938 BHRC / API Roles Responsibilities March 2007 Review A 1 2 B 3 Source Document Section 4 5 Contract 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 3 5b 8a 8b 8c 8d CD API BHRC Incorporation by Reference - With respect to conduct of the Program by API under Ssection 8, this Agreement incorporates by reference all API Policies and Procedures. Oversight Committee has authority over such administrative and managerial obligations as, but not limited to, * accepting new mem-bers, * determining the scope of the Program pursuant to Section 7 below, * the choice of investigators, * approving additional expenditure of funds, and * assuring that API performs in conformance with the Program and this Agreement. * The Oversight Committee shall have the authority to form subcommittees. Termination - The Research Group may terminate some or all further work under this agreement upon a 2/3 vote among all 6 members API will, among other duties, negotiate, enter into, and administer agreements for the conduct of the research program. Provide administrative oversight for the program. Calculate, collect and disburse the financial contributions required of the Research Group under this Agreement. Communicate results to the Research Group and others as directed by the Oversight Committee. E F GH &[DATE] SH ELL-MCCLU RG-067939 BHRC I API Roles Responsibilities March 2007 Review AB C D E F GH In negotiating agreements with investigators, API agrees to use its best efforts to obtain a contractual promise and insurance coverage for negligence from the investigator(s) to fully 24 8e indemnify API and participating companies. 25 API Policies & 26 Procedures Environmental & heatlh Relationship I Overlap wi 27 research includes subscription projects Special programs 28 semi-annual reports Standard of 29 Confduct No specific relevance Delegation of All disbusements mader only with signed 30 "Authority authority Ckmges to Self-SuPP'rni"ing 1-3::..,1+_ _ _ _ _-+-_ _ _ _--t1 Jnd SpeGal Solicltatioll Pf(!gf~>lnso':~ll)% c'r $.500.0n-o Authorized to Approve: CFO With approval by President and General Committee on Special 32 Programs 33 Commitments 34 35 In the case ot seH-snpponmg programs. im nnlJw:lge'ed cmmmtment may be ma<:.ie ,;I..-nere 36 fhnding has not been budgekd iil rhe cnrn:llt yem. provided it meet'; the bu~.iness cw,,;: cmd a 37 t'imd balrmce is fl"vailable 38 , " 39 \i\rriUell commi.tmems mllst hefally e:'\.ecuted prior to<lny expen<;es he:ing IncUlTed. The PUl!S 40 i~ 011 th.e DeFflrtmeTlt Head w ensme cmnphan.:e. 41 42 43 .. 111 compeUing, ti.me s::n',itive SitUfltlOllS, 'w(,ric mfly j)i'oceed v.. Hh v::1'bal authorization by API 44 staff (c('Ilsistent 'v,'itlI the Delegatiml Policy. Policy JGl J. prior to a controct bdng signed. 45 46 47 Sneh 'l11thoriz~jtioIlS shall require the prior ;]ppwy,]l of the API o111ci;]1 havillg ~.igllah!re ~~------------+-----------r ......,.48=_+------------+-----------1- authority and ~honld be (llsdosed [IS pmt of the background material provided ,,,,,hen the ~49=_+------------+-----------1- contract is subnutled fl)r r,;:\'ie,y. 50 51 I I I I 52 III 1 _ _+------1 Special O\vnersbip cQfthe special. programs resid.es "\.vith API's Executive: Committee ~md Board of 53 54 Programs Directors, 55 I 56 1 1 11 &[DATE] 2 SH ELL-MCCLU RG-067940 BHRC / API Roles Responsibilities March 2007 Review A 57 58 59 60 JJ JB C D E FI RC'1renuc m excess of expenses ,and the recommended fund balance rc::sen'"e may be used to reduce API member dues, approved annuaHy lhmugh the pwgranl and budget planning process, Need assurance from API that any excess funds will be dispersed and/or refunded at 61 the discretion of the consortium, 62 63 i~-66~:45'-: '-: :---t ----- ----- -~--- ----t ----- ------- --- Spoocial solicitation programs are generally shorter lenn in dUTation than prol:,rrams that s:ell producls and servk:e8, Funds remaining at the end of other special a special sohdtation ~6+6-----------+--------- program should be disbursed ,as directed by those companies who partkipa1ed in the 67 68 program, 16-9= + - - - - - - - - - - - + - - - - - - - - - 1 1 11 70 I I I BHRC Roles & Responsibilities 71 Document Rc<;pon<;:ibilities: The Bnsines<; Over"igilt COHuuirke "hl111 be the ultimJte i,dministrath'e anthority for the C('l1E,ol'tium ,llld "hall nwkc all final decision" regal'dingr budget, n;~pons 72 required to o,'ers~e lwmcinl disburs~m~llts and oiher agreed mil~swne:s. The Bmines-; 73 Oversight Committee manElf!e<; Consortium intenJction~ \'dth th", study illYestig:?ltor<; ami 74 75 ,)thel' emities, )1" exampi~ go",":11l.1I1':lli offidals or other intelested parti.es, The Bu,;in..::ss 76 Over;,.ight Cf'l111uittee appi"')ve:,; extenlaI cOIImllmicatif'rls, The Bn;,.iness O\"er:>ighr 77 Commitlee see};::; legal udvice fI'om contracted counsel ilud the API legal department. The 78 Busine:% Oversight C:mllluttee o','ersee.;, the adminisiT<ltion aftIle pr..:ject by API. kl 79 incluc!,e oversight of cant1"acr~, The Business Overslght Committee slmH have finnl 80 81 approyal oyer initial membership of th~ Ethics Review Panel <md the Scientific Revie\N 82 PCtnel. The Busine'>s O\"e.l'sight COB.unitke Elpproyes membel';,hip in the Technical 83 Commiltee fol' those olher than financially contributing members of the COH:'>m-rium, \See 84 l'Jdm.v fll!" Pan..:b membershIp and r..:".ponsilnWies "ub"equen! to initial membership 85 86 dedsions and 1(nmiltion, ) 87 88 The Business Oversight Committee shall Ieport flnImaHy k~ the member cmnpanies 011 the 89 finmlci"l status L.f the Consortium, The Busine"s OVJ;O'fsight CL.mmiUee shilll authorize 90 collection of funciingmonies and all expenditure" of the Con,:,ortium. 91 92 I I 93 Re'3pOlbilnirlie5 The 'T'e:~,hmcd O..'er31g11t Cc}mmiHee "l1dl act a, the kchmcal <:'~)lNJ,ltar:l 94 to) ,he B~\;;m~~s Oy,=,rs"f!l:, C')l.rrmitt~e of th", C('21s;o11:im11, Tll.S (:o:>lnll11itoee ~llal1 :>21"';"'= <1S 95 96 the c::"nta:::l h<:'t'I'(een 1]1<:' Cou',un;:JEl :Jl1tJ 11w PrHlcipal Inl.'<:""l!?l1t01"'- Thi; l.'olmnitte'e shaH 97 :fm.'llitat- Pl":)l-::! l'<:'yie\", b<'tv,'eell t112 Sel;:-t:r~fk :~nd Ethies Re\-ie1.\: Pano2'h ilnd H102' 98 Prine ipJl bl'".,tlg3tor,. Tbi', i:ommitlee ,;,h<111 fdlc',,,' the progre:;,. ,of the l'E';,.eJrcl'L 99 j":lentif,,in:g ki"v Blile"'O:le"\.. ff.'HeO,\'i:n'" l'e:pm,;; ii'um :he ?rill:::-iD"li 111"\'::;;;110;0\1:)10> ar,d 1 I G H - - &[DATEI 3 SH ELL-MCCLU RG-067941 A 100 101 102 103 104 105 106 107 108 109 110 BHRC / API Roles Responsibilities March 2007 Review BI . C I .~ . . LD _. E oth"'I1i,'!Se :Jndel'<;mndmg the <:t2lt,IS wlthou' 111 any "''''\-' ll~lpanlB"" tlIt' Im'c-';t,~aWl's lIK1"peaden'::e or tile res<2'arcll. pr'og;:IU1l. as set Q~lt m, ihe proto;x'l';. Thi$ c:)raml.ttee ",\,ill 'p)'!)vi.::le !)',.8):':ie'....." (,f?ll mml.mc.l'ipt, p~"e"2med f;)f public;"4ti')11 and abst~"i<:cts !)!' pI<2";e,It:1ti;),]S ';:emmillg fr;,}lll th'2 [;),]sGl't~~m, It";t':,rd1. Tht' Tedmi.'al (J1,.'els1ght COH:ll'nit1:e'e ;::OBunent:- on .'111d pI0nde" i1-;';e~~merE-; of am: p;'c;w;:'(ll ,di",ntioll, JcCUlllI)!i",aded by the p,'im:lp,l] Iil1'E'sri:giltoE, tlle Sr.~E'n,.iJk ReY1E",V Parle] 0;' the EthiC:; RiO';'lE'',?; Pmlei. The Tedlllj,:al Oyt:Slg-:lt C~)mml~tec' ,hall prepare, ab5trad, ,::i' preseL:&hen,. aLdmanu'3uipb a', needed ;}, ilS l'eque','itetl by the Bu"me" OYE'l';lgh, CC<ill:mi.tkE' f'), it~ ,",SE'. F GH &[DATE] 4 SH ELL-MCCLU RG-067942