Document NEo2DdQq8591Yo2aydjxg7g1g

"McCrea, Deborah" <rnccrea@taftlaw.com> 08121/2009 10 :52 AM To NCIC OPPT@EPA cc "gilott, Robert A." <bilott@taftlaw.com> bcc Subject 08/21/2009 Letter To EPA Docket Center P,6 - S Taft I J Deborah McCrea / Legal Assistant Taft Stettinius & Hollister LLP 425 Walnut Street, Suite 1800 Cincinnati, Ohio 45202-3957 NJ Tel : 513 .381 .2838 " Fax : 513 .381 .0205 www.taftlaw .com / mccrea@taftlaw .com Internal Revenue Service Circular 230 Disclosure: As provided for in Treasury regulations, advice (if any) relating to federal taxes that is contained in this communication (including attachments) is not intended or written to be used, and cannot be used, for the purpose of (1) avoiding penalties under the Internal Revenue Code or (2) promoting, marketing or recommending to another party any transaction or matter addressed herein . This message may contain information that is attorney-client privileged, attorney work product or otherwise confidential . If you are not an intended recipient, use and disclosure of this message are prohibited . If you received this transmission in error, please notify the sender by reply e-mail and delete the message and any attachments . 4749_001 .pdf p. 2 Taft/ Taft Stettinius & Hollister LLP 425 Walnut Street, Suite 1800/Cincinnati, OH 45Z02-3957 /Tel: S13 .381 .2838 /Fax: 513 .381 .0205 /www.taftiaw.com Cincinnati /Cleveland /Columbus /Dayton /Indianapolis /Northern Kentucky /Phoenix /Beijing ROBERT A BILOTT 513-357-9638 bdottMattlaw.com August 21, 2009 FEDERAL EXPRESS EPA Docket Center, MC 2822T U .S. Environmental Protection Agency EPA West, Room 3334 1301 Constitution Avenue, NW Washington, D.C. 20004 Re: Submission to IRIS and AR-226 Database For PFOA/PFOS : EPA-HQORD-2003-0016 To IRIS Database for PFOA/PFOS : In response to the Notice issued by USEPA on February 23, 2006, regarding USEPA's efforts to consider perfluorooctanoic acid (PFOA") and perfluorooctane sulfonate ("PFOS") within the Integrated Risk Information System ("IRIS"), 71 Fed. Reg. 9333-9336 (Feb. 23, 2006), we are submitting the following additional information to USEPA for inclusion in that review, and for inclusion in the AR-226 database: 1 . "Order Filing C8 Health Project Data and Establishing Criteria For Future Use of Data" (with attachments) (dated May 16, 2008), entered in Leach, et al, v. E.1. du Pont de Nemours & Co., Civil Action No. 01-C-608 (Wood Cty. W.Va. Cir. Ct.) RAB : mdm Enclosure Cc'. Gloria Post (NJDEPxwI encl.) (via U .S . Mail) Helen Goeden (MDH}(wl enci.) (via U .S. Mail) Lora Werner (ATSDR)(w/ encl.) (via U.S. Mail) CONTAINS NO CBI IN'1'IfE CIRCUIT COURT OF WOOD COUNTY, WEST V'HtGINiA JACK W. LEACH, et aL, Plaintiffs, VS. CIVIL AC`I'ION NO. 01-C-609 E. L DU PONT DE NEMOURS AND COMPANT, Defeadedk ORDER FILING C8 HEALTH PROJECT DATA AND ES !"LLSHING CRITERIA FOR IrI1TU$E USE OF DATA This day carne Robert G. Astorg, CPA. Htait}i Project Settletnent Fund Administrator (the "Health Project Administrator''), by his counsel, Richard A. Hudson, and tenderod to the Court for filing, tinder seal, two sets of the data acquired in and through conduct of the Court approved Health Project by Brookmar, Inc., which Health Project was previously approved and endorsed by this Court in its Order dated February 28, 2005. The filed data consists of two groups. The "first groitp" consists of t DVD disk labeled "De-Identified Dataset DVD t" containing de-identified data about Heahh Project participant demographic data, health histories, blood cttemistries, and CS related blood levels, and 1 DVD disk labeled "Quality Assurance Data" containing data collected by Exygen Laboratories and Axys Laboratories to assure accuracy of the testing procedures and results within appropriate scientific parameters . The De-Idcntified Dataset DVD 1 contains a Data Dictionary defining the data fields and elements in the database spreadsheet, the Microsoft SQL 2000 database backups, the Microsoft SQL 2000 database taw text exports and mating scripts, and Internet Browser-based sotlu~are to vieu" the database contents and irnages . The "second group" consists of 1 DVD disk labeled "Identified Dataset DVD i" that contains all of the data firom the first group plus all of the identifying data about Health Project Participants, together with a Data Dictionary defining the data fields and elements in the database spreadsheet, the Microsoft SQL 2000 database backups, the Microsoft SQL 2000 database raw text exports and creating scripts, and intemct 13rowserbased software to view the database contents and images, 1 DVD disk labeled "Science Panel Dataset DVD 1" oontaining all of the data from the first group plus the identifying data about. the Health Project Participants who gave their consent to provide identifying information to the Scie= Panel appointed by this Court, 1 DVD disk labeled "Science Panel Conswt Form Images" containing images of all the consent forms for Health Prfljaot Participants who gave their cansent to provide identifying infonnation to the Science Panel, and 26 DVD disks labeled "Images DVD 1 through 26" containing image files of all of the scaaned documentation used to -verify identity and eligibility of the Health Project Participants. All of the disks making up the "first group" and the "saeond group" arc hereby ORDERED Filed and Sealed Based upon prior testimony herein, the Court finds that the C8 Health Projeet and the data contained on the disks is tuiprecedented as to scope and significance in the scientific, epidotniologic, and medical communities. The Court notes the quarterly financial reports from the Health Project Administrator (previously filed herein) and the substantial cost of the projcct that culminated in the filing of these disks, and finds that the disks and the data contained thcreon are of incalculable value_ Therefore, the Clerk of this Court. is ORDERED to take appropriate measures to physically protect and preservG die filed disks to ensure that the disks will be properly safeguarded and the purposes of this Order can and will be implemented through the foreseeable future. Furthermore, it is ORDERED that the disks shall not be "archived" (as closed tiles eventually are archived) except upon court approval of a procedure to ensure proper preservation of the data contained on the disks and continued access as further provided hcrein. The prior order of this Court approving the use of settlement funds for the C8 Health Project allowed for the collection of confidential infortnation from the participants, and further provided for submission of health data and blood tcst inforniation to the Science Panel subject to appropriate confidentiality provisions. in addition, the testimony of witness A. Paul Brooks, 1r., M.D. included a description of the C8 Hcalth Project and his affirmation that the inforination from the C8 Health Project would benefit the class membership if placed in the public domain, but that the identification of the individual participants would never be released . Therefore, the liealtli Project data contained in the "first group" and the "second group" filed pursuant to this Order shall be sealed, and shall not be revealed, copied, or otherwise made available in any form to any person. court, or entity, with or without a subpoena, except upon further order of this Court as ftuiher prescribed and outlined herein. Any person, court, or entity that desires to access the "first group" data in any manner whatsoever shall file a petition with this Court identifying the requestor, stating the purpose or purposes for which disclosure of the data is requested, affirming that the data shall be used for no other purpose except those which are stated in the petition, and providing documentation and proposed protocols that reasonably satisfy the Court that the identities of the health project participants shali be. protected through the utilization of lnstitutioiiaI Review Board (TRB) methods or other reasonably reliable protocols to assure no breach in the de-identification of the data acquired by the requcstor . All costs ofduplicating or accessing the data, and alt costs of securing court approval for access to the data, shall be the responsibility of the person requesting copies or access. Notice of hearing to consider access to the data shail be niade upon attorneys of record for the parties, or their successms, but only for purposes of allowing the parties to provide the court with additional infonnation that may assist tha court with implementation of the goals and limitations of the Health project as stated in this Order and the prior Order of the Court and testimony before the Court regarding the Health project at the hearing previously conducted by this Court an February 28, 2005 . The parties or their attomeys shall not be required to attend the hearings regarding petitions to acxsess Health Project data except to the extent that the Court so orders after filing of ft petition. With or without utifizaiion of a "third party mechanism" as further described below, upon filing of any petition as provided herein, the Court shall appoirtt one or more "independent scientific evaltu'tior(s)," at the expense of the petitioner, for the purposes of advising the Court regarding scientific and other technical or ethical issues related to the petitioner's request for access to the datase filed herein and assisting the Court at the heanng mandated by this Order. After conducting a hearing, the Court may order that the non-identifiable data shall be provided to the requcstor subject to such conditions as the Court may find reasonable and necessary to protect the anonymity of the health project participants, while at the same time giving due consideration to the goals and purposes described during the hearing at which the health project approved by this Court on February 28, 2005 . At the February 28, 2005 hearing for final approval of the settlement, the attorneys for the class action plaintiffs, the attorneys for the defendant, and the principals of Brookmar, Inc., the primary contractor to the Health Project Administrator (:Brookmar") jointly represented to the Court that the de-identified results of the health project would be placed in the public domain at the conclusion of the CS Health Project~ and that the data shall not remain the property of any person (including individuals, associations, and corporations)- For that reason, when considering whether or not to allow duplication or ace= to the da-identified data by any person, the Court will encourage such access for purposes of any study of the do-identified data that wi11 benefit science, medicine, human health, the class, or society in general . When access to the data is approved, parties requesting data shall limit their analyses to the specific purposes requested . Stored data will be returned or destroyed. and access to shared data will end when the specific request is completed . Tha provisions of this Order limiting access to the "first group" data are included only far the following Purposes: (1) to ensure that the identities of health project participants are not discovered or revealed except as necessary to pratect the life or health of a participant to whom it is reasonably necessary to convey newly discovered information that Lis critically nocessaty to ensure [lie continued survival or well-being of that person; and (2) to ensure that requests for data reasonably meet minimal, customary guidelines for data sharing within the acadenticlscientiftc community . The Court shall not unduly restrict reasonable access to the deidentified data after the C',ourt is satisfied that sufficierit action has been taken to assure continued protection ofthe privacy ofthe health project participants. This Court presently has no infrastructure for data sharing with regard to data disks filed in the Office of the Circuit Clerk. Therefore, a third-party mechanism may be implemented to ensure that needed infcastructure and expertise for data sharing will maintain : (1) confidentiality of participants, (2) scientific purposes expressed in the proposals, and (3) institutional review boards or reasonably similar processes . The third party may be designated by the Court to hold the data, to evaluate and report to the Court regarding requests for data, and to implement data sharing if approved by the Court. In selecting a third party to assist the Court with data custody and sharing, the Court will consider the following relevant issues: the third party's familiarity with this type of environmental health data; the third party's ability to scrub and clean data to recognized standards of confidentiality; ft third party's presence or absence of an active institutional review board process that can correspond with institutional review boards of requesting parties; and the third party's ability to hold, dcidentify, and store the data for data-sharing purposes on behalf of the Court. [f a third party is designated for that purpose, the. third party may review requests and advise the Court whether the proposed data sharing can be confidential to accepted standards, and whether the proposed study of die de-identified data that will benefit science, medicuie, human health, the class, or society in general . Such third party may also be designated as the "independent scientific evaluator(s)" as provided for above. The Court recognizes that any third party data custodian (government agonoy, university, individual, or private corporation) and/or the Clerk of this Court holding the data wilt have legitimate costs associated with the data-sharing enterprise In that regard, any petitioner seeking access to the data will bear the cost of (a) third party consideration and reporting to the Court rega.rdirig proposals, and (b) de-identifying and storing the specific parts of the data needed to meet the request. To ensure safe data shanag for scientific purposes, the petitioner may present evidence to satisfy the Coun that the following standards (or such revised standards as are scientifically appropriate or legally necessary at the time of the request) for data sharing will be tnet : 1) identifiable data . Caitral disclosure control to prevent inappropriate sharing of individual, This may be accomplished by control over data access through a third-party mechanism, described above. Z) Data-access controls which enact restrictions on who can use the data, how the data can be used, where the data can be accessed, and by making informed decisions about what elements of the data are redacted or suppressed before they are stored transferred_ If necessary, for example, in the instance of birth dates, or very rare diseases in a limited geographic area., data keepers may choose to apply additional, statistical-disclosure control tools so that individuals may not be identified by unique attributes . The degree to which this is done is part of a process called deidentification . It is the intention of this Order that only de-identified data be transferred to the petitioning party. The disclosurc-control process therefore may include statistical methods of deidentification, such a briefly described above; and restricting access to those Mth legitimate scientific interests through various release options, including reliance on reciprocal arrangements between institutional review boards, or unilateral reviews to a single standard at the home institution holding the data in the absence of such arrangements. The Court is advised by tho Health Project Administrator that when a petitioning party is granted access to the de-identified raw data that is filed pursuant to this Order, the petitioner is likely to receive the requested data through the meahattism of a restricted-use microdata file. The entire database contains so many elerttents for each participant that unwanted intrusions, also called data snoopiug, arc not ftlliy preventable in a pu6iic-use file. Therefore, data transfers will likely consist of a restricted-use data set limited to the specific interest of petitioning party and die specific purposes which the petitioning party articulates am which are approved under a data-use agreement. In that regard, petitioning parties that are granted access may be required to fill out a data-use agreement fornm that allows the requesting researcher to use e restricted-use microdata file. Such an agreement will usually require: a) nonidentification of individuals, b) nonlinkage with other data resources (except by individual consents), c) a computer security plan, d) a specified time of usage, including an agreement of return or destrucfion . of data at the end of that time period, e) a specified use, including specific research needs, and f) an agreement for third-party review before release of work product to ensure that privacy is protectod The Court has been informed by the Health Project Adminisaator that while this kind of restricted-use microdata file sounds daunting, it is routine in the scientific cornmunity. Petitioning requesbors can envision a11 the questions in the survey, and all the lab values available, and request those needed, making their case for their need as pan of their proposal, 'Me Health Project Administrator has further informed the Court that this procedure is routine for institutional review boards . In order to achieve privacy without denying data use, any court desighated third party holding the data will be entitled to use standard statistical methods such as data suppression (for example, use of persona( identifiers), data coarsening (for example, year of birth rather than birth date, or removal of very rare diagnoses in some cases); recoding (for example, combining certain types of rare diagnoses that "go together,, so that most of the value of the data is retained yet still deidentifeed ; "top coding" and "bottom coding" (for example, replacing outlier variables with an arbitrary highest or lowest value, so tthat the abnormality is available for scientific review, but individuals cannot be identified) . . The Health Project Administrator has advised the Court that such eft"orts at privacy protection am an essential part of good science. and they require substantial infrastructure and wor(c The agency doing this work- is entitled to take the steps necessary to ensure that privacy is in plaee, including but not limited to the routine steps described above, and to charge the receiver reasonable costs associated with the process . Separate from the "first group" de-identified data that may be disclosed pursuant to notice and hearing as stated above, the Health Project Administrator has filed a '`second group" of disks consisting of ail data and records of any kind or nature that were examined, acquired, or utili2ed in conducting the C8 Health Project. The Court finds that this "second group" set of records are private and confidential and shall noi be made available under the procedures outlined herein . The Health Project Administrator has also advised the- Court tlhat he, along with the principal CS Health Project contractor - Brookmar, Inc_, enterc;d into agreement dated April 27, 2006 with West Virginia University Medical Corporation dib/a University Health Associates for storage of the remaining blood sera samples drawn from participants in the C8 Health Project and for use in subsequent scientific research, including without limitation use by the Science Panel (the "Pathology Services Agroernent"). A copy of the Pathology Services Agreement is attached to this Order as Exhibit "A." The Court finds the provisions of the Pathology Services Agreement concerning the maintenance of the privacy of C8 Health Project participants and the conditions under which die blood sera samples will be made available for appropriate scientific researeii are consistent with the principles enunciated in this Order. Accordingly, the Court hereby ORDERS the Pathology Services Agrcement be filed. WHEREFORE . the- Court hereby ORDERS that the inforination contained in the "second group" of disks shall be scaled and shall not be disclosed in any manner or form except in a -circumstance where the disclosure is unquestionably necessary for purposes of a matter critical and essential to the life of the C8 Health Project participant for whom disclosure is requested. Therefore, it is the order of this Court that no disclosure of the private records shall be made, and no request for disclosenre or subpocna of those records shall be made by any person or attomey for any person except in the circunnsianco where the requestor contends that disclosure is solely in the best interest of the C8 Hcalth Project participant whose records are requested . It shall be a violation of this Order and a contempt of this Court for any attomey to request or acquire an order of any other court or a subpoena in an effort to circumvent the hearing requircnents of this Order regarding disclosure of the C8 Health Project data filed in this civil action pursuant to this Order . Nothing contained herein shall prevent an individual C8 Health Project participant from requesting and receiving his or her "'second group" personal information or identifying number at his or her own expense from 8roolmar or the Clerk of this Court at any time for any l0 Purpose. and the fact that such person requests or receives his or her inforcnation from Brool,mer, the Clerk, or Court sha11 not be disclosed by the Clerk to anyone except with permission of the person who requests such information. In the event of an individual request for records, the person making the request shall deposit sufficient funds with Broolhnar's infommatioij technology representative or other couri designated and approved technician to cover the cost of accessing the scaled disks, recovering the requested data, and re-sealing the disks and dataset . It shah be a contempt of this Court for the dasignaied and approved technician to access, review or copy any information beyond that which is necessary to comply with the participant's request_ It is ORDERED that no access to the disks filed herein sha11 be attowed by the Clerk of this Court at any time except after thirty days notice to the Court, and thst any person requesting such access shall also provide a copy of this Order to the fudge to whom the request is made. Entered this . 11n__ day ofMay, 200$ PREPARED AND SUBMITTED BY: / Richard A. Hudson ('WV Bar It 1808) Bowlas Rice McDavid Ciraff&- L.ovc, PI..LC 501 Avery Street, Fifth Floor P.O. Box 49 Parkersburg, WV 26102 (304) 420-5511, (304) 420-5587 fixcsirnile rhudsonCbowlesrice .com 11 PATHOLOGY SERVICES AGREVARNT This PATHQLOGY SERVICES AGR&BdWT (this -Agreement-) is entered into as of the 2" day of Apal 2006 ("P.fkdive Data"), by and between WEST VIRGINIA. UNIVERSITY 11MICAL CORPORATION dlbla UNIVSRSSIT( HEALTH ASSOCIATES ("UfiA") located et P.O . 0897 , West Vkgin9a Univeaity, Nfprgaatown, WV 26507-0897, and ROBERT Q ASTORG, CPA, in his official capacity as the court-appoioted Heft Project Administrator of the C8 HeaM Project Devgaatod Settlement Fund ("WA"), whoae present meiing address * Snito 9000 UNH, 501 Avery -Street, Parknsb+ag, West V'nSiais, 26101, and BROOKMAB INC. ("Broolonar"}, whose preset mesllng address is 417 Grand Park Drive, Soiba 201, Vicuna, West Virginia 26105 (ooflaxivdy, ". Depositor") WHfiRFAS, the EPA is the court-appomted "Heft Project Admbistrator in connection with the "C8 Health Project" described and authorized in the court-approved settlement agreement in the class action fawaurt Leach, a al. v. E. l. DuPont De Nwourr & Co ., Civil Action No . 01-C-608 (Circuit Cow of Wood County, West Virginia), andis lawfully authorized pursuant to court order dated February 28, 2005 to coatraet and pay for the services contemplated in this Agreement; Wf1gREAS, Baroolomma is the eourt-designated contractor responsible for the desigq implanmdation, operation and sdmioWrsdon of the C8 Health Project and, as such, is nesponable for collecting the boehh data ad blood aatan samples of CB Health Project parricipairts f'specimm"); . WFIEREAS, UHA is the Fscutty Praotice Plan of the %culty physicians of the West Virgmia 'University School of Medicine ("WW") which School of Modiome includes a Uirivesity-bsml Pathology Department, providing Pathology seivices throngh URA and conducting biomedical research, . WFIBRTsAS, iJHA, m conjuuction with the WVU Pathology Departmdnt and other reseerchers af6lieted with the WVU Health Scimcea Center, maintains a WVU Tissue Archival Bank, to support WVU -basod medical research proMms; WHEREAS, Broolcmar desies to store and preserve the Specimeas et the UFiA Department of Pathology T'mne Bank repository m accordance with the terms and conditions set forth herein; and WHEREAS, the activities contemplated by this Agreement are consistent whh the mission ofUHA to support WVtJ. NOW 'CAERBFORE, in consideration of the foregoio& of the mutual covenants Containedherein, theparties intending to be legally bound 6aeby agree as Mows: o51osos.i EX F1 1 ta, r _ ARTICY.,$1 PATHOLOGY SBBVICES AND FEES 1.1 ~.lo$X..$~ The Pathology Services will uiclade. 1) the swap and maintenance of the Specimens in 3m1 vials at -80 degrees C in the UHA Departzeent of Pathology Tissue, Bank repository, in such amounts and at such. times as am requested by Broolmtar and mutually agreed upon by the partis+ Z) maintenance of inventory data related to the Specimens in accordance with the reesonable needs and reqwmunts of Hroolar, 3) distribution and find &position of the Specimens in accordaQlce with the Mowing : (a) Research RoQ~, During the Term (defined below) of this Agromaau, i,THA may make the Specinems available for valid and reasonable research pluposes and shall evahxate all snch requests in accordance with the protocols and procedures of URA as descnbed in 8xhi8it A, attached heteto, provided that consideration and priority ahaII be even to projects that demonstrate a benefit to the class members of that certain class action lawauit entitled Leach, et aL v E. L DuPont De Maw= & Co., Civil Action No. 01-C-b08 (Circuit Court of Wood County; West V'>zginia) . (b) cci r Panel -Resol4s11 $M=. in evaluating and Voting research requests made upon the specimens under section l .l(a), LTFIA shall give priority to reaearch reqltests from Dr. ICyle Steenland, Dr. Tony Fktdlc, and Dr . David A. Savitz (collectively, the "Scimce PaaeP') made during the Term of this Agreement If Out only lf each of the foiiowin.g circumstances apply'. (i) the Science Panel's use of the requested Specimens is necessary to fulSll its responxbftes under the wurt-approved sattianeaYt agreamcnt ul the class action lawsuit Leaoh, et aL t. E. L DuPont De Nmoura & Co., CivH Action No. Ol-C-608 (Circuit Court of Wood County, West Virginia). M_d. (il',~ UHA determinos, in its sole du=ei0n, either (A) that the Science Panel can not reasonably obtain a new seaum sample from a C8 Health Project participant whose, serum sample is requested 4I (B) that the Science Panel presents a compelling need to perform a new test or assay on the Specimens, and (iu) no individual sampk of the requested Specimens sW be depicted below sixhundred microlitas (500 PL). (c) C,'.ondaions to C,rnntime Koseerh RMn~~ In the event a research request is granted m accordance with either sections 1 .1(a) or 1.1(b), each of the following conditions sball be first saaisfcd: (1) Four hundred mic.rolitexs (400 VL) of each individuai sample of the Specimens shaA be aliqnotted into two separate containers, each coutamiag two hundred microliters (200 yi .), and immediately restored. Such portion sha91 not be made availabie 2 t518S03 .1 for any research Putposa for and during the Tam of this Agreement, and Broobw andlor HPA may request the rebna of such portion at any time during the Tam of tbi4 Agreement for anyreason and at their sole discrCtioa . (2) Any portion of co& individual sample of the Specimens after complying wl<h section 1.1(e)(1) end dastriludoog raquested amounts tor approved reBOarCh request under ieCl3onS 1 .1(a) or l.lroj shall be a1lQpouOd into separate containers each contanomg no more then two lamdred microllteas (200 ILL) and .u+w+ww.w7lOSL01'ed. . (3) Al fm and rqmm assooiated with rouieving the Specimens and aliquotting and restoring the Specimens as required by this section 1.1(c) s5a1 be either borne by UHA or collected in advance as a condition for granting such research requegs made pursuant to sections 1.1(a) or 1.1(b). (4) UHA shell mdr.e reason" efforts to consnh with Arthur A Msher andlor A. Paul Brooks, Jr., MD. an its evaluation of.research requests preswed by the Science Panel. (d) D9soosrtian at End of Tesm. At the termination of the Tam of this Agreement, and without regard to The priority described in section 1.1(b) or the retention requirements of 1 .1(c), UHA may malte the Specimens available for valid and reasounWe research purposes and sball evaluate all snch requests in accordance with the protocols and procedures of UHA, or, m its discretion, sock funding for additional storage sasviaes. 1-Z PlI*P3Cafid4ofuft and Privacv. Broolmar hereby egre.p to abide by EIIPAA and all other applicable regulations in the course of its access to the Pathology services described by this Agreement and to enter into a Business Associate Agroeanent with URA as prescribed by FIIPAA . . 1.3 Status of M Tmsne Bank. Nothing in the agreement shall be construed to encumber in any way the.WVIJ Tissue Bank or the sole authority by which it shall be operated, by the WVU Pathology Depmrtoamt. 1 .4 Em For the services dascnbod above, iJ13A ahall invoice Broolanar once upon the parties execution of this Agreement in an amount equal to Three Hundred Thirty- Three Thousand. Six %mdred Dollars ($333r,600 .00) . This dm-ge is not for the Spa=oaa themselves, bat re8ects the comb of collecting, hsmd6ng, preparing andlor storing the specimens in accordance with the reasonabia detailed requirements of Broolmar. Brookmar and EPA abaII be rosponsible for providing storage containes and delivery ofthe Spechnena to the UHA Department ofPathology Timae Bank Repository. 3 1siasa3 .1 ARTICLE 2 RIPRESENTATIONS AND WARRANTIES 2.1 Rcc,msm ' ns of Brookmar. BroobnAr rqmmts and waa'amts that the Speciaaeas or my oth,cr time or cell materials obtined from C8 Health Project pardcipants and related information provided via the Speconew under this Agreement bave been obtained by obwmag written, inS~oramed couseat from s+u;h pamtnpants, using an informed and federal consemt fiorm *at is m material laws and regulations regantmg compl9ancx with all applicable local, state de collection, storage, transfer, use and disposal of human tissum . 2.2 Pudmm. NEITHER PARTY MAKES ANY OTHER WARRANTY OF ANY KIND WHATSOVER, EXPRESS OR DOYIED, AND ALL 134PLIED WARRANTIES, INCL[JDIIVG THE WARRANTY OF FITNESS FOR A PARTICULAR USE OR PURPOSE AND THE WARRANTY OF 1MERCHANTABIIdTY, ARE HEREBY DISCLAIMED BY THE PARTIES AND EXCLUDED FROM THIS A. GREEMENT ARTICLE 3 LTIrIITAT[ON ON LTABIIdTY NEITHER PARTY SHALLBE LIABLE TO THEOTHERPARTY HEREUNDER FOR ANY INDIRECT, INCIDENTAL, SPBCTAL, OR CONSEQUENTIAL DAMAGES. ARITCLE 4 TERM AND TERMINATION 4.1 TAM Tfis Agreement sheR cemoneax as of the Effective Date and Shall contiaue in fixII fnrce. and effoa, for five (5) years from the Effective Date or the dote of delivery of the Specimens to UfLA, if later (the Term). At the end of the Term, this Agreement shall temmste. ARTICLE 5 MISCELLANEOUS 5 .1 Relstionabm of the Partim Notbiag ia this Agreement is intended or sbail be deemed to constitute a pairbnaahip, agency or joint venture rdationsbip between the p. arties-hereto 5.2 An1,Gcable Law, This Agreement shall be governed by the laws of the State of West V''ffginia, without giving effect to the cho'we or conflict of taws rules or principles of 4 1319503 .1 the State of West Virginia or of any otherjurisdiction, andshall have the effect of a sealed insuumaort. 5.3 CMypjcqwj& Min Agreement may be executed in my number of counterpetts, each of which shall constitute an original and all of whicb togetber shall constitute one and the same agreement. 5 .4 Ngo=. Any aotioe, approval, or consent required under this Agreement shaR be in writing and shall be considered given when (i) delivered personally, or (2) mailed by registered or certified ma% return reoelpt requested or (3) received by facs=7e with a coaSrmiag copy amt 5y overnight mad or courier usvica, return receipt reqneated, to the parties at the addresses indccated below (or to such other party or at such other address as a party may spxify if by notice to the other pursuant hereto). Notice given by a paityrs coiuod shall be considered notice given by do party. (a) If to UHA: Uaivecsity H:eatth Associates P.O Box 0897 Morgantown, WV 26507-0897 With a copy to : Dcpactmeut of Pathology Robert C. Byrd Fi=lth Sciences Center West V'agmia Uuiveraity Mor9antown, WV 26506-9203 Attention: BarbaraDucatm- MD, Chairman Facsinnla (304) 293-6249 (b) Ifto FiPA: Robert G. Astorg, CPA, C8 Health Project Admnnatrator Suite 9000 UNB, 501 Avery Street, Parlcaaburg, WV 26101 Faasunl-- (304) 422-6254 (c) If to Broolaoar: Broobnar, fir417 Grand Park Drive Suite 201 V'U=, WV 26105 Attention: Arthur Maher 5 151e5os.i With acopy to : Richard A Hudson, Esq. Bow1es Rice McDavid t9raff &Love, LLP P.O. Box 49 Perkasbtuz WV 26102 Facsmde:. (304)-420-5587 5.5 Force 'eure. if any circumstance beyond the reasonable control of suLer party occurs which delays or readers impossible the pafarmance of that party's obligations under this Agreement as herein providcd, ,ncb obligations shall be postponed for such tine as such pes5oimance nccea:anly has had to be suspended or delayed on account thereot provided such party shall notify the other party m writing as soon as practicable, but in no event more than thirty (30) days after the occurreoce of such force majeure. In such event, du partles sbatl meet promptly to determine an equitable solution to the efiects of any such evtat, provided that such party who fob because of force majeure, to perform its obtigation heramder sLaII upon the cessation of the force majeare take all reasonable stops within its power to resume with ft least posatble deky compliance with its obtigations . Eveats of form Won" shall iachtde, without limitation, war, revolution, invasion, insizrrection, riots, mob violence, sabotage or otiw c,iv1 disorders, acts of God, limitations imposed by Gxrhanga of control regulations or roles of any govetnment or governmental ageaey, and any inordinate ad uaantiuapatnd delays m the regulatory review or governmeatai approval process that are .within the control of such govcr==t or governmental agency. 5 .6 FVjjre Ag~ . The teams aud conditions ham contained constitute the eatiro agreement between the parties relating to the subject matter of this Agreecneat and shall aupercede aR previous communications betwem the parties with respect to the subject matter of this Agreement. Neither party has catered into this Agreement in reliance upon any representation, warranty, covenants or undeitalking of the other party that is not set out or refetroi to in this Agreememt . 5 .7 AmodaM. This Agreement may be amended only by a written docuament signed and properly authorized by each ofthe parties hereto. 5 .8 5 t If any provision of this Agreement shell be deemed invalid or unenforceable, the balance of this Agreement shag remain in effect and if any provision shail be deemed imappltcable to any person or cacumstances it shall nevertheless be construed to apply to all other persons and circumstances . 5 .9 No Waiver of Rights . No fabtro or delay on the part of either party in exercise of any power or right hereunder shall operate as a waiver thereof No single or partial exercise of any right or power hereunder shall operate as a waiver of such right or of any other right or power . The waiver by either party of a breaoh of any provision of this Agreement shall not operate or be ooastraed as a waiver of any other or subsequent breach hereunder. 6 IsIuo3.1 5.10 Third Party R. ights The tema and provisions of this Agreeneut are intended to or shall be for de bae6t of the class numbers of that oataaa class action lawsuit entitled Leach, et al. v E. L DuPont De Nentours & Co., Cm'l Action No. 01-G608 (C'acuit Court of Wood County, West V'aghda) and the Sciaace P=ut, or their suthoriaed rqxeseatatives. 5.11 AWpp Trlma. This Ap{eemenr and the terms and provisions hercof s6a11 mare to the benefit of and be bindmg upon the parties bereto and their legs3 mpzrsaatatives, saccesaors and assigas. IN wrnv$SS W=xsoF, the pubes 1acto 1m c=sed their duly antborized reprasentWm to execute thie Agreemou on behalf,of the parties as of the date appeaang at the beginning of this Apeenwat . WEST VIRGINIA LJNr%flM1TY MEDICAL CORPORATIONdiVa UMVF.RSPPY FMALTR ASSOCIATES Tstle -ftidcntand rP0 - ROBERT 0. ASTORG, CPA, Project Administrator of the CS Project Dosigneted Sademcot Fund Health Hc&M 7 1sissow.z iHA Earldbi9 .4 b am P-odma fsteso3 .t Caegories sad Procedures: Exempt, Expedieod and Quom Review - WVU IItB Guiddi ... Page I of 8 &I T----, Ow sugo, - - I Chapter 11 Categories and Procedures : Exempt, Expedited and Quorum Review All research falls into one of the foBowing threecategories : " Exemnt from Board RevigN (.see ,Qgdon A) " Expedited Review (see Section R) " Quorum ftfm (sea Section Q " Case Studies and Oral Histories (see on Dl Protected populations have additional requirements (see ChaplQrVI1. All written oommunication with subjects must display a signed and dated 1RB approval stamp. A. Exempt Research "Exempt research" is research that does not requin3 expedited or quorum review by the Board. although It~does require an "exemption approval .' (See A.3 below.) 1. Criteria for Exemption from Board Review A project is exempt if all the research activities belong in one or more of the following Categories: 1 . Research conducted in established or commonly accepted educational settings, Involving norrrraf educadonalpracUcaB, such as : a. research on regular and special education instructional strategies, or b. research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods. 2. Research involving the use of educational tests(cognitive, diagnostic, aptitude, achievement), *urveys or interviews, or observaSon of public behavior, unless a. information obtained is recorded in such a manner that human subjects can be identifled, dire* or through identiWs (see hMJlwww.wvu .edul-rdirblirb oUidbh(jden h m) linked to the subjects; and b. any disclosure of the human subjects' responses (or conduct) outside the research msuabyjecptlsa'cfeitnhanecisaulbjsetcatnsdiatngr.isekmpolfocyraibmiilniatly,aorcirveilpulitaabtiiliotny.or(Ibf ethidsaImsasguisnpgecttoetdh,ethe study will be subject to quorum review). Some additional institutional restrictions apply: Research Involving the use of educational tests (cognitive, diagnostic, aptitude. fi1ea/C:Oocumeats and Setuagalbci:dldU,oce1 SetFings\TeMplBfoolr,mer WVU 1RH Qnid ... 411412006 ~Catagosies andProctdures: Exrolx, Expedmed andQoonm2 Review - WVU IItB Cnndeli... Page 2 of 8 achievement) may be exempt only if none of the investigata's own current students are subjects . (In these cases, if someone otherthan the investigator has contact with subjects, the study can be exempt.) Research involving observation of public behavlorwia be exempt only if a] the subject's responses do not deal with sensitive aspects of personal behavior (for example, illegal conduct, drug use, sexual behavior or use of alcohol), and b] the investigator does not participate in the activities being observed . Research involving surveys or interviews will be exempt only if a] the subject's responses do not deal with sensitive aspects of personal behavior (for example. illegal conduct, drug use, sexual behavior or use of alcohol), and b] itnhactaesreaosfeseltehcetrroentiucrnsuardvderyess,sth(aeylemtutesrtfrhoamveITtihsetreeqcuhinroeldo)g. yWientbeCgrTatseudrivneytshewimll not require such a letter . 3. Research involving the use of educational tests (cognitive, diagnostic, aptitude achievement), survey procedures, interview procedures, or observation ofpublic behavior that is not exempt under 2(b) . g: a. the human subjects are elected or appointed public officlals or candidates for public ofl9ce. (Public officials are defined as those individuals elected or appointed to local. state or federal o. ; ffi)ce or b. Federal statute(s) require(s) without exception that confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. 4. Research involving the collection or study of eds8ng data by retrospeotive revletis;-Including documents. records, pathological specimens or diagnostic specimens-if a. these sources are publicly available. or b. the Information is recorded by the investigator in such a manner that human sub" cannot be Identified, directly or through identifiers linked to the subjects . Some additional institutional restrictions apply: The above exemption applies if the investigator only gathers those data that exist prior,to the date of IRS approval (e .g ., If the protocol is approved on May 1, 2003. the researcher may collect data that existed prior to that date; the researcher must not collect data that are created in the record on or after that date as such action is not consistent with retrospective record review). Please note that for this category, the application for exemption must always include a data collection sheet (that itemizes all variables that will be coNecled from the reoorcslapeclmens to be reviewed). 5. Research and demonstration projects that are conducted by or'subject to the approval of (federal] department or agency heads, and that are designed to study, evaluate, or otherwise examine: a. public benefit or service programs ; b_ procedures for obtaining benefits or services under these programs ; c. possible changes in or alternatives to these programs or procedures : or d. possible changes in methods or levels of paymentfor benefits or services under these programs. 6. Research Involving only taste and food quallry evatuatlons and consumer acceptance studies. a. If wholesome foods without additives are consumed or file :llC:\Dor.nmeats andSeuings\briselldlLocal Settiags\Teap\Srooiansr WVU MB Cruid... 4114/2006 Categories and Procad+ures: Exempt, Fxpeditad ad QaommReview - WVU IRB t3uiddi... Page 3 of 8 b. Notes: d a food is consumed that contains a food ingredient at or below the level and use found to be safe, or agricxlturai chemical or envkonmental contaminant at or below the level found to be ask by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S . Department of Agriculture . " If a oonsent form is used, the protocol cannot qualify for exemption. " Anyresewch in which the subjects are filmed or videotaped cannot qualify as exempt and must undergo eq)edited or quorum review. " Focus group studies are not exempt. 11 . Exeenpt Research Involving Children Children can be subjects of exempt research unless : a) it involves surveys or interviews; or b) it comes underthe provisions of categories 5 or 6. See .LA for more information about research Involving children . III. Procedures for Exempt Research a. Exemption Procedures for Investigators If a study is eligible for exemption, a written approval must be obtained from the IR8 staff or school or college (see below) before beginning any research activities involving human subjects . (See Appendix C for the 'AINlication for Exemption"- view as 1E[h8L) The following schools and coileges have approved exemption policies and procedures : Arts & Sciences Business & Economics Dentistry Extension Human Resources & Education Journalism Medicine Nursing Physical Education !f a school or college does not appear in the above list, submit an "Application fQ( Exemption" to the IRB staff. This list is subject to change; please check with the IRB staff. b. Exemption Procedures for Schools and Colleges Each school or college within the university may develop its own policies and procedures goveming exempt research . The Board must approve these policies and procedures before they can become effective and must also review and app'rove any proposed revisions . Schools and colleges with approved exemption policies are responsible for ensuring that the population serving as subjects of the research and the nature of the data to be collected are eligible for exemption and also that the methods of data collection and storage are in accordance with IRB guidelines . At the end of each calendar quarter .(end of March, June, September and December), the school or college must submit to the IRB a list of all.exempt research approved during the file:NC:\Documents and Satingslbriselldll.oca1Settiags\Temp\8rookmar RrVU IRB Guid... 411412006 . ' Categories and Procedures : Exempt, Expedited ead Quorum Renew - WVU MB Cwidedi... Page 4 of 8 preceding quarter. The list will include the principal investigator's name and department, the Utle of the study, the date of approval, the exemption category as stated in the guidelines and a short description . The Board may review any documents submitted to the school or college and may, at Its discretion, conductfurther review . B. Expedited Review "Expedited review" is the review of a protocol by one or two board members and applies to certain types of minimal risk research as authorized by 45!QFR 4Q .11o and 21CER 5.6 .110 . "Minimal risk" means that the probability or magnitude of physical or psychological harm does not exceed that encountered in ordinary daily life or during routine physical or psychological examinations or tests. I . Research Eligible for Expedited Review Research Is eligible for expedited review if all of the research activities are minimal ftk and belong in one or more of the following categories . The categories In this list apply regardless of the age of subjects, except as noted. 1. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows : a. from healthy, nonpregnant adults who weigh at least 110 pounds . For these subjects, the amounts drawn may not exceed 550 ml (about a pint) in an 8-week period. and collection may not occur more frequently than 2 times perweek ; or b. from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects . the amount may not exceed the lesser of 50 ml (about 3 and a third Tbs) or 3 ml per kg in an 8-week period and collection may not occur more frequently than 2 times perweek . 2. Prospective collection of biological specimens for research purposes by noninvasive means. Examples : a. hair and nail clippings in a nondisfiguring manner, b. deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction ; c. permanent teeth if routine patient care indicates a need for extraction ; d. excreta and external secretions (including sweat) ; e. uncannulated saliva collected either-in an unstlmulated fashion or stimulated by chewing gumbase or wax w by applying a dilute citric solution to the tongue; f. placenta removed at delivery ; g. amniotlc fluid obtained at the time of rupture of the membrane prior to or during labor, h. supra- and subgIngIval dental plaque and calculus, provlded the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophytactia techniques ; ;- mucosal and skin cells oolieoted by buocal scraping or swab, skin swab, or mouth fileJ/C:1Documeuts and ScttingslbrisdldlLocal SetdngslTemplaroolmar WVU MB Cr~id.., 4/14/2006 Categories andProcedures: Exempt, Expedited mid Quorum Ravicw - WVCJ MB Gaiddiw Page 5 of 8 washings ; j. sputum collected after saline mist nebulization. 3. Collection of data through noninvasive procedures (not Involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves . Whom medical devices are employed, they must be cleared/approved for marketing. (Studies Intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of approved medical devices for new indications.) Examples : a. physical sensors that are applied either to the surface of the body or at a distance and do notinvolve input of significant amounts of energy into the subject or an invasion of the subject's privacy; b. weighing or testing sensory acuity ; c. magnetic resonance imaging ; d. electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography; e. moderate exercise, muscular strength testing. body composition assessment, and flexibility testing where appropriate given the age, weight. and health of the individual . 4. Research involving materials (data, documents, records, or specimens that have been collected or will be collected solely for nonreseanch purposes (such as medical treatment or d. iagnosis) Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects 45 CFR 4B.1o1(b)(2) and (b)(3). This lis'ting refers only to research that is not exempt .) Please note that for this category, the protocol application must always Include a data collection sheet that itemizes all variables that wilt be collected from the records/specimens to be reviewed . 5. Collection of data from voice, video, digital, or image recordings made for research purposes. 6. Research on individual or group characteristics or behavior (Including, but not limited to, research on perception, cognition, motivation, identity. language, communication, cultural beliefs or practices, and social behavior) or research empbying survey. interview, oral hlstory, focus group, program evaluation, human factors evaluation, or quality assurance methodologies in which there there are potential Identifiers if. a. the Investigator does not manipulate" the subjecYs behavior, and b. the research wilt not Involve stress* to the subject, and c. the research will notinvolve deception* of the subject. Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects 45 CFR 48.101(b)(2) and (bx3). This listing refers only to research that is not exempt. 7. Continuing review of research previously approved by the convened IRS as follows : a. where iJ the research is permanently closed to the enrollment of now subjects : ii] a0 subjects have completed all research-Mated interventions: iii] and the research remains active only for long-term follow-up of subjects : or b. where no subjects have been enrolled and no additional risks have been identified ; or file:/IC :1Docaments and Settings\brSseIldU.oca1 SetsingslTemplBrooicmar WVU IRB Gvid... 4I14IZ006 Categories and Procedia=: Exempt, Expedited and Quorum Review - WVU IIt8 (fuideii ... Page 6 of 8 c. where the remaining research activities are limited to data analysis . ' Manipulation ' Stress " Deception The Investigator attempts to change the subject's psychologicai or physical functioning . Situations in which the demands on Individuals tax or exceed their resources, with a potential to endanger well being or heath. or which Involve questions about stressful life events . Procedures that conceal or mislead subjects about the true purpose of a study. All research ahgible for expedited review requires informed consent (see Ch ter y1 unless the IRB grants a waiver. It . Procedures Required for Expedited Review The format and content of a protocol are described in ChApWIII, and are the same for both expedited and quorum review.'The R8 staff screens all protocols for compliance with the required format, necessary signatures and Inclusion of consent and assent forms. The staff then sends the protocol to one or two reviewers. Protocols may be submitted at any time for this type of review. investigators must have an official. written approval letter from the IRB Wore enrolling subjects In the study. All consent forms, letters, NiPAA authorization forms or waivers of authorization (as appropriate) and recruitment ads to be used must have a signed official approval stamp. The approval is valid for a maximum of one year, if not reapproved by the anniversary date, the protocol will be closed . Note that approval of an addendum does notconstitute "prove] foranother year . No consent documents (consent forms/assent forms/cover IettersladsIHIPAA forms) may be used after the expiration date indicated on the stamp. Of . Results of Expedited Review Reviewer(s) may: " Approve the protocol . Require changes for approval under expedited review (changes must be made within 60 calendar days). " Refer the protocol for quorum review. Reviewers may not disapprove a protocol or amendment. Any protocol that does not fall in one of the above categories, will automatically be referred for quorum review. C. Research Requiring Quorum Review "Quorum review" is the review of a protocol by a quorum of board members attending a convened iRB meeting. fsle:lIC:\Documeuts and Satingslbrisdidli.ocal SettingslTamplBrookmar WVU IRB Ouid... 4114/2006 Categories and Proceduras: Exempt, F6cpod9tcd and Qnonw Review - WVU MB Ooi.deii... Page 7 of 8 1. Criteria for Qeorum Review Quorum review is necessary for research Involving risk of physical or ical greater than that encountered in daily life or during routine examinatiopsyocrhotleo"g- research Involving deception, stress or manipulation also requires quorum review. Any research that rdeoveisewn.ot satisfy the requirements for exemption or expedited review will undergo quorum A humanitarian device exemption (HDE) is an exemption that the FDA grants to companies that allows them to market and use their device in medical practice. The devices can be used oinnlaynfoHrDtEh,e aincdoicmaptlieonteldistperdotionctohleaHndDEap.prInoporridaetrefcoromanpainnvyelsittiegraattourretomuusste abedesvuibcmeitItneddictaottehde IRIS for approval . After IRB the device and any adverse approval, events to the the Investigator iRt3 as they must submit a summary of occur. If the investigator is each use of not planning to obtain data for publication and/or research, a consent form Is not required . Il . Procedures Required for Quorum,Review Protocols requiring quorum review will be reviewed at regularly scheduled IR8-meetings. These occur on the 2nd and 4th Wednesdays of each month (Maejbg dates and ubmisaen dgadlines . In order for a protocol to be considered, submit the original plus eighteen copies of aalplpplriceapbalree.ddimsactuesrsiiaoln(,iancnldudaetstparcohtmoecnotlss)taatnedmtehnet,oraibgsitnraalcpt,lucsotnwsoenctopaineds aosfsaelnltmaftoerrmisal- if provided material, by a sponsor (this could include a protocol prepared by investigator brochure, IND safety reports, etc.), if this is the sponsor, addendum sponsored research . All imnavtoelrviianlgm'umsatJorrecahcahntgheesc'ormepqluiiarnincgeqcufioircue mbyretvhieedwea(dSleienCehdaanttee. rIVn .tSheeccfaisoen Aof1,atmheensdammeentrsules will be followed . Breeqfuoirreeda fporromtaotc,olneccaensbsearpylsaicgendaotunretsheaangdeinndcal,ustihoenioRfBcosntasfefnstcarneednassisfefnotr cfoomrpmlsi. aInfcpemw1itwhetdhe hesith information will be collected, appropriate HIPAA documents must be submitted. information on preparing a protocol, see Chapter III . For Ill . Results of Quorum Review At Its convened meeting the Board may: " Approve the protocol as submitted. " Require modifications or request additional information calendar days). FormodHied consent or assent forms, (must be received within 60 a new submission date must appear on the bottom left of each page. Depending on the nature of the information, subcommittee or an IRS staff member will review the material . Approvals by a subcommittee must be unanimous or the protocol Will be referred to the next regularly scheduled Board meeting . " Invite Investigator(s) to attend next meeting to address concerns. " Disapprove the protocol. If disapproved, all signatories will receive a copy of the disapproval letter (Including all co-ft, deans, and chairs). Investigators must have an official, written approval letter from the IRB before enrolling filea/C:1Doauaeats and Setfi.ngslbriseAdlf.ocal SetfingslTcmplBroolinar WVU MB Chlid... 4/i4/2006 Categories and P: rocedures Exempt, Expedited and Q== Review - WVCJ YRB (3uidali... Page 8 of 8 subjects in the study. All consent forms, letters, H1PAA forms (if required), and recruitment ads must have an official, signed approval stamp. The initial approval is va8d for a maximum of one year; if not reapproved by the anniversary date, the protocol will be dosed. Note that approval of an addendum does rrot constitute reapprovai for another year . The board may decide (on a case-by-case basis, based primarily on the tisklbenefit analysis of the study) that a protocol requires reappravai more often than once a year. It the Board disapproves a protocol, any resubmittal must be accompanied by a now "Protocol Mment " (view as HTML including all appropriate signatures . investigators may invoke the appeal procedures outlined In Chapter XI if a protocol is not approved . D. Policy on "Case Studies" and "Oral Histories" Case studies are reports, usually of a single medical case that has characteristics that the investigator feels would be of Interest to others . Case studies are ordinarily reported to peers in the form of Grand rounds or discussed with students as part of an educational experience. Occasionally case studies are presented at scientific meetings and may be published in medical journals. Oral histories are experiences and reminiscences of Individuals recorded by a historian or other individual. These oral histories may be of general interest and may be published or presented in an oral format. Both of these activities are important, but neither, in most instances, meets the definitions of human subject research . Research is defined by the regulations as "a systematic Investigation, Including research development testing and evaluation, designed to develop or contribute to generaliz.able knowledge" . In most instances, case studies and oral histories do not meet this definition and do not quality as research . Therefore they do not require IRB approval. However, it must be pointed out that there are instances in which case studies or oral histories do satisfy the above definition of research and would require IiZB approval. If there are questions about a particular study and whether IRB approval Is necessary, the WVU Office of Research Compliance should be contacted- TQNo...paaoao+.mnawianrmMc.oambmyomWA.:oQffRioC..aweRb e-own canae.ao. LotM~. Awr, f. MW file:ilC:lDocnmeats and Settings\brisdldlLoosi Sextings\TcmplBroolmar WVU IRH Cuid ... 4/14/2006 West Virginia University Tissue Bank Release of Tissue Policy Upon request for tissue samples from a researcher, the following forms must be submitted to the Tissue Bank before the samples are released : iftB approval cover letter " Copy of the approved protocol " Compteted'App6cation for Participation in the West Virginia University Tissue Bank' " Signed 'Agreement 13miting Tissue Use and Transfer" In addition. the West Virginia University Tissue Bank is in accordance with ft tissue policies stated in the W11U IRS Guidelines, Appendix F: Ill . Guidelines for Approval of Protocols Using Tissue Banking : A. Piscenent of human tissue into a bank for research punposps Human tissue, accompanied by a copy of an approved consent agreement signed by the donor, can be placed into an approved Issue bank for unspecified research purposes . Human tissue can be deposited: (1) as part of an tRB approved protocol, (2) following standard operating or delivery room procedures. (3) following standard diagnostic and treatment procedures (e .g ., dental extraction, collection of bodily fluids). and (4) from a non-affiliated institution that conforms to comparable standards for the protection of human subjects . 1 . Approved P. rotocol if human tissue is to be placed into a bank as part of an approved protocol for unspecified research purposes other than that. outlined in that protocol, a separate consent form obtaining approval of the donor mut be obtained (See sample form 6: Consent Form for the Coile&n of Human Tissue for Research Purposes . 2. operating or DelNery Room. If human Issue obtained through standard operating or delivery room (non-research) procedures is to be placed into a bank for potential research purposes, a separate consent form obtaining approval of the donor must be obtained in addition to the standard operating room consent form (See sample form 5: SuroicallClini i Consent Form for The Collection of Human Tissue for Reseerch Purppsesl. . 3. Standard Diagnostfc and Treatment Pmcedures. If tissue obtained for purposes of standard medical or dental diagnostic and treatment (nonresearch) procedures is to be placed Into a bank for potential research purposes. a separate consent form must be approved by the IRB for this purpose. For example, If a blood sample is obtained for standard clinical diagnostic purposes and then discarded, no consent is required. If the remaining blood or components of blood from a standard clinical diagnostic test are banked for potential research use, a signed approved consent Is required (See sample form 5: SuraicallClinical Consent Form for the Collection of Human Tissue for I Research i>uroosesl. 4. Tfssue Acqu6red from a NorrsffQlated Instltution If human tissue is acquired from an institution, laboratory, or company not affiliated with West Virginia University for the purpose of tissue banking for research, the tissue must be accompanied by an approved consent agreement signed by the tissue donor. The approved consent agreement must contain comparable language to' the approved tissue banking language, providing assurance that the tissue can be used without additional consent as long as donor identification with confidentiality is maintained, additional consent, and that that tissue can be used with subject financial oonaiderations regarding the cost and potential financial advantage to Institutions are enumerated. if CORE (Center for Organ Recovery and Education) is involved, their consent form may be substituted . i3 . Removat of human tissue from a bank for research purposes Human tissue can be removed from an approved tissue bank for research purposes using the normal established guidelines for exempt, expedited, or quorum review outlined in Cha er 11" of the IRB Guidelines . 7 . Exempt Research. If human tissue Is removed from a bank forresearch purposes and the information is provided to the investigator In such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects, the research project qualifies as "axempt research' The investigator should follow the procedures for Exempt Research (Chaoter 11, section A~3) . 2- Expedited or Quorum Review. If human tissue is removed from a bank for research purposes and Information is provided to the investigator in such a manner that human subjects can be or are identified, the research project must follow the procedures for Expedited Review (8ection i~) or Quorum Review (Section C.21. 3. Tissue Sent to a Nonaff0iated irrstAtron. If human~fissue is removed from an approved bank at West Virginia University and sent to an Institution, laboratory, or company not affiliated with West Virginia University~for purposes of research, the investigator must conform to the iRB Guidelines for the Protection of Human Subjects by obtaining approval through exempt research or expedited review as outlined above. "Chapter Il of the IRS Guidelines is attached in a separate document Application for Participation In the West Virginia University Tbsue Bank wra~- % I.: Mftwa+amft ---A~mo : r.~w~.a~c~e+ .nsmt~trc ~~a: 1ls~oRr~rrrrUrd~sY~ r~r~re~.aaarr~tra~~r~ww~r,rrtrs~d~ewze++nu SbIlq*mg address: Dept ofPaboloo TerwhVINt Mxo*awsfrt.e~msdrN,.dirlet~@.br.iaWrlet~r~mrWwtrtr~r..~td .mstmwr++rertt~.~c aaerwena~~+w~a.iw~sor.w.n+~..warwrr*ILwwmWatirwmurir,ww~o n- )k zhsagFemnnmenu: Id ~ owdfwhf* oT Tlpdybm balm w IfimodMwrmin+WMsYirhA -rnor.+ot w A1*M1melrmuA~lbeh".wLwplf~rw~~le~~oleY~C Tu Maori e.+oo~wao~ra~ea+aaa+~~uru.'ra~rowamrro~~rak~s,raedroift m Tarmmrr.tlwaamrrm fp iMf~Odllorf:'U'~~Ilb~i+rlpdllrdrlnlt 0! Io1am"Imiritltielnla tpi'toarapp"brioR= rlow Tae M I osdqsland t!w rda and rKulatiom for do WVO'Ciaue Boolc sad agree to oamptywith the goidelinsa a stated by W IRE . I underrtand fLn spprorfi is aaDie!t to yearly removeal. 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