Document RjNq6xK3KzoM34eog6kxBLQ7X

P-1 "M cC rea, Deborah" < m ccrea@ taftlaw .co m > 0 8 /2 1 /2 0 0 9 10:52 AM To N C IC O P P T @ E P A cc "Bilott, R obert A." < bilott@ taftlaw .com > bcc S ubject 0 8 /2 1 /2 0 0 9 Letter To E PA D ocket C enter P tL X ^ -^ a i Taft/ Deborah McCrea / Legal Assistant Taft Stettinius & Hollister LLP 425 Walnut Street, Suite 1800 Cincinnati, Ohio 45202-3957 Tel: 513.381.2838 Fax: 513.381.0205 www.taftlaw.com / mccrea@taftlaw.com o 7cz cn ro o o PO 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 CONTAINS NO>CBi '5 ^ P -2 Taft/ Taft Stettinius & Hollister LLP 425 W alnut Street, Suite 1 8 0 0 /Cincinnati. OH 4 5202-3957 /Tel: 513.3 8 1 .2 8 3 8 /Fax: 5 1 3 .381.0205 / www.taftlaw.com Cincinnati / Cleveland / Columbus / Dayton / Indianapolis / Northern Kentucky / Phoenix / Beijing Ro bert a . B ilott 513-357-9638 bHott@taft1aw.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-HQO R D -20 0 3 -00 1 6 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 perfluonooctane 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.l. du Pont de Nemours & Co., Civil Action No. 01-C-608 (Wood Cty. W .Va. Cir. Ct.) Robert A. Bilott RAB:mdm Enclosure cc: Gloria Post (NJDEPXw/ end.) (via U.S. Mail) Helen Goeden (MDHXw/ end.) (via U.S. Mail) Lora Werner (ATSDRXw/ end.) (via U.S. Mail) 11486066.1 CONTAINS NO CBI P-3 IN THE CIRCUIT COURT OF WOOD COUNTY, WEST VIRGINIA JACK W. LEACH, etal., Platatiffs, vs. CIVIL ACTION NO. 0I-C-608 E. L Dl? PONT DE NEMOURS AND COMPANY, Defendant ORDER FILING C8 HEALTH PROJECT DATA AND ESTABLISHING CRITERIA FOR FUTURE USE OF DATA This day came Robert G. Astorg, CPA. Health Project Settlement fund Administrator (the "Health Project Administrator"), by his counsel, Richard A. Hudson, and tendered to the Court for filing, under seal, two sets of the data acquired in and through conduct o f 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 o f two groups. The "first group" consists of l DVD disk labeled "De-identified Dataset DVD l " containing de-identified data about Health Project participant demographic data, health histories, blood chemistries, and C8 related blood levels, and 1 DVD disk labeled "Quality Assurance Data" containing data collected by Exygen Laboratories and Axys Laboratories to assure accuracy o f the testing procedures and results within appropriate scientific parameters. The De-identified 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 raw text exports and creating scripts, and Internet Browser-based software to view' the database contents and images. The "second group" consists of 1 DVD disk labeled " Identified Dataset DVD 1" that contains all o f the data from the first group plus all o f the 3 identifying data about Health Project Participants, together with a Data Dictionary defining the data fields and elements in the database spreadsheet, die Microsoft SQL 2000 database backups, the Microsoft SQL 2000 database raw text exports and creating scripts, and internet Browserbased software to view die database contents and images, 1 DVD disk labeled "Science Panel Dataset DVD 1" containing all o f the data from (he first group plus the identifying data about the Health Project Participants who gave their consent to provide identifying information to the Science Panel appointed by this Court, 1 DVD disk labeled "Science Panel Consent Form Images" containing images o f all the consent forms fot Health Project Participants who gave their consent to provide identifying information to the Science Panel, and 26 DVD disks labeled "Images DVD 1 through 26" containing image files of all o f the scanned documentation used to verify identity and eligibility o f the Health Project Participants. AH o f the disks making up the "first group" and the "second group" arc hereby ORDERED Filed and Sealed. Based upon prior testimony herein, the Court finds that the C8 Health Project and the data contained on the disks is unprecedented as to scope and significance in the scientific, epidemiologic, and medical communities. The Court notes the quarterly financial reports from the Health Project Administrator (previously filed herein) and the substantia! cost of the project that culminated in the filing o f these disks, and finds that the disks and the data contained thereon are o f incalculable value. Therefore, the Clerk o f this Court is ORDERED to take appropriate measures to physically protect and preserve the 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 2 P-5 closed files eventually are archived) except upon court approval of a procedure to ensure proper preservation o f the data contained on the disks and continued access as further provided herein. Ih e prior order o f this Court approving the use o f settlement funds for the C8 Health Project allowed for die collection o f confidential infonnation from the participants, and further provided for submission of health data and blood test information to the Science Panel subject to appropriate confidentiality provisions, in addition, the testimony o f witness A. Paul Brooks, Jr., M.D. included a description o f the C8 Health P ro ject and his affirmation that tire infonnation 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 Health 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 further prescribed and outlined herein. Any person, court, or entity that desires to access the "first group" data in any m a n n a whatsoever shall file a petition with this Court identifying the requestor, stating the purpose or purposes for which disclosure o f 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 o f the health project participants shall be protected through the utilization of Institutional Review Board (fRB) methods or other reasonably reliable protocols to assure no breach in the de-identification o f the data acquired by the requestor. All costs of duplicating or accessing the data, and all costs 3 P -6 o f securing court approval for access to the data, shall be the responsibility o f the person requesting copies or access. Notice o f hearing to consider access to the data shall be made upon attorneys of record for the parties, or their successors, but only for purposes o f allowing the parties to provide the court with additional information that may assist the court with implementation o f the goals and limitations o f the Health Project as stated in this Order and (he prior Order o f the Court and testimony before the Court regarding the Health Project at the hearing previously conducted by this Court on February 28,2005. The parties or their attorneys shall not be required to attend the hearings regarding petitions to access Health Project data except to the extent that the Court so orders after filing o f the petition. With or without utilization o f a "third party mechanism" as further described below, upon filing o f any petition as provided herein, the Court shall appoint one or more "independent scientific evaluator(s)," at the expense o f 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 dataset filed herein and assisting the Court at the hearing mandated by this Order. After conducting a hearing, the Court may order that the non-identifiable data shall be provided to the requestor subject to such conditions as the Court may find reasonable and necessary to protect the anonymity o f 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. 4 p.7 At the February 28, 2005 hearing for final approval o f the settlement, the attorneys for the class action plaintifls, 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 C8 Health Project, and that the data shall not remain the property o f any person (including individuals, associations, and corporations) For that reason, when considering whether or not to allow duplication or access to the de-identified data by any person, the Court will encourage such access for purposes o f any study o f the de-identified data that will 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 wilt end when the specific request is completed. The provisions o f this Order limiting access to the "first group" data are included only for the following purposes: (1) to ensure that the identities o f health project participants are not discovered or revealed except as necessary to protect the life or health of a participant to whom it is reasonably necessary to convey newly discovered information that is critically necessary to ensure tire continued survival or well-being o f that person; and (2) to ensure that requests for data reasonably meet minimal, customary guidelines for data sharing within the academic/scientific community. The Court shall not unduly restrict reasonable access to the deidentified data after the Court is satisfied that sufficient action has been taken to assure continued protection o f the privacy o f the health project participants. 5 This Court presently has no infrastructure for data sharing with regard to data disks Bled in the Office of the Circuit Cleric. Therefore, a third-party mechanism may be implemented to ensure that needed infrastructure and expertise for data sharing will maintain: (1) confidentiality o f participants, (2) scientific purposes expressed in the proposals, and (3) institutional review boards or reasonably similar processes. The third party m ay 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 (he Court. In selecting a third party to assist the Court with data custody and sharing, the C ourt 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 o f confidentiality; the third party's presence or absence o f an active institutional review board process that can correspond with institutional review boards o f requesting parties; and the third party's ability to hold, deidentify, and store the data for data-sharing purposes on behalf o f the Court. If 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 o f the de-identificd data that will benefit science, medicine, 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 agency, university, individual, or private corporation) and/or the Clerk o f this Court holding the data will have legitimate costs associated with the data-sharing enterprise In that regard, any petitioner seeking access to the data will bear the cost o f (a) third party consideration and reporting to the 6 P -9 Court regarding proposals, and (b) de-identifying and storing the specific parts o f the data needed to meet the request To ensure safe data sharing for scientific purposes, the petitioner may present evidence to satisfy the Court that the following standards (or such revised standards as are scientifically appropriate or legally necessary at the time o f the request) for data sharing will be met: 1) Central disclosure control to prevent inappropriate sharing o f individual, identifiable data. This may be accomplished by control over data access through a third-party mechanism, described above. 2) Data-access controls which enact restrictions on who can use the how the data can be used, where the data can be accessed, and by making infonned decisions about what elements o f the data are redacted or suppressed before they arc 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 o f a process called deidentification. It is the intention o f this Order that only de-identificd data be transferred to the petitioning party. The disclosure-control process therefore m ay include statistical methods o f de identification, such a briefly described above; and restricting access to those math legitimate scientific interests through various release options, including reliance o n 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. 7 The Court is advised by the 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 mechanism of a restricted-use microdata file. The entire database contains so many elements for each participant that unwanted intrusions, also called data snooping, are not fully preventable in a public-use file. Therefore, data transfers will likely consist of a restricted-use data set limited to die specific interest o f petitioning party and the specific purposes which die petitioning party articulates and which are approved under a data-use agreement. In that regard, petitioning parties that are granted access m ay be required to fill out a data-use agreement form that allows the requesting researcher to use a restricted-use microdata file. Such an agreement will usually require: a) nonidentification of individuals, b) noulinkage with other data resources (except by individual consents), c) a computer security plan, d) a specified time o f usage, including an agreement o f return or destruction . o f data at the mid o f 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 protected The Court has been informed by die Health Project Administrator that while this kind o f restricted-use microdata file sounds daunting, it is routine in the scientific community. Petitioning requestors can envision all the questions in the survey, and all the lab values available, and request those needed, making their case for their need as part o f their proposal. The Health Project Administrator has further informed the Court that tins procedure is routine for institutional review boards. In order to achieve privacy without denying data use, any court designated third party holding the data will be entitled to use standard statistical methods such as data suppression 8 (for example, use o f personal identifiers): data coarsening (for example, year o fb u th rather than birth date, or removal o f very rare diagnoses in some cases); recoding (for example, combining certain types o f rare diagnoses that "go together" so that most of the value o f the data is retained yet still deidentified; "top coding" and "bottom coding" (for example, replacing outlier variables w ith an arbitrary highest or lowest value, so that the abnormality is available for scientific review, but individuals cannot be identified). . The Health Project Administrator has advised the Court that such efforts at privacy protection are an essential part of good science, and they require substantial infrastructure and work. The agency doing this work is entitled to take the steps necessary to ensure that privacy is in place, 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 o f all data and records o f any kind or nature that were examined, acquired, or utilized in conducting the CS Healdi Project. The Court finds that this "second group" set of records are private and confidential and shall not be made available and- the procedures outlined herein. The Health Project Administrator has also advised the Court that he, along with the principal C8 Health Project contractor - Brookmar, Inc., entered into agreement dated April 27. 2006 with West Virginia University Medical Corporation d/b/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 9 Panel (the "Pathology Services Agreement*'). A copy o f the Pathology Services Agreement is attached to this Order as Exhibit "A." The Court finds the provisions o f the Pathology Services Agreement concerning the maintenance of the privacy o f C8 Health Project participants and Ac conditions under which the blood sera samples will be made available for appropriate scientific research are consistent with the principles enunciated in this Order. Accordingly, the Court hereby ORDERS the Pathology Services Agreement be filed. WHEREFORE, the Court hereby ORDERS that the information contained in the "second group" o f 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 o f a martcr critical and essential to the life o f the C8 Health Project participant for whom disclosure is requested. Therefore, it is the order o f this Court that no disclosure of the private records shall be made, and no request for disclosure or subpoena o f those records shall be made by any person or attorney for any person except in the circumstance where the requestor contends that disclosure is solely in the best interest o f the C8 Health Project participant whose records are requested. It shall be a violation o f this Order and a contempt o f this Court for any attorney to request or acquire an order of any other court or a subpoena in an effort to circumvent the hearing requirements o f fois Order regarding disclosure o f 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 Brookmar or the Cleric o f this Court at any time for any 10 purpose, and the fact that such person requests or receives his or her information from Brookmar, the Clerk, or Court shall not be disclosed by the Clerk to anyone except with permission o f the person who requests such information, In the event o f an individual request for records, the person making the request shall deposit sufficient funds with Brookmar's information technology representative or other court designated and approved technician to cover the cost o f accessing the sealed disks, recovering the requested data, and re-sealing the disks and dataset. It shall be a contempt o f this Court for the designated 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 shall be allowed by the Clerk o f this Court at any time except after thirty days notice to the Court, and that any person requesting such access shall also provide a copy o f this Order to the fudge to whom the request is made. Entered this ..day o f May, 2008. PREPARED AND SUBMITTED BY: Richard A. Hudson (WV Bar #1808) Bowles Rice McDavid G raff & Love, PLLC 501 Avery Street, Fifth Floor P.O. Box 49 Parkersburg, WV 26102 (304) 420-5511, (304) 420-5587facsimile rhudson@bowlesrice.com 11 PATHOLOGY SERVICES AGREEMENT T his PA TH O LO G Y SERV ICES AGREEM EN T (this "Agreement") is entered into as o f th e OH* day o f April, 2006 ("Effective Date"), by and betw een W EST V IR G IN IA U NIVERSITY M EDICAL CORPORATION d /b /s U NIVERSITY H E A L T H A SSOCIA TES ("UHA") located at P.O. 0897 , W est V irginia University, M organtow n, WV 26507-0897, and R O B ER T G A STO RG, C PA , in his official capacity as th e court-appointed Health Project Administrator o f th e C8 H ealth Project D esignated Settlem ent Fund CHPA"), w hose present m aiing address is S uite 9000 UNB, 501 A very Street, Parkersburg, W est Virginia, 26101, and B R O O K M A R IN C. ("B rookm ar"), w hose present mailing address is 417 Grand Park D rive, Suite 201, V ienna, W est Virginia 26105 (collectively, "D epositor"). W HEREAS, the HPA is the court-appointed "Health Project Adm inistrator" in connection w ith th e "C8 Health Project" described and authorized in d ie court-approved settlem ent agreem ent in the class action lawsuit Leach, et al. v. E. I. DuPont De Nemours & Co., C ivil A ction N o. Oi-C-608 (Circuit C ourt o f W ood County, W est V irginia), and is law fully authorized pursuant to court order dated February 28,2005 to contract and pay fo r th e services contemplated in this Agreement; W HEREAS, Brookmar is die court-designated contractor responsible for the design, implementation, operation and adm inistration o f th e C8 Health project and, as such, is responsible for collecting the health data and blood serum sam ples o f C8 Health P roject participants ("Specimens''); ' W HEREAS, UHA is the Faculty Practice Plan o f the faculty physicians o f the W est V irginia University School o f M edicine ("WVU") which School o f Medicine includes a University-based Pathology Departm ent, providing Pathology services through UHA and conducting biomedical research; ' W HEREAS, UHA, in conjunction with the WVU Pathology Departm ent and other researchers affiEated w ith the WVU H ealth Sciences Center, maintain a WVU Tissue A rchival Bank, to support W VU--hacd mM irai nemarrh program; W HEREAS, Brookmar d e n e s to store and preserve the Specimens at the UHA D epartm ent o f Pathology Tissue Bank repository in accordance w ith th e term s and conditions set forth herein; and W HEREAS, the activities contem plated by this Agreement are consistent w ith the m ission o f UHA to support WVU. NOW THEREFORE, in consideration o f foe foregoing, o f the m utual covenants contained herein, foe parties intending to be legally bound hereby agree as follows; 1511503.! f a m - r 'V _ A R T IC L E 1____________ p a t h o l o g y s e r v ic e s a n d f e e s 11 Pflthftlngy Services The Pathology Services w ill include: l) the storage and m a m te n ^ r o f th e ^ e ^ e n s in 3ml vials at -8 0 degrees C in th e UHA Department of Pathology Tissue Bank repository, in such amounts and at such tim es as are requested by B rookm ar and mutually agreed upon by th e parties, 2) maintenance o f inventory data related to the Specimens in accordance w ith the reasonable needs and- requirem ents of Brookm ar, 3) distribution and final (fispositkm o f the Specimens in accordance w ith the follow ing: (a) ttw jiiests P urine th e Term (defined bekaw) o f this Agreement, UHA may make th e Specimens available for valid and reasonable research purposes and <;V,a'i evaluate all such requests in accordance w ith the protocols and procedures o f UHA as {H '-n V 't in Exhibit A, attached hereto, provided that consideration and priority shall be given to projects that demonstrate a benefit to the class members o f that certain class action law suit entitled Leach, etaLv.E. I. DuPont De Nemours & Co., Civil Action No. 01-C-608 (Circuit Court o f W ood County, W est Virginia). (b) Science Panel Research Requests. In evaluating and gnmting research requests upon the Specimens under section 1.1(a), UHA shall give priority to research requests from Dr, Kyfe Steenland, Dr. Tony Fletcher, and Dr. David A. Savhz (collectively, the "Science Panel") made during the Term o f this Agreement i f and ynly if each o f th e following circumstances apply: 0 ) the Panel's use o f th e requested Specimens is accessary to fulfill its responsibilities under th e court-approved settlem ent agreement in the I* action lawsuit Leach, etaLv.E. I. DuPontDe Nemours & Co., Civil Action No. 01-C-608 (C ircuit C ourt o f W ood County, W est Virginia), figi (ii) UHA in its sole discretion, either (A) that the Science Panel can not reasonably obtain a new serum sample from a C8 H ealth Project participant whose serum sample is requested 1 (B) that the Science Panel presents a r-nmjvffing need to perform a new test o r assay on the Specimens, and (iii) uo individual sample o f the requested Specimens shall be depleted below six hundred microBters (600 pL). (c) Conditions to Granting Research Requests. In the event a research request is granted in accordance with either sections 1.1(a) or 1.1(b), each o f the following conditions hw be first satisfied: (1) Four hundred m icroliters (400 pL) o f each individual sample o f the Specim ens shall be aliquotted into two separate containers, each containing two hundred m icroliters (200 pL), and immediately restored. Such portion shall not be made available 2 IS18503.1 for m y research purpose for and during th e Term o f this Agreement, and Brookmar aad/or HPA m ay request foe return o f such portion at any tim e during foe Term o f this A greem ent fo r any reason and at their sole discretion. (2) Any portion o f each individual sample o f th e Specimens remaining after complying w ith section 1.1(c)(1) snd distributing requested amounts for approved research request under sections 1.1(a) or 1.1(b) shall be aSquottcd into separate containers each containing no more than tw o hundred nricroliters (200 jiL) and im mediately restored. . (3) AD fees and expenses associated w ith retrieving the Specimens and aliquotting and restoring the Specimens as required by this section 1.1(c) shall be either borne by UHA o r collected in advance as a condition for granting such research requests m ade pursuant to sections 1.1(a) or 1.1(b). (4) UHA shah make reasonable efforts to consult w ith A rthur A M aher and/or A. Paul Brooks, Jr., M.D. m its evaluation ofrescarch requests presented by th e Science P anel (d) D isposition at End n f Term A t the term ination o f the Term o f this A greem ent, and w ithout regard to foe priority described in section 1.1(b) o r the retention requirem ents o f 1.1(c), UHA may make the Specimens available for valid am i reasonable research purposes and shall evaluate all such requests in accordance w ith the protocols and procedures o f UHA, or, m ils discretion, seek funding for additional storage services. 1.2 Patient rn n fidm tnilitv and Pm/urv. Brookmar hereby agrees to abide by H1PAA and ah other applicable regulations in th e course o f its access to the Pathology services described by this Agreem ent and to enter into a Business Associate Agreement with UHA as prescribed by HIPAA.. 1.3 Status o f WVU Tissue Rav Nothing in tile agreem ent shall be construed to encum ber in any w ay the.WVU Tissue Bank, or the sole authority by w hich it shall be operated, by the W VU Pathology D epartm ent 1.4 Fee. For th e services described above, UHA d u ll invoice Brookm ar once upon th e parties execution o f this Agreement in an amount equal to Three Hundred ThirtyTbree Thousand, Six Hundred Dollars ($333,600.00). This charge is not for foe Specim ens them selves, but reflects foe costs o f collecting, handling, preparing and/or storing the specim ens in accordance w ith foe reasonable detailed requirements o f Brookm ar. Brookm ar and HPA shall be responsible for providing storage containers and delivery o f th e Specim ens to the UHA Departm ent o fPathology Tissue Bank Repository. 1513503.1 3 A RTIC LE 2 REPRESENTATIONS AND W ARRANTIES 2.1 Rgprt-RentmioM o f Bronlrmar Brookmar repreacms and w arrants that die Specim ens or any other tissue or cell m aterials obtained from C8 Health Project p prtifipanf and related information provided via the Specimens under this Agreement have been obtained by obtaining w ritten, informed consent from such participants, using an inform ed consent form that is in m aterial compliance w ith all applicable local, state and federal law s and regulations regarding tire collection, storage, transfer, use and disposal o f human tissues. 2.2 TW hmrwr NEITHER PARTY MAKES ANY OTHER WARRANTY OF ANY KIND WHATSOVER, EXPRESS OR IM PLIED, AND ALL IM PLIED WARRANTIES, INCLUDING THE WARRANTY O F FITNESS FOR A PARTICULAR USE OR PURPOSE AND THE WARRANTY O F MERCHANTABILITY, ARE HEREBY DISCLAIM ED BY THE PARTIES AND EXCLUDED FROM THIS AGREEMENT. A RTIC LE 3 LIM ITA TIO N ON LIABILITY N EITH ER PARTY SHALL BE LIABLE TO THE OTHER PARTY HEREUNDER FOR ANY INDIRECT, INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES. A RTICLE 4 TERM AND TERM INATION 4.1 T i m This Agreement hn commence as o f tire Effective D ate and shall lYinrimw in & n force, and for five (I ) years from the Effective D ate or th e date o f delivery o f th e Specimens to UHA, if later (the Term). At th e cod o f the T am , this Agreement shall terminate. A R TIC LES M ISCELLANEOUS 5.1 RrintiniwMp o f the Parties. N othing in this Agreement is intended or shall be flrmrA to constitute a partnership, agency or joint venture relationship between the parties hereto. 5.2 Applicable Tm This Agreement hail be governed by the law s o f the State o f W est V irginia, w ithout giving effect to th e choice or conflict o f laws rules or principles o f 131S5M.1 . 4' p. 18 th e S tate o f W est Virginia o r o f any other jurisdiction and shall have th e effect o f a sealed instrument, 5.3 C ounterparts. This Agreement may be executed in any num ber o f counterparts, each o f w hich shall constitute an original and all o f which together shall constitute one and th e sam e agreem ent. - 5.4 N otices. Any notice, approval, or consent required under this Agreement shall be in w riting and shall be considered given when (1) delivered personally, o r (2) mailed by registered o r certified mail, return receipt requested or (3) received by facsimile w ith a confirm ing copy sent by overnight m ail o r courier service, return receipt requested, to the parties a t th e addresses indicated bolow (o r to such other party o r at such other address as a party may specify if by notice to th e other pursuant hereto). N otice given by a party's counsel shall be considered notice given by th party. (a) If to UHA: University H ealth Associates P.O . Box 0897 M organtown, WV 26507-0897 W ith a copy to: Departm ent o f Pathology Robert C Byrd H ealth Sciences Center W est V irginia University M organtown, WV 26506-9203 A ttention: Barbara Ducatman, MD, Chairman Facsimile: (304) 293-6249 (b) if to HPA: R obert G. Astorg, CPA, C8 H ealth Project A dm inistrator Suite 9000UNB, 501 Avery Street, Parkersburg, WV 26101 Facsimile: (304) 422-6254 (c) IftoB rookm an Brookmar, Inc. 417 G rand Park D rive Suite 201 Vienna, WV 26105 A ttention: A rthur M aher 1318503.1 5 With a copy to: Richard A. Hudson, Esq. Bowles Rice McDavid Graff & Love, LLP P.O .B ox 49 Parkersburg, WV 26102 Facsimile:. (304)-420-5587 5.5 Force M aieure. If aqy circumstance beyond the reasonable control o f either party occurs which delays o r renders impossible the performance o f drat party's obligations nnHw this Agreement as herein provided, such obligations shall be postponed for such time, as such performance necessarily has had to be suspended or delayed on account th ereo f provided such party shall notify the other party in writing as soon as practicable, but in no event m ore than thirty (30) days after the occurrence o f such force majeure. In such event, d ie parties hall meet promptly to determine an equitable solution to the o f any such event, provided dial such party who fails because o f farce m ajeure to perform its obligation hereunder shall upon the cessation o f the force m ajeure take all reasonable stops w ithin its power to resume with die least possible delay compliance w ith its obligations. Events o f force nugeure shall include, without limitation, w ar, revolution, invasion, insurrection, riots, mob violence, sabotage or other civil disorders, acts o f God, lim itations im posed by exchange o f control regulations or rules o f any government or governm ental agency, and any inonfinate and unanticipated delays in th e regulatory review o r governm ental approval process that are.within the control o f such government o r governm ental agency. 5.6 F-ntire Agreement. The tenns and conditions herein contained constitute the entire agreem ent between the parties relating to the subject m atter o f this Agreement and ghyii supercede all previous communications between die parties w ith respect to the subject m atter o f this Agreement. N either party has entered into this Agreement in reliance upon any representation, warranty, covenants or undertaking o f the other party that is n o t set out or referred to in this Agreement 5.7 Anmndmftnt This Agreement may be only by a w ritten document signed and properly authorized by each o fth e parties hereto. 5.8 Severabilitv. If any provision o f this Agreement shall be deemed invalid or unenforceable, the balance o f this Agreement shah remain in effect and if any provision shall be deemed inapplicable to any person or circumstances it shah nevertheless be construed to appty to 1 other persons and circumstances. 5.9 N o W aiver o f Rights. No failure o r delay on the part o f cither party in exercise o f any pow er or right hereunder hall operate as a waiver thereof No single or partial exercise o f any right or power hereunder shall operate as a waiver o f such right or o f any other right or power. The waiver by either party o f a breach o f any provision o f this Agreement <*11 not operate or be construed as a waiver o f any other or subsequent breach hereunder. . 6 151*503.1 5.10 T hird Party Kipht The term s and provisions o f this Agreem ent are intended to or shall b e fo r the benefit o f the class members o f that certain class action law suit nptitfat Leach, et dL v. E. J. DuPont De Nemours & Co., Civil A ction N o. 01-C-608 (Circuit C ourt o f W ood County, W est V irginia) and the Science Panel, o r their authorized representatives. 5.11 Bmdmp Terms. This Agreement and the terms and provisions h ereo f shall inure to die benefit o f and be landing upon die parties hereto and their legal representatives, successors and assigns. IN W ITNESS W H EREO F, die parties hereto have caused th d r duly authorized representatives to execute this Agreement on b eh alfo f th e parties as o f the date appearing at th e beginning o f das Agreement. WEST VIRGINIA UNIVERSITY MEDICAL CORPORATION d/b/a UNIVERSITY HEALTH ASSOCIATES Tide Jeffrey L. N eely, M.D. President and CEO Ro b e r t o . a s t o r g , c p a . H eath Project A dm inistrator o f th e C8 Health Project Designated Settlem ent Fond T itle ___ P'iA.JtM. IS 1U 01.I 7 ExhibitA H A Protocol M d F roctdprgs Categories and Procedures: Exempt, Expedited and Quorum Review - WVUIRB Guideli... Page] of 8 tiu m aty& g yg jte Chapter II Categories and Procedures: Exempt, Expedited and Quorum Review Ail research falls into one of the following three categories: Exem pt from Board Review (see Section At Expedited Review fsaa Section B) Quorum Review (see Section C) C ase Studies and Oral Histories (see Raritan n ) Protected populations have additional requirements (see Chapter V i) All w itte n communication with subjects must display a signed and dated IRB approval stamp. A. Exempt Research "Exem pt research" is research ttiat does not require expedited or quotum review by the Board although It does require an "exemption approval." (S ee below .) I. Criteria for Exemption from Board Review A project is exem pt if a ll the research activities belong in one or more o f the following categories: 1. Research conducted in established or commonly accepted educational settings, involving norm al educationalpractices, 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 erf educational tests (cognitive, diagnostic, aptitude, achievem ent), surveys o r interviews, o r observation o f public behavior, unless a. Information obtained is recorded in such a m anner that human subjects can be identified, directly or through identifiers (see httoV/www.wvu,edu/-fc/irtrflrfa ould/bhi iden htm ) linked to the subjects; and b. any disclosure of the human subjects' responses (or conduct) outside the research m ay place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. (If this is suspected, the study will be subject to quorum review). Som e additional institutional restrictions apply: Research involving the use of educational tests (cognitive, diagnostic, aptitude. filK//C:\Documarts and Settin*iVbrijdld\LocaI Settmgs\Temp\Brookmar WVU IRB Quid... 4/14/2006 Categories and Procedures: Exempt, Expedited and Quoram Review - WVU K B Guidcli... Page 2 of 8 achievem ent) may be exem pt only if none of the investigator's own current students are subjects. (In these cases, if someone other than the investigator has contact with subjects, the study can be exem pt) Research involving observation o f public behaviorw ill be exem pt only if a] toe subject's responses do not deal with sensitive aspecto of personal behavior (for exam ple, illegal conduct drug use, sexual behavior or use of alcohol), and b) foe investigator does not participate in the activities being observed. Research involving surveys o r interviews will be exem pt only if a] the subject's responses do not deal with sensitive aspects o f personal behavior (for exam ple, illegal conduct drug use, sexual behavior or use of alcohol), and b] in case o f electronic surveys, they must have the technology integrated in them that erases the return address (a letter from IT is required). W ebCT surveys will not require such a letter. 3 . Research involving foe use of educational tests (cognitive, diagnostic, aptitude achievem ent), survey procedures, interview procedures, o r observation o fpublic behavior that is not exempt under 2(b), if. a. the hum an subjects are elected o r appointed public officials o r candidates for public office. (Public officials are defined as those individuis elected or appointed to local, state or federal office.); 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 e x is tin g data b y re tro s p e c tiv e review -- including documents, records, pathological specimens or diagnostic specimens--if a. these sources are publicly available, or b. the Information is recorded by foe investigator in such a m anner that human subjects cannot be identified, directly or through Identifiers linked to the subjects. Som e additional institutional restrictions apply: The above exemption applies if the investigator only gathers those data that exist prior to the date of IRB approval (e.g.. if foe protocol is approved on M ay 1.2 003 . the researcher m ay collect data that existed prior to that date; the researcher must not collect data that are created in foe 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 exem ption must always include a data collection sheet (that itemizes all variables th at will be collected from foe records/spedm ens to be reviewed). 5. Research and demonstration projects that are conducted by or subject to foe approval of (federal] departm ent or agency heads, and that are designed to study, evaluate, or otherwise exam ine: a. public benefit or service programs; b. procedures for obtaining benefits or services under these programs; c. possible changes in or alternatives to foese programs or procedures; or d. possible changes in methods or levels of payment for benefits or services under these programs. 6. Research Involving only taste and food quality evaluations and consum er acceptance studies. a. if wholesom e foods without additives are consumed or file://C:\Docoments and SettingsVbrisdUNLocal SettmgsYTanp\Brookmar WVU IRB Guid... 4/14/2006 Categories and Procedures: Exempt, Expedited and Quorum Review - W VUIRB Guideii... Page 3 of 8 b. Notes: if a food is consumed that contains a food ingredient a t or below the level and use found to be safe, or agricultural chemical or environmental contaminant a t or below the level found to be safe, by foe Food and Drug Administration or approved by foe Environmental Protection Agency or foe Food Safety and Inspection Service of foe U .S . Department o f A piculture. If a consent form is used, the protocol cannot qualify for exem ption. A ny research in which the subjects are filmed or videotaped cannot qualify as exempt and m ust undergo expedited or quorum review. Focus group studies are not exem pt. It. E xe m p t R esearch Involving C h ildren Children can be subjects o f exem pt research unless: a) it involves surveys or interviews; or b) it com es under the provisions o f categories 5 or 6. S e e V I.A for m ore information about research involving children. HI. P ro ced u res fo r Exem pt R esearch a. Exem ption Procedures for Investigators If a study is eligible for exemption, a written approval must be obtained from foe IRB staff or school o r college (see below) before beginning any research activities involving human subjects. (S ee Appendix C for foe Application for Exemption.*- view as HTM L) T h e following schools and colleges have approved exemption policies and procedures: Arts & Sciences Business & Economics D entistry Extension Human Resources & Education Journalism M edicine Nursing PhysicalEducation If a school or college does not appear in the above list, submit an "Application for Exemption" to the IR B staff. This list is subject to change; please check with the IRB staff. b. Exem ption Procedures fo r Schools and Colleges Each school or college within foe university may develop its own polities and procedures governing exem pt research. The Board must approve these policies and procedures before th ey can becom e effective and m ust also review and approve an y proposed revisions. Schools and colleges with approved exemption policies are responsible for ensuring that the population serving as subjects of the research and foe nature of the data to be collected are eligible fo r exemption and also that the methods of data collection and storage are in accordance with IRB guidelines. A t the end of each calendar quarter (end of March, June, Septem ber and December), the school or college must submit to the IRB a list of all exempt research approved during the file://C:\Doeunenls and SemngsVbriselldVLocal Stttmgs\Temp\Brookmar WVU IRB Quid... 4/14/2006 Categories and Procedures: Exempt, Expedited and Quonim Review - WVUIRB G riddL . Page 4 of 8 preceding quarter. The list will indude the principal investigator's name and department the title 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, conduct further 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 bv 45 C FR 46.110 and 21 C F R 5 6 .1 10. ` 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 exam inations or tests. I. Research Eligible for Expedited Review Research Is eligible for expedited review if all of the research activities are minimal risk and belong in one or m ore of the following categories. The categories in this list apply regardless of the age o f 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 per week; 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 m ay not exceed the lesser of 50 ml (about 3 and a ttird Tbs) or 3 ml per kg in an 8-w eek period and collection may not occur more frequently than 2 times per w eek. 2. Prospective collection of biological specimens for research purposes by noninvasive m eans. Examples: a. hair and nail clippings in a nondisfiguring manner; b. deciduous teeth at tim e of exfoliation or if routine patient care indicates a need for extraction; c. perm anent teeth if routine patient care indicates a need for extraction; d. excreta and external secretions (including sweat); e. uncannulated saliva collected eltherm an unstlmuiated fashion or stimulated by chewing gum base or w ax or by applying a dilute citric solution to the tongue; f. placenta removed at delivery; g. am nlotlc fluid obtained at the time of rupture of the membrane prior to or during labor h. supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; I- mucosal and skin cells collected by buocal scraping or swab, skin swab, or mouth filcy/C:\Documeots and Scttings\briselld\Local SetringsVTeaqABrookmar WVU IRB G rid... 4/14/2006 Categories and Procedures: Exempt, Expedited and Quorum Review - WVUIRB G niddi... Page 5 of 8 w ashing s; 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 m icrowaves. W here m edical devices are employed, they must be cleared/approved for m arketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligfcle for expedited review, including studies o f approved m edical devices for new indications.) Examples: a . physical sensors that are applied either to th surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of th e subject's privacy; b. weighing or testing sensory acuity; c . m agnetic resonance imaging; d. electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flew , and echocardiography; e. m oderate 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 w ill be collected solely for nonresearch purposes (such as medical treatment or diagnosis). Note: Som e research in this category m ay be exem pt from the HHS listing refers only to research that Is not exem pt.) R eese note that fo r this category, (he protocol application must always include a data collection sheet that item izes all variables that w ill be collected from d ie records/specimens to be reviewed. 5. Collection of data from voice, video, digital, or im age recordings m ade 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 employing survey, interview, oral history, 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 subject's behavior, and b. the research will not involve stress* to the subject, and c. the research will not involve deception* of the subject. Note: Som e research In this category may be exem pt from the HHS regulations for the protection o f human subjects 45 C FR 46.101(b)(2) and (bX3). This listing refers only to research that is not exem pt 7. Continuing review of research previously approved by the convened IR B as follows: a. w here i] the research is permanently dosed to the enrollm ent of new subjects; ii] ell subjects have completed alt research-related interventions; til] and the research rem ains active only for long-term follow-up of subjects; or b. w here no subjects have been enrolled and no additional risks have been identified; or filoe//C:\Documeas and Settings\bmelld\Local Sings\Temp\Broolmar WVU IRB Guid... 4/14/2006 Categories and Procedures: Exempt, Expedited and Quorum Review - WVUIRB Guidefi... Page 6 of 8 c. w here the remaining research activities are limited to data analysis. * M an ip u latio n The investigator attempts to change the subject's psychological or physical functioning. * S tress Situations in which the demands on individuals tax or exceed their resources, with a potential to endanger well being or health, or w ch Involve questions about stressful life events. * D ecep tio n Procedures that conceal or mislead subjects about the true purpose of a study. All research eligible for expedited review requires informed consent {see Chapter v ) unless the IRB grants a waiver. it. P ro ced u res Required fo r E xpedited Review T h e form at and content of a protocol are described in Chapter ill and are the same for both expedited and quorum review .The IRB staff screens all protocols for compliance with the required form at, necessary signatures and inclusion of consent and assent forms. The staff then sends the protocol to one or two reviewers. Protocols m ay be submitted a t any time for this type of review. Investigators m ust have an official, written approval letter from the IRB before enrolling subjects in foe study. AH consent form s, letters, HIPAA authorization forms or waivers of authorization (as appropriate) and recruitm ent ads to be used must have a signed official approval stamp. The approval is valid fo r a maximum of one year; if not reapproved by the anniversary date, the protocol will be closed. Note that approval of an addendum does n o t constitute re-approval fo r another year. No consent documents (consent forms/assent forms/cover lettens/ads/HIPAA forms) may be used after fo e expiration date indicated on the stamp. III. R esu lts o f Expedited R eview R eview ers) may: Approve foe protocol. Require changes for approval under expedited review (changes must be m ade within 60 calendar days). Refer foe protocol for quorum review. Review ers m ay not disapprove a protocol or amendment. Any protocol foat does not fall in one of the above categories, wBI 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. filei//C;VDocumems and SettmgsVbriselldVLocal SettmgsYTemp\Brookmar WVU IRB Quid... 4/14/2006 Categories and Procedures: Exempt, Expedited and Quorum Review - WVUIRB Qrndefi... Page 7 of 8 1. Criteria for Quorum Review Quorum review is necessary fo r research involving risk of physical or psychological harm greater than that encountered in daSy life or during routine examinations or tests; research involving deception, stress or manipulation also requires quorum review. Any research that does not satisfy the requirements for exemption or expedited review will undergo auorum review . A humanitarian device exemption (HDE) is an exemption that the FDA grants to companies that allows teem to m arket and use their device In medical practice. The devices can be used only fo rth e indication listed in the HD E. In order for an investigator to use a device indicated io n n*2 D E ' 3 c0Jnpitecl protocol and appropriate company literature must be submitted to the IRB for approval. After IRB approval, the Investigator must submit a summ ary of each use of toe device and any adverse events to toe IRB as they occur. If the investigator is not planning to obtain data for publication and/or research, a consent form is not required. 9 It. Procedures Required for Quorum-Review Protocols requiring quorum review will be reviewed a t regularly scheduled IRB meetings These occur on the 2nd and 4th W ednesdays of each month /M eeting dates and snhmic'ciTM deadlines). In order for a protocol to be considered, submit to ^ rig ira lp lu s eighteencopies of all prepared m aterial (includes protocol statem ent abstract, consent and assent fo rm s -if applicable, discussion, and attachments) and the original plus two copies of ail material provided by a sponsor (this could include a protocol prepared by toe sponsor, addendum m aterial, investigator brochure, IND safety reports, etc.), if this is sponsored research All m aterial must reach toe compliance office by the deadline date, in the case of amendments w iflb e fo lto iS ? Chan9flS fBqUirin9 qUOrUm revlew (See A) the sam e rules Before a protocol can be placed on toe agenda, the IRB staff screens ft for compliance with toe required format, necessary signatures and inclusion of consent and assent forms. If m to d P d baaito information win be collected, appropriate HIPAA documents must be submitted For information on preparing a protocol, see Chanter 111. ' Hi. R esu lts o f Q uorum R eview At its convened meeting toe Board may: Approve toe protocol as submitted. Require modifications or request additional information (must be received within 60 calendar days). For modified consent or assent forms, a new submission date must botton?Jeft of each page. Depending on toe nature of the information, a subcommittee or an IRB staff member wiB review toe material Approvals by T,USt unanimous or toe protocol wHI be referred to the next regularly scneduled Board m eeting. 1 Invite investigators) to attend next meeting to address concerns. Disapprove toe protocol. If disapproved, all signatories will receive a copy o f toe disapproval letter (including all co-PIs, deans, and chairs). 1 Investigators must have an official, written approval latter from toe IRB before enrolling fiIe:/7C:\Documents and Settings\briseUd\Loca] Settings\Temp\Brookmar WVU IRB Quid.., 4/14/2006 Categories and Procedures: Exempt, Expedited and Quorum Review - W VUIRB Guideli... Page 8 of 8 subjects in toe study. All consent forms, letters, H1PAA forms (if required), and recruitment ads m ust have an official, signed approval stamp. The initial approval is valid fo r a maximum of one year; if not reapproved by toe anniversary date, the protocol will b e closed. Note that approval of an addendum does n o t constitute reapproval far another year. The board may decide (on a case-by-case basis, based primarily on toe risk/beneflt analysis o f the study) that a protocol requires reapprovai more often than once a year, tf toe Board disapproves a protocol, any resubmittal must be accompanied by a new "Protocol Statem ent.* (view as HTML1 including all appropriate signatures. Investigators m ay invoke toe appeal procedures outlined In Chapter X I if a protocol is not approved. D. Policy on "Case Studies" and "Oral Histories" C ase 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 to e form of G rand rounds or discussed with students as part o f an educational experience. O ccasionally case studies are presented at scientific meetings and may be published in m edical journals. O ral 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 form at. Both of these activities are important, but neither, in m ost instances, m eets the definitions of human subject research. Research is defined by the regulations as "a system atic Investigation, including research development, testing and evaluation, designed to develop or contribute to gen eralizare knowledge*. In most instances, case studies and oral histories do not m eet this definition and do not qualify as research. Therefore they do not require if approval. However, it must be pointed out that there are instances in which case studies or oral histories do satisfy toe above definition of research and would require IRB approval, if there are questions about a particular study and whether IRB approval is necessary, the W VU Office o f Research Compliance should be contacted- TN s page m aliifelntf by t a Q ftc* of R s tttrc h CooipBanca Qoorioita and/or com m nia; QRCwab Last MetflfM; Ape. 7.2006 file://C:\DocumLts and Settings\briseUd\Local Settings\Temp'J3rookmar WVU IRB Gmd... 4/14/2006 p. 30 West Virginia University Tissue Bank Release of Tissue Policy Upon request for tissue sam ples from a researcher, the following forms must be submitted to th e Tissue Bank before the sam ples are released: IR B approval cover letter Copy of the approved protocol Completed ` Appfication fo r Participation in the W est Virginia University Tissue Bank* Signed 'Agreem ent Lim iting Tissue Use and Transfer* In addition, the W est Virginia University Tissue Bank is in accordance with the tissue policies stated in the W VU IRB G uidelines, Appendix F: ill. Guidelines for Approval of Protocols Using Tissue Banking: A . Placem ent of human tissue into a bank for research purposes Human tissue, accom panied by a copy o f an approved consent agreem ent signed by tire donor, can be placed into an approved tissue bank fo r unspecified research purposes. Human tissue can be deposited: (1) as part of an IRB approved protocol, (2) following standard operating or delivery room procedures. (3) following standard diagnostic and treatm ent procedures (e .g ., dental tractio n , collection of bodily fluids), and (4) from a non-affiliated institution th at conforms to comparable standards for the protection of human subjects. 1. A pproved Protocol. If human tissue is to be placed into a bank as part of an approved protocol for unspecified research purposes o fiier than th at outlined in that protocol, a separate consent form obtaining approval of the donor must be obtained (See sample form 6: Consent Form for the Collection o f Human Tissue for Research Purposes!. 2 . Operating o r D elivery Room. If human tissue 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 (S ee sample form 5: Suroical/Clinical Consent Form for foe Collection of Human Tissue for Research BtiSSSSS)- 3. Standard Diagnostic and Treatm ent Procedures, if tissue obtained for purposes of standard medical or dental diagnostic and treatm ent (nonresearch) procedures is to be placed Into a bank for potential research purposes, a separate consent form must be approved by the IRB fo r 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: Surqical/Clinical Consent Form for the Collection of Human Tissue for 1 4 . Tissue A cqu'red from a NonaffBlated Institution. If human tissue is acquired from an institution, laboratory, or company not affiliated with W est Virginia Unhreraity for the purpose of tissue banking for research, the tissue must be accompanied by an approved consent agreem ent signed by the tissue donor. The approved consent agreem ent 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 confidentiality is maintained, that tissue can be used with subject identification with additional consent, and that financial considerations regarding the cost and potential financial advantage to institutions are enum erated. If CO RE (Center fo r O rgan Recovery and Education) is involved, their consent form may be substituted. B. Rem oval o f human tissue from a bank for research purposes Hum an 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 S ia E t e r jr of the IRB Guidelines. 1. E xem pt Research. If human tissue is removed from a bank fo r research purposes and the information is provided to the investigator in such a m anner that human subjects cannot b e identified, directly or through identifiers linked to the subjects the research project qualifies as "exempt research." The investigator should follow toe procedures for Exempt Research fChapter II. section A.3V 2 . Expedited o r Quorum Review. If human tissue is removed from a bank for research purposes and information is provided to toe investigator in such a manner that human subjects can be or are Identified, the research project must follow the procedures for Expedited R eview (Section 6.21 or Quorum Review (Section C 9V 3 . Tissue Sent to a N onafSiated Institution, tf human tissue is removed from an approved bank a t W est Virginia University and sent to an institution, laboratory, or company not affiliated with W est Virginia University for purposes of research, the investigator must conform to the IR B Guidelines for the Protection of Human Subjects by obtaining approval through exem pt research or expedited review as outlined above.* **Chapter II o f the IRB Guidelines is attached in a separate document 2 Application for Participationin the WestVirginia University Tissue Baltic p. 32 DepL c fPatktloo Shipping addrwc 1 tP tfIN t______________________________________________________ on# tfinptffpfeebptfpipftrnspt________________________ s n s i p i B iwiwn< iye p'SMta r itts a ia M w m i eia-- im M ieiasw i 01 nptfibniP nM feim S.krtk.iiM t. Id ifeptfkr-- w ssd w--itP fti P U M nrb.prtffeM iiP b ii dferIP n S P tP * p 8feal-- fc V ittrtMpMtfpferinipMULfeMPiPPtflk n ilPMTl.________________________________________________ u fc iw m s s m itfi*i> ia s iiiiin u iw n -- la a k a -- n ip T y _______ * t ________ I adrtod tb* ra iu mnd far tttt WVO Titnie Bank tnd tree to complywitli the {nidclinM u itatod by the IBB. laiidentcnd that appM vtl la rn b jtct to ]*wr{f r*nev?*l AmwWSwof tfMn u m vh t cannot batfn --m n> a obfrbod. M n rp S # :.________________________________________ ___ ISM tfIB nm * ltfP tafeb ^ rtp ,M trP ltflrT P S K M p p tfiP rfeM d p M p rn rS rtb rte iw C T M L M t i>>Pn.M iii fibw iC b .tfm w > s a M iiii .w iB m .a p n M O n ra M H . mi..... mu mm rt-inrnmm-- ... .....-- i------------- ------------------ n i ------ p is iip p rn M tn tn itfp tfir tfitiiiiw B tiiiin * .AnptfyrpS#: