The ACTG does not require the disclosure of travel expenses; investigators who disclose only to the ACTG network do not need to report this item.

Transcription

1 AIDS CLINICAL TRIALS GROUP (ACTG) Netwrk Standard Operating Prcedure Title ACTG Netwrk-Specific Financial Disclsure and Cnflict f Interest Prcedures SOP number ACTG-107 Effective: 01/23/2013 Versin 10.0 Last reviewed: 04/27/2014 Originatr ACTG Netwrk Crdinating Center Page 1 f 2 This preface prvides netwrk-specific infrmatin t accmpany the NIAID (DAIDS)- Supprted and/r Spnsred HIV/AIDS Clinical Trials Netwrks Financial Disclsure and Cnflict f Interest Guidelines, frm the Office f HIV/AIDS Netwrk Crdinatin (HANC). That dcument fllws this preface. Reprtable interests: The ACTG des nt require the disclsure f travel expenses; investigatrs wh disclse nly t the ACTG netwrk d nt need t reprt this item. Netwrk members required t disclse financial interests: Members f the ACTG Executive Cmmittee (AEC); Scientific Agenda Steering Cmmittee, Transfrmative Science Grups (TSGs) and Cllabrative Science Grups (CSGs); Wmen's Health Internetwrk Scientific Cmmittee (WHISC); and the TSG, CSG, and Scientific Cmmittees Study Mnitring Cmmittees. Nte that Cmmunity Scientific Subcmmittee representatives t these cmmittees are nt required t disclse financial interests. Prtcl team members serving in the rles f chair, c-chair, vice chair, c-vice chair, pharmaclgist, immunlgist, virlgist, statistician, clinical trials specialist, and data manager. Specialty labratry directrs. Identificatin and management f cnflicts r ptential cnflicts: Fllwing the annual slicitatin fr financial disclsure (FD), the netwrk Financial Disclsure Crdinatr (FDC) will prvide the AEC Cnflict f Interest Subcmmittee (AECCOI) with a reprt f members wh disclsed significant financial interests (SFIs) and fr whm there might be a ptential cnflict n current cmmittees r prtcl teams. The AECCOI will determine whether a cnflict r ptential cnflict exists and at what level. The ACTG recgnizes three levels f SFI: Aggregate sums between $5,001 and $15,000 annually. Aggregate sums between $15,001 and $25,000 annually. Aggregate sums ver $25,000 annually. When SFIs have been identified and graded, the FDC, n behalf f the AECCOI, will then ntify the netwrk member in questin f an apprpriate management plan:

2 ACTG SOP ACTG-107, Netwrk-Specific Financial Disclsure and Cnflict f Interest Prcedures Versin 10.0, 01/23/2013 Page 2 f 2 Members with a relatinship in the $5,001 t $15,000 range must disclse that relatinship prir t any discussin related t a study that includes the cnflicted cmpany s prduct. Once that disclsure has been nted, the member may participate in prtcl, scientific cmmittee, r leadership discussins and decisins. Members with a relatinship in the $15,001 t $25,000 range must disclse that relatinship prir t any discussin related t a study that includes the cnflicted cmpany s prduct. Once that disclsure has been nted, the member may participate in prtcl, scientific cmmittee, r leadership discussins but may nt vte n decisins. Relatinships that exceed $25,000 cnstitute a cnflict and must be reduced belw the $25,000 level in rder fr there t be cntinued participatin n a cmmittee r a prtcl team; eliminatin r reductin f an SFI is always an acceptable ptin. The FDC will frward t the relevant scientific cmmittee crdinatr a list f that cmmittee s members with SFIs and the cmpanies invlved, fr psting at the cmmittee s restricted grup-specific prtal. Cmmittee members will have access nly t their cmmittee s list; the lists will nt be generally available. Respnsibilities f the FDC at the time f prtcl team frmatin: In the case f netwrk members with a current FD: Prvide the team chairs with a list f relevant members (cf. 2.2, belw) wh have an SFI with any entities whse drugs, devices, r bilgic prducts are included in the study. Institute the apprpriate level f SFI management, as indicated abve. In the case f relevant team members with n current FD: Ntify HANC that an FD statement is required. Perfrm any relevant SFI identificatin and management steps set ut abve. Grievances and arbitratin: If a dispute ver SFI management prves irreslvable by the AEC, parties have recurse t the grievance prcedure utlined in the SOP ACTG-120, Appeal and Grievance.

3 NIH HIV/AIDS CLINICAL TRIALS NETWORKS Financial Disclsure and Cnflict f Interest Guidelines Standard Operating Prcedure Owner HIV/AIDS Netwrk Crdinatin (HANC) Adpted By Versin Histry Versin 5.0 Effective 23 September 2013

4 NIH HIV/AIDS CLINICAL TRIALS NETWORKS Financial Disclsure and Cnflict f Interest Guidelines Standard Operating Prcedure Table f Cntents 1.0 General Principles Definitins Reprtable Interests Other Definitins Respnsibilities Netwrk Members Required t Reprt Under This Plicy Financial Disclsure Crdinatr (FDC) Review Cmmittee Netwrk Operatins Center PHS... 6 APPENDIX A NIH HIV/AIDS Clinical Trial Netwrks Statement f Significant Financial, Equity, and Intellectual Prperty Interests Wrksheet... 7 APPENDIX B Guidelines fr Cmpleting Statement f Financial, Equity, and Intellectual Prperty Interests... 8 APPENDIX C Crss-netwrk Financial Disclsure & Cnflict f Interest Reprting Wrkflw... 9

5 NIH HIV/AIDS CLINICAL TRIALS NETWORKS Financial Disclsure and Cnflict f Interest Guidelines Standard Operating Prcedure 1.0 General Principles Title 42CFR50, Respnsibility f Applicants fr Prmting Objectivity in Research fr Which PHS Funding Is Sught, requires the netwrks t establish and manage a system that ensures the research is nt biased by any cnflicting financial interest. In rder t satisfy this requirement fr the U.S. Public Health Service (PHS), the fllwing guidelines have been develped and are intended t identify significant financial interests f researchers in the NIH HIV/AIDS Clinical Trials Netwrks and avid cnflicts f interest, r the appearance f such cnflicts, in activities f the netwrks. Netwrk members and affiliated investigatrs play many prfessinal rles and it is expected that netwrk members have nn-netwrk prfessinal activities. Such interactins might be viewed as nes that engender cnflicts f interest and/r influence the decisins f members as they relate t the netwrks. This dcument utlines the netwrks' apprach t dealing with financial disclsure and with any real r perceived cnflicts f interest s that they may be managed r eliminated. Submissin f a financial disclsure statement t the netwrk(s) des nt release members frm their institutin's cnflict f interest submissin requirements. Rutine disclsure f significant financial interests by netwrk members will allw mst ptential cnflicts f interest t be addressed by the apprpriate netwrk review cmmittee. Please cntact yur netwrk(s) fr mre infrmatin n the review and reslutin f perceived cnflicts f interest Definitins 2.1 Reprtable Interests Equity Interest "Equity Interest" is defined as any wnership interest in a relevant entity. Members are required t disclse all equity interests in any and all relevant (including nn-publicly traded) entities that, when aggregated with family members hldings, amunt t mre than a five percent wnership interest (excluding wnership f diversified mutual fund shares, unless yu r a family member directly cntrl the investment decisins), r exceed $5,000 annually, per entity determined by fair market value. Intellectual Prperty Interest Intellectual prperty rights with a relevant entity (patents, cpyrights, licensures, and ryalties) 1 NOTE: This SOP des nt address r satisfy FDA Financial Disclsure by Clinical Investigatrs Requirements identified in 21 CFR and 21 CFR which state that the IND/IDE spnsr shall btain sufficient accurate financial infrmatin that will allw an applicant f a marketing applicatin t submit cmplete and accurate certificatin r disclsure statements as required under 21 CFR 54. Members may be required t submit additinal cnflict f interest reprts at the request f an IND hlder. 1 f 9

6 declare nly upn receipt f incme related t such rights and interests, if thse payments, in aggregate with all ther stipulated surces exceed $5,000. Significant Financial Interest Significant Financial Interest means anything f mnetary value frm a relevant entity (e.g., cnsultant fee including lecture/seminar fees; intellectual prperty incme; teaching fees; equipment; gifts; hnraria; travel; direct salary supprt r ther direct benefits frm industry-spnsred research; service grant; cntract; r membership n scientific/clinical advisry bard) frm a public r nnprfit entity that when aggregated fr the netwrk member and family members exceed $5,000 annually. Whether made directly r indirectly, all payments made n behalf f a cmpany (including its agent r cntractr reimbursements) must be cnsidered in determining the aggregated ttal f the mnetary interest in an entity. Title 42CFR50 des nt require the reprting f: Salary, ryalties, ther remuneratin prvided frm the member s institutin t the netwrk member r family member (e.g., salary supprt frm an industry grant r cntract that is given t a netwrk member s institutin and that pays a prtin f his/her salary as cmpensatin fr his/her time and effrt spent n a specific clinical trial r research prject). Anything f mnetary value given t the institutin r t the member exclusively in supprt f research r the clinical trial. Incme frm seminars, lectures, r teaching engagements spnsred by and service n advisry r review panels fr a federal, state, r lcal gvernment agency, an Institutin f higher educatin as defined at 20 U.S.C. 1001(a), an academic teaching hspital, a medical center, r a research institute that is affiliated with an Institutin f higher educatin. Incme frm investment vehicles, such as mutual funds and retirement accunts, as lng as the investigatr des nt directly cntrl the investment decisins made in these vehicles. Stck Optins A stck ptin is an ptin t buy stck in a cmpany at a future date at an agreed price ( strike price ). All stck ptins in relevant entities must be disclsed. 2.2 Other Definitins Cnflict Management Plan A cnflict management plan describes ne r mre actins t manage, reduce, r eliminate a cnflict r ptential cnflict identified by the relevant cmmittee chair. Disclsure Disclsure is the act f reprting all significant financial interests r intellectual prperty rights n a Statement f Financial, Equity, and Intellectual Prperty Interests. Disclsures will be made thrugh the crss-netwrk nline reprting system (fund at Family Member A family member is defined as a spuse r dependent child f a netwrk member required t disclse under this plicy. Grantee Institutin A grantee institutin is defined as the entity r rganizatin that received and manages the NIH HIV/AIDS netwrk clinical trial research funding. 2 f 9

7 Netwrk A netwrk is defined as an affiliated grup f natinal and internatinal medical research institutins and investigatrs supprted and/r spnsred by NIH t cnduct clinical HIV/AIDS research t develp safe and effective drugs, preventin strategies, and HIV vaccines. In the terms f its grant awards, DAIDS has delegated the financial disclsure reprting respnsibilities t the netwrks. The netwrks adhering t this plicy include: the AIDS Clinical Trial Grup (ACTG), the HIV Preventin Trials Netwrk (HPTN), the HIV Vaccine Trials Netwrk (HVTN), ), the Internatinal Maternal Pediatric Adlescent AIDS Clinical Trials Grup (IMPAACT), the Micrbicide Trials Netwrk (MTN), and the Pediatric HIV/AIDS Chrt Study (PHACS). Netwrk Members required t disclse under this plicy The fllwing peple will be asked t submit financial disclsure statements frm each f the six NIH HIV/AIDS Clinical Trials Netwrks: All members f leadership (executive), endpint, and scientific review cmmittees; All members f netwrk study mnitring cmmittees; and/r Prtcl team chairs, c (vice) chairs, and prtcl team members that make direct and significant cntributin t the data r the study as determined by netwrk leadership (e.g., prtcl virlgist, immunlgist, SDMC persnnel, and pharmaclgist). Members f a prtcl team wh d nt have key decisin-making rles are nt required t disclse under this plicy. Neither are industry representatives and federal gvernment emplyees, wh are required t reprt under ther federal guidelines. Ptential Cnflicts f Interest When a netwrk member r family member hlds a significant financial interest, equity interest, stck ptins, r intellectual prperty interest (all as defined abve) in a relevant entity whse prduct r treatment: Is invlved in a netwrk trial; Is being cnsidered fr inclusin in a study; Cmpetes with a prduct r treatment included in a netwrk clinical trial; and/r Will benefit a member vting n a matter and thereby ptentially influence his/her vte. Recusal Recusal is the act f remving neself frm deliberatins r vting n a matter because f a ptential r real cnflict f interest that has been previusly identified by the member and/r relevant review cmmittee chair and that has been fully disclsed and addressed in a cnflict management plan. All recusals shuld be recrded in the relevant summaries f cmmittee and ther grup meetings. Relevant Entity An example f a relevant entity wuld be a cmpany with business interests in pharmaceutical, diagnstic, bilgic, sftware, assay r related prducts engaged in cllabratins with the netwrks. Review Cmmittee Review Cmmittee is the grup(s) charged by each netwrk t cnsider and adjudicate ptential r actual cnflicts f interest. 3 f 9

8 3.0 Respnsibilities 3.1 Netwrk Members Required t Reprt Under This Plicy All netwrk members wh are required t reprt under this plicy must cmplete an nline Statement f Financial, Equity, and Intellectual Prperty Interests (fund at: at least annually, r when jining a prtcl team r cmmittee. The FDC (via the crss-netwrk nline reprting system) will infrm netwrk members required t reprt f the need t submit a new r revised Statement f Financial, Equity, and Intellectual Prperty Interests annually as determined by the netwrks. If there is a significant change in the member s interests in the fllwing year, it is incumbent upn the member t reprt said change t his/her netwrk at the time f the change. Each cmpleted statement shuld cver the previus 12 mnths and present day circumstances. Members new t the netwrk and wh are required t reprt must submit the statement within 60 days f jining the netwrk. Members are bliged t reprt their financial, equity, and intellectual prperty interests until ne year after the cmpletin f the study as defined by DAIDS (i.e.; primary analysis is cmplete, primary manuscript is accepted, and all participants are ff study). Failure t prvide the statement by the stated deadline will result in suspensin f member participatin in cmmittee and prtcl team activities until a statement is received. In the event that a netwrk clinical trials site will discntinue participatin in netwrk-spnsred studies, the financial disclsure plicy will cntinue t apply fr a 12-mnth perid subsequent t the final prtcl visit cmpleted at the site, r until the prtcl database at the netwrk statistical and data management center is fficially lcked, whichever is sner. In the event f a clinical trial staff member being invlved in a manuscript, the netwrk financial disclsure plicy will cntinue fr this member until the manuscript is cmpleted r the staff member n lnger cllabrates n it. It is a netwrk expectatin that members required t disclse under this plicy are taking the apprpriate actins t ensure that they are in cmpliance with the financial disclsure requirements f their hme institutins. Netwrk members are als required t infrm their hme institutins f any ptential r actual cnflict f interest identified by a netwrk review cmmittee. If a ptential cnflict is identified by the netwrk s review cmmittee, the individual must prepare a cnflict management plan describing ne r mre actins t manage, reduce, r eliminate such cnflicts f interest. This management plan shuld include an answer t the questin f whether the individual believes that the significant financial interest pses a cnflict f interest, i.e., will a decisin made by a grup benefit the member vting n a matter and thus ptentially influence his/her vte? The management plan may include, but is nt limited t, the fllwing: Mnitring f research activities by independent reviewers; Mdificatin f the research plan; Disqualificatin frm participatin in all r a prtin f the study(ies); Divestiture f significant financial interests that create actual r ptential cnflicts; Severance f relatinships that create actual r ptential cnflicts; Recusal frm vting n questins r matters invlving prducts f the entity in questin r its direct cmpetitrs. In any case in which it is determined that netwrk-affiliated research whse purpse is t evaluate the safety r effectiveness f a drug, medical device, r treatment has been designed, cnducted, r reprted by a netwrk member with a cnflicting interest that was nt disclsed r managed as required, the member must disclse the cnflicting interest in each public presentatin f the results f the research. 4 f 9

9 If an individual des nt agree with the decisin f the chair(s) f the relevant cmmittees regarding a significant financial interest psing a cnflict f interest which, in turn, requires a cnflict management plan, the individual may appeal the decisin. T d s, the netwrk member shuld refer t his/her respective netwrk(s) plicies and prcedures guide. 3.2 Financial Disclsure Crdinatr (FDC) An FDC will cllect the statements, maintain a database f recrds, and fllw netwrk plicies n managing ptential cnflicts f interests. 3.3 Review Cmmittee Open disclsure is the primary means f managing ptential cnflicts f interest. If the relevant cmmittee(s) are aware f the netwrk members disclsure, degrees f invlvement, and status n teams, actins and/r statements f thse members can be evaluated based n knwledge f the disclsure. A cnflict f interest r perceptin f a cnflict exists when the relevant chair(s) reasnably determines that a significant financial interest culd be perceived as cmprmising bjectivity in the design, cnduct, r reprting f the study. If the relevant chair(s) determines a cnflict r ptential cnflict exists, the chair(s) will request that the netwrk member submit in writing a prpsed cnflict management plan that may be apprved r mdified by the relevant chair(s). The review cmmittee members will cnsider the submitted cnflict management plan and reprt their findings t the relevant Netwrk Operatins Center. 3.4 Netwrk Operatins Center An FDC shall be appinted by the netwrk peratins center t maintain a secure recrd f all Statements f Financial, Equity, and Intellectual Prperty Interests submitted t the peratins center. Database recrds f netwrk members disclsing significant interests by relevant entity will be maintained t assist the relevant cmmittee chair(s) and prtcl chairs t determine whether ptential cnflicts f interest exist. If a cnflict is identified, the netwrk peratins center will dcument and assist in the administratin f the resulting cnflict management plan. The netwrk peratins center and/r grantee institutin will infrm the relevant funding agency chief grants management fficer r chief cntracting fficer, as apprpriate, f the existence f any financial cnflict f interest befre spending any PHS funds awarded under a new award. Cnflicts identified during the award perid will be reprted t the PHS within 60 days f identifying them. The netwrks and/r grantee insititutins will reprt all cnflicts f interest thrugh the nline era Cmmns Mdule. These reprts will indicate whether the cnflict f interest has been managed, reduced, r eliminated. The netwrk peratins center will maintain recrds f all actins taken by the netwrk with respect t each cnflict f interest fr at least three years frm the date f the final expenditure reprt f the grant and make infrmatin available t the Department f Health and Human Services as necessary regarding all cnflicts f interests identified by the netwrk and hw thse cnflicts f interest have been managed, reduced, r eliminated. The netwrk peratins center and/r grantee institutin is required t ensure public accessibility, via a publicly accessible website r written respnse t any requestr within five business days f a request, f infrmatin cncerning any significant financial interest disclsed t the institutin that meets the fllwing three criteria: 5 f 9

10 The significant financial interest was disclsed and is still held by the investigatr; The institutin determines that the significant financial interest is related t the netwrk research; and The institutin determines that the significant financial interest is a financial cnflict f interest. 3.5 PHS The infrmatin t be made public will include, at a minimum: the member s name; the title and rle with respect t the research prject; the name f the entity in which the significant financial interest is held; the nature f the significant financial interest; and the apprximate dllar value f the significant financial interest; r a statement that the interest is ne whse value cannt be readily determined thrugh reference t public prices r ther reasnable measures f fair market value. Infrmatin cncerning the significant financial interests f an individual subject t paragraph will remain available, fr respnses t written requests r fr psting via the netwrk s and/r grantee institutin s publicly accessible website fr at least three years frm the date that the infrmatin was mst recently updated. The netwrk peratins center will maintain cpies f the cnflict management plans apprved by the relevant cmmittees. When PHS staff has cncerns that a cnflict r perceived cnflict f interest may exist, the cncerns and relevant infrmatin will be frwarded t the relevant cmmittee(s) fr determinatin and apprpriate actin. PHS representatives at NIH Divisin f AIDS (DAIDS) will cnsult with the relevant cmmittee(s) abut any general issue r specific prblem that may arise during the curse f any DAIDS-spnsred trial. The Directr f DAIDS r his/her designee may review these guidelines and make apprpriate recmmendatins. An audit f the Financial Disclsure and Cnflict f Interest Prgram f the netwrk (including guidelines, educatin, and implementatin) may be undertaken by DAIDS as part f the perfrmance evaluatin f the grup. 6 f 9

11 APPENDIX A NIH HIV/AIDS Clinical Trial Netwrks Statement f Significant Financial, Equity, and Intellectual Prperty Interests Wrksheet This wrksheet is designed t aid yu as yu prepare t submit yur nline financial disclsure. List belw any relevant entity (cmpany); e.g., pharmaceutical, diagnstic, bilgical, sftware r assay cmpany, in which yu r yur family member(s) have any stck ptins and/r have had/have mre than $5,000 f financial, intellectual prperty, travel, r equity interest, in the 12 mnths prir t the date f this dcument, as defined by the NIH HIV/AIDS Clinical Trial Netwrks Financial Disclsure and Cnflict f Interest Guidelines. If there is a significant change in the member s interests, it is incumbent upn the member t reprt said change t his/her netwrk at the time f the change. Each cmpleted statement shuld cver the previus 12 mnths and present day circumstances. NAME OF ENTITY TYPE OF INTEREST DESCRIPTION OF INTEREST/COMMENTS Stck Optins (Any) Equity Financial Intellectual Prperty Travel Stck Optins (Any) Equity Financial Intellectual Prperty Travel Stck Optins (Any) Equity Financial Intellectual Prperty Travel Stck Optins (Any) Equity Financial Intellectual Prperty Travel Stck Optins (Any) Equity Financial Intellectual Prperty Travel 7 f 9

12 APPENDIX B Guidelines fr Cmpleting Statement f Financial, Equity, and Intellectual Prperty Interests On the NIH HIV/AIDS Clinical Trial Netwrks Statement f Financial, Equity, and Intellectual Prperty Interests frm, please use the fllwing categries when listing the activities fr which yu r a family member receive financial cmpensatin, have equity interest, r have intellectual prperty interest. Direct salary supprt r ther direct benefits frm industry-spnsred research Cnsultant fee, direct and indirect (including lecture/seminar fees) Teaching fees Service grant, cntract, r membership n scientific/clinical advisry bard Equipment Gift Hnraria Stck wned by yu r a family member Stck ptin wned by yu r a family member Mutual funds wned by yu r a family member, if yu have/the family member has direct cntrl ver the investment decisins. Cpyrights Ryalties Travel Equity Interest Intellectual prperty rights with a relevant entity (patents, pending patents, cpyrights, licensures, and ryalties) r ptential earnings frm any patent held by any ther party. If there is a significant change in the member s interests, it is incumbent upn the member t reprt said change t his/her netwrk at the time f the change. Each cmpleted statement shuld cver the previus 12 mnths and present day circumstances. Please cnfirm need t declare individual interests befre submitting the Statement f Financial, Equity, and Intellectual Prperty Interests. The mst recent HHS rule n Respnsibility f Applicants fr Prmting Objectivity in Research fr which Public Health Service Funding is Sught and Respnsible Prspective Cntractrs can be fund at: Additinal NIH guidance can be fund at: Fr substantive questins cncerning the HHS Rule, FCOICmpliance@mail.nih.gv. Fr questins abut netwrk-specific plicies and prcedures (including cnflict management prcesses), please refer t yur netwrk(s) peratin center r member website. 8 f 9

13 APPENDIX C Crss-netwrk Financial Disclsure & Cnflict f Interest Reprting Wrkflw Netwrks cllabratively prepare a crss-netwrk Cnflict f Interest (COI) frm that requires annual reprting f significant financial interests (SFI) as defined in the U.S. Public Health Service (includes FDA and NIH) rules and plicies. Each netwrk identifies study investigatrs and ther persnnel (members) wh must reprt their SFIs. The netwrks uplad these names int the nline crss-netwrk reprting system database. During the furth quarter f the netwrks budget year, the netwrks will distribute the COI requests. Members will receive an requesting they enter their SFIs in the nline reprting system. The netwrk and/r its grantee institutin is required t ensure public accessibility, via a publicly accessible website r written respnse t any requestr within five business days f a request. Reprting must be cmpleted by the annual deadline. Failure t reprt will results in suspensin frm netwrk activities until the the reprt is received. Members wrking with multiple netwrks will nly have t reprt their SFIs nce and will have ne accunt reflecting their netwrk affiliatins. Submissin f a financial disclsure statement t the netwrk(s) des nt release members frm their institutins' cnflict f interest submissin requirements. Upn submissin, the reprts are archived and queried. Upn request, the netwrk shall make infrmatin n cnflicting interests available t the U.S. Public Health Service. The netwrk review cmmittees review all reprts with SFI t reasnably determine if any culd directly and significantly affect the design, cnduct, r reprting f netwrk research. COI reprts, assciated materials, and recrds f netwrk review cmmittee actins are retained fr a minimum f three years frm the end f the netwrk grant cycle, r any ther perid required by law r regulatin, whichever is later. Failure t cmply with cnditins r restrictins t manage t cnflicting interests, may result in sanctins prescribed by the netwrk review cmmittee. Any determinatin f cnflicting interests must be fllwed by the impsitin, within 60 days, f cnditins f restrictins t manage, reduce, r eliminate the cnflicting interests. 9 f 9