DREXEL UNIVERSITY

Faculty Senate Committee on Research and Scholarly Activities

Policies and Operations Subcommittee April 5, 2012

Response to Policy Proposal Policy Name: Managing Conflicts of Interests in Sponsored Projects SCRSA seeks endorsement of the Drexel Faculty by Senate vote to forward the attached comments pertaining to the attached research policy draft entitled E. COI Policy to the Sr. Vice Provost for Research.

Respectfully Submitted, Cameron F Abrams Associate Professor, Chemical and Biological Engineering Chair, Senate Committee on Research and Scholarly Activities Karen Moxon Associate Professor, BIOMED Chair, SCRSA Policies and Operations Subcommittee

Attachment 1: Comments of P&O Subcom.

Compilation of faculty comments on the Big Book of Policies E. Managing Conflicts of Interest in Sponsored Projects The comments below were acquired when the SCRSA Committee members sent the Big Book of Policies to their faculty and requested input. Subsequently, the SCRA Committee met and discussed the comments. Finally, a subcommittee was formed to go through the policies and provide feedback. The first policy the subcommittee addressed was the COI policy. All of the comments from all of the sources are included. Line numbers and page numbers are from the accompanying copy of the policy dated September 21, 2011.

I. CONTEXT AND SCOPE a. P1 L11: It would be helpful if there was an overall understanding that part of the goal of ORCA must be to educate faculty about these policies e.g. conflicts of interest are not inherently bad. They must be managed. This policy sets guidelines for helping faculty identify COIs and for managing COIs b. P1 L11: The context and scope need to include an understanding of how this policy serves 1) the individual (faculty member), 2) the University and 3) the public, and if any of these constituencies take precedence over the others. c. P1 L30 & 64: The definition of an individual and institutional COI should either remove the financial modifier of interest or explain its purpose (is there no need to manage a COI that does not have a financial interest? On the other hand, we recognize that the policy cannot include all COI. However, more clarity on the scope is requested. d. P2 L76-80: Reason for creating the policy either add c) to protect the interest of the individual or remove this statement from later in the document (P4, L 157-159) and explain clearly that this policy is NOT meant to protect the individual faculty member. Again this is a place where the idea of whether and how this policy also serves the public could be placed. e. P3 L87: The policy applies to . take out in a substantive way for the involvement of students or define better. II. POLICY No comments

MANAGING COI POLICY

III. GUIDING PRINCIPLES a. P 3 L109: This policy supplements the University Policy on COI . perhaps some clarity here e.g. repetition of issues in the college COI that are particularly relevant for sponsored research COI b. For the entire section: need references to further clarity on the statements. IV. ADMINISTRATIVE RESPONSIBILITIES a. P4 L158 163: Given that Drexel does not have experience with actively managing COIs, it would be useful if the faculty understood that the Outside interest committee was to receive some kind of guidance or training from someone who does. This may be outside the scope of the written policy but the committee is relaying concerns raised by faculty.

V. POLICY IMPLEMENTATION A. Reporting Conflicts of Interests in Sponsored Projects a. P 6 L200: Individual must disclose new COI . within 10 days . A clear statement of HOW this should be done should be included (e.g. email? to whom?, a form?, etc). b. P6 L206: Some activities need not be included as in section c) No section c) is given B. Reviewing Conflicts of Interest Reported in Sponsored Projects a. P 7 L 259-260: If a conflict is reported Office of Outside interest notifies relevant individual . This represents a welcome and important change from current policy where we submit our conflicts and never hear anything back. b. P 7 Line 259: Remove neglibile. There should either be or not be a COI. c. P8 L 262-267: Importantly, if the Office of Outside interest states there is NO or NEGLIGIBLE conflict, does this indemnify the individual from future legal action? Will the University support (with full legal support) any issues that might arise from the individual acting on this response from the Office of Outside Interest? C. Managing Conflicts of Interest Identified a. P 8 L 282: Could examples of unmanageable conflicts be provided and updated as they are encountered to further educate the faculty. b. P8 L 285: Include the phrase In collaboration with the investigator before the start of The Outside Interests Committee is responsible for preparing a Management Plan. Alternatively, explain why the PI should not be involved. c. P10 L 343: if should be is D. Appeals a. In several places: The faculty feel that that 10 days is not enough to make an appeal. It is requested that it be increased to 21 working days. b. P10 L 359: Please add that at each level of appeal, a rationale will be reported for the decision. This again goes to educating the faculty on what is appropriate and what is not and why. c. P10 361 367: Who is this individual and what is their relationship to the project? If the answer is none, it would help to say this explicitly. d. P11 L 369 and 371: The Audit Committee should be modified to state the Trustees Audit Committee. E. Reporting Required by the Code of Federal Regulations (42 CFR part 50) a. P11 L 386: Please add that the PI will receive a copy any notifications to the PHS Awarding Component (do you mean Component?). VI. SANCTIONS a. P11 L 396 399: How is failure monitored? What are the requirements to notify faculty of their imminent failure? Who determines that there is a failure? What is the timeframe for determining a failure that requires sanctions? b. P12 L 424: Please add a statement about what happens if it is the President who is in conflict. c. P12 L 429: Please increase the time frame for appeal to 21 working days.

Attachment 2: Policy Draft

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 DREXELUNIVERSITY POLICYON MANAGINGCONFLICTSOFINTERESTINSPONSOREDPROJECTS Summary:ThispolicydescribestheUniversityscommitmenttomanageconflictsofinterestinsponsored projectsandtheprocessandproceduresusedindoingso.ThispolicysupplementstheUniversitysPolicy onConflictsofInterest. I.CONTEXTANDSCOPE ThemissionofDrexelUniversity(theUniversity)istopromotepublicgoodbycreating,sharingand applyingknowledgeinthepublicinterest.Ourmissionisaccomplishedinmanyways,including providingworldclasslearningopportunitiesforstudentsatalllevels,conductingbothinquirybasedand useinspiredresearch,creativeandscholarlyactivities,bytranslatingtheiroutcomesintopracticeand forpublicgoodthroughcommercialization,theestablishmentofnewventures,andbyothermeans, andbyfacultyconsulting.

Universityresearchers,scholars,andadministratorsareincentivizedtoparticipateinthese kindsofactivitiesviaprogressiveuniversitypoliciesthat,forexample,reward commercializationactivitiesthroughroyaltyrevenuesharingschemes,encouragethecreation ofpartnershipswithprivatesectororganizationsintenureandpromotionpoliciesandin cooperativeeducationprograms,andallowtimeawayfromthecampusforconsulting. Itiswidelyrecognized,however,thattheseactivitiescreatethepossibilitythatanindividual's actionsordecisionsmadeinthecourseofhisorherUniversityresearch,creativeandscholarly activitiesmightbemotivatedbyconsiderationsofpersonalfinancialgainthataremadeatthe expenseoftheUniversitysmissiontopromoteknowledgecreationandsharinginthepublic interest.Thisinherentconflictcancallintoquestiontheprofessionalobjectivityandethicsof theindividual,anditalsocanreflectnegativelyontheUniversity.Anindividualconflictof interestinasponsoredprojectoccurswhenapersonengagedintheprojecthasafinancial interestthatmightadverselyaffectorappeartoareasonablepersontoadverselyaffectthe Universitysresponsibilitytothepublic,tothesafetyofhumansubjectsparticipatinginthe sponsoredproject,tothesponsor,ortotheintegrityofresearch,creativeandscholarly activities.Some,butbynomeansall,examplesofsituationsthatmaycreateanindividual researchconflictofinterestinclude: Servingasaninvestigatoronasponsoredprojectinvolvinghumansubjectsthatiseither sponsoredbyacompanyorrelatedtothecompanysproductswhilethatinvestigatoris receivingroyalties,consultingfees,orhasequity(orstockoptionsorafutureinventors share)inthesamecompany.
1

41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82

Ghostwritingorhavinganinvestigatorsnameattachedtoapaperwrittenbyanother individualconsultingforordirectlyemployedbyindustry,includingpapersfeaturing researchdatathatweresimplypresentedtotheindividualwithouttheopportunityto analyzedirectly,performcalculations,reviewand/orquestiontheresearchdata. Afacultymemberactingasathesisordissertationadvisortoagraduatestudentina sponsoredprojectwheretheresearchoutcomesgeneratedarelikelytosubstantially enhancethevalueofacompanyinwhichthefacultymemberhasasignificantownership interest. Aprofessorrequiringstudentscurrentlyenrolledinhisorherclasstoparticipateinhisor heroranotherprofessorssponsoredproject. IssuingaUniversitysubcontractforworktoanoutsideentityinwhichtheinvestigatoron thesponsoredprojecthasafinancialinterest. Receivingprojectsupportforhumansubjectsresearchfromaprivatesectororganization withoutacontract,orformorethanthereasonablecostsofconductingthesponsored project. Receivingpersonalpaymentsconditioneduponaparticularsponsoredprojectresultortied tosuccessfulprojectoutcome. Whileservingonaboardofdirectors,participatinginsponsoredprojectsinvolvinghuman subjectsonatechnologyownedbyorobligatedtothebusiness,orreceivingsponsored projectsupportfromthebusiness.

ItisalsorecognizedthatbecausetheUniversityoritsseniorleadershipmayhavefinancialintereststhat conflictwiththeUniversitysmissiontopromoteknowledgecreationandsharinginthepublicinterest, thatinstitutionalconflictsofinterestalsomayarise.Aninstitutionalconflictofinterestinasponsored projectariseswhenthefinancialinterestsoftheUniversity,oraUniversityofficialactingwithinhisor herauthorityonbehalfoftheUniversity,mayinfluenceorappeartoinfluenceprocessesforthe conduct,review,oroversightofthesponsoredproject,possiblyaffectingtheUniversitysresponsibility tothepublic,tothesafetyofhumansubjectsparticipatinginthesponsoredproject,tothesponsor,or totheintegrityofresearch,creativeandscholarlyactivities.Examplesofactivitiesinwhichan institutionalconflictofinterestmayariseinclude:

SituationsinwhichtheUniversityhasanequitystakeinanorganizationseekingtosupport asponsoredproject. SituationsinwhichtheUniversity,itsPresident,ormembersoftheBoardofTrusteeshavea considerablefinancialstakeintheoutcomeofasponsoredproject.

Thus,theUniversityhascreatedaPolicyonConflictsofInterestandaPolicyonManaging ConflictsofInterestinSponsoredProjectstohelpmanagetheseconflicts,ensuringthatthe UniversityandallUniversitypersonnelconducttheiraffairsinwaysthata).holdthe Universitysmissionfirstandforemost,andb).donotcompromisetheintegrityofthe University.

2

83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120

Thispolicyappliestoallindividualsengagedinsponsoredprojectssubmittedandmanagedbythe University,andallindividualsresponsibleforoverseeingormanagingsponsoredprojectsatthe University,withtheexceptionofstudentsandpostdoctoralfellowsandscholarsunlesstheycontribute tothedevelopmentorexecutionofasponsoredprojectinasubstantiveway.Suchindividualsmight includemembersoftheBoardofTrustees;allUniversityofficers;senior(cabinetlevel)officialsofthe UniversityandanyotherindividualthatthePresidentdesignates;allUniversityfaculty,staff,and administratorsengagedinsponsoredprojects;IRBchairsandmembersoverseeingsponsoredproject protocols;IACUCchairsandmembersoverseeingsponsoredprojectprotocols;emeritusfacultywhoare engagedinsponsoredprojects;and,membersoftheOutsideInterestCommitteeoverseeingsponsored projects.UniversityfacultyarethoseindividualsdefinedasUniversityfacultyintheFaculty Handbook. II.POLICY ThispolicyofDrexelUniversityrequiresthatrelevantpersonnelmakeprojectspecificconflictofinterest disclosuresatthetimeaproposalforsponsoredsupportiscreatedandsubmittedtotheOfficeof ResearchAdministration,andthatrelevantpersonnelengagedinorresponsibleforoverseeingaproject makeadhocconflictofinterestdisclosurestotheUniversityatthetimetheyariseduringtheperiodin whichasponsoredprojectisactive.Individualscoveredunderthispolicymustcomplywith managementcontrolsstrategiesdevelopedtomanageormitigateconflicts,andpotentialconflictsof interest,insponsoredprojects.Thispolicyappliesregardlessofwherethesponsoredprojectactivities areconducted.

I.

GUIDINGPRINCIPLES
ThispolicysupplementstheUniversitysPolicyonConflictsofInterest.Inmanagingconflictsof interestinsponsoredprojects,theOutsideInterestsOfficewilldrawuponconflictsofinterest disclosuresmadebyUniversitypersonnelasrequiredbytheUniversitysConflictsofInterestPolicy. Universityresearchersandscholarsengagedinsponsoredprojectsmustfosteranatmosphereof opennessasdefinedintheUniversitysPolicyonOpennessinResearch,CreativeandScholarly Activitiesbypromotingtheopenandtimelyexchangeoftheresultsofsponsoredprojects.In particular,facultyandotherresearchersmustensurethattheiradvisingofstudentsand postdoctoralscholarsaspartoftheseprojectsisindependentofpersonalcommercialinterests. Studentsandcolleaguesshouldbeinformedaboutoutsideobligationsthatmightinfluencethefree exchangeofresearch,creativeandscholarlyinformationbetweenthemandtherelevantresearcher orscholar. AdditionalrequirementsoftenexistwhenUniversitypersonnelareengagedinprojectssupported 3
Comment [DC1]: Insertlink

Comment [DC2]: Insertlink

121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160

byexternalsponsors.Insuchcircumstances,theUniversityhasobligationstothesponsorsofthese activitiestomeettheirpublishedrequirementsforrecipientinstitutions.

Universitypersonnelengagedinasponsoredprojectmustdiscloseonatimelybasisthe creationordiscoveryofallpotentiallypatentableinventionscreatedordiscoveredinthe courseofasponsoredproject.Ownershipofsuchinventionswillbeassignedtothe Universityand/ortothesponsordependentuponthetermsandconditionsofthe sponsoredagreement.Theinventorswillshareinroyaltiesearnedasindicatedinthe UniversitysPolicyonInventions,PatentsandLicensing ResearchersandscholarsengagedinsponsoredprojectsmustdisclosetotheUniversity whetherthey(ormembersoftheimmediatefamily,asdefinedbelow)haveconsultingor employmentrelationshipswith,and/orfinancialinterests(asdefinedintheUniversitys GeneralConflictsofInterestPolicy),inanoutsideentitybeforetheUniversitywillapprove thefollowingproposedsponsoredprojectarrangementsinvolvingthembetweensuch entitiesandtheUniversity:a)gifts;b)sponsoredprojects;c)technologylicensing arrangements;andd)certainprocurements.Insomecases,approvalbytheSeniorVice ProvostforResearchwillberequired,inconsultationwiththeOutsideInterestsCommittee, priortoenteringintoaproposedarrangement. Allinformationcontainedinreportsorobtainedinthecourseofreviewingapotential conflictofinterest,institutionalconflictofinterest,isstrictlyconfidential.Theinformationis onlyavailabletotheOutsideInterestOfficeandtheindividualschargedwiththe responsibilityforreviewintheparticularcase. Insponsoredprojectsituationsinwhichtheobjectivityofaresearcherorscholarmight reasonablybequestioned,theSeniorViceProvostforResearchwillconsultwiththe OutsideInterestsCommittee,to:reviewtheappropriatenessoftheproposedprojecttobe conductedatDrexel,tooverseetheconductofthesponsoredproject,andtoensureopen andtimelydisseminationoftheprojectresults. TheengagementoftheOutsideInterestsCommitteewillberequiredforallclinicaltrials raisingquestionsofconflictofinterest. ShouldanindividualwishtoappealadecisionmadebytheSeniorViceProvostfor Research,heorshemaypresenttheappealtotheProvost.

Comment [DC3]: Insertlink

IV.ADMINISTRATIVERESPONSIBILITIES TheOutsideInterestsOfficeadministersandhelpsoverseetheprocessformanagingconflictsof interestinsponsoredprojects. TheOutsideInterestsCommitteeseekstomitigateconflictsofinterestinsponsoredprojectstoprotect theinterestsoftheindividualandtheUniversity.MembersoftheOutsideInterestsCommitteeare appointedbythePresidentandincludefaculty,nonfacultyemployees,andadministrators.TheOutside InterestCommitteeincludesatleastonememberofthepublicwhoservesasaregularmember,anda 4

161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193

secondmemberofthepublicwhoservesasanalternatemember.Themembersofthepublicmustnot haveanyaffiliationwiththeUniversity(includingasalumni,faculty,clinicalfaculty,adjunctfaculty,or emeritusfaculty)orwithitsaffiliatedhospitals(otherthanaspatients).Tothemaximumextent possible,themembersofthepublicmustbeindependentofthelineofauthorityforinstitutional oversightofsponsoredprojects.AmajorityofthemembersoftheOutsideInterestCommitteeare membersofthefacultyandoneofthesefacultymembersisappointedbytheExecutiveCommitteeof theFacultySenate.MembersoftheOutsideInterestCommitteerecusethemselvesfromconsideration oftheirownconflictsofinterest,orinstitutionalconflictsofinterestthatrelatetotheirownconflictsof interest. ThePresidentoftheUniversity,orhis/herdesignee(s),administersthisPolicy.ThePresidentmay,at his/herdiscretion,referselectedissuesormatterstotheAuditCommitteeoftheBoardofTrustees. V.POLICYIMPLEMENTATION A.ReportingConflictsofInterestsinSponsoredProjects a.IndividualConflictsofInterest AtthetimeaproposalissubmittedtotheOfficeofResearchAdministrationforsubmissiontoa potentialsponsor,orwhenasponsoredprojectissubmittedtoarelevantreviewbody(suchasthe InstitutionalReviewBoard(IRB),theInstitutionalAnimalCareandUseCommittee(IACUC),andaffiliated IRBs),individualscoveredbythispolicymustreportpotentialconflictsofinteresttotheOfficeof OutsideInterests.Reportingrequirementsarebroad,inordertoprovideadequateprotectionfor individualscoveredbythepolicy,theUniversityandaffiliatedinstitutions,andthepublicinterest.Itis importanttorecognizethatareportingrequirementdoesnotindicatethattheactivityinquestionisin anywayobjectionable;indeed,reportingisrequiredinconnectionwithmanyactivitiesinwhich membersofUniversityareexpectedtoengage,suchastechnologycommercialization,orthatare otherwisepraiseworthy,suchasthereceiptofhonoraryawards. Onasponsoredprojectbysponsoredprojectbasis,individualsmustreportanyfinancialinterest1,no matterhowsmall,thattheindividualortheindividualsspouse,dependentchildren,domesticpartner, oranyotherdependentperson(fortaxpurposes)livinginthesamehouseholdastheindividual,hasin anyentitythatsponsorsorsupportstheprojectorthatholdsafinancialinterestinthesubjectofthe
1

InsertdefinitionoffinancialinterestasdefinedinPolicyonConflictsofInterest
5

194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228

worktobeconducted,andalsomustreporttheacceptanceofanygift,favor,oranythingofvaluefrom anentitythatsponsorstheprojectorthatholdsafinancialinterestinthesubjectoftheproject activities. IndividualsengagedinsponsoredprojectsmustalsodisclosetotheOfficeofOutsideInterests,onanad hocbasis,whenanynewpotentialconflictofinterestarisesduringtheperiodinwhichasponsored projectagreementisactive..Anindividualhas10dayswithinwhichtheymustdiscloseanew reportableinterestorafteraconflictofinteresthasbeeneliminated. Wheneveranindividualcoveredbythispolicyhasanydoubtaboutwhetherornotanactivitymustbe reported,theindividualshouldreporttheactivity. Someactivitiesneednotbereported.Typically,theseareactivitiesnotcoveredinsectioncabovein whichacademicsroutinelyengageandinwhichanindividualsfinancialinterestsarenotexpectedto influencetheindividualsjudgment.Examplesofsuchactivitiesinclude:

Receivingroyaltiesforpublishedscholarlyworkandotherwritings. Acceptingreasonablemealsandothercustomarybusinessamenities(suchaspadsand pens)thatareprovidedaspartofaseminar,course,meeting,orotherbusinessrelated gathering. Incomeandtravelexpensesfromserviceonadvisorycommitteesorasareviewerfor governmentalandrecognizedintergovernmentaloracademicentitiesorprofessional societies. Honorariaforreviewingscholarlymanuscriptsforpublicationbyacademicjournalsor presses. Incomefromdiversifiedmutualfunds. HonorariaandtravelsupportforscholarlypresentationstoU.S.federalagencies(such astheNationalScienceFoundation,NationalInstitutesofHealth,DepartmentofEnergy, DepartmentofDefense,NationalEndowmentfortheArts,andNationalEndowmentfor theHumanities). GrantsandcontractsadministeredthroughtheUniversity.

Wheneveranindividualhasanydoubtaboutwhetherornotanactivitymustbereported,theindividual shouldreporttheactivity.

229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261

b.ReportingInstitutionalConflictsofInterestinSponsoredProjects Inordertomanageinstitutionalconflictsofinterestinsponsoredprojects,thefollowingUniversity organizationsmustreporttotheOutsideInterestOffice:

TheSeniorVicePresidentofFinanceandChiefFinancialOfficer,mustprovidealistof theentitiesinwhichtheUniversityhasanyfinancialinterest. TheBoardofTrusteesAuditCommitteemustprovidealistoftheentitiesinwhich membersoftheBoardofTrusteesandseniorofficialsoftheUniversity,theirspouses, dependentchildren,domesticpartners,oranyotherdependentpersonlivinginthe samehouseholdastheindividual,haveanyfinancialinterest.Thelistofentities providedneednotcontaintheidentitiesoftheindividualswhohavethefinancial interestinthoseentities. TheSeniorVicePresidentforInstitutionalAdvancementmustprovidealistofmajor giftstotheUniversity. TheSeniorAssociateViceProvostforTechnologyCommercializationmustprovidealist oftheUniversity'sequityholdingsandtechnologylicenses.

B.ReviewingConflictsofInterestReportedinSponsoredProjects TheOutsideInterestOfficeconductsaninitialreviewofallreportsitreceivesregardingpotential individualconflictsinsponsoredprojects.Ifnecessary,theyobtainadditionalinformationfromthe individualandfromotherindividualswhopossessrelevantinformation.TheOutsideInterestOfficethen identifiesthoseconflictsthatmustbereferredtotheOutsideInterestsCommitteeforappropriate conflictmanagement,andthosethatmayproceedwithouttheengagementoftheCommitteebecause theconflictisdeemedtobenegligibleoritdoesntexistorbecausetheapproachtomanagetheconflict identifiediscommonpractice. TheOutsideInterestsOfficenotifiestheOutsideInterestCommitteeofthoseconflictsofinterest referredtoitforrecommendation,andtheprojectprincipalinvestigatorisnotifiedofthereferral. Ifaconflictreportedisnegligibleordoesntexist,theOfficeofOutsideInterestsnotifiestherelevant individualandtheprojectprincipalinvestigatorthatthisisso,andwhy.

262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294

Ifaconflictreportedcanbemanagedaccordingtocommonpractices,theOutsideInterestsOfficeso notifiesthePrincipalInvestigator.IndeterminingwhethertoreferamattertotheOutsideInterest Committee,theOutsideInterestsOfficeconsidersthesignificanceoftheconflictofinterest(suchasthe sizeoftheindividualsfinancialinterest);whetherornottheindividualisuniquelyqualifiedbyvirtueof expertiseandexperiencetoconductthesponsoredprojectandtheprojectcouldnotbeconductedas safelyoreffectivelywithoutthatindividual;andthedegreeofriskimposedonhumansubjects). Foreachsponsoredproject,theOutsideInterestsOfficealsoreviewspotentialinstitutionalconflictsof interestthatmayormaynothavebeenreportedbyanindividual,suchasnonreportablepotential conflictsthattheOutsideInterestsOfficebecomesawareofbasedonitsreviewofthelistsitreceives fromtheSeniorVicePresidentofFinanceandChiefFinancialOfficer,theBoardofTrustees,theOfficeof Development,andtheOfficeofTechnologyCommercialization.TheOutsideInterestsOfficethen identifiesthoseactivitiesthatmustbereviewedbytheOutsideInterestCommittee,andthoseactivities thatmayproceedwithoutreviewbytheOutsideInterestCommittee,andnotifiestheOutsideInterest Committeeofthoseactivitiesasappropriate. C.ManagingConflictsofInterestIdentified InreviewingreferralsforwardedbytheOutsideInterestsOffice,theOutsideInterestCommittee assumesthattheprojectcannotbeundertakenwithoutasuitableManagementPlan.Insomecases, theCommitteemayfindthattheconflictisunmanageable,andmayrecommendthatthesponsored projectbeterminated. TheOutsideInterestsCommitteeisresponsibleforpreparingaManagementPlanforeachprojectto mitigateconflictsofinterest.ManagementPlansaredevelopedaccordingtothenatureofthe significantfinancialinterestandofthesponsoredproject,e.g.,whetherthereisaninstitutionalaswell asanindividualconflictofinterest,andwhethertheinvestigatorisconductingbench,animalorhuman subjectsresearch. AManagementPlandevelopedtomanageaconflictofinterestinasponsoredprojectmay,for example:

Requireanindividualtorecusehim/herselffromparticularbusinessdecisions.

295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336

Requireanindividualtoreduce,modify,defer,waive,oreliminatethefinancialinterest thatisthesourceoftheconflict,suchasequityholdings,royaltyincome,stockoptions andmilestonepayments. Requireanindividualtoinformcertainpersonsorinstitutionsabouttheconflictof interestandtheManagementPlan(suchastheOfficeofResearchAdministration,IRBs, IACUCs,subjects,stateandfederalofficials,projectsponsors,coinvestigators, colleagues,juniorcolleagues,students,trainees,membersandprospectivemembersof theindividualslaboratory,journalstowhichmanuscriptsabouttheprojectare submitted,andmedia,lay,andprofessionalaudienceswithwhomtheresearchorother activityisdiscussedorallyorinwriting). Preventanindividualfromservingastheprincipalinvestigator,coprincipalinvestigator, orinvestigatorontheresearchproject. Requireanindividualtorefrainfromparticipatingincertainactivitiesoraspectsof activitiesrelatingtothesponsoredproject(suchasrequiringIRBmemberswithconflicts ofinterestinconnectionwithresearchprotocolstorecusethemselvesfrom deliberationsonthoseprotocols,or,wherecompellingcircumstancesexisttoallow certainresearchstagesoractivitiestoproceeddespiteaconflictofinterest,restricting theindividualsrolestothosestagesandactivities,includingestablishingapointintime forstoppingparticipationandstrategiestokeeptheindividualsinvolvementata minimum). Requiretheactivitytobeapprovedbyadditionalindividualsorentities(suchasdeans, departmentchairs,orprogramchairs). ProhibittheUniversityfromacceptingsponsorsupportfromcompaniesfoundedbyan individual. RequirethattheUniversityreduceormodifyitsfinancialstakeinanoutsideentityor sponsoredproject. Requireotherstoreviewacademicdecisionsinwhichtheindividualparticipates. Requireindependentinvolvementintheproject(suchasinrecruitingandselecting subjects,participatinginordesigningtheconsentprocess,providingclinicaltreatment tosubjectsapartfromtheresearchinterventionorprocedures,monitoringdata, reviewingstudydesign,collectingdata,anddeterminingauthorshipstatusororder). Requireanindividualtovacateaposition. Prohibitanindividualfromdisclosingconfidentialinstitutionalinformationor channelingdiscoveriestoanoutsideentity. Prohibitanindividualfromservingontheboardofdirectorsoftheoutsideentity,oras anofficer,memberofthescientificadvisoryboard,memberofaspeakersbureau,or consultant. ProhibittheprojectfromtakingplaceontheUniversitycampus. Enhanceorcreatefirewallsorotherconflictmanagementapproachestoseparate financialandsponsoredprojectdecisionmaking. RequirecontinuedoversightoftheactivitybytheOutsideInterestsCommittee.

337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368

BeforefinalizingaManagementPlan,theOutsideInterestCommitteemustreviewitwiththe appropriateDeanorDirector;inthecaseofUniversityofficers,withtheappropriateseniorofficial;and inthecaseofnonschoolbasednonfacultyemployees,withtheseniorUniversityofficialwithoversight overthem. IftheDean,DirectororseniorofficialandtheOutsideInterestCommitteeareunabletoagreeonthe termsoftheManagementPlan,thematterifreferredtotheSeniorViceProvostforResearchfor appeal. D.Appeals IfanindividualisdissatisfiedwithadeterminationoftheOutsideInterestsCommittee,theindividual maysubmitawrittenappealtotheSeniorViceProvostforResearchwithin10daysofreceiptofthe decision.IftheSeniorViceProvostforResearchupholdstheOutsideInterestsCommittees determination,theSeniorViceProvostforResearchsdecisionisfinal.IftheSeniorViceProvostfor ResearchmodifiesoroverrulestheOutsideInterestCommitteesdetermination,theOutsideInterest CommitteemayappealtotheProvost. If,whentheOutsideInterestCommitteeandthedeanorseniorofficialwhoreviewsaManagement PlanareunabletoagreeonthetermsoftheplanandthematterisreferredtotheSeniorViceProvost forResearch,theOutsideInterestCommitteeorthedeanorseniorofficialisdissatisfiedwiththe decisionoftheSeniorViceProvostforResearch,theymayreferthemattertotheProvost.The Provostsdecisionwillbefinal. Intheeventthatanindividualwhodoesnothaveanindividualconflictofinterestisdissatisfiedwitha determinationoftheOutsideInterestCommittee,theindividualmaysubmitawrittenappealtothe SeniorViceProvostforResearchwithin10daysofreceiptofthedecision.Iftheindividualisthe President,thePresidentmaysubmitawrittenappealtotheAuditCommitteeoftheBoardofTrustees within10daysofreceiptofthedecision.IftheindividualisamemberoftheAuditCommittee,theAudit Committeesdeliberationsanddecisionisconductedinaccordancewiththepoliciesandproceduresof theBoardofTrustees.

10

369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400

IfthePresidentortheAuditCommitteeupholdstheOutsideInterestCommitteesdetermination,the decisionisfinal.IfthePresidentmodifiesoroverrulestheConflictofInterestCommittees determination,theOutsideInterestCommitteemayappealtotheAuditCommittee. E.ReportingRequiredbytheCodeofFederalRegulations(42CFRpart50) AspertheCodeofFederalRegulations(42CFRpart50),theUniversitywillreportaconflictofinterest relatedtoPublicHealthService(PHS)fundedresearchtothePHSawardingcomponent.Whenever possible,thisreportwilltakeplacepriortotheexpenditureofgrantfunds.Italwayswilltakeplace within60daysofidentifyinganewconflictofinterest. ThereporttothePHSAwardingcomponentwillspecifywhethertheUniversityhasmanaged,reduced, oreliminatedthefinancialconflictofinterest.IfthefailureofanindividualtocomplywithPHS regulationshasbiasedthedesign,conduct,orreportingofPHSfundedresearch,theUniversitymust promptlynotifythePHSAwardingcomponentofthecorrectiveactiontakenortobetaken.Note:The PHSAwardingComponentwillconsiderthesituationand,asnecessary,takeappropriateaction,orrefer themattertotheUniversityforfurtheractionwhichmayincludedirectionstotheInstitutiononhowto maintainappropriateobjectivityinthefundedproject. Inaccordancewith42CFR50.604(e),theUniversitywillmaintainrecordsofallfinancialdisclosuresand allactionstakenbytheUniversitywithrespecttoeachconflictinginterestforatleastthreeyears,andin thecaseofPHSfundedresearch,fromthedateofsubmissionofthefinalexpendituresreportor,where applicable,fromotherdatesspecifiedin45CFR74.53(b)fordifferentsituations(e.g.,transferred records,instancesoflitigation,etc.) VI.SANCTIONS Failuretocomplywiththispolicyincludesfailingtosubmitarequiredreport,providingfalse information,omittingrequiredinformation,failingtomaintainconfidentiality,failuretocarryoutduties prescribedbythispolicy,andrefusalorfailuretocomplywithaManagementPlanadoptedunderthis policy

11

401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434

Afailuretocomplywiththispolicymay,inthecaseofsponsoredresearch,resultinadecisionbythe SeniorViceProvostforResearchtosuspendtheprojectorrefusetoapproveanewsponsoredproject fortheindividualwhofailstocomply. AfailuretocomplyalsoissubjecttothefullrangeofUniversitydisciplinaryprocedures,including:

Formaladmonition. Aletterintheindividualsfileindicatingthattheindividualsgoodstandingasamember oftheUniversityhasbeencalledintoquestion. Ineligibilityoftheindividualtoapplyforgrants,IRBapproval,orsupervisionofgraduate orprofessionalstudentsortrainees. Nonrenewalofappointment. Terminationofemployment.

Ifanindividualfailstocomplywiththispolicy,theOutsideInterestCommitteedeterminesifthematter canbehandledbyrequiringtheindividualtocomplywithacorrectiveactionplandevisedbythe OutsideInterestCommittee.Ifso,theOutsideInterestCommitteedevisestheplanandadvisesthe individualofitsrequirements.IftheOutsideInterestCommitteedeterminesthatthemattercannotbe handledbyrequiringtheindividualtocomplywithacorrectiveactionplan,ortheindividualrefusesto comply,theOutsideInterestCommitteerefersthematter,alongwithitsrecommendationsabouthow themattershouldbehandled,totheSeniorViceProvostforResearch.InthecaseoftheSeniorVice ProvostforResearch,theProvost,GeneralCounsel,ChiefFinancialOfficer,andanyotherindividualthat thePresidentdesignatesasaseniorcabinetlevelofficial,theOutsideInterestCommitteerefersthe mattertothePresident. IfanindividualotherthananonfacultyemployeeisdissatisfiedwithadeterminationoftheOutside InterestCommitteetoimposeacorrectiveactionplanorwithadministrativeactionbytheSeniorVice ProvostforResearchtosuspendorrefusetoapproveasponsoredproject,theindividualmaysubmita writtenappealtotheProvostwithin10daysofreceiptofthedetermination. IftheProvostmodifiesoroverrulestheOutsideInterestCommitteesdetermination,theOutside InterestCommitteemayappealtothePresident.IfPresidentupholdstheOutsideInterestCommittees determination,thedecisionofthePresidentisfinal.

12

435 436 437 438 439 440 441 442

GrievanceproceedingsareconductedinaccordancewiththeproceduresprovidedinUniversityFaculty Handbook.

VII.EFFECTIVEDATE ThisPolicyonManagingConflictsofInterestinSponsoredProjectsshallbeeffective ________________________________________.

13