3.2 Equity. An interest in a business consisting of any stock, stock option, or similar ownership interest in such business.

Transcription

1 UNIVERSITY OF SOUTH ALABAMA INSTITUTIONAL CONFLICT OF INTEREST POLICY 1. PREFACE This plicy is established t prvide apprpriate institutinal safeguards t sustain an envirnment where spnsred prjects, dedicated gifts, research, schlarship, entrepreneurial endeavrs, and technlgy transfer are carried ut respnsibly, and in s ding fster an culture f transparency and integrity. The University engages in relatinships with a range f cmpanies that may lead t financial benefit fr the University in many frms, including ryalty payments, ther payments and equity frm licensing intellectual prperty, spnsred educatin and research agreements, dedicated gifts and purchasing. Relatinships with cmmercial entities are generally part f custmary educatinal, research, and business activities, and cnsequently will lead in sme cases t cnflicts f interest. Given the scpe f University activities, the variatin in its relatinships, and the pursuit fr the University t act as gd stewards f its funds, it is inherent that University relatinships and ptential institutinal cnflicts f interest are unavidable. The intent f this Plicy is nt t restrict r discurage such relatinships, but, rather t manage them s they d nt cmprmise, r reasnably appear t cmprmise, the safety and integrity f the University s missin. 2. POLICY The University plicy n Institutinal Cnflicts f Interest applies t Emplyees and Cvered Entities f the University f Suth Alabama as defined belw in Sectin 3. This plicy cncerns cnflicts that arise frm the University s financial relatinships with external entities such that the University must cnduct its business free f imprper influence resulting frm external institutinal financial relatinships. The gal f this dcument is t raise awareness f the issues and situatins that shuld be disclsed, reviewed, and managed n behalf f the University by the individuals wh serve as its leaders and administratrs. Each institutinal financial interest that presents the ptential fr cnflict f interest shuld be disclsed t the Supervisr and/r the Vice President f the divisin, within which, that activity wuld ccur as nted in Sectin DEFINITIONS 3.1 Institutinal Cnflict f Interest (ICOI). A situatin which arises when financial interests f the University, r a University fficial acting within his/her authrity n behalf f the University, may influence r appears t influence the research, educatin, clinical care, business transactins, r ther activities f the University. 3.2 Equity. An interest in a business cnsisting f any stck, stck ptin, r similar wnership interest in such business. 3.3 University Officials (hereinafter referred t as Cvered Individuals). Fr purpses f this Plicy, Cvered Individuals include thse administratrs wh are in a psitin t make r significantly influence decisins n behalf f the University invlving the fllwing: the use f University resurces, including decisins invlving expenditures, purchasing, investments, equity and technlgy transfer; the cnduct f research, in particular research invlving human subjects the executin f grants and cntracts, r

2 Institutinal Cnflict f Interest Plicy Page 2 f 7 the licensing f University intellectual prperty t external parties Based n the freging, Cvered Individuals include but are nt limited t: University President and Chief f Staff Bard f Trustees University Vice Presidents and Assciate/Assistant Vice Presidents Deans, Vice/Assciate/Assistant Deans Institute Directrs 3.4 Cvered Entities. This term refers t the fllwing sites: University campuses USA Medical Center USA Children and Wmen s Hspital USA Health Systems Mitchell Cancer Institute 4. AREAS OF INCREASED RISK FOR INSTITUTIONAL CONFLICTS OF INTEREST Institutinal financial cnflicts f interest can ccur in varius cntexts acrss campuses, but generally they cncern the University and the public if they have a significant ptential t cmprmise the University's missin, regardless f the field r cntext. 4.1 Institutinal Financial Cnflict f Interest Cnsists f Tw Majr Types: Ptential Cnflict f Interest invlving University equity hldings r a ryalty arrangement related t Spnsred Prgrams, and Ptential Cnflict f Interest invlving University fficials wh make decisins with institutinal-wide implicatins, which can include department heads and center and institute directrs, in additin t senir management 4.2 University Intellectual Prperty. The University has a legal duty t manage its intellectual prperty. In accrdance with University plicies, the University has the authrity t license and receive cmpensatin fr its intellectual prperty. In certain cases, the entity licensing the intellectual prperty may have ther research, financial r business relatinships with the University that culd raise a cnflict. Fr example, institutinal cnflicts f interest may arise when an entity bth licenses University intellectual prperty fr a cmmercial purpse and als spnsrs University research n the intellectual prperty at issue. When the University is cnducting research n its wn intellectual prperty such research and related findings may als be subject t challenge. Even when the individual researcher des nt have a financial interest in the intellectual prperty, the knwledge that the University, campus r research labratry stands t gain financially frm successful develpment f a licensed technlgy can influence the directin f related research r ther University r campus activity, the bjectivity f research, the disseminatin f results and the allcatin f resurces amng cmpeting prjects and activities Equity and Licensing Arrangements. The University wns stcks and ther frms f equity in cmpanies as part f its investment hldings and endwment prtfli. A ptential institutinal cnflict may ccur when the University licenses an inventin t an entity that als has a financial r business relatinship with the University. Fr example, the University has btained a significant wnership interest r an entitlement t significant equity in a cmpany that is (i) the spnsr f research at the university, r (ii) the manufacturer r distributr f a

3 Institutinal Cnflict f Interest Plicy Page 3 f 7 prduct that is either studied r tested in research at r under the auspices f the University, r based at least in part n technlgy develped here. Direct investments by the University r its management cmpany in University-related start-up cmpanies warrant sensitivity t ensure that n vilatins f this Plicy ccur as a result f such investments. The Vice President fr Research, in cnsultatin with the University Cnflict f Interest Cmmittee, is respnsible fr putting in place and maintaining apprpriate ffice plicies and prcedures t versee the strategies under which the Office f Technlgy Transfer negtiates equity psitins in licensing agreements cnsistent with the University s equity plicy. 4.3 Gifts frm Cmpanies. Ptential cnflicts may arise when a cmpany that has a financial r business relatinship with the University als dnates a gift t the University. Fr example, if the University is ffered r has received significant gifts (including, but nt limited t, gifts in kind, discunts, fellwships, and unrestricted educatinal grants) frm a cmpany r a fundatin established by r clsely affiliated with a cmpany that is (i) spnsring r ffering t spnsr research at the University, r (ii) the manufacturer r distributr f a prduct that is either studied r tested in research at r under the auspices f the University, r based at least in part n technlgy develped here. 4.4 Purchasing. A vendr r ptential vendr als has a financial r business relatinship with the University r campus. A cnflict, r the appearance f a cnflict, may arise in purchasing situatin when a cvered indiviudal as defined under this plicy r University fficial has a financial, persnal, r business interest in a vendr whse prducts r services prvided are cnsidered fr purchase. 4.5 University Officials with Persnal Cnflicts f Interest. Due t supervisry and institutinal decisin making functins, University fficials encunter cnflict f interest situatins beynd thse cnfrnted by mst faculty r ther administratrs. As they ften d nt cnduct research, teaching r faculty service in their capacity as an administratr, hwever, may be in a psitin t influence hw they are cnducted and reprted. Their business and financial relatinships with external entities shall be disclsed t prevent any real r perceived institutinal cnflicts f interest. 4.6 Human Subjects Research. Research invlving human subject s research requires additinal versight because f the ptential t cmprmise the health r safety f human subjects. The financial interests f senir University Officials must nt affect, r reasnably appear t affect, the design, cnduct, reprting, review r versight f human subjects research carried ut in USA s department(s) ver which they have authrity r whse access t University resurces are under their direct versight. 5. DISCLOSURE AND REVIEW PROCESS Disclsures shuld be filed n a case by case basis using the Institutinal Cnflict f Interest Disclsure frm. Due t the variety and cmplexity f University activities, n set f guidelines can anticipate and deal with all pssible scenaris. Therefre, a majr respnsibility fr thse wh represent the University is t: (1) disclse cnflict f interest situatins when they arise, whether ptential, apparent, r actual, and (2) seek directin at the apprpriate levels n hw t manage the situatin apprpriately. 5.1 Identify and disclse the ptential cnflict. Ptential ICOI will be identified when University Officials reprt financial interests in an entity cnducting business with the University in an area ver which that University Official has direct supervisin r decisin-making respnsibilities. Reprts shuld be disclsed and dcumented by cmpleting the Institutinal Cnflict f Interest Disclsure frm and prvide t their Supervisr and/r the Vice President f the divisin, within which, that activity wuld ccur. As such, areas that invlve fiscal r human resurce matters must be disclsed t the Vice President fr Financial Affairs and fr research related activities t the Vice President fr Research. Ptential cnflicts are als identified by emplyees r ther individuals wh are cncerned abut pssible cnflicts f interest and reprt thse situatins t their supervisrs r ther apprpriate University Officials.

4 Institutinal Cnflict f Interest Plicy Page 4 f Ryalties and Other Incme Researchers cnducting human subjects research will be asked when cmpleting IRB applicatins if the prpsed study evaluates directly r indirectly a University inventin. If s, a cpy f the applicatin is reviewed by the Directr, Research Cmpliance and Assurance. If warranted, the ptential cnflict will be elevated t the designated Vice President fr review. The Office f Technlgy Transfer in preparatin f exclusive license r ptin agreements check infrmatin abut research spnsrs, vendrs and gift dnrs t determine if the ptential licensee r start-up cmpany als has ther types f financial r business relatinships with the University Start-ups and equity interests Fr cnflicts f interest that culd arise when the University is negtiating a pssible equity interest in a start-up cmpany, ptential cnflicts will be identified when the Office f Technlgy Transfer are develping agreements that include an equity interest in the new cmpany. Additinally, there is n threshld if it is likely that that start-up cmpany may spnsr the research at the University that invlves human subjects. Befre finalizing agreements, Spnsred Prgrams will be the pint f cntact fr infrmatin n current and ptential research prjects. Fr cnflicts that culd arise when the University already hlds equity in a cmpany, the University typically avids risks assciated with this type f intuitinal cnflict by separating equity infrmatin and decisin-making frm the research enterprise. Emplyees in the psitin t directly influence the research, teaching r ther activities d make decisins regarding these equity interests Purchasing. Purchasing Staff may identify ptential cnflicts as they participate in r review purchasing decisins. They refer the ptential cnflict t the Directr f Purchasing and elevated t the designated Vice President fr review. Emplyees r ther individuals cncerned abut pssible Institutinal cnflicts f interest in the purchasing cntext shuld reprt situatins t University fficials Gifts. Identify the ptential cnflict: Thrugh disclsures by Cvered Individuals. Ptential institutinal cnflicts f interest may arise if yur department r area received a gift frm a cmpany that als spnsrs research r supplies equipment r services t yur area f versight. Thrugh situatins reprted t University fficials by emplyees r ther individuals cncerned abut pssible cnflicts f interest Human Subjects Research. Direct financial interests f a University Official in an external entity which is spnsring human subject s research r a financial interest specific t intellectual prperty that is the subject f human subjects research must be disclsed when an individual in the department fr which he/she is the institutinal leader prpsing such research, as subject t the pints described belw. Direct financial interests include: Equity hldings that are held directly by the University Official, r his/her immediate family, but exclude (a) mutual funds fr which the individual has n cntrl ver the investment decisins f the fund r (b) dllars fr which the University Official des nt actively manage. This indiviudal shuld nt participate in decisin making regarding the purchase f r sale f individual stcks.

5 Institutinal Cnflict f Interest Plicy Page 5 f 7 Ryalties (whether paid thrugh USA r thrugh anther surce). Payments fr cnsulting, bard service r ther services and any ther financial relatinship that invlves funds received by the cmpany t the University Official Bard f Trustees. Members f the Bard f Trustees are gverned by Bylaws such that Article VI cntains cnflict f interest plicies t assist Bard members in identifying, disclsing and minimizing cnflicts. These Bylaws are accepted as plicy fr purpses f cmpliance with Institutinal Cnflict f Interest. 5.2 Review the ptential cnflict. Areas that invlve fiscal r human resurce matters are reviewed by the Vice President fr Financial Affairs and fr research related activities the Vice President fr Research. The respective designated Vice President is respnsible fr evaluating the risk f an institutinal cnflict, cnsulting with individuals and ffices as necessary. In the event f a cnflict r any unreslved situatins, the review will be elevated t the University Cnflict f Interest Cmmittee. This review will include determinatin f whether a management plan is apprpriate and necessary. Additinally, the designated Vice President will implement and mnitr pst-apprval cmpliance with its determinatin. The designated Vice President will share all reprts f institutinal cnflicts f interests t the President and University Cnflict f Interest Cmmittee n an annual basis Review Criteria. Reviews must cnsider whether the financial r fiduciary interests disclsed in accrdance with this plicy affect r may ptentially affect any f the fllwing: Safety f human research subjects; Safety f patients; Integrity f research; Apprpriate allcatin f resurces; Objectivity and independence f educatinal activities, including undergraduate, graduate, pst-graduate, and cntinuing educatin; Objectivity in business and cntracting decisins 5.3 Recmmendatin Prcess. The designated Vice President review f a specific case may result in ne f fur recmmendatins: N Institutinal Cnflict: In cases resulting in a finding that there is n actual, ptential, r perceived institutinal cnflict, the designated Vice President must cmmunicate his/her decisin t the apprpriate individual(s) respnsible fr the activity and any University Official whse interest was at issue Manageable Institutinal Cnflict: In cases where the designated Vice President cnsiders manageable, a recmmendatin f ne r mre management measures will be prvided. Examples include, but are nt limited t: (1) effective recusal frm decisin-making regarding the prpsed arrangement by the financially interested University Official and disclsure f the recusal t the apprpriate individuals t implement the recusal; (2) reductin in the magnitude f the financial interest; (3) disclsure f the financial interest in relevant publicatins, presentatins, human subject cnsent frms, clinical prcedure r ther cnsent frms, educatinal material, etc., (4) versight by a disinterested senir individual r cmmittee, and/r (5) ther measures as deemed apprpriate Institutinal Cnflict in Human Subject Research: Primary cnsideratin will be given t ptential impact n the safety and welfare f human research subjects. In additin, the ptential impact f real r perceived institutinal cnflict n the integrity r credibility f research data that culd affect future clinical use will be cnsidered carefully. As apprpriate, the designated

6 Institutinal Cnflict f Interest Plicy Page 6 f 7 Vice President review will be crdinated with and prvided t the University s Institutinal Review Bard and Office f Research Cmpliance and Assurance fr its cnsideratin in exercising its respnsibility fr the prtectin f human research subjects Unmanageable Institutinal Cnflict: In cases where the cnflict is cnsidered nt manageable, the designated Vice President will reprt his/her recmmendatin t the apprpriate recipient f the recmmendatin with written justificatin. In cases judged t invlve an unmanageable institutinal cnflict, it is expected that the designated Vice President will make recmmendatins t eliminate cnflicting financial interests where practical in ways that d nt cmprmise the prpsed research, prfessinal, business transactin, r educatinal activity. Generally, the Institutin shuld give precedence t activities that carry ut Institutinal missins ver cnflicting financial interests. 6.0 PROCEDURES FOR REPORTING CONCERNS AND MECHANISMS FOR REVIEW Any University Official r emplyee wh has cncerns abut the legitimacy f any relatinship r activity n behalf f the University r its emplyees invlving an external relatinship shuld cnsult with his/her immediate supervisr r with ther individuals r thrugh ther mechanisms, including vic , , mail r fax, prvided fr in the applicable University plicy. If after examinatin f the situatin is determined that a ptential ICOI exists r the circumstances pse a cncern fr public perceptin f an ICOI, the matter shuld be referred t the designated Vice President f the divisin that invlves the activity fr investigatin. As such, areas that invlve fiscal r human resurce matters must be disclsed t the Vice President fr Financial Affairs and fr research related activities t the Vice President fr Research. In the event f a cnflict in decisin making, the matter will be referred t the University Cnflict f Interest Cmmittee. Any act f retaliatin r reprisal against an indiviudal fr reprting in gd faith a ptential ICOI r vilatin f this Plicy shall be a vilatin f this Plicy. Such vilatins will be dealt with thrugh regular administrative prcess fr vilatin f University plicies. 6.1 Appeals. When an individual with a ptential institutinal cnflict f interest als has an individual cnflict f interest, the appeal prcess under the individual cnflict f interest plicy applies as defined in Sectin 7.6 f the plicy n University Cnflict f Cmmitment/Financial Cnflict f Interest.

7 Institutinal Cnflict f Interest Plicy Page 7 f 7 Appendix - Examples f Institutinal Cnflicts f Interest While there is n inclusive list f institutinal cnflicts f interest, sme situatins naturally create ptential and actual institutinal cnflicts. The fllwing list is ffered as illustratins f situatins which require attentin. The University has a financial r business relatinship with an utside entity and that entity seeks t influence the award r terms and cnditins f a University cntract, the directin review r disseminatin f research, r the allcatin f resurces regardless f the type f financial r business relatinship. The University has a financial r business relatinship with an external entity, and decisins abut the activities related t the relatinship may affect the financial r business interests f the University. A University Leader is in a supervisry r administrative psitin, and a decisin n behalf f the University abut a financial r business relatinship with an external entity may directly affect the University Leader s persnal financial interest in that utside entity. The University hlds a financial interest in an utside entity and the University makes decisins regarding the financial and business relatinship with that utside entity which directly affect its wn financial interest in that entity. A University Leader is appinted t serve as an fficer, directr, r bard member f an utside entity that has financial r business relatinships with the University. The University invests funds with an utside entity and University Leaders apprving the investment have a persnal financial interest in the utside entity. Surce f Examples: University f Nrth Carlina Institutinal Cnflict f Interest Plicy