1. Howdo Iknowifi Have Tosubmitan Annualdisclosure Form?

FrequentlyAskedQuestions

Disclosure:

1. Howdo IknowifI have tosubmitan annualdisclosure form?

Allkey personnel involved in UI research,regardlessofthe presenceof/sourceof funding, mustsubmit an annual disclosureform. Key personnel are those individuals who arelistedin thepersonnel sectionof aUI Proposal Routing FormOR identified as such on an IRB application.

2. Whose name should be listed on a UIProposalRoutingForm?

Thefollowing individuals should belisted ona Routing Form and are, therefore, key personnel:

• Principal Investigator –individual(s)wholead the project,assuming responsibilityfor theproject’sfiscalmanagementand/or academicprogress.

• Co-Investigator(s)- individual(s)whocollaboratewiththePI(s)inthedevelopment or executionof theproject,contributing ameasurableefforttoadvancethe projectgoals, whethertheprojectbudgetincludessalaryfor theindividual or not.

• OtherKey Personnel –individual(s)whohavetheauthoritytomakeindependent decisionsaboutthedirection oftheresearch and thesubsequentconclusionsaboutthe results. Alsoincludesindividuals whoarelikelyto beauthorsonmanuscriptsor to presentresearch findingsatnationalconferences. It doesnot includeadministrative personnelor individualswhoperformroutine,pre-defined, or incidental tasksrelated to theproject.

3. WhatmustI disclose?

Youmustdiscloseanything ofmonetaryvaluethatbelongstoyou,your spouseand/oryour dependentchildrenthatisrelatedto yourUniversityresponsibilities.Thisincludes

• Stockorotherequityinterestin apublicly-tradedcompany
• Incomefroma publicly-traded company
• Stockorotherequity/ownership interestin aprivatecompany
• Incomefroma privatecompany
• Licensingor royaltyincomerelatedto your inventionsor copyrights
• Holding a company position with a fiduciary duty (legal responsibility to ensure the financial well-being of the company), such as Director, employee, officer, etc.
• For investigators with funding from the U.S. Public Health Service, details about reimbursedorsponsoredtravel (seeFAQ #10)

4. Do Ihaveto disclose paymentsfromanotheruniversity?

No, not if the university is in the U.S. Incomefromseminars,lectures,or teaching engagements sponsored bythe following types of U.S. organizationsdoes not have to be disclosed: an institutionof highereducation,academicteaching hospitals,or research institutesaffiliatedwith institutionsofhigher education. Note that payments from all non-U.S. institutions must be disclosed. Also, incomerelatedtointellectual propertyrights(patents,copyrights,etc.)fromanon-UI university must be disclosed.

5. Do I have to disclose that I review grant applications for the National Institutes of Health?

No, activities and travel sponsored by a local, state, or federal agency do not have to be disclosed.

6. I’m an officer in the American PhysiologicalSociety, a non-profit professional association. Do I have to disclose it?

If you are key personnelon research funded by the US Public Health Service, then you do have to disclose activities and sponsored/reimbursed travel related to this association. That is because the federal regulation specifies that researchers who receive or anticipate receiving PHS funding must disclose activities with non-profit entities as well as for-profit entities.

7. Whatis meant byUniversity responsibilities?

Universityresponsibilitiesare theprofessionalobligations involving your expertise,carried out onbehalfof the University.Examplesincludeactivitiessuchasresearch,researchconsultation,teaching,professional practice(e.g.,providing patientcare,accounting services, legal counsel),participation in purchasing decisions, evaluating productsor serviceson behalfof theUniversity, and serving on Universitycommittees such asthe InstitutionalReviewBoard.

8. Whatdoesownership interestmean?

Ownership interest meansanystock,stockoptions,orotherownership in a companythatis either publicly-traded (stockis availablefor purchase bythegeneral public)or non-publicly traded (privatelyheld,such asa start-up company).

9. Do Ihaveto disclose stockholdingssuch asmyTIAA-CREF accountormymutualfunds?

No. You don’t havetodisclose your investments,suchasmutual funds orretirementaccounts, aslong asyou do not directlycontroltheinvestmentdecisions.

10. Whataboutpaymentstomyspouse and dependentchildrenfrom outside entitiesand ownership intereststhattheyholdinoutside entities? Mustthese be disclosed?

If theoutsideentitiesarerelatedto your Universityresponsibilities,then asan individual involved in researchattheUniversity,youmustdisclosethesepayments and ownership interests.

11.Whathappens if myfinancialinterestschange duringthe period of the researchaward?

You haveanongoingobligation todisclosefinancial intereststhroughouttheyear. Youmust updateyour disclosureform within thirty(30)daysofa changein a previously-disclosedfinancial interestortheoccurrenceof/discoveryof a newfinancial interest.

Travel:

12.Do Ineed to disclose allreimbursed orsponsored travel?

Yes.You arerequired todisclosetheoccurrenceofanyprofessional travelwhereyourexpensesare either paidout-of-pocket(and then reimbursed bya non-UIentity)or paid directly bythe non-UI entitytotheairline,hotel, etc. Ifyouareinvolved in researchfunded bythe Public Health Service,you willneed to provideadditional details about your travel,including thenumberof days, estimatedamount oftravelexpenses,and thedestinations. Thisincludestravel reimbursedorsponsored bya non-profitentitysuch asa professional association.

However,disclosuredoesnotapplytotravelthatisreimbursedor sponsored bythefollowing typesoforganizations:

•a federal,stateor local governmentagency

•a U.S. institutionof higher education

•a U.S. academicteaching hospital

•a U.S. medicalcenter

•aU.S. research institutethatisaffiliated with an institution of highereducation

Finally,travelthatisrequired asa partof a research project,such astoattend aninvestigators’meeting,isnotrequired to bedisclosed.

Training Requirement:

13. Am I required to do conflict t of interest training?

Yes, all key personnel involved in research at the University are required to complete training on conflict of interest in research. The training module is built into the online disclosure system so that review of the content is required before you can complete your disclosure form.

Subcontracting under PHS Funding:

14.Iaminvolved inresearch that receivespass-throughfunding(forexample,fundingfromthe NationalInstitutesofHealth to anotheruniversity,then tothe UniversityofIowa.) Doesthis policyapplyto me?

If you are named as key personnel on the UI routing form or IRB application, then youmustsubmit an annual disclosureformof allofyourand your family’sfinancial interestsrelated to your Universityresponsibilities.

15. I plan to involve a researcher at another institution in my sponsored project. Does that researcher need to do a disclosure form also?

Yes, if the funding will be from the U.S. Public Health Service and if you determine that the outside researcher meets our definition of key personnel (doing a substantive portion of work; likely to be an author on study results; able to make independent decisions about the research), then he/she must complete a financial interest disclosure form prior to submission of your application to the funding agency. If the subrecipient organization certifies that it has its own conflict of interest policy that complies with the federal regulation, then the collaborating researcher will have already done an annual disclosure form at his/her organization, just as you have done at the UI. However, if the subrecipient organization does not have its own compliant policy, then it will be required to follow UI’s policy. That means that the researcher at that organization will need to complete the University of Iowa’s financial interest disclosure form and conflict of interest training module. If these are not completed by the grant submission deadline, then Sponsored Programs will require that subrecipient to be removed from your grant application. (See FAQs under Subrecipients.)

Management of Financial Conflict of Interest:

16. If the University determines that I have a conflict of interest, what happens next?

Research projects where a team member has a financial conflict of interest cannot be initiated until the Conflict of Interest in Research Committee (CIRC) had completed its review. The CIRC, which meets on a monthly basis, will review your financial interest and your research proposal and discuss the degree to which the interest could be directly and significantly affected by the research. CIRC members includes faculty representing a broad range of research disciplines, and they will decide if there are any management strategies that could allow you to participate in the research while preserving the objectivity of the research and avoiding the introduction of bias. In the vast majority of cases, a management plan is developed and, if approved by the Vice President for Research, it will be sent to you for signature.

Typical management plans require that the researcher:

• Disclose the conflict of interest in publications and presentations
• Disclose the conflict of interest to students, trainees, and other members on the research study team
• In the case of human subjects research, disclose in the informed consent document

At times, the management plan includes an obligation for independent, third party monitoring or data review

17.Mymanagementplan saysthat itis“subjectto monitoring.”Whatdoesthismean?

All management plansissued bytheOfficeof theVicePresidentfor Research aresubjectto monitoring. Thismeansyou could becontacted annuallyand asked toprovidedocumentation of yourcompliancewiththemanagementplan. Therefore,it’simportantthatyou retain copies of conflictof intereststatementssubmittedtojournaleditorsormeeting organizers.

Public Accessibility:

18. Will my disclosed financial interests be available to the public?

The University is required by federal regulation to make information about your financial interests publicly available if the following apply:

1. You are senior/key personnel on an active research project funded by the US Public Health Service;
2. Your financial interest is related to the research funded by the PHS;
3. The University has determined that your interest is a financial conflict of interest.

If the University receives a request from the public, and if your financial interest meets the above criteria, then the required information will be released to the requestor.

If your employment appointment is under the auspices of UI Health Care, data from your disclosure form will be published on a public web site, pursuant to their conflict of interest policy.

Students/Trainees:

19.Iamastudent/trainee (graduate studentorpost-doctoralfellow).Howdoesthispolicyaffectme?

If youarenamed as key personnel on a UI routing form or IRB application (seeFAQ#1),then youneed tosubmitan annual financial interest disclosure form.

Also,if yourmentor (laboratory director,thesis advisor,etc.)hasa financial conflictof interestrelatedto research inwhichyou participate,youwill beinformed in writingof yourmentor’sconflictof interest.