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Indiana State University Financial Conflict of Interest Policy Table of Contents

Section Application Page #

I. Introduction All investigators/agencies 2

II. Investigator Responsibilities All investigators/agencies 3

III. Institutional Responsibilities All investigators/agencies 3

IV. Designation of Institutional Official

All investigators/agencies 3

V. Administrative Process All investigators/agencies 4

VI. PHS Requirements Investigators seeking or awarded PHS funds

5

VII. NSF Requirements Investigators seeking or awarded NSF funds

12

VIII. State Requirements Investigators awarded State of Indiana funds

17

IX. Appendix All investigators 19

Acknowledgement: This PHS portion of this policy is largely based on draft policies the University of 1

Nebraska Lincoln and Eastern Illinois University. Indiana State University thanks UNL and EIU for 2

granting their permission to use their Conflict of Interest materials in the development of this policy. 3

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I. Introduction

______________________________________________________________________________

Indiana State University recognizes the importance of promoting objectivity in research for 1

which external funding is sought or accepted. This policy sets forth Indiana State University's 2 policy and procedures regarding significant financial conflicts of interest in relationship to 3 research or projects funded in whole or in part by external sponsors. The University and 4 investigators have a responsibility to manage, reduce, or eliminate any actual or potential 5 conflicts of interest that may be presented by a financial interest of an investigator. 6

7 Indiana State University’s policy is designed to comply with all relevant regulations of the 8

sponsoring entity. ISU acknowledges the following regulations and policies on which this policy 9 is based. 10 11 For work funded by the U.S. Public Health Service (PHS), including the National Institutes of 12

Health, Agency for Healthcare Research and Quality, the Health Resources and Services 13 Administration and other PHS agencies: 14

15 42 CFR Part 50 Subpart F (grants and cooperative agreements) 16 45 CFR Part 94 (contracts) Initial Regulation effective 10-1-95 17

http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm 18 Revised Final Rule published on 8-25-11 and effective August 2012: 19

http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf 20 21

For work funded by the National Science Foundation: 22 23

National Science Foundation’s Grant Policy Manual 05-131 § 510 24 25 For work funded by the U.S. Department of Education: 26

27 34 CFR Part 75.524, 28

34 CFR Part 75.525 and 29 34 CFR Part 74.42. 30

31 For Food and Drug Administration regulated research: 32 33

21 CFR Part 54. 34 35 For work funded by the state of Indiana: 36 37

Indiana Code 35-44-1-3 38 39 Any other relevant state, federal regulations or sponsor disclosure requirements applicable to the 40 work but not listed above. 41

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II. Investigator Responsibilities ______________________________________________________________________________

A. Disclose all financial interests (at time of submission and annually for PHS/NSF awards). 1 B. Complete training modules as required by relevant regulation. 2

C. Ensure that students, collaborators and subawardees submit required disclosures and 3 complete training as required by relevant regulation. 4

D. Work collaboratively with ISU to develop a management plan, if required. 5 E. Comply with ISU policies and procedures. 6

III. Institutional Responsibilities ______________________________________________________________________________

A. Develop and implement policies and procedures that promote compliance with relevant 7 regulations. 8

B. Provide information to Investigators, including: 9 a. the existence of the relevant federal and state regulations (see I. Introduction) 10 b. ISU’s FCOI policy 11

c. the Investigator’s responsibility to disclose financial interests 12 d. the Investigator’s responsibility to complete training 13

C. Evaluate Significant Financial Interests and identify any that qualify as a Financial 14 Conflict of Interest. 15

D. Work collaboratively with investigator(s) to develop a management plan, if required. 16

E. Report to the funding agency, if required. 17 F. For PHS funded work, make disclosure/management plan information available within 5 18

days of request as required. 19 G. Make the ISU Financial Conflict of Interest policy available on ISU’s website. 20

21

IV. Designation of Institutional Official 22

______________________________________________________________________________ 23

Indiana State University designates the Chief Research Officer as the Institutional Official 24 responsible for compliance with Financial Conflict of Interest regulations. The Institutional 25

Official shall solicit and review disclosures of significant financial interests from each 26 Investigator who is planning to participate in, or is participating in, the PHS-funded research. 27 Chief Research Officer may delegate any or all of these responsibilities by writing a letter that 28 documents the delegation. 29

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V. Administrative Process Overview

______________________________________________________________________________

1

2

Investigator submits the appropriate Financial Interest Disclosure Survey and

for PHS projects, completes training

Institutional Official (IO) or designee reviews ISU Financial Interest Disclosure Survey. OSP

submits initial disclosures with grant proposal

Conflict?

No action is required

Management is required

IO contacts the investigator for

clarification

Investigator meets with the COI committee, department chair, and/or dean to draft a

management plan

If required, IO submits management plan to agency and makes information publicly

available

Department chair works with the investigator to ensure that the

management plan is implemented

Post approval monitoring by COI Committee

Yes No Not sure

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VI. Public Health Service (PHS) Requirements

______________________________________________________________________________

A. Applicability 1

This portion of the policy applies to any ISU investigator who participates in the design, conduct 2

or reporting of research supported by PHS as a result of a proposal submitted or awarded on or 3

after August 24, 2012. This part of the policy also applies to subawardees, consultants and 4

collaborators on PHS projects. This policy does not apply to SBIR Program Phase I applications. 5

Indiana State University’s policy is designed to comply with all the regulations of PHS. ISU 6 acknowledges the following portions of the Code of Federal Regulations as the source of the 7 applicable regulations on which this section of the policy is based. 8

9 42 CFR Part 50 Subpart F (grants and cooperative agreements) 10 45 CFR Part 94 (contracts) Initial Regulation effective 10-1-95 11

http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm 12 13

Revised Final Rule published on 8-25-11 and effective August 2012: 14 http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf 15

16

This policy applies to projects funded by any agency within PHS including, but not limited to, 17 the following: 18

Administration for Children and Families (ACF) 19

Administration on Aging (AoA) 20

Agency for Healthcare Research and Quality (AHRQ) 21

Agency for Toxic Substances and Disease Registry (ATSDR) 22

Centers for Disease Control and Prevention (CDC) 23

Centers for Medicare & Medicaid Services (CMS) 24

Federal Occupational Health (FOH) 25

Food and Drug Administration (FDA) 26

Health Resources and Services Administration (HRSA) 27

Indian Health Service (IHS) 28

National Institutes of Health (NIH) 29

Substance Abuse and Mental Health Services Administration (SAMHSA) 30

B. PHS Definitions 31

Research. Research means a systematic investigation, study or experiment designed to 32

develop or contribute to generalizable knowledge relating broadly to public health, 33

including behavioral and social sciences research. The term encompasses basic and applied 34

research (e.g., a published article, book or book chapter) and product development (e.g., a 35

diagnostic test or drug). The term includes any such activity for which research funding is 36

available from NIH or any other PHS component. The funding may be a cooperative 37

agreement, a research grant, a career development award, a center grant, an individual 38

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fellowship award, an infrastructure award, an institutional training grant, a program project, 1

or a research resources award. 2

Investigator. An investigator is the project director or principal investigator or any other 3

person, regardless of title or position, who is responsible for the design, conduct, or 4

reporting of research funded by NIH or PHS or proposed for such funding. Collaborators, 5

consultants and some student employees are investigators. 6

Senior/key personnel. Senior/key personnel means the PD/PI and any other person 7

identified as senior/key personnel by the Institution in the grant application, progress 8

report, or any other report submitted to the PHS by the ISU as part of compliance with 9

FCOI regulations. (This definition differs from the one found in the NIH Grants Policy 10

Statement.) 11

PD/PI. PD/PI means a project director or principal investigator of a PHS-funded research 12

project; the PD/PI is included in the definitions of senior/key personnel and Investigator. 13

Institutional Responsibilities. Institutional responsibilities are an investigator’s professional 14

responsibilities on behalf of Indiana State University. Examples of institutional 15

responsibilities include—but are not limited to—teaching, research, research consultation, 16

professional practice, and service on university committees. 17

Institutional Official (IO). The designated person responsible for soliciting and reviewing 18

disclosures of significant financial interest from each investigator. The IO may delegate 19

these responsibilities in writing to other persons. 20

Financial Interest. A financial interest is anything of monetary value, whether or not the 21

value is readily ascertainable. A financial interest can be created by any of three routes. 22

1. Equity or remuneration from an entity: An investigator has a financial interest in an 23

entity if, within the twelve months preceding the reporting date, the investigator 24

receives remuneration from or owns equity in an entity. (A financial interest by the 25

investigator’s spouse or dependent child is considered to be a financial interest of the 26

investigator.) 27

2. Revenue from intellectual property: An investigator has a financial interest in 28

intellectual property (e.g., patents and copyrights) if he/she receives revenue from such 29

property within the twelve months preceding the reporting date. 30

3. Travel: An investigator has a financial interest in travel if, within the twelve months 31

preceding the reporting date, the investigator has received reimbursement or 32

sponsorship for travel that is related to institutional responsibilities. (Sponsorship 33

means that the travel is paid on behalf of the investigator, and the exact monetary value 34

may not be readily available.) However, travel support paid by a Federal, state, or local 35

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government agency, an institution of higher education, an academic teaching hospital, a 1

medical center, or a research institute affiliated with an academic institution does not 2

require disclosure. 3

Significant Financial Interest (SFI).A financial interest rises to the level of a SFI only if 4

three criteria are met: 5

1. The financial interest reasonably appears to be related to the investigator’s 6

institutional responsibilities. 7

2. The value of the financial interest exceeds specific threshold values. 8

a. Interest in a publicly traded entity, the sum of remuneration from and equity in 9

the entity exceeds $5,000. (Remuneration includes salary and any other payment for 10

services, e.g., consulting fees, honoraria, and paid authorship. Equity includes 11

stock, stock options, or other ownership interest, as determined through reference to 12

public prices or other reasonable measures of fair market value.) 13

b. Interest in a non-publicly traded entity, total remuneration from the entity 14

exceeds $5,000 or the investigator (or spouse or dependent child) holds any equity 15

interest. 16

c. Interest in intellectual property rights (e.g., patents and copyrights), total income 17

related to such rights exceeds $5,000 for property rights not held by the university. 18

d. Interest in travel, any reimbursed or sponsored travel paid by industry is a 19

significant financial interest. However, travel support paid by a Federal, state, or 20

local government agency, an institution of higher education, an academic teaching 21

hospital, a medical center, or a research institute affiliated with an academic 22

institution is not a significant financial interest and does not need disclosed. 23

3. The financial interest does not arise from any of the following sources, all of which 24

are excluded from the PHS definition of a significant financial interest: 25

a. Salary, royalties or other remuneration paid by ISU to the investigator. 26

b. Intellectual property rights that have been assigned to ISU and agreements to 27

share in royalties produced by such rights. 28

c. Income from investment vehicles such as mutual funds and retirement accounts, 29

provided the investigator does not control the investment decisions made in 30

these vehicles. 31

d. Income from seminars, lectures, or teaching engagements sponsored by a 32

federal, state, or local government agency, an institution of higher education, an 33

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academic teaching hospital, a medical center, or a research institute that is 1

affiliated with an institution of higher education. 2

e. Income from service on advisory committees or review panels for a federal, 3

state, or local government agency, institution of higher education, an academic 4

teaching hospital, a medical center, or a research institute that is affiliated with 5

an institution of higher education. 6

The foregoing five exclusions are the only ones that ISU recognizes as valid. 7

Indiana State University, rather than the investigator, makes the determination of 8

whether a financial interest should be considered a SFI. 9

Financial Conflict of Interest (FCOI). An SFI that could directly and significantly affect 10

the design, conduct, or reporting of research funded by NIH (or PHS) is a Financial 11

Conflict of Interest (FCOI). Indiana State University, rather than the investigator, makes 12

the determination of whether an SFI should be considered an FCOI. 13

FCOI Report. An FCOI report is ISU’s report of a financial conflict of interest which is 14

submitted to PHS. 15

16

C. Disclosure of financial interest related to research 17

The ISU Financial Disclosure Survey for PHS-Funded Programs must be completed annually by 18 all investigators. Disclosures must include the financial interests of investigator’s spouse and 19

dependent children as well as the investigator. Any changes to the information provided annually 20 must be submitted within 30 days of the change. Changes include, but are not limited to: 21

22

Creation of a new startup company 23

Sponsorship of a research project by a new outside entity 24

Changes in the amount of personal financial remuneration received from outside 25 entities, e.g. additional consulting 26

Engagement in or changes in an existing unremunerated service role or position, 27

e.g. serving on a Board of Directors of a non‐profit corporation 28

Submission of an SBIR Phase II or later or an STTR application 29

Reimbursed or sponsored travel 30

Addition of new investigators 31

32 As of August 2012, Public Health Service (PHS) rules require disclosure of reimbursed or 33 sponsored travel related to the investigator’s institutional responsibilities. Travel that is 34 reimbursed or sponsored by federal, state, or local government agencies, institutions of higher 35 education, academic teaching hospitals, medical centers, or research institutes affiliated with 36

Institution of higher education does not have to be disclosed. 37 38

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D. Training 1

Public Health Service (PHS) rules require that conflict of interest training occur prior to 2 engaging in research and every 4 years following the initial training. In addition, training may be 3 required when there is a change in institutional policies, an investigator joins ISU or there is a 4 case of noncompliance. The Financial Conflict of Interest training modules can be accessed at 5 https://www.citiprogram.org . 6

7

E. Guidelines for Analyzing Financial Interests 8

Upon receipt of the ISU Financial Disclosure Survey for PHS-Funded Programs, IO shall use the 9

definition found in this policy (see section V. B. Significant Financial Interest) to identify SFI’s. 10

After determining that a financial interest is a SFI, the Institutional Official shall use the 11

following two criteria to determine whether each SFI is a Financial Conflict of Interest: 12

1. The SFI could be affected by the PHS-funded research, or the SFI is in an entity 13

whose financial interest could be affected by the research. 14

2. The SFI could directly and significantly affect the design, conduct, or reporting of 15

PHS-funded research. 16

If both criteria are true of a given SFI, then the Institutional Official shall determine that the SFI 17

is a Financial Conflict of interest. 18

F. Management of Financial Conflicts of Interest 19

Once a FCOI has been identified and documented, Indiana State University shall be responsible 20

for developing and implementing a management plan that shall specify the actions that have 21

been, and shall be, taken to manage such financial conflict of interest. The Institutional Official 22

shall develop this management plan in consultation with the investigator, the department chair 23

and dean. Management plans will be implemented when the PHS-funded research begins or 24

within 60 days of the disclosure of a new SFI. A management plan may specify any or all of 25

three options: manage, reduce, or eliminate the FCOI. Examples of each type of action include, 26

but are not limited to the following: 27

Manage: Public disclosure of financial conflicts of interest (e.g., when presenting or 28

publishing the research). For research projects involving human subjects research, 29

disclosure of financial conflicts of interest directly to participants. 30

Reduce: Appointment of an independent monitor capable of taking measures to protect the 31

design, conduct, and reporting of the research against bias resulting from the financial 32

conflict of interest. Modification of the research plan. Change of personnel or personnel 33

responsibilities, or disqualification of personnel from participating in all or a portion of the 34

research. Reduction of the financial interest (e.g., by sale of equity interest) 35

Eliminate: Elimination of the entire financial interest (e.g., by sale of equity interest) or 36

severance of relationships that create financial conflicts. 37

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1

G. Management Process 2 Management plans are the typical vehicle for managing most conflict of interest situations. The 3 disclosure and management process is described below. 4

1. The faculty, staff member or student completes the ISU Financial Disclosure annually. 5 2. The IO or Director of the Office of Sponsored Programs (OSP) evaluates each Disclosure. 6 3. If no management plan is necessary, the IO or Director of OSP notifies the person who 7

submitted the disclosure. If a management plan is necessary, IO or the conflict of interest 8 committee meets with the faculty, staff member or student and their immediate supervisor, 9 department head/chair and/or dean/director as appropriate to develop and approve a 10 management plan. A management plan may include elements such as: 11

Disclosure of the conflict of interest in all presentations and publications, written 12 notification to the research sponsor, and in the informed consent to human 13 research participants 14

Independent monitoring of the research or other academic project (Scientific 15 Advisory Board) 16

Eliminate potential bias through means such as modifying the scope of the project, 17 and/or setting timetables for delivery of the product 18

Designate a colleague or department chair with no conflict of interest relationship 19 to the research to serve as an academic co‐advisor or lead investigator 20

Divest the financial interest giving rise to the conflict 21

Sever relationships that are the source of the conflict of interest 22

Remove contract terms that create the conflict of interest in research (e.g., where 23 payment depends upon the outcome of the research) 24

After careful consideration, disqualify an individual from participation in the project 25 (Only in rare instances will the committee determine that no management 26 plan can manage, reduce, or eliminate the conflict of interest adequately.) 27

4. OSP reports to the federal funding agencies that the management plan has been established if 28 required. 29

5. If a FCOI is not identified or managed in a timely manner (ie: non-compliance to the disclosure 30 requirements or management plan), ISU will complete a retrospective review of the 31 Investigator’s activities and research project to determine whether the research was biased. If 32 bias is found, ISU will notify PHS and submit a Mitigation Report. 33

34

H. Records 35 Records of disclosures and management plans will be kept for a minimum of three years following the 36 end of the grant or contract period. 37 38

I. Post-approval Monitoring 39 An appropriate management plan must be in place before the University will accept any sponsored 40 award in which a financial or management conflict is judged to exist. Post‐approval monitoring 41 processes may be put into place and can include updates to the Financial Interest Disclosure Survey, 42 reviews of student progress, and visits to the laboratory, research center, office, or place of business of 43 the faculty, staff member or student. Any post‐approval monitoring requirements will be included in the 44 approved management plan. 45 46 All disclosure forms, records, management plans, and minutes from the conflict of interest 47

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committee meeting will be retained by OSP for seven years following the end of the research 1 activity. This information is confidential and available only to pertinent personnel. 2

J. Corrective Action 3 Failure of the faculty, staff or students to comply with the conflict of interest policy or failure to 4 comply with the management plan will be referred to the IO, the conflict of interest committee and the 5 department head/chair for noncompliance review. Failure to comply will also be reported to the 6 awarding agency and corrective action may affect the award process. The University may also decline or 7 withhold funding in all cases in which the investigator does not comply with the established conflict of 8 interest management plan. Other consequences may include a letter of reprimand or the removal of an 9 investigator from an ongoing project and corrective action may result up to and including termination of 10 employment. 11 12 For PHS research and any other sponsor with reporting requirements, the Director of Office of 13 Sponsored Programs will notify the relevant agency when the IO and the conflict of interest committee 14 have determined that noncompliance occurred. 15 16 PHS also requires each institution to conduct a retrospective review in those cases of noncompliance 17 with the regulation. The Institution will be required to notify the PHS Awarding Component promptly 18 and submit a report to the PHS Awarding Component only in cases where bias is found. The report will 19 address the impact of the bias on the research project and the actions the Institution has taken, or will 20 take, to eliminate or mitigate the effect of the bias. 21

K. Appeal Process 22

A decision by the conflict of interest committee may be appealed to the IO within 30 days of the date of 23 notification of the committee's decision. 24 25

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VII. National Science Foundation (NSF) Requirements

______________________________________________________________________________

A. Background 1

2 On June 28, 1994, the National Science Foundation (NSF) issued notice of its policy on financial 3 disclosure by scientific investigators in sponsored research (59 Fed. Reg. 33308), which is 4 designed to protect the integrity of NSF-funded research and at the same time to promote sharing 5

and publication of research results. The notice, entitled Investigator Financial Disclosure 6 Policy, became effective October 1, 1995. 7 8 Placing primary responsibility on the institution to develop information-gathering and reporting 9 procedures, the National Science Foundation requires that grantee institutions employing more 10

than 50 persons maintain "an appropriate written and enforced policy on conflict of interest." 11 Researchers and institutional representatives must comply with the institutional requirements. 12 13

B. Requirements 14

Federal regulations require institutions to have policies and procedures in place to ensure that 15

investigators disclose any significant financial interest that may present an actual or potential 16 conflict of interest in relationship to externally sponsored projects. Such disclosures must be 17

made prior to the submission of a proposal for funding; and institutions must certify compliance 18 on each proposal as well as develop specific mechanisms by which conflicts of interest will be 19 satisfactorily managed, reduced, or eliminated, prior to award or acceptance of an award. The 20

institution must also maintain appropriate records. If a new reportable significant conflict of 21

interest arises at any time 22 during the period after the submission of the proposal through the period of the award, the filing 23 of a disclosure is also required. 24

25

C. NSF Definitions 26

The term investigator means the principal investigator, co-principal investigator(s), and any 27 other person at the University who is responsible for the design, conduct, or reporting of research 28 or educational activities, funded or proposed for funding by an external sponsor. In this context 29

the term investigator includes the investigator's spouse and dependent children. 30 31 A conflict of interest may take various forms, but arises when a principal investigator is or may 32 be in a position to influence the University business, research, or other decisions in ways that 33

could lead to any form of personal gain for the principal investigator (including his/her spouse 34 and/or dependent children) or give improper advantage to others to the University's detriment. 35 36 A potential conflict of interest occurs when there is a divergence between an individual's private 37 interests and his or her other professional obligations to the institution such that an independent 38

observer might reasonably question whether the individual's professional actions or decisions are 39 determined by considerations of personal gain, financial or otherwise. An actual conflict of 40 interest depends on the situation, and not on the character or actions of the individual. 41 42

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An actual or potential conflict of interest exists when the reviewers reasonably determine that a 1

significant financial interest could affect the design, conduct, or reporting of the research or 2 educational activities, funded or proposed for funding by an external sponsor. 3 4

Significant financial interest means anything of monetary value, including, but not limited to, 5 salary or other payment for services (e.g., consulting fees or honoraria); equity interest (e.g., 6 stocks, stock options, or other ownership interests); and intellectual property rights (e.g., patents, 7 copyrights, and royalties from such rights). 8 9

The term does not include (a) salary, royalties, or other remuneration from Indiana State 10 University; (b) income from seminars, lectures, or teaching engagements sponsored by public or 11 nonprofit entities; (c) income from service on advisory committees or review panels for public 12 or nonprofit entities; (d) salary, royalties or other payments that, when aggregated for the 13

investigator and the investigator's spouse and dependent children, are not expected to exceed 14 $10,000 during the twelve month period; (e) any ownership interests in the institution, if the 15

institution is an applicant under the Small Business Innovation Research Program or Small 16 Business Technology Transfer Program; or (f) an equity interest that, when aggregated for the 17

investigator and the investigator's spouse and dependent children, meets both of the following 18 tests: does not exceed $10,000 in value as determined through reference to public prices or other 19 reasonable measures of fair market value, and does not represent more than a 5% ownership 20

interest in any single entity. 21 22

Significant financial interests which must be disclosed are (a) any financial interests of the 23 investigator (including those of the investigator's spouse and dependent children) that would 24 reasonably appear to be directly and significantly affected by the research or educational 25

activities funded or proposed for funding by an external sponsor; or (b) entities whose financial 26

interests would reasonably appear to be directly and significantly affected by the sponsored 27 activities. 28 29

D. Policy 30

1. Indiana State University requires each investigator submitting a proposal for NSF funding to 31

submit all required financial disclosures at the time of proposal submission and to update this 32 information annually or as new interests are obtained during the life of the award. 33

34

Disclosure of significant financial interests shall be made to the Office of Sponsored 35 Programs (OSP) by completing the ISU Financial Conflict of Interest Disclosure Survey for 36 NSF-funded Programs. 37

38

2. In accordance with NSF regulations, a complete disclosure must be made by the investigator 39 prior to submission of the proposal. 40

41 3. The procedure to review disclosures, assess their potential for conflicts of interest, and 42

develop resolution strategies to "manage, reduce or eliminate" such conflicts shall be 43

incorporated with the standard proposal signature process and integrated into the normal 44 proposal submission process. 45

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4. A conflict of interest review committee, its members appointed by the Chief Research 1

Officer, shall be charged with responsibility for review of significant financial disclosures to 2 determine whether an actual or potential conflict of interest exists; determine what conditions 3 or restrictions, if any, should be imposed by the institution to manage, reduce, or eliminate 4

such conflicts of interest; and as necessary, recommend sanctions. 5 6 5. The Office of Sponsored Programs shall be responsible for appropriate follow-up reporting 7

and records management procedures. 8

9

E. Guidelines 10

1. Each investigator is required to disclose the following significant financial interests: 11

12 i. any significant financial interest of the investigator that would reasonably appear to be 13

directly and significantly affected by the research or educational activities funded, or 14 posed for funding, by an external sponsor; or 15

16 ii. any significant financial interest of the investigator in an entity whose financial interest 17

would reasonably appear to be directly and significantly affected by the research or 18 educational activities funded, or proposed for funding, by an external sponsor. 19

20 Regardless of the above minimum requirement, a faculty or staff member, in his or her own 21

best interest, may choose to disclose any other financial or related interest that could present 22

an actual conflict of interest or be perceived to present a conflict of interest. Disclosure is a 23 key factor in protecting one's reputation and career from potentially embarrassing or harmful 24

allegations of misconduct. 25

26

2. Each investigator shall complete ISU Financial Conflict of Interest Disclosure Survey for 27 NSF-funded Programs. As required by NSF regulation, all significant financial interests must 28 be disclosed prior to the time a proposal is submitted. Information about this survey can be 29

found at the OSP website at http://www.indstate.edu/osp . 30 31

Supporting documentation that identifies the business enterprise or entity involved and the 32 nature and amount of the interest should be submitted electronically or in hard copy to the 33 Director of the Office of Sponsored Programs. 34

35 3. All financial disclosures must be updated by investigators during the pendency of the award, 36

either on an annual basis or as changes are made to previously reported significant financial 37

interests. If a new reportable significant financial interest arises at any time during the period 38

after the submission of the proposal through the entire period of any resulting award, the 39 filing of a disclosure form is also required. 40

41 4. The Director of Sponsored Programs or official designee shall conduct an initial review of all 42

financial disclosures to determine if any disclosed significant financial interest could affect 43

the design, conduct, or reporting of the proposed sponsored project. If the initial 44 determination is made that there may be a potential for conflict of interest covered by this 45

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policy, then the disclosure packet will be referred to the conflict of interest review 1

committee. 2 3 Committee members are appointed by the Chief Research Officer. The committee shall 4

contain, at a minimum, researchers representing a cross section of disciplines, a research 5 administrator, and other appropriate University personnel. The committee shall determine 6 what conditions or restrictions, if any, should be imposed by the institution to manage actual 7 or potential conflicts of interest arising from disclosed significant financial interests. 8

9

5. Prior to consideration by the conflict of interest review committee, the investigator, in 10 cooperation with the investigator's department and school or college, shall develop and 11 present to the committee a resolution plan that details proposed steps that will be taken to 12 manage, reduce, or eliminate any actual or potential conflict of interest presented by a 13

significant financial interest. 14 15

At a minimum the resolution plan shall address such issues as public disclosure of significant 16 financial interests, review of research protocol by independent reviewers, and monitoring of 17

research by independent reviewers. 18 19 Where the committee deems appropriate, the committee shall review the resolution plan and 20

approve it, add conditions or restrictions, including the following: (1) modification of the 21 research plan, (2) disqualification from participation in all or a portion of the research 22

funded, (3) divestiture of significant financial interests; (4) severance of relationships that 23 create actual or potential conflicts of interest; (5) public disclosure of significant financial 24 interests; or (6) monitoring of research by independent reviewers. 25

26

If the committee determines that imposing the above-referenced conditions or restrictions 27 would be either ineffective or inequitable, and that the potential negative impacts that may 28 arise from a significant financial interest are outweighed by interests of scientific progress, 29

technology transfer, or the public health and welfare, then the committee may recommend 30 that the research go forward without imposing such conditions or restrictions. In these cases, 31

the Chief Research Officer shall make the final decision regarding resolution. 32 33

6. The approved resolution plan shall be incorporated into a memorandum of understanding that 34 details the conditions or restrictions imposed upon the investigator in the conduct of the 35 project or in the relationship with the business enterprise or entity. The memorandum of 36 understanding shall be signed by the investigator and the investigator's chair and dean. 37

Actual or potential conflicts of interest will be satisfactorily managed, reduced, or eliminated 38 in accordance with these guidelines prior to accepting any award, or they will be disclosed by 39 the Office of Sponsored Programs to the sponsoring agency for action. 40

41 7. Records of investigator financial disclosures and actions taken to manage actual or potential 42

conflicts of interest shall be retained by the Office of Sponsored Programs until three (3) 43 years after the later of the termination or completion of the award to which they relate, or the 44 resolution of any government action involving those records. All records, forms, 45

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correspondence, and all copies thereof shall be returned to the investigator at the 1

determination of award or resolution of government action involving those records. 2 3 8. Whenever an investigator has violated this policy or the terms of the memorandum of 4

understanding the conflict of interest review committee shall recommend sanctions which 5 may include disciplinary action ranging from a public letter of reprimand to dismissal and 6 termination of employment. The committee's recommendations on sanctions shall be 7 presented to the investigator's chair and dean who, in consultation with the director of the 8 Office of Sponsored Programs, shall enforce any disciplinary action in accordance with the 9

University procedures then in force. 10 11 9. The Director of Sponsored Programs or official designee shall report annually to the Provost 12

and Vice President for Academic Affairs about the status and workings of this policy and the 13

actions of the conflict of interest review committee. 14 15

16

17

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VIII. State of Indiana Requirements

______________________________________________________________________________

A. Disclosure Requirement 1

This form is intended to meet the requirements for disclosure of a pecuniary (financial) interest 2 under Indiana's Conflicts of Interest Law, I.C. 35-44-1-3, as amended. Public servants can 3 avoid violating that law by making a disclosure of their pecuniary interests in contracts or 4 purchases made by the governmental entity which they serve, provided that the disclosure is 5

submitted to the entity prior to final action on the contract or purchase and complies with I.C. 6 35-44-1-3(d) or (i). 7

B. Definitions 8

A public servant has a "PECUNIARY INTEREST" in a contract or purchase if the contract or 9 purchase will result or is intended to result in an ascertainable increase in the income or net 10

worth of the public servant or a dependent of the public who (a) is under direct or indirect 11

administrative control or the public servant, or (b) receives a contract or purchase order that is 12 reviewed, approved, or directly or indirectly administered by the public servant. "Dependent" 13

means any of the following: (1) the spouse of a public servant; (2) a child, stepchild or adoptee 14 of a public servant who is unemancipated and less than 18 years of age; or (3) any individual 15 more than one-half of whose support during a year is provided by the public servant. The 16

following interests should also be disclosed: that of an owner or partner of a proprietorship, 17 firm, partnership, or association; or that of a shareholder, director, trustee or officer of a 18

corporation, whether for profit or not for profit. An employment relationship need not be 19 disclosed unless that employee shares directly or indirectly in the revenues or profits of his/her 20

employer. 21

A "PUBLIC SERVANT" is defined in I.C. 35-44-1-24 as a person who: 22

1. Is authorized perform an official function on behalf of, and is paid by, a 23 governmental entity; 24

2. Is elected or appointed to office to discharge a public duty for a governmental entity; 25 or 26

3. With or without compensation, is appointed in writing by a public official to act in 27 an advisory capacity to a governmental entity concerning a contract or purchase to be 28 made by the entity. 29

4. According to an Opinion issued by the Attorney General or Indiana, all of the 30

university's trustees, officers and employees are considered to be "public servants" as 31 that term is used in I.C. 35-44-1-3/. Therefore, such persons should follow the 32 statutory procedures for disclosing any pecuniary interest that they may have in a 33

contract or purchase made by the University (other than their contracts or 34 employment with the University). 35

In cases where a state supported college or university makes contracts or purchases of a 36 particular type on a regular basis from a particular vendor, a public servant who has a 37

18 Rev 6/28/12

pecuniary interest in such contracts or purchases is only required to file a disclosure statement 1

on an annual basis. 2

C. Sanctions 3

Criminal liability cannot be imposed on account of a conflict of interest in the following 4 situations, even though no disclosure is made: 5

(a) Where the contract or purchase involves utility services from a utility 6

whose rate structure is regulated by the state and federal government; 7

(b) Where the public servant's interest in the contract or purchase and all 8 other contracts and purchases made by the governmental entity during the 12 9 months before the date of the contract or purchase was $250 or less; 10

(c) Where the public servant acts only in an advisory capacity for a state 11 supported college or university and does not have authority to act on behalf 12

of the college or university in a matter involving a contract or purchase. 13

NOTICE: It is the responsibility of each public servant --- not the University or its 14

representatives --- to determine whether he/she is required to make a disclosure under the 15 Indiana Conflicts of Interest Law and, if he/she determines that such a disclosure is necessary, 16 to make it in a timely and proper manner. Violation of this law is a Class D felony, punishable 17

by imprisonment for 1 1/2 years and a fine of not more than $10,000. 18

Disclosures to ISU should be sent to the Office of the Legal Affairs for consideration and 19 action by the Board of Trustees. 20

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Appendix 1

2

Financial Conflict of interest (FCOI) can result from a variety of situations ‐ the 3

following table represents some common situations along with the recommended 4

management. 5

Research Bias Issue III.a: Having a financial interest or holding a management position in a company that sponsors research may lead to biased research results. Conflict: Investigator(s) may be conflicted about: (c) Publishing potentially damaging research findings in the open literature without regard for the company’s reputation - OR – (d) Censoring research findings that might Damage the sponsoring company

Recommendation:

Prior to submission for publication, authors should have the manuscript internally reviewed by a peer without COI issues

Authors should disclose their business relationships with research sponsors in publication

Student authors should be reminded of the Student Advocate for COI issue

Anyone holding an ownership or management position in the Entity may not be the chair of the thesis committee

The voting majority of the committee must not have an ownership or management position in the entity

The Research Compliance Office will meet with the student annually

Issue III.b: Having a financial interest or holding a management position in a company with a license to technology invented at ISU may lead to biased research results. Conflict: Investigator(s) may be conflicted about:

(a) Publishing potentially damaging research findings in the open literature without regard for the company’s reputation -OR-

(b) Censoring research findings that might damage the sponsoring company

Recommendation:

Prior to submission for publication, authors should have the manuscript internally reviewed by a peer without COI issues

Authors should disclose their business relationships with research sponsors in publications

Student authors should be reminded of the Student Advocate for COI issues

Anyone holding an ownership or management position in the Entity may not be the chair of the thesis committee

The voting majority of the committee must not have an ownership or management position in the entity

The Research Compliance Office will meet with the student annually

20 Rev 6/28/12

Issue III.c: Having a financial interest or holding a management position in a company receiving a subcontract from an ISU grant may lead to biased research results. Conflict: Investigator(s) may be conflicted about: (a) Using grant funds to support university re- search -OR- (b) Using the funds to further advance the company efforts

Recommendation:

Authors should disclose their business relationships with research sponsors in publications

Student authors should be reminded of the Student Advocate for COI issues

Senior Vice Chancellor for Business and Finance approval is required

Issue III.d: Accepting sponsored research from a company with a license to technology invented at ISU may lead to biased research results Conflict: Investigator(s) may be conflicted about:

a) Publishing potentially damaging research findings in the open literature without regard for the company’s reputation -OR-

b) Censoring research findings that might damage the sponsoring company

Recommendation:

Prior to submission for publication, authors should have the manuscript internally reviewed by a peer without COI issues

Authors should disclose their business relationships with research sponsors in publications

Student authors should be reminded of the Student Advocate for COI issues

Anyone holding an ownership or management position in the Entity may not be the chair of the thesis committee

The voting majority of the committee must not have an ownership or management position in the entity

The Research Compliance Office will meet with the student annually

Issue III.e: Allowing an outside entity to provide salary for investigator(s) may lead to biased research results. Conflict: Investigator(s) may be conflicted about:

(a) Publishing potentially damaging research findings in the open literature without regard for the company’s reputation -OR-

(b) Censoring research findings that might damage the sponsoring company

Recommendation:

Prior to submission for publication, authors

should have the manuscript internally

reviewed by a peer without COI issues

Authors should disclose their business

relationships with research sponsors in

publications

Student authors should be reminded of the

Student Advocate for COI issues

Anyone holding an ownership or management

position in the Entity may not be the chair of

the thesis committee

The voting majority of the committee must

not have an ownership or management

position in the entity

The Research Compliance Office will meet with the student annually

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Issue III.f: Consulting for companies or businesses that university employees endorse in their university position may lead to biased research results Conflict: Investigator(s) may be conflicted about: (a) Publishing potentially damaging research findings in the open literature without regard for the company’s reputation -OR-

(b) Censoring research findings that might damage the sponsoring company

Recommendation:

Authors should disclose their business relationships with research sponsors in publications

Student authors should be reminded of the Student Advocate for COI issues

Anyone holding an ownership or management

position in the Entity may not be the chair of

the thesis committee

The voting majority of the committee must

not have an ownership or management

position in the entity

The Research Compliance Office will meet with the student annually