These guidelines and procedures apply to: (1) all academic appointees, including part-time and visiting faculty, faculty who are neither tenured nor on tenure-track appointments, lecturers, and academic specialists; (2) students, and anyone else with an appointment at IU who is involved in the design, conduct, or reporting of research, teaching, or service; and (3) retired faculty to the extent that they are still actively performing research, teaching, or providing service under the auspices of the university.

State Law

Interests in University Purchases or Contracts

According to Indiana state law, it is a criminal offense for university employees and their dependents to have an aggregate financial interest of $250 or more per year in, or deriving an aggregate profit of $250 or more per year from, any contract(s) or purchase(s) connected with the university, unless certain exceptions apply. The terms of the state conflicts law are set forth in the Statement of Compliance with State Law on Conflicts of Interest (http://www.in.gov/legislative/ic/code/title35/ar44/ch1.html ).

Required Disclosures

1. All academic appointees must disclose any significant financial interest of themselves or their Family Members that would reasonably appear to affect, or be affected by the research, teaching, service, or other professional activities in which they are engaged as part of their university responsibilities. However, academic appointee engaged in medical or clinical trial research shall disclose all financial interests of themselves, or of outside entities in which they hold significant financial interests, that reasonably would appear to affect or be affected by that research, without regard to any monetary threshold. The following must be disclosed unless listed as an exclusion:

Disclosures required by the IU COI Policy:

• • 1. An equity interest that exceeds $10,000 or represents more than a 5% ownership interest in any one enterprise or entity (equity in a privately held entity for which the value is not known will be treated as above the 5% threshold), when aggregated for the Academic Appointee or Family Members;
    2. Salary, royalties, or other payments expected to exceed $10,000, when aggregated for the Academic Appointee or Family Members over the twelve month period.

Other Required Disclosures:

1. Compensation to the Academic Appointee or Family Members of any amount that could be higher for a favorable outcome than for an unfavorable outcome, such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest;
2. Proprietary or other financial interest by the Academic Appointee or Family Members in the product to be used in clinical trials including, but not limited to, a patent, trademark, copyright or licensing agreement. Fiduciary, director, board, or executive position of the Academic Appointee or Family Members in any enterprise or entity regardless of whether the position is compensated.

GUIDELINES FOR IDENTIFYING CONFLICTS OF INTEREST

The Policies of Indiana University references state statutes and federal guidelines regarding conflicts of interest, and the Code of Academic Ethics addresses ethical conduct generally. The IU Indianapolis guidelines and procedures on Conflicts of Interest specifically address conflicts of interest arising from relationships between academic appointees and external entities. These guidelines and procedures call for disclosure and review of relationships with external entities and avoidance or resolution of conflicts of interest.

Relationships with external entities arise from a variety of academic and external activities. Activities with external entities are organized in five broad categories listed below. A representative list of activities subject to these guidelines and procedures on Conflicts of Interest is set forth below. The first category does not require disclosure while those in Category II-IV must be disclosed by academic appointees before any definitive action by them takes place. The responsible department head and dean shall promptly review the disclosures represented in Category II and determine the appropriate course of action. Disclosures represented in Category III-IV shall be promptly reviewed by the responsible dean and then reviewed by the appropriate campus conflict of interest review sub-committee (Health Science or General Academic). The respective conflict review sub-committee will forward their recommendations to the chancellor (or chancellor’s designee) for a final determination. Such activities may be permitted after disclosure, review and agreement to proposed management plans. If in doubt about whether an Activity falls in Category I through V, an Academic Appointee should confer with the dean or other person designated in school or unit procedures.

1. Category I - Activities Normally Acceptable – No Disclosure is required. The following are examples:
   1. Receipt of royalties from licensed University technology when no further related research, teaching or service activities will be pursued within the University by the individual.
   2. Receipt of royalties or honoraria for published scholarly works, commissioned papers, and occasional lectures.
   3. Serving as a consultant to a domestic government agency.
   4. Isolated, nonrecurring consulting activities that result in payments which do not exceed an income of $10,000 annually from a single source.

2. Category II - Activities Unlikely To Lead To Conflicts of Interest –These activities will be reviewed by the dean or the dean’s designee of the school in which the Academic Appointee is appointed. If an individual wishes to appeal the administrative decision, the individual may request a review by the Campus Conflict of Interest Committee.
   1. Receipt of income from multiple sources (with no single source providing more than $10,000 of annual income) for lectures or consulting activities that result in an annual income equal to or greater than $10,000.
   2. Receipt of annual income equal to or greater than $10,000 for lectures or consulting activities that are not related to current university responsibilities

2. Category III - Activities with Potential for Conflicts of Interest –These disclosures will be reviewed by the dean or the dean’s designee of the school in which the Academic Appointee is appointed and then referred to the appropriate campus Conflict of Interest Advisory Committee for recommendations to the individual’s dean or the dean’s designee. The following are examples:
   1. Receipt of income from a single source for lectures or consulting activities that result in an annual income equal to or greater than $10,000.
   2. Activities (independent of compensation) that use University personnel to further external professional activities, especially when the individual or immediate Family Members has a Financial Interest related to the activities

4. 3. Assigning or permitting the participation of University personnel in activities sponsored by an external entity in which the individual or immediate Family Member has a Financial Interest.
   4. Support for research, except for clinical studies (see 4.1), from a business in which the Academic Appointee or Family Members have a Financial Interest.
   5. Research evaluating technology, except for clinical studies (see 4.2), that is owned by a business in which the Academic Appointee or their immediate Family Members have a Financial Interest.
   6. Conducting or reporting on research activities related to technology for which the individual or their Family Members has Royalty Income from Licensed Technology.
5. Category IV - Activities that Present a High Potential for Conflicts of Interest. These activities must be reviewed by the dean or the dean’s designee of the school in which the Academic Appointee is appointed and then referred to the appropriate campus Conflict of Interest Advisory Subcommittee for recommendations to the individual’s dean or the dean’s designee. The following are examples:

1. 1. Clinical research           in which the Academic Appointee or member of his/her Family Member has a

Financial Interest or Royalty Income from Licensed Technology.

1. 2. Evaluating technology in clinical studies that is owned by a business in which the Academic Appointee or his/her Family Member has a Financial Interest.
   3. Commitment of University space or other resource by an entity for which the Academic Appointee working in that laboratory’s department or section is a consultant and/or he or she or a member of his/her Family Member has a Financial Interest.
   4. Agreements with any entity or entities which provide exclusive access to information, developed with University resources or supported by independent sponsors, to an entity in which the Academic Appointee or Family Member has a Financial Interest.
   5. Acceptance for personal benefit of compensation from an entity for serving on the governing or advisory body when the Academic Appointee has been appointed to that position by the University or is representing the University in that position.
   6. Applying for, receiving, and conducting any sponsored research activities for another organization that ordinarily would be conducted under the auspices of the University.

4. 7. An Academic Appointee or Family Member assuming a board, director, fiduciary, or executive position in an External Entity engaged in activities related to the Academic Appointee’s University research.
5. Category V - Activities that are Not Allowable - - The following are examples:

1. 1. Acceptance of payments, consideration, or honoraria that substantially exceed the value of services provided.
   2. Agreements with any entity or entities contracted through the University that prohibit or unduly limit publication, or evaluation of project data by bona fide internal or external reviewers, or which link payment to favorable research results.

1. 3. Compensation to the Academic Appointee or Family Members of any amount that could be higher for a favorable outcome than for an unfavorable outcome, such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.

1. 4. Responsibility for making or influencing administrative decisions on behalf of the University regarding activities that may benefit the individual’s Financial Interests. Persons (Academic Appointee, and administrators) who have this type of conflict of interest must excuse themselves from participation in the decision making process and also must make sure that subordinates do not participate in the decision making.

IMPLEMENTATION

All IU Indianapolis employees and others to whom this policy applies on the IU Indianapolis campus must annually file a disclosure statement of financial interests.  Academic Appointees and others who serve as principal investigators will submit the names of all individuals under their supervision who are involved with the design, conduct or reporting of research. These individuals must also annually file disclosure statements of financial interests to the dean of the school in which they are appointed.

All disclosure statements are to be submitted to the dean’s office of the individual submitting the disclosure statement. The dean or the dean’s designee will review submitted disclosure statements within 30 days. For those activities that require management by the University, the dean or the dean’s designee will determine whether the decisions can be administered within the school (typically Category II activities), or the activities need to be refereed to the Campus Conflict of Interest Committee (typically for Category III and IV activities. The dean or the dean’s designee should work with the individual to develop a management plan to minimize the potential conflict of interest issues. Management plans should seek to ensure the objectivity of the University activity and that the Financial Interest does not affect the protection of Human Subjects.

Deans shall annually submit financial disclosure statements to the Chancellor or the Chancellor’s designee. The review of these disclosure statements will be handled in a manner similar to the procedures described above for academic employees.

The disclosure statement and proposed management plan will be reviewed by the appropriate subcommittee (Health Science or General Academic) of the campus Conflict of Interest Committee. The Committee recommendations are transmitted back to the individual and dean or the dean’s designee for implementation. Examples of management plans may include one or more of the following:

1. 1. 1. Disclosure - Disclosure is required in every case approved by the dean or Chancellor, including: (i) public disclosure of the financial interests of the Academic Appointee in all relevant publications, presentations (whether or not academic presentations), and (ii) disclosure to the appropriate co-investigators, members of the laboratory or research group, and students or trainees, and (iii) disclosure on Human Subject consent forms;
      2. Limiting the role of the Academic Appointee with a Financial Interest - requiring that the role of the investigator with the financial interest be limited in some way (e.g., the Academic Appointee may not be allowed to i) serve as principal investigator, (ii) analyze data, (iii) determine whether potential subjects are eligible for enrollment, iv) solicit consent, or v) determine whether an adverse event report is required);

1. 1. 3. Oversight - appointment of a disinterested individual or group to monitor the relevant research activity. An oversight committee might be charged, at a minimum, with reviewing abstracts and manuscripts before they are submitted for publication to ensure that the research is conducted and reported according to scientific and ethical standards and that conflict of interest management measures are observed. In other cases, an oversight committee might meet quarterly and review protocols, subject accrual, complications, and other issues as appropriate;

1. 1. 4. Restriction on Equity - i) placement of stock in escrow until a trigger date specified by the Committee, or ii) requirement that options, warrants, and similar instruments not be exercised without the prior permission of the Committee;

1. 1. 5. Divestiture - allow arrangements to go forward contingent upon the sale or disposal of specified financial interests to eliminate or reduce the financial conflict of interest by a date certain;
      6. Severance of relationships that heighten or create actual or potential conflicts - for example, relinquishing a seat on a board of directors or terminating a consulting arrangement with an outside entity in order to reduce the Financial Interest.

The Committee may recommend other conditions or restrictions on the proposed arrangements if, in its view, such conditions or restrictions will contribute to the elimination, reduction, or management of the conflict of interest.

If an individual wishes to appeal the decisions made regarding managing a conflict of interest, then they may appeal to the appropriate subcommittee of the campus Conflict of Interest Committee for those decisions made by deans or their designees. Decisions made by the campus Conflict of Interest Committee may be appealed to the campus Chancellor.

The Chancellor of IUPUI shall be responsible for implementation of this policy and shall appoint an IUPUI Committee on Conflicts of Interest. The Chancellor may delegate responsibility for administering this policy to another campus administrative officer.

Schools

The Academic Appointees of each school (and appropriate campus administrative units) in cooperation with the dean (or administrative unit head) may directly implement these guidelines and procedures or shall establish their own procedures as long as they are consistent with the University Conflict of Interest Policy and these guidelines and procedures. School procedures must be submitted to the IUPUI Chancellor or designee within 30 days of their adoption. The dean (or equivalent administrative officer) is to ensure that the school or unit's responsibilities are met in accord with approved procedures. Specifically, the dean (or equivalent administrative officer) or designee shall:

1. Assist in establishing school procedures and in revising established procedures as required;
2. Assist Academic Appointees in interpreting the campus Guidelines and Procedures and school procedures;
3. Implement school procedures for disclosure and review of Categories II-IV activities;
4. In consultation with individual Academic Appointees, seek avoidance or resolution of conflicts of interest; and
5. Promptly transmit recommendations concerning unresolved conflicts to the IUPUI Campus Committee on Conflicts of Interest.

IUPUI Campus Committee on Conflicts of Interest The IUPUI Committee on Conflicts of Interest shall:

An Academic Appointee is any person, including but not limited to anyone holding an academic at IU Indianapolis, whether full or part-time, who is engaged in the design, conduct or reporting of research or Educational Activities.

Activities Outside of the University and Outside Activities are defined as activities not directly related to the research, teaching, and service mission of the university.

Covered Persons means persons to whom these guidelines and procedures apply, as specified in Section 1.

Dependent is defined as any person who receives more than one-half of his or her annual support from an employee, whether or not he or she is related to that employee.

An Educational Activity may include the dissemination and application of knowledge through teaching, executive education, consulting, service, and publication (except those publications reserved to individuals through the Indiana University policies on copyright and intellectual property). The specific definition of "Educational Activity" may be further developed by each school or administrative unit to reflect the diverse missions of units and the varied work of academic appointees.

Eligible Domestic Partner is defined as being the same sex as the employee; at least 18 years of age and competent to enter into a contract; not legally married or the domestic partner of another individual; has lived with the employee as a couple for at least six consecutive months; and has submitted documentation to verify an interdependent relationship with the employee that is the functional equivalent of a marriage.

Employee is defined as any person employed by Indiana University, whether full or part-time (hourly employees are not included).

An External Entity includes any individual, corporation, company, trust, organization, enterprise, or other entity (including government agencies) that is not an entity under the control of or under common control with the university.

Family Members are defined as the member's spouse, Dependent and Eligible Domestic Partner.

A Financial Interest is "significant" if:

1. it is an equity or similar interest (e.g., stocks, stock options, or other ownership interests), allowance, forbearance, forgiveness of debt, interest in real or personal property, dividends, rent, capital gain which exceed $10,000, or represents more than a 5 percent ownership interest in any one enterprise or entity, when aggregated for the member and his or her Family Members;
2. or it is salary, commissions, consulting fees, honoraria, or similar payments which exceed, or are expected to exceed $10,000 within any one-year period, when aggregated for the member and his or her Family Members;
3. or intellectual property rights that exceed $10,000 in value (e.g. patents, copyrights, and royalties from such rights).

Exclusions:

1. Receipt of royalties from licensed university technology when no further related research, teaching or service activities will be pursued within the university by the individual;
2. Salary or other remuneration from Indiana University.
3. Income from seminars, lectures, or other educational activities sponsored by not-for-profit entities;
4. Income from service on advisory committees or review panels for governmental or not-for-profit entities;
5. Any financial interest arising solely by means of investment in a mutual, pension, or other institutional investment fund over the management and investments of which the member of the university community does not exercise control;
6. Receipt of royalties or honoraria for published scholarly works, commissioned papers, and occasional lectures as long as they are not required for purchase for the author’s classes;
7. Serving as a consultant to a domestic government agency;
8. Income received from a private practice plan recognized and approved by the IU School of Medicine (or other schools that may establish practice plans).

It should be noted, however, that the state law on conflict of interest establishes $250 as the threshold at which a Financial Interest is de minimus, or insignificant; accordingly, the facts of each situation must be considered carefully.

A Human Subject is a living individual about whom an investigator (whether professional or student) conducting research obtains (l) data through intervention or interaction with the individual, or (2) identifiable private information, or an individual who is or becomes a participant in research, either as a recipient of an FDA-regulated test article or as a control.

Professional Activities are defined as activities related to the research, teaching, or service missions of the university, or an employee's discipline, profession, or craft, irrespective of whether those activities are compensated or constitute university activities.

Research means a systematic investigation designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research and product development. For biomedical research, this includes any experiment that involves an FDA-regulated test article on one or more human subjects that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act: or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for research or marketing.

Royalty Income from Licensed Technology means the receipt of or the entitlement to receive future royalty income derived from the licensing of technology or other processes or products. Not included is income derived from the sale of books, journals, or artistic works.

Statement of Compliance is defined as “A Statement of Compliance with State Law on Conflicts of Interest and Federal Law on Financial Conflicts of Interest in Research,” and any amendments thereto.

University means Indiana University and IU Indianapolis campus specifically.

University Activities are defined as activities directly relating to the research, teaching, and the service mission of the university.

University Responsibilities are defined as the responsibilities of a university employee to perform university activities as defined by the university or unit policy, contract, or collective bargaining agreement,