A. Purpose
This policy presents and discusses circumstances which can create real or perceived conflicts of interest in research and establishes requirements for annual certifications and financial disclosures.

B. Revision History
Originally issued: March 2000

C. Persons Affected
All Northwestern Health Sciences University faculty, staff and students responsible for the design, conduct or reporting of federally funded research, and their immediate family. Collaborators, subrecipients, and subcontractors from other academic or not-for-profit institutions must either comply with this policy or provide a certification from their institutions that they are in compliance with Federal policies regarding investigator significant financial interest disclosure.

D. Related Research Policy Documents
Rights and Responsibilities in the Conduct of Research
Misconduct in Science
Secrecy in Research
Annual Certification of Compliance Form [Downloadable Word file]

E. Policy

Section 1. INTRODUCTION
A conflict of interest occurs when there is a divergence between an individual's private interests and his or her professional obligations to the University such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal gain, financial or otherwise. This policy is not intended to eliminate external activities or to preclude financial interests of researchers, rather its intent is to limit and control conflicts of interest that might compromise the objectivity of scientific research. The policy places responsibility, and therefore, an obligation, on the part of the researcher to discern and to make known the existence of significant financial interests that would reasonably appear to be affected by the activities proposed for funding by the PHS or NSF.

This policy does not supplant nor obviate any provisions of the University's policy on Conflict of Interest as presented in the Faculty Manual, but instead addresses specific additional requirements for participants in PHS and/or NSF projects. As always, faculty members are expected to conduct their affairs in a manner consistent with the teaching, research, and service missions of the University.

This policy shall apply to any individual at Northwestern Health Sciences University who is responsible for the design, conduct, or reporting of research proposed for funding by the PHS or NSF. Such individuals must report the existence of any significant financial interest that would reasonably appear to be affected by that research activity. Collaborators, subrecipients, and subcontractors from other academic or not-for-profit institutions must either comply with this policy or provide a certification from their institutions that they are in compliance with Federal policies regarding investigator significant financial interest disclosure and that their portion of the project is in compliance with their institutional policies. The PHS requires certification from any subcontractor, including commercial firms, stating that it is in compliance with Federal Policies regarding investigator significant financial interest disclosure.

Section 2. APPLICABLE REGULATIONS
The U. S. Public Health Service (PHS) regulations in 42 CFR Part 50, and 45 CFR Part 94, under the heading of Objectivity in Research became effective October 1, 1995, and carry the weight of federal regulation. The federal policies stipulate requirements for:

• annual financial disclosures on the part of ALL research investigators covered by this policy;
• institutional certification that all proposed and ongoing PHS and /or NSF sponsored research is either free of conflicts of interest, or that such conflicts are adequately managed;
• implementation of an institutional mechanism for managing conflicts of interest in research;
• sponsoring agency notification if Northwestern Health Sciences University is unable to satisfactorily manage actual or potential conflicts of interest;
• sanctions where appropriate; and,
• Maintenance of records relating to this policy, for at least three years following the termination of a given project.

Section 3. DEFINITIONS
Business: any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other legal entity organized for profit or charitable purposes.

Conflict of Interest: a situation in which significant financial interests in a business, or other personal considerations provided by a business, may compromise, or have the appearance of compromising, an investigator's professional judgment in conducting or reporting research, the results of which could affect the aforementioned business, either directly or indirectly

Immediate Family: the Investigator's spouse, minor children, and any other persons living in the same household.

Investigator: the Principal Investigator and any other person at Northwestern Health Sciences University , who is responsible for the design, conduct or reporting of research, and the investigator's immediate family. This shall include faculty, students, and research staff.

Participate: to be part of the described activity in any capacity, including but not limited to serving as the Principal Investigator, Co-Investigator, research collaborator or provider

of direct patient care. The term is not intended to apply to individuals who provide primarily technical support or who are purely advisory, with no direct access to the data (e.g., control over its collection or analysis) or, in the case of clinical research, to the trial participants, unless they are in a position to influence the study's results or have privileged information as to the outcome.

Significant Financial Interest: anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). The term does not include:

• salary, royalties, or other remuneration from Northwestern Health Sciences University ;
• income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;
• income from service on advisory committees or review panels for public or non­profit entities; or
• an equity interest that when aggregated for the investigator and the investigator's spouse and dependent children, meets both of the following tests: Does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than 5% ownership interest in any single entity; or,
• Salary, royalties or other payments that when aggregated for the investigator and the investigator's spouse and dependent children over the next 12 months, are not expected to exceed $10,000.

Research: a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. The term encompasses basic and applied research, and product development.

Technology: any compound, drug, device, diagnostic, medical, dental or surgical procedure intended for use in health care or health care delivery.

Section 4. KEY ELEMENTS OF THE POLICY
This policy is designed to identify actual or potential sources of conflicts of interest in research; and to either eliminate, reduce or manage such conflicts. As such, the following subsections outline the procedures that will be followed to assure compliance with this policy, and all applicable federal regulations related to conflicts of interest.

4.1 Notification of Investigators
Upon adoption of this policy, a copy will be sent to all investigators (as defined in Section 3 above). Any changes of the policy will be annotated and distributed to all investigators. This will be the responsibility of the Office of Research Administration and Compliance. Subsequent to the initial distribution of this policy, a copy of this policy shall be provided to all new and visiting investigators.

4.2 Financial Disclosure Procedures
All Northwestern Health Sciences University Department Heads shall annually distribute and collect the Northwestern Health Sciences University Conflict of Interest Financial Disclosure form. The form will be sent to all investigators engaged in research conducted in the department. For investigators who may join departmental research efforts between annual distributions of the Conflict of Interest Financial Disclosure form, Department Heads will ensure that the form is completed and reviewed prior to the initiation of research by those investigators.

The Vice President and Provost is the designated official whose responsibility will be to review the Conflict of Interest Financial Disclosure forms to determine if a conflict of interest exists with respect to the conduct of research of any investigator. If a conflict of interest is noted, the Conflict of Interest Financial Disclosure form will be forwarded to the Conflict of Interest Management Committee. In addition, investigators and department heads will be responsible for ensuring that an updated Conflict of Interest Financial Disclosure form shall be completed and filed at any time during a year when an investigator's significant financial interests may change.

4.3 Review of Financial Disclosure and Certification of Conflict of Interest Status
Upon review of the Conflict of Interest Financial Disclosure form, the Vice President and Provost shall be responsible for notifying the department head of the conflict of interest status of all investigators within that department. Certification that investigators have complied with the requirement to complete the Conflict of Interest Financial Disclosure form, and that NO Conflict of Interest exists, will be accomplished as the Vice President and Provost signs off on the proposal face page, each time an investigator submits a proposal for extramural funding.

In the event a conflict of interest has been identified, the Vice President and Provost shall notify the Department Head that such a conflict has been identified, and that steps have been initiated to eliminate or manage the conflict of interest, as outlined in Section 4.5 below. During the period of resolution, no proposals for extramural support (that are the subject of the conflict of interest) for the investigator(s) shall be approved by that department. Once a resolution of the conflict has been achieved, the Vice President and Provost will notify the Department Head of the terms of the resolution, and authority to process all proposals will be reinstated.

In the event that the conflict is not resolved within 45 days of discovery, the Vice President and Provost shall notify the department head of this, and the facts surrounding that case. In the event that notification of research sponsors is required, the Vice President and Provost will be responsible for effecting this notification.

4.4 Resolution and/or Management of Conflicts of Interest
If a conflict of interest has been identified as a result of the procedures outlined in Section 4.3 above, Department Heads will be responsible for taking the appropriate following action(s):

• Notify the investigator(s) that as a result of the financial disclosure process, a conflict of interest has been discovered in relation to research in which the investigator(s) are involved
• Refer the matter to the Conflict of Interest Management Committee

4.5 Conflict of Interest Management Committee
The Vice President and Provost shall appoint a Conflict of Interest Management Committee composed of five (5) senior faculty, one of whom will be appointed as chair.

The committee will be responsible for reviewing cases referred to it and determine whether the financial interest identified in the disclosure process could affect the design, conduct, or reporting of the research of the affected investigator(s), and determine what conditions or restrictions, if any, should be imposed to manage such conflicts; or it may decide that the probability that the financial interest would affect the design, conduct or reporting of the research is too remote to warrant any specific conditions or restrictions. The committee will be authorized to request any other information that it deems necessary to assist it in this determination. Examples of conditions or restrictions that might be imposed to manage actual or potential conflicts of interest include:

• public disclosure of significant financial interests;
• monitoring of the research by independent reviewers;
• modification of the research plan;
• disqualification from participation in all or a portion of the research subject to the conflict of interest;
• divestiture of the financial interests; or,
• severance of relationships that create actual or potential conflicts.

This committee's operating guidelines will be developed subsequent to the adoption of this policy. Every effort will be made to maintain the privacy of information gathered in the committee's deliberations, within the limits imposed by applicable laws and regulations.

4.6 Maintenance of Records
All records related to the implementation of this policy, e.g., Conflict of Interest Financial Disclosure forms, minutes of meetings called to resolve or manage conflicts, minutes of the meetings of the Conflict of Interest Management Committee, notifications to funding agencies, etc., shall be maintained in the home department of the investigators in question. These records shall be maintained, with an appropriate degree of security, for a period of at least three years following the termination of the given project. Departmental conflict of interest records shall be subject to periodic review for compliance with this policy by the Administration, or by any sponsoring agency, per the regulations cited in Section 2 above.

4.7 Notification of Research Sponsors
The Vice President and Provost shall be responsible for timely notification of research sponsors, as may be required by the sponsors' policies or agreements between Northwestern Health Sciences University and the sponsors, of any actual or potential conflicts of interest; including any measures taken to reduce, manage or eliminate such conflicts.

Section 5. APPEALS
In situations where the investigator(s) dispute the decision of a conflict of interest management committee, the matter will be referred to the Faculty Review Board, whose decision regarding the management of conflicts of interest shall be final.

Section 6. PROHIBITED ACTIVITIES
Consistent with the regulations outlined in Section 2, it is the policy of Northwestern Health Sciences University that conflicts of interest in research may be allowable, provided that an acceptable plan of management, as outlined in Section 4 above, can be developed and implemented in situations where such conflicts arise, as long as such management plans are not in conflict with applicable federal regulations.

Section 7. SANCTIONS
Sanctions and penalties for those who knowingly and willfully disregard this policy, or refuse to comply with its terms, will be determined by the Vice President and Provost with advice from the investigator(s) Department Head. Sanctions include, but are not restricted to:

• Letter of reprimand
• Notification to professional and/or scientific societies, funding agencies and/or professional journals
• Reassignment of duties
• Termination of grant support
• Adjustment of research space allocation
• Adjustment of salary
• Suspension
• Dismissal

Section 8. EXAMPLES OF ACTIVITIES WHICH ARE NOT A CONFLICT OF INTEREST
The following synopsis is presented as another educational resource to the research community. It is simply a set of different scenarios that have been gleaned from various institutional policies and publications about conflicts of interest in research. For purposes of this policy, the definition of conflict of interest is as stated in Section 3 above.

Activities Which Are NOT Conflicts of Interest:

• receiving royalties for copyrights and patents obtained in accordance with
  University policy and State law;
• receiving honoraria for giving seminars or guest lectures;
• duty to professional organizations, peer review panels, publication boards, and accreditation bodies;
• ownership of company where there is no relationship to University responsibilities;
• ownership in a company where the only involvement with the University is paid consulting;
• ownership of mutual funds which may invest in companies that support the investigator's research.