OSR-100 Instructions

last updated 03/20/08

Introduction

These guidelines define general Northwestern University policy and procedures regarding conflicts of interest in relation to sponsored projects involving research, education and University service. Their purpose is to protect the integrity and credibility of the University and its faculty and staff, and to ensure compliance with federal regulations.

A potential conflict of interest exists when an individual's personal or private interests might lead an independent observer to reasonably question whether the individual's professional actions or decisions are determined by considerations of significant personal interest, financial or otherwise. In accordance with federal regulations, the University has a responsibility to manage, reduce, or eliminate any actual or potential conflicts of interest that may be presented by a financial interest of an investigator (as defined in this policy). Thus, the University requires that all investigators disclose any significant financial interest (as defined in this policy) that could reasonably appear to affect or be affected by a NIH-, NSF-, AHA-, or ACS-sponsored project as defined in the University document entitled Criteria for Defining Sponsored Projects. This policy applies to all investigators.

Definitions

A. Investigator

As defined in the regulations, an investigator includes: "the principal investigator and any other person who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding. For the purposes of this subpart relating to financial interests, "Investigator" includes the Investigator’s spouse and dependent children." This includes all Northwestern University key personnel listed on the application and any other Northwestern researchers working on the project and deemed by the PI to be subject to the federal conflict of interest regulations.

B. Conflict of Interest

For purposes of federal regulations and this policy, a conflict of interest exists when a significant financial interest could directly and significantly affect the design, conduct or reporting of a sponsored project.

C. Significant Financial Interest

Significant financial interest means anything of monetary value including, but not limited to, the following:

1. Salary or other payments for services (e.g., consulting fees or honoraria) that, when aggregated for the investigator and the investigator's spouse and dependent children over the next twelve months, are expected to exceed $10,000
2. Equity interests (e.g., stocks, stock options or other ownership interests) that, when aggregated for the investigator and the investigator's spouse and dependent children, either (a) exceed $10,000 in value (as determined through reference to public prices or other reasonable measures of fair market value) or (b) represent more than a 5-percent ownership interest in any single entity
3. Intellectual property rights (e.g., patents, copyrights and royalties from such rights) that, when aggregated for the investigator and the investigator's spouse and dependent children over the next twelve months, are expected to exceed $10,000

The term does not include the following:

1. Salary, royalties, or other remuneration from the University
2. Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities
3. Income from service on advisory committees or review panels for public or nonprofit entities

Guidelines

Investigators engaged in NIH-, NSF-, AHA-, or ACS-sponsored activity must, in accordance with federal and University policy, disclose to the Director of the Office of Sponsored Research (OSR) on Significant Financial Interest Disclosure forms (OSR-100) whether or not they have any significant financial interests (including those of their spouse and dependent children) that would reasonably appear to affect or be affected by the sponsored activity. Investigators may choose to disclose any other financial or related interest that could present an actual or perceived conflict of interest. Any disclosure of a significant financial interest or any other financial or related interest should provide sufficient detail to permit an accurate and objective evaluation.

The principal investigator/project director is responsible, for each proposed activity(pre-proposal or proposal stage), for determining who meets the definition of investigator as set forth in this policy and for ensuring and certifying that each investigator has submitted a completed Significant Financial Interest Disclosure form along with the proposal submitted to OSR. Such disclosure forms must be completed and submitted to OSR before a proposal is endorsed by the University and forwarded to NIH, NSF, AHA, or ACS.

The disclosure must be reviewed to determine if further action is required before the University expends any awarded funds or issues a purchase order or subcontracts for the acquisition of goods and services related to any award that may result from the proposal.

If the Director determines, after reviewing the disclosure form and other available information, that a significant financial interest could affect the design, conduct, or reporting of research activities, the Director shall refer the matter to the Vice President for Research or his/her designee. The Vice President for Research or his/her designee will then review the matter and will determine which of the following actions to take:

• Accept the proposed sponsored project.
• Accept the proposed sponsored project provided certain conditions or restrictions are imposed so that the conflict will be managed, reduced, or eliminated.

Following are examples of possible conditions or restrictions:

1. Public disclosure of significant financial interests
2. Monitoring of research by independent reviewers
3. Modification of the research plan
4. Disqualification from participation in the portion of the sponsored funded research project that would be affected by the significant financial interests
5. Divestiture of significant financial interests
6. Severance of relationships that create actual or potential conflicts

• Refuse the proposed sponsored project.

If the investigator is dissatisfied with the determination of the Vice President for Research, the investigator may, within ten (10) calendar days of such recommendation, submit a written appeal to the Provost. In reviewing the matter and determining whether a conflict of interest exists and/or what actions should be taken to manage, reduce or eliminate a potential conflict, the Provost or his/her designee may consult the University standing Committee on Conflicts. After such review, the Provost will make the final decision.

The required disclosure forms must be updated if new reportable information is obtained during the period of an award. Records of investigator financial disclosures, and of actions taken to manage actual or potential conflicts of interest, shall be retained by OSR until three years after the termination or completion of the award to which they relate, or the resolution of any government action involving those records, whichever is later.

Collaborators/sub-recipients/subcontractors from other institutions involved in externally sponsored projects of the University must either comply with this policy or provide a certification from their institutions that they are in compliance with federal requirements regarding disclosure of conflicts of interest and that their portion of the project is in compliance with their institutional policies.

Compliance

All persons subject to this policy are expected to comply with it fully and promptly. Whenever an investigator has violated this policy, the Vice President for Research shall report such violation to the appropriate University official (for faculty, to the Provost; for staff, to the Senior Vice President for Business and Finance; and for students, to the Vice President for Student Affairs) and, where appropriate, sanctions will be imposed in accordance with the following procedures:

1. When a faculty member is subject to sanctions, the provisions of the Faculty Handbook on Termination or Suspension of Faculty for Cause, Imposition of Minor Sanctions, and Procedures for Termination or Suspension of a Faculty Member for Cause and for Appeal of Minor Sanctions shall apply.
2. For staff, the sanctions set forth in the Policy on Staff Conflict of Interest shall apply.
3. For students, the disciplinary procedures set forth in the Offenses and Disciplinary Procedures section of the Student Handbook shall apply.

In addition, the University shall follow federal regulations regarding the notification of the sponsoring agency in the event an investigator has failed to comply with this policy. The sponsor may take its own action as it deems appropriate, including the suspension of funding for the investigator until the matter is resolved.

Underlying Regulatory Requirements