OSR-100 Instructions

last updated 09/08/09

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Policy on Conflict of Interest for Sponsored Projects Supported by the Public Health Service, National Science Foundation, American Heart Association, American Cancer Society, and Industry Sponsored Clinical Researc

• Introduction
• Definitions
• What Must be Disclosed
• Subsequent Identification and Reporting
• Record Retention Policy
• Compliance
• Underlying Regulatory Requirements

Introduction

All Public Health Service* (PHS), National Science Foundation (NSF), American Heart Association (AHA), American Cancer Society (ACS) and industry sponsored clinical research proposals, including flow-through funding from other entities via consortia arrangements, must include signed OSR-100 forms or electronically signed eProposal forms from all Northwestern University Investigators before OSR will endorse the proposal. It is intended to comply with regulations issued 42 CFR Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought regarding mandated disclosures by individuals having certain responsibilities with respect to sponsored projects funded by the PHS. Other agencies and sponsors which have mandatory conflict of interest requirements, including the NSF, AHA and ACS, refer to the NIH policy and 42 CFR 50, Subpart F as the basis for their own reporting requirements. The purpose of these regulations is to promote objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded by these sponsors under grants, cooperative agreements or contracts will be biased by any conflicting financial interest of an Investigator. 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.

* Includes the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Agency for Healthcare Research and Quality.

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 goal of the University's conflict of interest review and management system is to ensure that the personal interests of an individual do not unduly influence their primary obligations to science, sponsor, University, colleagues or students.
The University requires that all Investigators disclose any significant financial interest that could reasonably appear to affect or be affected by a PHS-, NSF-, AHA-, or ACS-sponsored project as defined in this policy below. This policy applies to all Investigators and includes Investigators performing industry sponsored clinical research.

Definitions

A. Investigator

Although the implementation of this policy is the responsibility of Northwestern, the regulation is applicable to the Investigator(s). An Investigator is defined by the NIH as: "the principal Investigator and any other person who is responsible for the design, conduct, or reporting of research funded by NIH, or proposed for such funding, including subgrantees, contractors, or collaborators." The definition includes the Investigator's spouse and dependent children. Individuals who are responsible for the design, conduct or reporting of research include the key personnel listed on the application and any other Northwestern researchers working on the project. When the definition of investigator is limited to titles or designations (e.g., to principal investigators, key personnel, faculty), the risk that an unidentified financial conflict of interest may compromise the research enterprise increases. Guidance on who would be considered an Investigator is provided in "FAQs on Definition of Investigator" in reference: http://grants.nih.gov/grants/policy/coifaq.htm#b8:

I am a post-doctoral fellow receiving funding from the NIH. Does this regulation apply to me?
The regulation is applicable to each Institution that applies for NIH grants or cooperative agreements for research or submits a proposal for a research contract whether in response to a solicitation or otherwise and, through the implementation of the regulation by each Institution, to each Investigator participating in such research. As noted above, an Investigator is defined as the Principal Investigator and any other person who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding. Thus, if a post-doctoral fellow meets the definition of an Investigator, he or she would be subject to the regulation. The regulation would apply to a postdoctoral fellowship application to the NIH if the funding is for research and the fellow's role in the research meets the definition of "Investigator." You should consult with your Institutional designated official(s) to ensure you comply with the appropriate requirements.

I am a graduate student working on research funded by the NIH. Am I subject to the requirements of the FCOI regulation?
As stated above, the term "Investigator" is defined to encompass individuals "responsible for the design, conduct or reporting" of research funded by the NIH. You should confirm with your Institutional designated official(s) whether you, as a graduate student co-author, meet this definition.

I am a collaborator/contractor/subcontractor/subrecipient performing research funded by the NIH but am not employed directly by the Institution that received the award. Does this regulation apply to me?
Yes, if you meet the definition of an "Investigator." Please consult your Institution's policy. If you meet the applicable definition, you may either need to report your Significant Financial Interests directly to the awardee Institution or your entity may need to provide assurances to the awardee Institution that will enable the awardee Institution to comply with the regulation. The awardee Institution is responsible for reporting to the NIH any conflicting interests it has identified, including those of its subrecipients/subcontractors, and assuring that the interest has been managed, reduced, or eliminated in accordance with the regulation.

Collaborators, sub-recipients, and 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 at the time of award 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. This certification will be an integral subaward agreement term.

B. Conflict of Interest

The University's conflict of interest policy promotes objectivity in research by establishing standards to ensure that there is no reasonable expectation that the design, conduct, or reporting of sponsored research funded under grants, cooperative agreements or contracts from these sponsors will be biased by any conflicting financial interest of an Investigator.

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
4. any ownership interests in the institution, if the institution is an applicant under the SBIR and STTR program

What Northwestern Must Report to the NIH and Other Sponsors and when it Must be Reported

Each Investigator who is planning to participate in PHS-, NSF-, AHA-, or ACS-sponsored activity, or in industry sponsored clinical research, must provide to the Director of the Office for Sponsored Research (OSR) at the time of proposal submission a disclosure in which they indicate that they, including their spouse and dependent children, may have a Significant Financial Interest (1) that would reasonably appear to be affected by the research for which funding is sought; and (2) in entities whose financial interests would reasonably appear to be affected by the research. The principal Investigator/project director is responsible for determining who meets the definition of Investigator as set forth in this policy and for ensuring that each Investigator has submitted a completed OSR-100 form. Investigators may choose to disclose any other financial or related interest that could present an actual or perceived conflict of interest. Disclosures should be made on the Significant Financial Interest Disclosure form (OSR-100), or electronically on the eProposal form. 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. Prior to committing or expending any funds under an award, Northwestern must report to the NIH the existence of any conflicting financial interests and assure that the interest has been managed, reduced, or eliminated in accordance with the regulation. NSF requires notification only when a conflict is unmanageable.

Subsequent Identification and Reporting

All financial disclosures must be updated during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained during the period of the award. For any interest that Northwestern identifies as a significant financial conflict of interest subsequent to the University's initial review under the award, the conflicting interest must be managed, reduced, or eliminated, at least on an interim basis, and the sponsor needs to be informed within sixty days of that identification.

Review of the Potential Significant Financial Conflict of Interest Disclosure
The Director of OSR will provide initial review of the disclosure and may request additional supporting documentation from the Investigator. If the Director of OSR determines on the basis of the disclosure and other available information that the disclosure meets the definition of a significant financial conflict of interest, the Director will forward the information to the Investigator's school-based conflict of interest committee for review and determination. The committee will review the disclosure information and make a decision as to whether a significant financial conflict of interest exists and whether it can be managed, reduced, or eliminated. The following are examples of possible plans

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
7. Refuse the proposed sponsored project

If the Investigator is dissatisfied with the determination of the school-based conflict of interest committee, the Investigator may submit a written appeal to the Dean. In reviewing the matter and determining whether a significant financial conflict of interest exists and/or what actions should be taken to manage, reduce or eliminate a potential conflict, the Dean or his/her designee may consult the University standing Committee on Conflicts. After such review, the Dean will make the final decision. The conflict of interest committee will communicate the results of the determination to the Director of OSR and the Director will endorse and forward the determination to the sponsor (or to the prime awardee when Northwestern is a subrecipient). It is possible a conflict will be determined to be unmanageable, in which case Northwestern may elect not to accept the award; or may elect to identify, and obtain sponsor approval, if necessary, to substitute a researcher without a conflict in place of the conflicted researcher.

Record Retention Policy

OSR is required pursuant to 42 CFR Part 50, Subpart F to maintain all conflict of interest disclosure forms and related communications with Investigators and all actions taken for a period of three years from the date of submission of the final expenditures report or, where applicable from other dates specified in 45 CFR 74.53(b) for different situations. Departments and schools involved in the review and management of conflicts of interest are also required to maintain rewards for the three year period.

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, if an Investigator fails to comply with the University's conflict of interest policies and the non-compliance biases the design, conduct or reporting of the research, Northwestern is obligated under the regulations to notify the sponsor of the corrective action taken or to be taken. The sponsor may take its own action as it deems appropriate, which may include suspension of funding, or require Northwestern to take further action to maintain objectivity in the research. For clinical research projects supported by the PHS, If the Department of Health and Human Services determines that a PHS-funded project of clinical research, whose purpose was to evaluate the safety or effectiveness of a drug, medical device, or treatment, was designed, conducted, or reported by an investigator with a conflicting interest that was not disclosed or managed, the University must require the Investigator(s) to disclose the conflicting interest in each public presentation of the results of the research.

References

Northwestern University Faculty Conflict of Commitment and Conflict of Interest: http://www.research.northwestern.edu/policies/faculty-conflict-of-interest.html

Northwestern University Staff Conflict of Interest Policy: http://www.northwestern.edu/hr/policies/conflict.pdf

NIH Conflict of Interest Website: http://grants.nih.gov/grants/policy/coi/index.htm

May, 2009