University Policy 5201

1. Responsibilities of Investigators

Investigators on research projects are required to report to the Office of Research financial interests, outside professional activities, and any other interests or activities, as requested, including foreign engagements that could affect or appear to affect their research, including their Significant Financial Interests (SFI) that reasonably appear to be related to their professional expertise and Institutional Responsibilities. Investigators must make all disclosures as required by this policy.

Conflict of Interest (COI) and Conflict of Commitment (COC) reporting for research is completed annually and at various transactional points, as outlined below.

1. Annual Reporting: Investigators must submit a COI/COC Disclosure annually during an announced open filing window. An annual disclosure must be submitted even if the individual has no outside interest or there have been no changes to the priordisclosure.
2. Transactional Reporting: In addition to the annual COI/COC reporting requirement, Investigators must also comply with transactional COI/CO reporting requirements throughout the reporting year and in accordance with the University’s reporting procedure and timeframes. Transactional COI/COC reporting includes submitting a COI/COC Disclosure or certifying the accuracy of an existing COI/COC Disclosure when:
    
   1. participating as an Investigator on a new sponsored research proposal submission;
   2. being added as a new Investigator to an ongoing sponsored research project; and
   3. within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI.
       
3. Investigators must complete the Financial Conflict of Interest training available online as directed from the Office of Research prior to engaging in sponsored research. Investigators must be re-trained every four years and whenever there is a substantive change to this policy. The Office of Research must also provide retraining of any Investigator who has been found to be non-compliant with National Science Foundation (NSF), PHS COI regulations or the DOE COI Policy, and/or University’s COI/COC Research Policy before engaging or continuing sponsored research.

   In addition to annual and Transactional Reporting, the Office of Research may, within its discretion, request that Investigators submit or update their COI/COC Disclosures from time-to-time.
    

4. Report Sponsored or Reimbursed Travel

   Investigators participating in PHS- or DOE-funded Research are required to report on their annual COI Disclosure the occurrence of any Reportable Travel.

   Any reimbursed or sponsored travel must be disclosed by Investigators. Exceptions to this reporting requirement are set forth in PHS COI regulation and the DOE COI Policy, and include when travel is reimbursed or sponsored by (1) a Federal, State, or local government agency; (2) an institution of higher education as defined at 20 U.S.C. 1001(a); (3) an academic teaching hospital; (4) a medical center, or (5) a research institution that is affiliated with an institution of higher education.

   Investigators must provide information on the purpose of the trip, the identity of the sponsor/organizer, the destination, amount funded, duration, and relatedness to their Institutional Responsibilities.

   In any case in which it is determined that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by the Institution as required, the Institution shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

   The Office of Research and the ODU Research Foundation have established a COI Disclosure System to assist investigators with their reporting responsibilities. Investigators should refer to the Conflict of Interest (COI) Overview website for information and reporting.

2. Responsibilities of the Office of Research and Old Dominion University Research Foundation

1. Review

   The Institutional Official or designee within the Office of Research, as appropriate, shall:

   1. Maintain and monitor an online COI/COC Disclosure system in collaboration with ODU Research Foundation. Additionally, the ODU Research Foundation’s Incident Reporting Hotline allows confidential reporting on matters of concern at rfhotline@odu.edu.
       
   2. Maintain confidentiality for all COI/COC disclosures submitted by individuals involved in research activities, except on a need-to-know basis to provide institutional or internal oversight as authorized by this policy and to comply with requests from Federal, State, and Foundation funding agencies as required under terms of a grant, contract, or cooperative agreement, University policy, or law;
   3. Review Investigator COI/COC disclosures and their research activity to reasonably determine whether an Investigator has an actual or potential COI/COC and request and document additional details, including precise dollar figures or percentages for ownership interests or remuneration, if such details appear necessary to determine whether there is an impermissible Conflict of Interest;
       
   4. If review indicates an actual or potential COI/COC or SFI exists, the disclosure is forwarded to the COIC for review, and if it is determined that the COI/COC or SFI requires management, they may take the following actions (among other options):
       
      1. Require specific type of administrative oversight or Conflict Management Plan; or
      2. Recommend the withdrawal of the proposal or suspension of the research activities.
          
   5. Identify additional individuals to advise on complex or novel issues of actual, potential, or perceived research conflicts of interest, such as representatives from the academic units, ODU Research Foundation, Human Resources, Export Control, the Graduate School, orother relevant units. If there is a possible conflict of interest, the review will be referred to the individual’s supervisor and appropriate administrative unit, as applicable;
       
   6. Notify the Investigator and their academic unit director (e.g., Chair, Dean) that an actual or potential COI/COC or SFI exists and that a Conflict Management Plan is required.

b. COI/COC Management

If it is determined that a conflict exists, a final written agreement to manage the conflict is established by the COIC in collaboration with the Investigator and the supervisor of the Investigator. The Conflict Management Plan is reviewed and signed by the Investigator, their supervisor or unit head and dean, and the Institutional Official or designee. Supervisors oversee the implementation of a Management Plan for Investigators who report to them, and Investigators are responsible for managing their conflict(s) in accordance with the terms of the Management Plan.

Examples of appropriate actions to resolve COI/COCs include:

1. Public disclosure of SFIs in abstracts, publications, presentations, press releases, and applications or proposals for research funding;
2. Monitoring of research by independent reviewers or an oversight committee;
3. Selection of a non-conflicted PI;
4. Disqualification from participation in all or a portion of the funded research;
5. Divestiture of SFIs;
6. Severance of relationships that create actual or potential conflicts;
7. Prospective discussions with the academic unit director of the time involved in any planned outside activities that may have the potential to conflict with, or appear to conflict with, commitments to the University;
8. Refusal by the University to enter into a research agreement if a COI/COC cannot be managed effectively;
9. Participation of one or more non-conflicted persons in the evaluation of research data and/or preparation of manuscripts;
10. Partition a graduate student’s work when that student is funded by a sponsor where the student’s advisor has an economic interest

Final COI/COC Management Plans will be uploaded into the ODU Research Portal by the COIC via the Institutional Official. The Conflict Management Plan must be approved prior to the start or continuation of any research expenditures. Further:

The Institutional Official or designee will notify the ODU Research Foundation that COI/COCs involving Federal agency sponsors are being managed and will inform the Research Foundation of any administrative mitigation strategies requiring additional support.

If the COI/COC and SFI cannot be managed, the Institutional Official or designee can recommend and initiate actions leading to sanctions for non-compliance with this policy or the approved management plan.

c. Annual Data Summary Report

1. The Office of Research, in partnership with the ODU Research Foundation, will compile annual statistical reports that will summarize the number of COI/COC disclosures, including the number of Investigators whose conflicts were resolved or were not managed, reduced, or eliminated.
2. The Institutional Officer or designee will provide each Dean of an academic college and other equivalent administrators with research investigators a COI/COC Annual Data Summary Report for the entire college.

d. Disclosure of Outside Income

The University requires the reporting of an SFI. Some units, however, may require disclosure of the actual dollar amount.

e. Reporting

1. When applicable, the Institutional Official or designee will notify the ODU Research Foundation of any financial conflicts of interest or non-compliance that the University is unable to satisfactorily manage, reduce, or eliminate, and research that proceeds without the imposition of conditions or restrictions when a conflict of interest exists. The ODU Research Foundation will then notify the sponsor in accordance with sponsor regulations and thereafter as required by the funding agency.

   If it is identified that an Investigator fails to disclose a SFI in a timely manner or if for any reason the University fails to review a SFI, the University must, within 60 days, implement a Conflict Management Plan, even if interim, if it is determined that the SFI is related to the research, and rises to the level of a financial COI. The Institutional Official or designee will notify the ODU Research Foundation via an interoffice memo of situation and that a financial COI report must be provided to the sponsoring PHS or DOE agency at this time.
    

2. In addition, a retrospective review must be completed within 120 days of the COIC’s determination that a financial COI exists and that it was not identified or managed in a timely manner (hereafter “retrospective review criteria”) to determine whether the research conducted during the period of noncompliance was biased in the design, conduct, or reporting of the research.
3. A financial COI could be identified or managed in an untimely manner in any of the following circumstances:
   
   1. An Investigator has failed to disclose a SFI that is determined by the COIC to constitute a financial COI;
   2. The University failed to review or manage a financial COI (e.g., not timely reported by a subrecipient or timely reviewed by the University); or
   3. An Investigator has failed to comply with a Management Plan.
       
4. If bias is identified, a mitigation report must be developed that outlines a plan of action to eliminate or mitigate the effect of the bias. The Institutional Official or designee will notify the ODU Research Foundation of the situation, the results of that determination, and the mitigation report must be submitted to PHS and DOE awarding agency. See Section F.5. for more information on Retrospective Review.

5. Retrospective Review

In cases of non-compliance, a retrospective review is required for later determined financial conflicts of interest. The review is not required to be submitted to the PHS or DOE-awarding agency unless bias is found.

Whenever a financial COI in PHS or DOE-funded research is not identified or managed in a timely manner, a retrospective review and, if appropriate, a mitigation report will be prepared and submitted to the extent required by 42 CFR Part 50.605(a)(3).

A retrospective review is not required if a COI is timely identified and managed. A COI is considered to have been timely identified and managed if the CMP is (1) implemented before the expenditure of project funds, or (2) is established within 60 days of an Investigator’s timely disclosure of an SFI. Since University policy requires an Investigator to report an SFI within 30 days of discovering or acquiring the interest (e.g. through purchase, marriage, inheritance), the COI is timely managed if a management plan is implemented, at least on an interim basis, within 90 days of its discovery or acquisition by the Investigator during the course of an on-going project.