Financial Conflict of Interest Disclosure (FCOI) Process in Research

Each investigator associated with the funded activity.

Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research or work product of a sponsored activity, including investigators working for sub-awardees, contractors, subcontractors, consortium participants, collaborators and consultants. The term investigator includes the Investigator’s spouse, dependent children, relatives, and individuals with whom they share a common household.

Disclosures are by individual instead of project so each person who meets the definition of investigator must complete a disclosure screening.

Financial interests related to sponsored activity

Any situation in which an individual’s significant financial interest or other interests in an outside entity conflict, or appear to conflict, with that individual’s ability to carry out his/her responsibilities to the University.

A conflict of interest does not imply wrongdoing or misconduct; rather it is a situation that will benefit from arm’s length management in an open atmosphere.

Examples:

1. Salary, royalties, or other payments from an outside entity

2. Ownership interest in an entity

3. Equity interest that when aggregated for the investigator and the investigator’s relatives exceeds $5000 in value as determined through reference to public prices or other reasonable measures of fair market value

4. An equity interest that when aggregated for the investigator and the investigator’s relatives exceeds $5000 of value in aggregate ownership interest among family members and individuals in the same household in any single publicly traded entity.

5. Any equity interest in a non-publicly traded entity.

6. Salary, royalties, or other payments (excluding dividends) from a single corporate entity that, when aggregated for the investigator and the investigator’s relatives at any point in time, exceed $5,000.

7. Intellectual property rights for concepts or technology that is utilized in the researchers research (e.g., patents, copyrights, and corresponding royalties)

8. Travel that is prepaid or reimbursed by any source other than a federal, state or local government agency, institution of higher education or academic teaching hospital, medical center or research institute affiliated with an institution of higher education that is provided based upon the investigators professional expertise or University association.

9. Family relationships and individuals in the same household that preclude an arm’s length business transaction.

1. Each investigator must complete and submit a Financial Conflict of Interest (FCOI) Disclosure screening questionnaire through the electronic conflict of interest disclosure portal at the time of their first external funding proposal through the electronic system and update that disclosure when a new FCOI is acquired or discovered, when submitting a new proposal or receiving an new award.

2. If a potential FCOI is indicated on the questionnaire, the investigator must complete a full disclosure prior to proposal submission to the agency or sponsor.

3. Full disclosures will be reviewed by the Office of Research Integrity to determine relatedness and if the conflict can be managed if funded.

4. Upon funding, the full disclosure statements and any updates will be reviewed by the GS Conflict of Interest Subcommittee of the Intellectual Property Committee or Associate Deans of Research to determine the methods appropriate to manage the conflict and assist in creating a management plan. A management plan will be required before the funded activity account can be established.

When a new investigator on a funded project submits a related and manageable conflict or an existing investigator identifies a new conflict, the completed full disclosure forms will be reviewed by the GS Conflict of Interest Subcommittee to determine the methods appropriate to manage the conflict and assist in creating a management plan. A management plan will be implemented within 60 days of full disclosure review.

1. Annually through the GS online disclosure system.  You will get a reminder email approximately 30 days in advance.  Your submission must be complete prior to submission of application for external funding (i.e. PHS).

2. When a new potential conflict is acquired, new reporting is required

• You must update your disclosure within 30 days of acquiring or discovering an additional potential financial conflict of interest.

Example triggers:

1. Investigators must disclose all potential financial conflicts of interest related to new research projects, grants, or contracts at the time of submission of the proposal to the Office of Research and Sponsored Programs and

2. Prior to entering into any new purchasing agreements or acquiring any new disclosable /reportable interests.

3. New investigators added to an existing project must complete the FCOI screening disclosure and report any potential financial conflicts of interests prior to joining the project.

4. Prior to requesting a renewal or extension on an existing externally sponsored grant or contract.

5. Annually when a managed financial conflict of interest exists.

6. Investigators requesting a continuing review by the IRB must ensure that reports have been submitted by all investigators.

7. Within 30 days of acquiring or discovering a new or altered significant financial conflict of interest.

8. When accepting a travel opportunity related to the Investigator’s sponsored or unsponsored institutional responsibility and travel costs are paid on behalf of the investigator by any source other than a federal, state or local government agency, institution of higher education or medical center, hospital or institute that is directly attached to an institute of higher education.

Each FCOI disclosure screening must be signed by the investigator. Signatory authority may not be delegated.

In signing the disclosure screening or disclosure form, the investigator certifies the truth and accuracy of the statement under penalty of disciplinary action.

Reports of financial or other outside interests are reviewed by the Office of the Research Integrity (ORI) through an assembled Conflict of Interest Subcommittee designated by the Associate Vice Provost for Research. Screening will be conducted by the Office of Research Integrity.

Conflict of Interest Subcommittee

1. The Conflict of Interest Subcommittee will be composed of an ad hoc subcommittee designated by the Office of Research Integrity under the guidance of the Associate Vice President for Research.  Members may be drawn from the Intellectual Property Committee, Research Council,  the Associate Deans for Research (or equivalent) within each of the academic colleges or 1-2 faculty members representing research interests within that college and related Ex Officio members.

2. A committee member will be recused from discussion and voting on a particular case if the committee member has a compelling personal interest in the case or a financial or other interest in the entity involved in the case under consideration.

3. Upon review of the relevant materials, the Conflict of Interest Subcommittee will make a determination whether:

a) the reported relationship represents a conflict of interest; and, if so whether

b) an appropriate management plan(s) can be established to mitigate or eliminate the conflict.

4. The committee will report its findings back to the investigator and the responsible Research Services grant coordinator to assure establishment of the management plan prior to the establishment of a funding account or expenditure of sponsored funds and reporting of the finding within the required 60 day time frame.

5. Department Chairs will be provided with access to management plans for faculty under their area of responsibility.

Preaward proposal screening:

Disclosure statements will be reviewed by the Office of Research Integrity prior to proposal submission to determine if the potential conflict is related and/or manageable.

Post award review:

Disclosure statements will be reviewed:

Upon notification of pending award to begin the process of establishing a management plan

Within 30 days of receipt of a new conflict disclosure on a funded activity to determine if the conflict is related and if related begin the process of establishing a management plan. It is the investigators responsibility to make this disclosure.

Where projects are funded through Public Health Service (PHS) funding:

1. The University, through the Office of Research Integrity, will report any significant FCOI related to the funded project and identified by a GS investigator to the University in the manner required under the FCOI Regulations, prior to the expenditure of funds and within sixty (60) days of any subsequently identified FCOI. It is the Principal Investigators responsibility to assure FCOI are reported in a timely fashion.

2. Annually at the time GS is required to provide the annual progress report, a multi-year progress report or extension, the University will provide a status report of managed conflict of interests to the agency, through the Office of Research Integrity, to provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project.

3. Following a retrospective review to update a previously submitted report, if appropriate (42CFR50.605(a)(3)(iii)

A management plan is an agreement between the investigator and the institution to document the conditions or restrictions the investigator will observe to assure that an identified potential conflict of interest associated with work done on a funded activity will not bias the research. The plan must include at least the following:

• The role and principal duties of the conflicted Investigator in the research project;
• Conditions of the management plan;
• How the management plan is designed to safeguard objectivity in the research project;
•  Confirmation of the Investigator’s agreement to the management plan;
•  How the management plan will be monitored to ensure Investigator compliance; and
• Other information as needed.

The Conflict of Interest Subcommittee designee will work with the investigator to identify appropriate precautions to reduce or eliminate the conflict and limit any appearance of potential for bias. Examples of potential management plan elements include:

•  Public disclosure of the significant financial interest;
•  Monitoring of the research, research plan and/or data by independent reviewers;
•  Alternate assignment of principal investigator;
•  Reassignment of duties on an affected phase of the project;
•  Divestiture or appointment of an autonomous caretaker over the interest;
• Alternate supervision for family members or students;
• Severance of relationships that create actual or potential conflicts
• Participation in Human Subjects Research where the investigator has a financial interest in the outcome.

A management plan must be in place to address each Financial Conflict of Interest as reported by any investigator on a funded activity before the project account can be set up. It is the principal investigators responsibility to assure that all investigators associated with their project complete the screening process.

Any newly identified or acquired potential significant financial interest must be disclosed within 30 days.

Your dean and department chair will assist in monitoring the effectiveness of the management plans.

Where appropriate precautions to reduce or eliminate the conflict and limit any appearance of potential for bias cannot be agreed upon by you (the investigator), your dean/department chair and Conflict of Interest Subcommittee, the research award may be transferred to an appropriate alternate Principle Investigator or declined by the University.

Sub-recipients of Public Health Services (PHS) funded research: (42 CFR 50.604 (c) NIH grants policy statement 15.2.1)

Per the GSRSF sub-award agreement, all proposed sub-recipients under a PHS funded activity shall have a financial conflict of interest policy that conforms to the requirements of the FCOI Regulations and make a certification to the University at the time of award that its financial conflicts of interest policy complies with the FCOI Regulations.

•  Sub-recipients who do not have a compliant financial conflict of interest policy will be deemed ineligible sub-recipients, or
•  Sub-recipients who do not have a compliant financial conflict of interest policy will be required to comply with the GS policy. Sub-recipients must provide all disclosures prior to:
  • a. Issuance of sub-award, and
  • b. Within 15 days of identifying a new FCOI to allow GS time to maintain regulatory reporting requirements.
•  The University, through the Office of Research Integrity, will report to the PHS funding agency any significant FCOI which are related to the funded project and which are identified by any sub-grantee, subcontractor, or collaborator to the University in the manner required under the FCOI Regulations, prior to the expenditure of funds and within sixty (60) days of any subsequently identified FCOI.

Sub-recepients of Non-PHS funded research will not be tracked by Georgia Southern University.

Screening and disclosure information are maintained in a confidential electronic storage system. They are accessible on a required use basis to:

• Grant Coordinators
• Research Accounting
• Legal Counsel
• Research Integrity
• Research Services Foundation
• Department Chair/Dean

Screening disclosure forms and full disclosure forms and management plans will be maintained for a minimum of three (3) years from the date of submission of the final expenditure report on the related funded project as required by 45 CFR 50.604(i). Electronic submissions will be housed in the electronic submission system.

If any litigation, claim, negotiation, audit or other action involving the records has been started before the expiration of the 3-year period, the records must be retained until completion of the action and resolution of all issues which arise from it, or until the end of the regular 3-year period, whichever is later. (45 CFR 74.53(b) and 94.2(b)

When associated with a PHS funded activity or required by the funding agency, initial reports and annual reports will be submitted according to agency guidelines. The listed content below is compliant with PHS information requests. Other information may be provided to meet specific agency guidelines.

Initial Report

• Project number
• PD/PI or contact PD/PI if multiple
• Name of investigator with the Financial Conflict of Interest;
• Name of the entity with which the Investigator has a Financial Conflict of Interest;
• Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
• Value of the financial interest (dollar ranges are permissible: $0-$4,999; $5,000- $9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value;
• A description of how the financial interest relates to the NIH-funded research and why the Institution determined that the financial interest conflicts with such research;
• A description of the key elements of the Institution’s management plan, including:

(A) Role and principal duties of the conflicted investigator in the research project;
(B) Conditions of the management plan
(C) How the management plan is designed to safeguard objectivity in the research project;
(D) Confirmation of the Investigator’s agreement to the management plan;
(E) How the management plan will be monitored to ensure Investigator compliance; and
(F) Other information as needed.

Annual Report

• The current status of the financial interest,
• Any changes to the management plan, and
• A statement that the management plan is still being managed or an explanation of the management termination

When associated with a PHS funded activity, a management plan summary will be made available to the public upon specific written request through the University Freedom of Information Officer within 5 business days of receipt of the written request as required by 45 CFR 50.94.5(a)(5) (ii). The disclosed information will include:

1. The investigator’s name
2.  Investigator’s position with respect to funded research project
3.  Nature of the significant financial conflict of interest
4.  Approximate dollar value of the significant financial interest in dollar ranges
   1.  Less than 20,000
   2.  Less than 500,000
   3.  Less than 100,000
   4.  Less than or equal to 250,000
   5.  Greater than 250,000 or
   6.  Value cannot be readily determined through reference, reasonable price or other reasonable measures of fair market value
5. A statement that the significant financial conflict of interest has been evaluated and subjected to management under a university management plan.

Information will be updated annually and when a new FCOI is identified.

 

Information will remain available for 3 years from the last update to the management plan.

Reporting Alleged Non-Compliance and Sanctions 42 CFR50.804(j)
Any third party who has a reasonable, good faith belief that an investigator has failed to comply with this Policy or related procedure may notify the Research Integrity Officer (912-478-0843; ehaynes@georgiasouthern.edu) or submit a concern anonymously through the Ethics and Compliance Hotline located on the Georgia Southern University website. Reports may be made anonymously or confidentially.

What should I report?

Non-compliance includes failure to:

• Report financial interests accurately, fully and in a timely manner, pursuant to this Policy and procedure;
• Provide additional information as requested by University officials responsible for reviewing reports;
• Comply fully and promptly with recommendations and decisions made by the Conflict of Interest Subcommittee, Conflict of Interest Subcommittee, Executive Director of the Research Services foundation or Research Integrity Officer;
• File an annual report or update an annual report as required by this Policy;
• Bias the design, conduct or reporting of the project results to benefit the investigator, member of the investigator’s household, or relative; or,
• Take any other necessary action required by this Policy.

Review of Alleged Non-Compliance and Appeals
1. Upon receipt of an allegation of non-compliance, the Conflict of Interest Subcommittee designee will review the allegation and determine whether there is cause for investigation.

1. If Conflict of Interest Subcommittee or Executive Director of the Research Services Foundation or Research Integrity Officer finds no violation, it shall inform the Investigator and his/her Unit Supervisor or Department Head in writing.

2. If there is cause for an investigation, the Conflict of Interest Subcommittee or Executive Director of the Research Services Foundation or Research Integrity Officer will provide a copy of the allegation to the Investigator and his/her Unit Supervisor or Department Head.

1. Every effort will be made to obscure the identity of the reporting individual.
2. The Investigator shall have the opportunity to present a written response and may request to meet with the Conflict of Interest Subcommittee or Executive Director of the Research Services Foundation or Research Integrity Officer.

3. If the Institutional Conflict of Interest Subcommittee or Executive Director of the Research Services Foundation or Research Integrity Officer finds non-compliance or research bias, it shall:

1. make a written finding and recommendation for appropriate action and send a copy of the letter to: the Investigator, the Unit Supervisor or Department Head.
2. make a mitigation report to contain the key elements of the retrospective review and a description of the effects of bias.

4. The investigator may present a written response and meet in person with the Conflict of Interest Subcommittee or Executive Director of the Research Services Foundation or Research Integrity within 30 business days of the finding. The Conflict of Interest Subcommittee or Executive Director of the GSRSF or Research Integrity shall then decide upon an appropriate action.

5. The investigator will receive the decision in writing (with a copy to the Unit Supervisor or Department Head). The Executive Director of the Research Services Foundation or Research Integrity will also notify the party making the allegation of the final disposition of the matter.

6. In the event that the investigator is the spouse or child of an employed investigator, the non-compliance shall be deemed to be the responsibility of the employed investigator.

2. The committee review process including initial screening, committee review and findings report shall not exceed 120 days. 42 CFR 50.506(a)(3)

3. The Investigator may appeal by sending written notice to the Provost within 15 business days after the decision of the Conflict of Interest Subcommittee or Executive Director of the Research Services Foundation or Research Integrity.

4. The appeal proceedings shall consist of a desk audit conducted by the Provost. The investigator or committee members may be consulted or interviewed at the Provost’s discretion.

Sanctions and Disciplinary Actions
1. Non-compliance with this Policy may result in sanctions or disciplinary action, including but not limited to one or more of the following:

1. Removal of the investigator from a particular project;
2. Written reprimand;
3. Suspension of project funding;
4. Restriction of investigator’s privileges;
5. Suspension without pay;
6. Dismissal; and/or
7. Other appropriate sanctions or discipline, depending on the severity and nature of the non-compliance.

2. Non-compliance with this Policy by an investigator involved in any externally sponsored research projects shall be reported to the research sponsor.

1. If non-compliance has biased the design, conduct, or report of the Public Health Service-funded research, the University will promptly notify the Public Health Service Awarding Component of the correction action taken or to be taken.

2. Any penalties imposed by the external sponsor shall be deemed to be separate from, and without limitation on, any imposed by the University or Board of Regents.

1. If the study purpose is to evaluate the safety or effectiveness of a drug, medical device or treatment, the investigator will be required to disclose any conflicting interest associated with the funded project in each public presentation of the results of the research in any instance in which PHS has determined that the research was conducted without the conflict being disclosed or managed, as required by 42 CFR 50.606 (c).
2. If results have been previously published, the investigator will be required to request an addendum to previously published presentation to disclose the unreported conflict.
3. A mitigation report shall contain the key elements of the retrospective review and a description of the effects of bias.

It is the investigators responsibility to maintain a current financial conflict of interest disclosure and to report any Significant Financial Conflict of Interest associated with their University responsibilities.

Auditing:
1. New external proposal

1. Grant coordinators will check to see that investigators listed on external proposals have completed the initial FCOI screening prior to submission of an external project.

1. Proposals seeking PHS funding may not be submitted without initial disclosure.
2. All other funding sources must have approval from the Office of Research Integrity to allow submission prior to completion of the screening by all investigators. This will be rare.
3. In all cases, the GS Principle Investigator is responsible to assure all investigators on the project have completed screening at the time of proposal submission and upon award.

2. New Funded external award

1. Grant Coordinators will request verification from the GS Principle Investigator that all investigator conflict of interest screening reports are up to date.
2. Grant Coordinators will verify through the online electronic submission system to see that all investigators listed on external proposals have completed initial FCOI screening prior to releasing the award to Research Accounting to set up the project account.
3. Where a financial conflict of interest is indicated on the screening tool, Research Accounting will identify that the conflict has been reviewed by the Office of Research Integrity and/or Conflict of Interest Subcommittee and, if required, a FCOI management plan executed prior to processing any expenditure against the account.
4. Where individuals are paid on an externally funded award, Research Accounting will assure that the payee has a valid and up to date conflict of interest screening and, if required, full disclosure and management plan, prior to approving payment.

Concerns can be reported through the University Ethics and Compliance Reporting Hotline. The hotline is a service provided by an independent company, Global Compliance. This service allows you to anonymously send additional information if available, attachments and also receive feedback or questions on your report via a report number and PIN.

If you prefer, you may contact the Research Integrity Officer directly at ehaynes@georgiasouthern.edu or 912-478-5465.

1. Where a Significant Financial Conflict of Interest is identified and managed on a PHS (or other agency/funder requiring such reporting), an initial report, annual report (for ongoing funding) and revised FCOI reports, including all reporting elements required by the regulation, to the NIH for the Institution and its subrecipients as required by the regulation.
2. In the event that bias is found within the design, conduct or reporting of PHS funded research, the funder will be notified promptly and a mitigation report supplied to the funder providing corrective actions taken or to be taken
3. To the institutional official and funder if an investigator fails to comply with the GS FCOI policy and procedure or if the management of a potential FCOI appears to have biased the design, conduct of reporting of NIH funded research.
4. Failure to disclose or or follow the agreed management plan will be managed through the disciplinary procedure as defined in the faculty handbook and described above.

Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research or work product of a sponsored activity, including investigators working for sub-awardees, contractors, subcontractors, consortium participants, collaborators and consultants. The term investigator includes the Investigator’s spouse, dependent children and relatives.

Disclosures are by individual instead of project so each person who meets the definition of investigator must complete a disclosure screening.