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Grant Conflict of Interest Policy

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Administration and Finance

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Fiscal Affairs - Grants Office

 

 

DRAFT

Worcester State University

Financial Conflict of Interest (FCOI) Policy for Research Funded by Federal Grants

 

Policy

 

 

 

Worcester State University (WSU) promulgates this Conflict of Interest policy as an assurance of its continued commitment to the integrity of its students, faculty, staff, and associates in the conduct of research; and to the implementation of grants in compliance with state and federal regulations. This Policy is to promote objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct or reporting of research grants or cooperative agreements will be biased by any conflicting financial interest of an investigator or other senior personnel. 

 

Procedure

 

 

 

 

1. Statement of Need & Purpose

The purpose of this policy is to promote objectivity in research and educational activities by establishing standards and processes that provide a reasonable expectation that the design, conduct, and reporting of externally sponsored research will be free from bias resulting from Investigator financial conflicts of interest.

 

A financial conflict of interest exists when it can be reasonably determined that an Investigator's personal financial concerns could directly and significantly influence the design, conduct, or reporting of sponsored research or educational activities, resulting in a “Significant Financial Interest” (See Section 4. What is a Significant Financial Interest?).

 

Worcester State University (WSU) is compelled by both its mission, state and federal regulations to uphold these standards. [See MA State Ethics website http://www.mass.gov/ethics/, WSU Employee Handbook http://worcester.edu/hr/Shared%20Documents/EmployeeHandbook.pdf National Institutes of Health’s guidelines (http://grants.nih.gov/grants/policy/coi/index.htm) and the National Science Foundation’s conflict of interest policies (http://www.nsf.gov/pubs/policydocs/pappguide/nsf11001/aag_4.jsp#IVA).

 

2. Investigator Requirements

Any Investigator responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by external sources is required to:

 

(1) Disclose, prior to applying for external funding, all “significant financial interests” (and those of his/her spouse/domestic partner, or dependent child) related to the Investigator’s institutional responsibilities. If an Investigator has no significant financial interests to disclose, he or she must still complete the disclosure documentation indicating this to be the case. This documentation should be sent to the WSU Grant Coordinator.

 

(2) Update the disclosure at the following points:

a. Prior to initial award activation (i.e., prior to the release of funds by Worcester State University);

b. Within 30 days of acquiring a new significant financial interest;

c. At least annually throughout the life of a sponsored agreement.

 

(3) Comply with FCOI management plans if instituted by Worcester State University.

 

(4) Complete FCOI training via meeting with the Grant Coordinator and the online Ethics CORE modules:

a.       prior to engaging in the externally sponsored research or educational activity.

b.      at least every 4 years;

c.       any time an investigator is new to the institution and plans to participate in externally funded research or educational activities;

d.      in the event an investigator has been found to be non-compliant with this policy or a management plan instituted by Worcester State University;

e.       if the institution makes substantive changes to this policy which affect Investigator requirements.

 

3. Applicability

3.1 General Applicability: This policy applies to each Investigator/Project Director who is planning to participate in, or is participating in, externally sponsored.

 

The policy also includes the Investigator's immediate family, which is defined as his/her spouse or domestic partner and dependent children.

 

This policy does not apply to SBIR (Small Business Innovation Research) applications.

 

This policy also does not apply to instances where external funding is paid directly to the individual Investigator, rather than to Worcester State University. For example, individual fellowships paid directly to the Investigator rather than to the University on his/her behalf are not covered by this policy.

 

3.2 Subrecipients: The responsibility to identify, manage, and report FCOIs to sponsoring agencies extends to collaborating Investigators under any subrecipient agreements. Subrecipient agreements issued by Worcester State University shall contain language documenting whether the subrecipient organization will be subject to the Worcester State University’s FCOI policy (this policy) or the FCOI policy of the subrecipient’s own institution.

 

·         When the subrecipient will be following its own institutional FCOI policy, Worcester State University will obtain a written certification from the subrecipient organization that its FCOI policy complies with the applicable sponsoring agency regulations regarding the identification, management, and reporting of FCOIs. Additionally, the subrecipient agreement will require the subrecipient organization to report identified FCOIs for its investigators to Worcester State University, and will specify an acceptable time-frame for this reporting that will allow Worcester State University to in turn report these FCOIs to the sponsoring agency as required.

 

·         If a subrecipient cannot certify that their FCOI policy and procedures meet sponsoring agency regulations, then the subrecipient agreement shall require the subrecipient organization to adhere to the Worcester State University policy and procedures, and to submit subrecipient Investigator disclosures to WSU. The timeframe for submitting disclosures will be specified so as to allow WSU to comply in a timely manner with its review, management, and reporting obligations under this policy.

 

 

4. What is a Significant Financial Interest (SFI)?

While many types of financial interests are excluded from this policy (see section 5. Exclusions), a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse/domestic partner and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities is considered a “significant financial interest” (SFI) and must be disclosed:

 

4.1 Interests in Publicly Traded Entities: With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, and any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this policy, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship). Equity interest includes stock, stock option, or other ownership interest, as determined by public prices or other reasonable measures of fair market value.

 

4.2 Interests in Non-publicly Traded Entities: With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse/domestic partner or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest), regardless of dollar value associated with that equity interest.

 

4.3 Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests once an aggregated value of $5,000 from a particular source is reached.

 

4.4 Reimbursed or Sponsored Travel: Investigators also must disclose the occurrence of any reimbursed or sponsored travel related to their institutional responsibilities (regardless of dollar value). Reimbursed travel includes instances where travel expenses incurred by the individual are ultimately covered by an outside entity through a reimbursement (pay back) process. Sponsored travel includes instances where the expenses are paid by the outside entity on behalf of the individual, rather than reimbursed to him or her. In the case of sponsored travel, the exact monetary value may not be readily known to the individual.

 

4.5 Other: An Investigator may choose to disclose any other financial or related interest that might present an actual, potential, or perceived conflict of interest. Disclosure can be a key factor in protecting an individual's reputation and career from potentially harmful allegations of misconduct.

 

5. Exclusions

Financial interests that are excluded from this policy and which need not be disclosed include:

 

·         Salary, royalties, remuneration paid by Worcester State University (as your current employer)

·         Income from seminars, lectures, or teaching engagements sponsored by:

o   A Federal, State, or Local government agency

o   An Institution of Higher Education

o   Academic Teaching Hospital

o   A Medical Center

o   A Research Institute that is affiliated with an Institution of Higher Education

·         Income from service on advisory committees or review panels sponsored by:

o   A Federal, State, or Local government agency

o   An Institution of Higher Education

o   Academic Teaching Hospital

o   A Medical Center

o   A Research Institute that is affiliated with an Institution of Higher Education

·         Travel reimbursed or sponsored by:

o   A Federal, State, or Local government agency

o   An Institution of Higher Education

o   Academic Teaching Hospital

o   A Medical Center

o   A Research Institute that is affiliated with an Institution of Higher Education

·         Intellectual property rights that you have assigned to Worcester State University or in instances where an agreement exists to share royalties to such property rights.

·         Income from investment vehicles or retirement accounts unless you directly control the investment decisions made in these vehicles.

 

6. Disclosure Process

Each Investigator applying for external funding for research and/or educational activities must disclose all significant financial interests (and those of his/her spouse, domestic partner, and dependent children) by completing a Worcester State University FCOI Screening and Disclosure Form and returning it to the University’s Grant Coordinator.  The following disclosure requirements should be used:

 

·         All significant financial interests must be disclosed prior to the time a proposal for external funding is submitted. The initial disclosure process will coincide with the normal proposal routing/approval process used by the Grant Office. No proposal will be submitted without FCOI Screening and Disclosure Forms being complete and up-to-date for each Investigator (e.g., any individual responsible for the design, conduct, or reporting of the proposed project, regardless of title). If an Investigator has no significant financial interests to disclose, he or she must still complete the disclosure documentation indicating this to be the case.

·         In the event of a new incoming award, Investigators must review and update their Disclosure Forms to ensure they are complete and accurate prior to expenditure of funds.

·         During the period of the sponsored agreement, all financial disclosures must be updated by Investigators within 30 days of discovering or acquiring a new significant financial interest.

·         All financial disclosures must be updated by Investigators at least annually during the life of the sponsored agreement.

·         Investigators newly hired or otherwise advancing to a role of responsibility in the design, conduct, and reporting of externally sponsored research or educational activities must contact the Grant Coordinator to disclose SFIs and complete the required training.

·         Individuals should contact the Grant Coordinator to update disclosures for ongoing sponsored projects.

 

7. Review Process

The FCOI Review Officers are the Worcester State University Provost or appropriate Vice President; or a designee chosen from the Worcester State University administration. The designee option is available at the Provost’s and Vice President’s discretion in order to facilitate the review process in a timely and appropriate manner in instances including, but not limited to: situations where compelling reasons exist to have another individual conduct the review in order to provide an appropriate, informed review; to avoid known conflicting interests between parties involved in the review; and/or the unavailability of the Provost or Vice President to conduct a timely review.

 

The FCOI Review Officer is responsible for reviewing FCOI Screening and Disclosure forms in which significant financial interests have been disclosed in order to determine whether the interests could reasonably be expected to directly and significantly affect the design, conduct, or reporting of the activities funded or proposed for funding. Forms containing SFI disclosures will be forwarded by the Grant Coordinator to the appropriate FCOI Review Officer.  The FCOI Review Officer may request additional clarifying information from the Investigator as necessary to complete the review.

 

In the case of initial awards, the FCOI Review Officer will conduct a review of disclosures, including the development of a management plan if necessary, prior to the expenditure of funds.

 

In the case of disclosures of new financial interests throughout the life of an on-going project, the FCOI Review Officer will conduct his/her review of disclosures, including the development of a management plan if necessary, within 60 days of receiving the disclosure.

 

8. Management/Monitoring Process for Identified Conflicts of Interest

The FCOI Review Officer is responsible for developing a management plan for any identified conflicts of interest to ensure that any conflict is managed, reduced, or eliminated. The FCOI Review Officer may include the Investigator in the development of this plan. In all cases, resolution of the conflict or establishment of an acceptable conflict management plan must be achieved before expenditure of any funds under an award.

 

8.1 Management Plan Conditions/Restrictions: Management plans may include conditions or restrictions such as, but not limited to, the following:

·         Public disclosure of significant financial interests;

·         Monitoring of the research by independent reviewers;

·         Modification of the planned activities (possibly subject to sponsor approval);

·         Disqualification from participation in all or part of the project;

·         Reduction or elimination of the significant financial interests (e.g., sale of an equity interest);

·         Severance of relationships creating financial conflict.

 

8.2 Management Plan Required Elements: Management plans will include at a minimum a description of the following elements:

·         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 the 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;

·         Other information as needed.

 

As part of the FCOI Screening and Disclosure form each Investigator must certify that if the

FCOI Review Officer determines a conflict exists, the Investigator will adhere to all conditions or restrictions imposed upon the project and will cooperate fully with the individual(s) assigned to monitor compliance throughout the life of the funded project.

 

9. Retrospective Review Process and Remedies

In instances where any of the following has occurred, the FCOI Review Officer will complete within 120 days a retrospective review of the research project to determine whether bias has occurred in the research:

 

·         Whenever a financial conflict of interest is not identified or managed in a timely manner, including instances where an investigator failed to disclose a significant interest that is determined by the FCOI Review Officer to be a financial conflict of interest;

·         Whenever the institution has failed to review or manage a financial conflict of interest;

·         Whenever an Investigator fails to comply with the conflict of interest management plan proscribed by the FCOI Review Officer.

 

If it is determined through retrospective review that the research has been biased by the Investigator’s financial interests, then the FCOI Review Officer will decide upon an appropriate set of remedies to eliminate or mitigate the bias.

 

Depending on the nature of the financial conflict of interest, the FCOI Review Officer may determine that additional measures are necessary with regard to the Investigator’s participation in the funded research project during the period of the retrospective review.

 

10. Maintenance of Records

The FCOI Review Officer will maintain records of all disclosures, reviews, and associated FCOI Review Officer actions. All records will be maintained for three years following the letter of termination or completion of the project or resolution of any government action involving the records.

 

All FCOI Screening and Disclosure forms and related documents are considered sensitive information and only those persons involved in the implementation of this policy will routinely have access to such records. However, all FCOI and SFI information (including institutional reviews and determinations) will be made available to the sponsoring agency upon request, or as required by this policy’s reporting requirements. Additionally, there may be circumstances in which FCOI related information is made public in accordance with sponsor regulations and the public accessibility requirements of this policy (see 11. Reporting Process and 12. Public Accessibility sections below).

 

11. Reporting Process

Worcester State University recognizes its obligation to report information emanating from the University’s FCOI process to sponsoring agencies, and will provide the necessary information to those agencies in a manner, format, and level of detail consistent with the sponsor’s requirements for such reporting. The Grant Coordinator, working with the FCOI Review Officer, is the individual designated to submit reports to the sponsoring agency, and he/she will review the sponsoring agency’s reporting requirements to ensure the appropriate information is submitted.

 

11.1 Reporting to PHS Awarding Components: Management plan reports to PHS awarding components will include at a minimum the following elements:

·         Sponsor Project Number or identifier;

·         Project Director (PD)/Principal Investigator (PI) or contact PD/PI;

·         Name of Investigator with the financial conflict of interest;

·         Name of 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

___ $20,000 - $39,999

___ $40,000 - $59,999

___ $60,000 - $79,999

___ $80,000 - $100,000

___ Over $100,000 (document in increments of $50K)

$_____________

___ Value cannot be readily determined;

·         A description of how the financial interest relates to the funded research, and the basis for the institution’s determination that the financial interest conflicts with such research;

·         A description of the key elements of the management plan, including:

o   Role and principal duties of the conflicted investigator in the research project.

o   Conditions of the management plan.

o   How the management plan is designed to safeguard the objectivity in the research project.

o   Confirmation of the Investigator’s agreement to the management plan.

o   How the management plan will be monitored to ensure investigator compliance.

o   Other information as needed.

 

 

11.2 Retrospective Review and Mitigation Reports to PHS Awarding Components: In the event that the failure of an Investigator to comply with this policy or with a financial conflict of interest management plan appears to have biased the research/educational activity, the Grant Coordinator, on behalf of the FCOI Review Officer, will notify the sponsoring agency of the corrective action taken, including the outcome of the retrospective review, and the mitigation plan (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable).

 

Retrospective Review and Mitigation Reports to PHS awarding components will include, at minimum, the following elements:

·         Project Number;

·         Project Title;

·         PD/PI or Contact PD/PI if a multiple PD/PI model is used;

·         Name of Investigator with the FCOI;

·         Name of the entity with which the Investigator has a financial conflict of interest;

·         Reason(s) for the retrospective review;

·         Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);

·         Findings of the review;

·         Conclusions of the review; and

·         Description of the impact of the bias on the research project and the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias.

 

12. Public Accessibility

Worcester State University recognizes the importance of transparency, and that some sponsors require information about FCOIs to be made accessible to the public. The University maintains an FCOI Public Accessibility webpage to fulfill this obligation. In instances where a financial conflict of interest of senior/key personnel has been managed (rather than eliminated) the following information will be made available to the public prior to expenditure of funds:

·         Name of Investigator with the financial conflict of interest, title, role on the research project;

·         Name of Entity with which the Investigator has a financial conflict of interest;

·         Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement honorarium);

·         Approximate value of the financial interest (in dollar ranges described in section 11.1).

 

Additionally, this information will be updated annually throughout the life of the funded project, and within 60 days of any new disclosure determined to be a financial conflict of interest. The information will remain available for 3 years from the date of the most recent update.

 

13. Enforcement Mechanisms, Remedies, and Noncompliance

Failure to properly disclose relevant financial interests or to adhere to conditions or restrictions imposed by the FCOI Review Officer will be considered a violation of this policy.

 

Alleged violations of this policy will be investigated by the FCOI Review Officer, who will make recommendations for action to the President. Breaches of policy include:

·         failure to file the necessary disclosure statements;

·         knowingly filing incomplete, erroneous, or misleading disclosure forms; or

·         failure to comply with procedures prescribed by the FCOI Review Officer.

 

If the President determines that this policy has been violated; he/she may impose a range of sanctions including but not limited to:

·         notification of sponsor and possible termination of award;

·         formal admonition;

·         a letter to the Investigator's personnel file;

·         suspension of the privilege to apply for external funding and/or to seek IRB/IACUC approval; and

·         other remedies necessary to eliminate or mitigate the impact of any potential bias.

 

If the allegations and review suggest a possible violation of the Commonwealth of Massachusetts policy prohibiting fraud, a concurrent report to the State will be made.

____________________________________________________________________________

14. Appendix

14.1 Definitions

14.2 Worcester State University Institutional Responsibilities

14.3 Informing the Campus Community of this Policy

 

14.1 Definitions

 

Disclosure of significant financial interests means an Investigator’s disclosure of significant financial interests to an Institution.

 

Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of externally funded research.

 

FCOI report means an Institution’s report of a financial conflict of interest to the external sponsor.

 

Financial interest means anything of monetary value, whether or not the value is readily ascertainable.

 

Institutional Responsibilities means your professional responsibilities on behalf of Worcester State University, which include: research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as IRB, IACUC, or other monitoring boards.

 

Investigator means any 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, which may include collaborators or consultants.

 

Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

 

PD/PI means a project director or principal investigator of a funded research project and/or educational activity; the PD/PI is included in the definitions of senior/key personnel and Investigator.

 

PHS means the Public Health Service of the US Department of Health and Human Services and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).

 

PHS awarding component means an organizational unit within PHS that funds research.

 

Research means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research, or product development. As used in this policy, the term includes any such activity for which federal funding is available for research through a grant (sponsored project) or cooperative agreement.

 

Significant Financial Interest (see section “What is a Significant Financial Interest?”)

 

Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted by the Institution to the external sponsoring agency.

 

Small Business Innovation Research (SBIR) Program means the extramural research program for small businesses that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Pub. L. 97-219, the Small Business Innovation Development Act, as amended. For purposes of this policy, the term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Pub. L. 102-56

 

14.2 Worcester State University Institutional Responsibilities

 

As an institution that receives external funding for research and sponsored programs, Worcester State University has the following responsibilities under this policy:

 

·         To establish standards that provide a reasonable expectation that the design, conduct, and reporting of funded research and educational activities will be free from bias resulting from Investigator financial conflicts of interest.

·         To maintain an up to date, written, enforced policy that complies with federal FCOI regulations and to make this policy available via a publicly accessible website.

·         To inform each Investigator of this policy and their responsibilities regarding disclosure.

·         To require each Investigator to complete training regarding this policy prior to engaging in externally funded research, at least every 4 years, and immediately when any of the following circumstances apply:

o   If the policy revised in a substantive way that affects investigator requirements.

o   If the Investigator is new to Worcester State University.

o   If an Investigator is found not in compliance with this policy or an FCOI management plan.

·         To take reasonable steps to ensure any subrecipient complies with either this policy or their own institutional policy which must meet the external sponsor’s FCOI requirements.

·         To designate an institutional official or officials to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, funded research.

·         To require that each Investigator disclose to the designated official(s) the Investigator’s significant financial interests, and those of the Investigator’s spouse/domestic partner and dependent children prior to submission of a proposal for external funding for research.

·         To require that the Investigator involved in the funded research submit an updated disclosure of significant financial interest at least annually.

·         To require that the Investigator involved in the funded research submit an updated disclosure of significant financial interest within 30 days of discovering or acquiring (through purchase, marriage, or inheritance) a new significant financial interest.

·         To provide guidelines for the designated officials to determine whether the significant financial interest is related to funded research, and if so related, whether it is a financial conflict of interest.

·         To take such actions as necessary to manage the financial conflict of interest, including any financial conflict of interest of a subrecipient Investigator. Management of an identified FCOI requires development and implementation of a management plan, and, if necessary, a retrospective review and a mitigation report.

·         To provide initial and ongoing reports as required by the sponsoring agency.

·         To maintain records of all Investigator disclosures of Investigator financial interests and the institution’s review of and response to such disclosures (whether or not a disclosure resulted in the institution’s determination of FCOI) and all actions under the institution’s policy or retrospective review if applicable. These records shall be maintained for at least 3 years from the date of submission of the final expenditures report, or as specified by the funding agency.

·         To establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance, as appropriate.

·         To provide certifications regarding our FCOI process in each application for funding when such certifications are required by the sponsor.

·         To disclose information about FCOIs currently being managed in relation to the institution’s sponsored agreements via a publicly accessible website.

 

14.3 Informing the Campus Community of this Policy

As a matter of process, Investigators will be informed of these requirements through several means and at several key time-points, including (but not limited to) some or all of the methods listed below. This list is not meant to be exhaustive or proscriptive, but rather to convey the institution’s commitment to establishing a culture of compliance with this policy by utilizing multiple and varied communication strategies.

 

·         Campus-wide communications/reminders regarding Worcester State University sponsored projects and research policies.

·         Publication of this policy on the College website.

·         The Worcester State University grant proposal routing process.

·         New award communications sent to the principal Investigator during the award set-up phase, and prior to expenditure of funds.

 

Approved by

Vice President/Date

 

 

Approved by

Cabinet/Date

 

 

Revised Date

 

June 6, 2013

 

 

Last modified at 10/15/2013 1:56 PM  by Hoxha, Anisa