EWU 302-08: Conflicts of Interest – Research & Technology Transfer

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University Operations – Administration

EWU Policy 302-08 Authority: EWU Board of Trustees
Effective:  February 22, 2019 Proponent: Vice President for Academic Affairs

 Purpose:  This policy prescribes ethical standards for conducting research or technology transfer by employees and students of Eastern Washington University.  The purpose of this policy is to comply with and support federal and state laws related to research.

History:  This policy is new and replaces chapter 2 of EWU Policy 302-05 (Ethics in Research).  It was adopted by the Board of Trustees on February 22, 2019. Housekeeping edits were made to position titles on March 10, 2023.

Applicability:  This policy applies to all faculty, staff, and students of Eastern Washington University and to any persons engaged in research activities conducted under the auspices of the University.

 

Chapter 1 – General

1-1. Introduction

Eastern Washington University (EWU) encourages participation in externally-funded research and technology transfer projects that carry out its education, research and community service mission.  Participation in research and projects funded by grants and contracts is important to encourage the free exchange and development of new ideas, information, materials and technology that may benefit the university, the community and the public at large.  At times, external activities may have the potential to affect activities pursued by the university.   EWU endeavors to maintain the highest standards of integrity and ethics. This includes the identification and management of actual and potential conflicts of interest that could bias the design, conduct, reporting of results, or sale of research and technology.

1-2. Compliance Requirements

EWU is required to have rules pertaining to conflicts of interest in research and technology transfer by state and federal law. As the recipient of federal grants and contracts, EWU is required by federal law to promote objectivity in research, provide oversight, and manage compliance for all grants and contracts developed and awarded to or conducted under the auspices of EWU. Compliance requirements include, but are not limited to, Department of Health and Human Services’ (HHS) Public Health Service (PHS) regulations  on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50, Subpart F) and Responsible Prospective Contractors (45 CFR Part 94). The PHS regulations also apply to funding obtained from the National Institute of Health.

In addition, the National Science Foundation (NSF) requires EWU to maintain an appropriate written and enforceable policy on conflict of interest, and to manage, reduce, or eliminate all identified conflicts of interest for each award prior to expenditure of award funds.

The Ethics in Public Service Act, chapter 42.52 RCW, requires EWU to have specific conflict of interest provisions for any employee engaged in research, technology transfer, approved consulting activities related to research and technology transfer, or other incidental activities.  RCW 42.52.360(2). Under state law, all research and technology transfer must comply with PHS regulations.

Recognizing that each federal awarding agency may have a different policy regarding conflicts of interest, EWU, as a grant recipient, has adopted this policy to comply with 2 CFR 200.112.

The policies and procedures contained herein are designed to address the necessary identification and management of potential conflicts of interest to ensure compliance with both federal and state laws and regulations relating to conflicts of interest.

1-3. Policy

EWU is responsible for ensuring that all faculty, staff, and students who direct or participate in research or technology transfer under the auspices of the university adhere to ethical standards in disclosing, managing, and eliminating potential conflicts of interest in an effort to promote objectivity in research. It is the obligation of all employees and students engaged in research, technology transfer, or consulting activities to comply with this policy and any applicable state and federal requirements.

This policy applies to all research, technology transfer, approved consulting activities related to research and technology transfer, or other incidental activities, at the university regardless of the funding source.

1-4. References

  • Chapter 42.52 RCW, Ethics in Public Service
  • EWU Policy 302-05, Ethics in Research
  • EWU Policy 401-02, Additional or Outside Employment
  • EWU Policy 901-01, Ethical Standards
  • EWU Policy 901-02, Appropriate Use of University Resources
  • EWU Policy 901-05, Nepotism
  • 2 CFR Part 200.112, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards – Conflict of Interest
  • 42 CFR Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought
  • 42 CFR Part 93, Public Health Service Policies on Research Misconduct
  • 45 CFR Part 94, Responsible Prospective Contractors
  • National Science Foundation Conflict of Interest Policy, Proposal & Award Policies and Procedures Guide, Chapter IX.A

 

Chapter 2 – Definitions

Actual Conflict of Interest depends on the situation and not on the character or actions of the individual.  For purposes of this policy, a conflict of interest exists when the university, through procedures described herein, reasonably determines that a significant financial interest could directly and significantly affect the design, conduct or reporting of the educational, research, and/or service activities that are funded or proposed for funding.

Financial Conflict of Interest (FCOI) means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of research.

Immediate Family refers to the investigator’s parents, siblings, spouse, registered domestic partner, children and any equivalent relatives by marriage. It also refers to any individual who resides on a regular basis in the researcher’s domicile.

Institution refers means the entity or organization that applies for or receives federal research funding. In most cases, the institution refers to Eastern Washington University.

Investigator means the project director (PD) or principal investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research or educational activities funded by external sources, or proposed for such funding, which may include, for example, collaborators or consultants. It also includes any employees who fall within this policy’s definition of Research Employee.

Investigator’s University Responsibilities means an investigator’s professional responsibilities on behalf of the university as outlined in the investigator’s job description, faculty activity plan, or university policies, such as research, teaching, professional development, or service.

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.

NIH refers to the National Institute of Health.

PHS means the Public Health Service, an operating division of the HHS, and any components of the PHS to which the authority involved may be delegated.

PHS Awarding Component means an organizational unit of the PHS that funds research that is subject to this policy.

Potential Conflict of Interest occurs when there is a divergence between an individual’s private interests and his or her professional obligations to the university such that an independent observer might reasonably question whether the individual’s professional actions or decisions are determined by considerations of personal gain, financial or otherwise.

Research means a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research, as well as product development. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Research Employee means any university officer or employee to the extent that they are engaged in research, technology transfer, approved consulting activities related to research and technology transfer, or other incidental activities.  For the purposes of this policy, a university research employee is also an investigator as defined above.

Senior/Key Personnel means the PD/PI and any other person identified as senior/key personnel by the university in the grant application, progress report, or any other report submitted by the university.

Significant Financial Interest (SFI) is:

1. A financial interest consisting of one or more of the following interests of the investigator (and those of the investigator’s spouse and dependent children) that reasonably appears to be related to the investigator’s university responsibilities. See the definition of SFI exclusions for items that may be excluded from determining whether a SFI exists.

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

b.  Non-Publicly Traded Entities: 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 or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests; or,

c.  Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests.

2. Travel: investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available), related to their university responsibilities, provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education. At minimum, the investigator must disclose the purpose of the trip, identify of the sponsor/organizer, destination, and duration. Per the procedures outlined below, EWU will determine whether additional information is needed to ascertain whether or not a financial conflict of interest exists.

SFI Exclusion. For any research or technology transfer that does not involve the National Science Foundation, the following items may be excluded when calculating whether a significant financial interest exists:

  1.  salary royalties, or other remuneration paid by the institution to the investigator if the investigator is currently employed by or otherwise appointed by the institution;
  2. intellectual property rights assigned to the institution and agreements to share in royalties related to such rights;
  3. any ownership interest in the institution held by the investigator, if the institution is a commercial or for- profit organization;
  4. income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles;
  5. income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education;
  6. income from service on advisory committees or review panels for a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher

 For Projects by the National Science Foundation (NSF):

 Significant Financial Interest (SFI): anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights).

NSF SFI Exclusion. For any research involving the National Science Foundation, the following items may be excluded when calculating whether a significant financial interest exists:

  1. salary, royalties or other remuneration from the applicant organization;
  2. any ownership interests in the organization, if the organization is an applicant under the Small Business Innovation Research Program or Small Business Technology Transfer Program;
  3. income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;
  4. income from service on advisory committees or review panels for public or nonprofit entities;
  5. an equity interest that, when aggregated for the investigator and the investigator’s spouse and dependent children, meets both of the following tests: (a) does not exceed $10,000* in value as determined through reference to public prices or other reasonable measures of fair market value; and (b) does not represent more than a 5% ownership interest in any single entity; or
  6. salary, royalties or other payments that, when aggregated for the investigator and the investigator’s spouse and dependent children, are not expected to exceed $10,000* during the prior twelve-month period.

 *While current NSF regulations designate a higher threshold of ($10,000) for SFIs than the PHS (NIH) policy, EWU identifies $5,000 as the standard monetary threshold in determining SFI for all funding sources.

Sponsor means the agency or organization providing funding to the university to carry out a program of research, and/or educational or services activities.

 

Chapter 3 – Responsibilities

3-1. Purpose

EWU seeks to promote objectivity in research, technology transfer, and other sponsored project activities by prescribing standards that protect the design, conduct, and reporting of projects from potential bias posed by conflicts of interest, and including standards for identifying and managing conflicts of interest in compliance with federal regulations and state laws. The intent of this chapter is to outline these standards.

3-2. Institutional Responsibilities

Eastern Washington University will:

a.  report and manage any conflicts of interest as required by the sponsor and in accordance with this policy;

b.  establish standards that provide a reasonable expectation that the design, conduct, and reporting of research will be free from bias resulting from investigator financial conflicts of interest;

c.  maintain an up-to-date enforceable policy that complies with applicable federal regulations;

d.  develop and maintain adequate enforcement mechanisms and provide employee sanctions or other administrative actions to ensure compliance;

e.  maintain records of all investigator disclosures of financial interests and the university’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 this policy or retrospective review, if applicable. Records must be maintained at least six years from the date of submission of the final expenditure report for the project;

f.  certify in each application for funding that the university complies with all appropriate sponsor regulations, terms and conditions;

g.  designate university official(s) to solicit and review disclosure statements from each investigator planning to participate in or participating in research, provide guidelines to identify conflicting interests related to sponsor funded research and develop management plans that specify the actions that have been and shall be taken to manage FCOI’s;

h.  inform each investigator of the applicable regulation, university policy on FCOI and investigator’s responsibilities regarding disclosure of SFI’s;

i.  for federally funded research projects and those funders who follow PHS policy, require that each investigator complete FCOI training prior to engaging in research at least every three years, and immediately when: the university revises this policy in a matter that affects the investigator, when the investigator is new to the university, when the university determines the investigator has failed to comply with the university’s research policies and/or conflict of interest management plan;

j.  manage investigator discosures of SFIs at the time of application, annually and within 30 days of discovering or acquiring a new SFI;

k.  take necessary actions to manage FCOIs of its investigators, including those of subrecipient investigators, develop managment plans and monitor compliance;

l. if the university identifies an SFI that was not disclosed or reviewed in a timely manner, the designated offical shall within 60 days review the SFI, determine if an FCOI exists and implement an interim mangagement plan if needed, and in cases of non-compliance, complete a retrospective review and submit a mitigation report to the sponsor if bias is found;

m.  provide FCOI reports to each sponsor as required;

n.  subrecipients:

  1. incorporate as part of a written agreement terms that establish whether the FCOI policy of the awardee institution or that of the subrecipient will apply to subrecipient investigators and include time periods to meet SFI disclosure, if applicable and FCOI reporting requirements;
  2. subrecipient institutions who rely on their FCOI policy must report identified FCOIs to the awardee institution in sufficient time to allow the awardee institution sufficient time to report the FCOI to the sponsor and meet reporting obligations;
  3. ensure that subrecipient investigators abide by any management plan that has been adopted to manage a FCOI;
  4. ensure subrecipeint investigators meet FCOI training requirements;
  5. provide oversight of FCOI requirements for subrecipients and consultants.

o.  make this policy available on the university’s website;

p.  prior to expenditure of funds, make certain information concerning FCOI’s held by senior/key personnel are publicly accessible on the university’s website, or provide written response within five business days of a request, and update information annually and within 60 days of identification of a new FCOI;

q.  implement retrospective reviews if a new or non-reported SFI has been identified;

r.  notify the sponsor if bias is found through a retrospective review, and submit a mitigation report as necessary.

3-3. Research Employee/Investigator Responsibilities

Each investigator will be held accountable for disclosure of any SFI as defined in this policy to the Office of Grant and Research Development and for compliance regarding any conditions and restrictions imposed by the university in order to manage actual or potential FCOIs.

Each research employee/investigator is responsible for regularly updating their disclosure status to ensure regulatory compliance.  Disclosures are required:

a. at the time of application:

  • If the investigator discloses known SFIs to the university, the designated official will review the disclosure to make a determination of FCOIs and report to the appropriate sponsor as required.

If a proposal is funded:

b.  annually, by submitting an updated Financial Conflict of Interest Disclosure form in accordance with university policy;

c.  within 30 days of discovering or acquiring a new SFI;

d.  within the specific time period designated by the university for a particular award, during the period of award, or as indicated by the sponsor; and,

e.  any annual or updated reports required as part of an approved conflict management plan.

3-4. Office of Grant & Research Development Responsibilities

The Office of Grant and Research Development (OGRD) is the primary point of contact for all matters related to this policy. Upon submission, the OGRD will inform each research employee/ investigator of:

a.  the applicable regulation(s), policy and their specific responsibilities regarding the disclosure of significant financial interests including updating disclosures as required by the sponsor;

b.  require training as determined by each sponsor;

c.  designate a person or persons to review and manage the disclosure process;

d.  maintain records of all financial disclosures and actions taken to resolve conflicts of interest for six years;

e.  manage subrecipient compliance with this policy.

Certification for Externally Funded Projects

Within each proposal submitted for external funding, the OGRD is responsible for certifying to the sponsor that EWU:

a.  has an up to date written and enforceable administrative process to identify and manage, reduce or eliminate conflicting interests;

b.  shall promote and enforce investigator compliance with this policy;

c.  will require all key personnel who meet the definition of investigator at time of submission to file a financial disclosure form, annually if required by the sponsor, and for each investigator who acquires a new SFI, within 30 days of discovery;

d.  will manage FCOIs and ongoing reports as required by the sponsor; and,

e.  will agree to make information available to the appropriate awarding agency regarding all conflicting interests identified by the institution and how those interests have been managed, reduced or eliminated to protect the research from bias.

Collaborators and Subrecipient Organizations

The OGRD also will take reasonable steps to ensure that any collaborator or subrecipient organization will provide assurances to comply this this policy by:

a.  requiring such entities to certify that they have their own policies in place that comply with this policy; or

b. requiring investigators working for such entities to follow the policies of EWU.

 

Chapter 4 – Conflict of Interest Procedures

4 -1. Preliminary Discussions

Prior to writing a proposal, each research employee/ investigator must consider whether a financial conflict of interest may exist.  Review by the unit head or college dean of relevant financial information at an early stage of proposal development may help identify actual or potential conflicts of interest and determine potential conditions to manage or eliminate the conflict of interest.

If the unit head or dean believes that it will be possible to develop and execute, prior to an award, a conflict of interest management plan that will adequately manage or eliminate the conflict of interest, they may endorse the proposal by signing the Financial Conflict of Interest Disclosure form.

Although involving the unit head dean in this preliminary manner is recommended to help expedite proposal processing, an investigator is not required to do so.  Alternatively, an investigator may consult informally with the staff of the OGRD or the chair of the Conflict of Interest Review Committee before filing a disclosure, or may simply proceed with the official disclosure process.

4-2. Financial Conflict of Interest Disclosure

Before engaging in research, technology transfer, approved consulting activities related to research or technology transfer, or submitting a proposal for a sponsored project, any university-affiliated investigator must complete must complete a Financial Conflict of Interest Disclosure form and submit a completed for to OGDR. When relevant, the investigator also must include supporting documentation identifying the relevant enterprises and the nature and amount of the investigator’s financial interest.

The investigator must identify whether there is any reportable SFI as specified in the Financial Conflict of Interest Disclosure form. If the investigator discloses a SFI, the investigator must also submit supporting documentation outlining the possible conflict to OGDR with the Financial Interest Disclosure form. Supporting documentation should be placed in an envelope marked “Confidential.” In addition, the Financial Interest Disclosure form must be signed by the investigator’s unit head or dean.

Regardless of whether or not a SFI will be disclosed, an investigator must submit the Financial Conflict of Interest Disclosure form (and enclosures, if applicable) to OGDR before submitting a sponsored research proposal.

If an SFI is being disclosed, the confidential information will remain sealed until a notification of award from the funding agency is received. If a conflict is identified, it must be resolved prior to research beginning or the expenditure of any funds.  Confidential information submitted for projects that are not funded will be returned to the investigator unopened or destroyed as requested by the investigator.

 4-3. Initial review

Upon notification of award, the Vie Provost or designee will review all Financial Conflict of Interest Disclosure documentation that was completed at the time of proposal submission to determine if an actual or potential conflict of interest may exist and could directly and significantly affect the design, conduct or reporting of the proposed project. The investigator is free to submit updated information that could potentially affect the SFI determination if applicable. If an initial judgement is made that an actual or potential conflict of interest may exist, the Provost’s Office will be notified.

4-4. Conflict of Interest Review Committee

 If the Vice Provost or designee determines an actual or potential conflict of interest exists, the case will be referred to the Conflict of Interest Review Committee. This three-member committee, of which one member serves as chair, will be appointed by the President with nominations submitted by the EWU Academic Senate for a two-year term.  The Vice Provost or designee will serve as an additional non-voting member.

The committee will develop a Conflict Management Plan, which may include investigation and consultation with individuals that the committee consider necessary and appropriate.  The plan will include measures that will reduce, eliminate or effectively manage the conflict of interest. The committee may discuss proposing alternative conditions which may be either more or less stringent or restrictive depending on the situation.  The investigator may propose, or the committee may require, one or more of the following as part of the resolution plan:

a.  no action beyond disclosure to the university, sponsor, and/or competitor, if appropriate;

b.  disclosure of FCOI to:

(i) the academic and professional communities, as well as at presentations and in publications,

(ii) to the   sponsor   through   written notification,

(iii) to participants through informed consent documents when human participants are involved. In determining an appropriate means of disclosure, consideration should be given to whether it should be written and/or oral and to the level of detail;

c. monitoring and oversight of the research by independent researchers either through an in-house quality assurance program or through an outside referee or coordinating center;

d.  modification of   the   research   plan   to   manage concerns of bias by establishing protocols that include actions such as blinding, modifying the scope of the project and setting timetables for the delivery of the product.  These modifications would require the approval and cooperation of the sponsor and possibly collaborating investigators at the university and elsewhere;

e.  designation of a co-investigator (peer or superior) who has no significant financial interest in the project to assume the lead role on the project;

f.  the sale or other divestiture of the significant financial interest in a sponsor or competitor and restrictions on re-investment after the project is completed for an appropriate period to provide for publication and critique of the project;

g.  placing interest in escrow for the term of the project and possibly a period beyond the end of the project to provide for publication and critique of the project;

h.  severance of other relationships with the sponsor or competitor that create actual or potential conflicts of interests;

i.  other strategies that may include variations of options presented, combinations of options, and/or new options not identified herein; and/or,

j.  disqualification of the investigator from participation in all or a portion of the research when no other resolution is acceptable to the investigator and the Conflict of Interest Review Committee.

The committee shall recommend to the Vice Provost or designee the conditions and restrictions, if any, to be imposed by the university to reasonably manage the actual or potential conflict of interest. The resolution plan shall not include any reduction in an employee’s base salary unless the plan also includes a leave of absence from the university. The final decision regarding management of the conflict of interest will be made by the Vice Provost or designee with due regard for the committee’s recommendations. The investigator shall indicate in writing acceptance of the resolution plan prior to acceptance and expenditure of any funds under the award.

For National Science Foundation (NSF) funded projects only: If the Vice Provost or designee determines the imposition of conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health or welfare, the university may allow the NSF-supported research, educational, or service activities to go forward without imposing such conditions or restrictions when permitted by applicable regulations.

4-5. Appeals

The Provost or designee has the ultimate responsibility for reviewing significant financial interest disclosures, determining whether an actual or potential conflict of interest exists, and for determining what actions should be taken by the university to manage any conflict of interest.

Investigators may appeal decisions of the Vice Provost or designee to the Provost. The appeal must be filed in writing and received by the Provost’s Office within 14 calendar days of the date the Vice Provost or designee issues a written decision. The Provost or designee should respond to the appeal within 14 calendar days of receipt. The Provost or designee may affirm, modify, or reverse the Vice Provost or designee’s determination. The Provost or designee’s decision is final and no further appeal is available.

4-6. Non-Compliance Enforcement

Violations of this policy may result in one or more of the following university actions:

a. suspension of the research until a corrective action plan is approved by the VPAA and has been initiated;

b.  completion of a retrospective review of the investigator’s activities and a mitigation report submitted to the NIH for PHS funded research;

c.  a report of misconduct to the federal Office of Research Integrity in the case of federally funded research;

d.  cancellation of the research;

e.  transfer of the research to another investigator;

f.  PI, staff and/or student dismissal from the university in the case of flagrant noncompliance resulting in bias in the design, conduct, or reporting of the research.

The university shall withdraw an application for funding or a funded project in all cases where the investigator, after the process of appeal, chooses not to comply with the resolution plan adopted in accordance with university policy and if the project cannot otherwise be completed without the services of the investigator.

4-7. Retrospective Review

To ensure compliance, EWU is responsible for keeping each sponsor appropriately informed if the university finds that it is unable to satisfactorily manage a conflict of interest or if the organization finds that research will proceed without the imposition of conditions or restrictions when a conflict of interest exists.

For PHS funded projects or those who follow PHS regulations, the university must complete a retrospective review of the investigator’s activities and the project to determine whether any research, or portion thereof, conducted during the time period of noncompliance was biased in the design, conduct, or reporting of research within 120 days of the determination of noncompliance whenever:

  • an FCOI is not identified or managed in a timely manner, including failure by the investigator to disclose an SFI;
  • failure by the university to review or manage an FCOI; or,
  • failure by the investigator to comply with a Conflict Management Plan.

EWU will notify the sponsor promptly and submit a mitigation report if bias is found.  The mitigation report will include: key elements of the retrospective review, description of the impact of the bias on the research project, and a plan of action to eliminate or mitigate the effect of the bias.

4-8. Reporting

General Reporting

The university will also submit required reports for SFI disclosure and FCOI in a timely manner as required by each individual sponsor.

Annual Updated FCOI Reporting

All investigators who are subject to a Conflict Management Plan shall provide annual reports in a timely manner to update their status, confirm that there has been no material increase in the nature and amount of the SFI, and that they are complying with the approved Conflict Management Plan.  Investigators who do not submit updated reports may be subject to sanctions.

4-9. Recordkeeping

The OGRD shall maintain all records related to this policy.  To protect the privacy of those involved, all information gathered under this policy will be maintained in a confidential manner and disseminated only as required by law or as is necessary for internal operations.  In the event a proposal is not funded, any related confidential information shall, at the direction of the investigator, either be destroyed unopened or returned to the investigator unopened to the extent permitted by law.

Records for funded projects will be maintained for six years after the projects concludes.