Policy and Procedures on Financial Conflict of Interest in Public Health Service Funded Research

Policy and Procedures on Financial Conflict of Interest in Public Health Service Funded Research

1.0 Summary

The Brookings Institution has adopted the Policy and Procedures on Financial Conflict of Interest in Public Health Service Funded Research (the “Policy”) to provide guidelines and procedures for the identification and resolution of real, potential, or apparent financial conflicts of interest that may arise with respect to the Institution’s employees and affiliates in Public Health Service-Funded research. The Policy details what constitutes a financial conflict of interest in these settings as well as the duties and disclosure requirements of employees and affiliates concerning financial matters with other organizations or businesses.

2.0 People Affected

The Policy applies to all Brookings employees and to all Brookings affiliates, regardless of location, who are Investigators on U.S. Public Health Service (“PHS”) funded research projects (See Section 4.0 for who is deemed an “Investigator”). The Policy applies to any application for or receipt of research funding from PHS, including without limitation the National Institutes of Health (“NIH”) and the U.S. Food and Drug Administration (“FDA”), whether such funding is by means of a grant, cooperative agreement, or contract. However, the Policy shall only apply to PHS-Funded Research with an issue date of the Notice of Award on or after August 24, 2012. For purposes of the Policy, “Affiliate” means any person who has a Brookings title but is not a Brookings employee.

All Brookings employees and affiliates remain subject to Brookings’s general Conflict of Interest Policy. The Policy is supplemental for those employees and affiliates who are Investigators on PHS-funded projects. For more information on the general Conflict of Interest Policy, please review the Conflict of Interest Policy guidelines.

Notwithstanding anything contained herein, the Policy does not apply to any Small Business Innovation Research Program (“SBIR”) or Small Business Technology Transfer (“STTR”) Program Phase I applications.

3.0 Purpose

The Brookings Institution adopts the Policy as required to implement and to comply with PHS regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94). The purpose of the Policy is to comply with PHS regulatory requirements and their goal of promoting objectivity in PHS-Funded Research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants, cooperative agreements, and contracts will be free from bias resulting from Investigators’ Financial Conflicts of Interest.

4.0 Definitions

Designated Administrator: The person selected to work with the Vice President to collect and assist in the review of financial conflict of interests. Typically, the Designated Administrator will be a program’s Chief of Staff, Senior Financial Officer, Director of Operations, or a similar position.

Financial Conflict Of Interest (“FCOI”): A Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS-Funded Research.

Institutional Responsibilities: An Investigator’s professional responsibilities on behalf of Brookings including, without limitation, research, education, administrative, and/or service responsibilities, and which may include for example such activities as research, research consultation, teaching, professional practice, committee memberships, and service on panels such as the Institutional Review Board, Institutional Animal Care and Use Committee, or data and safety monitoring board or committee.

Investigator: The project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of PHS Funded Research, or proposals for such funding, which may include, for example, collaborators or consultants. For purposes of the regulatory requirements relating to financial interests, the term ‘‘Investigator’’ includes the Investigator’s spouse and dependent children.

Manage: Taking action to address a Financial Conflict of Interest, which may include reducing or eliminating the Financial Conflict of Interest, to ensure to the extent possible that the design, conduct, and reporting of PHS Funded Research will be free from bias.

Management Plan: A plan to Manage a Financial Conflict of Interest.

PHS Funded Research: Any Research which is funded by PHS, including any PHS Unit.

PHS Regulations: PHS regulations promoting objectivity in research (set forth at 42 CFR §50.601 et seq. and 45 CFR §94.1 et seq.), as they may be amended, supplemented, or replaced from time to time, and any other similar PHS regulations that may be promulgated.

PHS Unit: The organizational unit of the PHS that funds PHS-Funded Research. PHS Units are the agencies within the Department of Health and Human Services (“HHS”) designated as components of PHS, as may be changed from time to time, including: (1) the Agency for Healthcare Research and Quality (“AHRQ”), (2) the Agency for Toxic Substances and Disease Registry (“ATSDR”), (3) the Centers for Disease Control and Prevention (“CDC”), (4) the Food and Drug Administration, (5) the Health Resources and Services Administration (“HRSA”), (6) the Indian Health Service (“IHS”), (7) the National Institutes of Health (“NIH”), (8) the Substance Abuse and Mental Health Services Administration (“SAMHSA”), and (9) the Office of the Inspector General (“OIG”).

Research: A systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book, or book chapter), and product development (e.g., a diagnostic test or drug). The term includes any such activity for which research funding is available from a PHS Unit through a grant, cooperative agreement, or contract, whether authorized under the Public Health Service Act (42 U.S.C. §201 et seq.) or other statutory authority, including without limitation a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.

Senior/Key Personnel: This term includes the project director or principal investigator and any other personnel considered to be essential to work performance in accordance with 48 CFR §352.242–70, and identified as key personnel in the sponsored project proposal and award.

Significant Financial Interest:

1. One or more of the following financial interests (i.e. anything of monetary value, whether or not the value is readily ascertainable) of an Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s Institutional Responsibilities:

a. Remuneration of any value from any entity during the twelve (12) months preceding the disclosure, including without limitation salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship) that, when aggregated, exceeds $5,000;

b. Any equity interest in any entities (including any stock, stock option, or other ownership interest) that, when aggregated, exceeds $5,000;

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

d. An asset in a blind trust, if (i) the Investigator is aware that the asset is in the trust, or (ii) if the trust is not managed by an independent fiduciary; or

e. 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).

2. The term “Significant Financial Interest” does not include the following:

a. Salary, royalties, or other remuneration paid by Brookings to the Investigator if the Investigator is currently employed or otherwise appointed by Brookings, including intellectual property rights assigned to Brookings and agreements to share in royalties related to such rights;

b. 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;

c. An asset in a blind trust, but only if (i) the asset is not known to the Investigator (e.g. it was purchased by the trust with proceeds from assets originally placed in the trust), and (ii) the trust is managed by an independent fiduciary;

d. Income from seminars, lectures, or teaching engagements sponsored by (i) a federal, state, or local government agency; (ii) an institution of higher education (as defined at 20 U.S.C. §1001(a)); (iii) an academic teaching hospital; (iv) a medical center; or (v) a research institute that is affiliated with an institution of higher education;

e. Income from service on advisory committees or review panels of (i) a federal, state, or local government agency; (ii) an institution of higher education (as defined at 20 U.S.C. §1001(a)); (iii) an academic teaching hospital; (iv) a medical center; or (v) a research institute that is affiliated with an institution of higher education; or

f. Travel that is reimbursed or 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.

5.0 Policy

A. Office of General Counsel Responsibilities

1. The Office of General Counsel has overall responsibility for the solicitation and review of disclosures of Significant Financial Interests from each Investigator who is planning to participate in, or is participating in, PHS-Funded Research.

2. The Office of General Counsel, in concert with the relevant Vice President(s) and Designated Administrator(s), is responsible for making determinations regarding Significant Financial Interests, Financial Conflicts of Interest, and Management Plans, as provided herein.

3. The Office of General Counsel is responsible for coordinating and facilitating the processes established to implement the Policy and shall coordinate such efforts with Brookings’s research programs, support staff, and executive members as appropriate.

4. Input and advice may be solicited throughout such processes, as appropriate, from other Brookings personnel, federal agencies, and from others unaffiliated with Brookings who may have relevant expertise.

B. Training

1. Each Investigator who is planning to participate in, or is participating in, PHS-Funded Research must complete training related to financial conflicts of interest (regardless of whether or not a Financial Conflict of Interest exists).

2. Such training must be completed:

a. Prior to engaging in PHS-Funded Research;

b. At least every four (4) years;

c. If the Investigator is new to Brookings, within sixty (60) days of the commencement of employment (but not later than the beginning of PHS-Funded Research by the Investigator);

d. Whenever Brookings revises the Policy in a manner that affects the requirements of Investigators; and/or

e. When so directed as a result of an Investigator’s non-compliance with the Policy or any Management Plan.

3. Training, or access to training, shall be provided by Brookings and shall include information regarding the Policy, PHS regulations, and the Investigator’s responsibilities under the Policy and the PHS Regulations to disclose Significant Financial Interests of the Investigator (and of the Investigator’s spouse and dependent children).

C. Disclosure of Significant Financial Interests

1. Each Investigator who is planning to participate in, or who is participating in, PHS-Funded Research shall disclose any Significant Financial Interest (including of the Investigator’s spouse and dependent children) through his/her Vice President or Designated Administrator to the Office of General Counsel, if it reasonably appears that a Significant Financial Interest is related to the Investigator’s Institutional Responsibilities. Such disclosures shall be made as part of the application submission process. Alternatively, if no such Significant Financial Interest exists, the Investigator shall so certify as part of the application submission process.

2. Disclosures of Significant Financial Interests (or certifications that no such Significant Financial Interests exist) shall be made by each Investigator as follows:

a. At or before the time of submission of an application for PHS-Funded Research;

b. At least annually during the period of the PHS-Funded Research award and during Brookings’s Annual Disclosure Statement of Outside Interests;

i. The annual disclosure shall include: (a) any new information that was not disclosed to the Office of General Counsel either initially or subsequently (e.g. any Financial Conflict of Interest identified on a PHS-Funded Research project that was transferred from another institution); and (b) updated information regarding any previously disclosed Significant Financial Interest (e.g., the updated value of a previously disclosed equity interest);

ii. Annual updates shall be required of all Investigators participating in a PHS-Funded Research project, regardless of whether or not a Significant Financial Interest was previously disclosed;

c. Within thirty (30) days of the discovery or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest.

3. The disclosures shall include without limitation the following information:

a. The nature and amount of remuneration received from any entity in the twelve (12) months preceding the disclosure;

b. The name and address of the entity;

c. If there is an equity interest in the entity, any value as of the date of disclosure; and

d. With respect to reimbursed or reimbursable travel expenses that require disclosure: the purpose of the trip; the identity of the sponsor/organizer; the destination; and the duration of the travel.

4. The Office of General Counsel shall notify the Investigator and/or the relevant Vice President or Designated Administrator if further information is needed, including without limitation a determination or disclosure of monetary value, in order to decide whether the disclosed Significant Financial Interest constitutes a Financial Conflict of Interest with PHS-Funded Research. The Investigator and/or Vice President shall provide any such additional information, as requested.

D. Determination of Financial Conflicts of Interest

1. Prior to Brookings’s expenditure of any funds under a PHS-Funded Research project, all Investigator disclosures of Significant Financial Interests shall be reviewed and the following determinations shall be made, as applicable, and consistent with the Policy and the PHS Regulations.

2. The Office of General Counsel, in concert with the relevant Vice President(s) and Designated Administrator(s), shall determine, in its reasonable discretion, whether any Significant Financial Interest is related to PHS-Funded Research.

a. A Significant Financial Interest is related to PHS-Funded Research if (as reasonably determined by the Office of General Counsel):

i. the Significant Financial Interest could be affected by the PHS-Funded Research; or

ii. the Significant Financial Interest is in an entity whose financial interest could be affected by the PHS-Funded Research.

3. If the Significant Financial Interest is related to PHS-Funded Research, the Office of General Counsel, in concert with the relevant Vice President(s) and Designated Administrator(s), shall then determine, in its reasonable discretion, whether a Financial Conflict of Interest exists.

a. A Financial Conflict of Interest exists if the Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of PHS-Funded Research.

4. If necessary, the Office of General Counsel may appoint members of a Subcommittee to conduct any review and/or determination regarding whether a Significant Financial Interest is related to PHS-Funded Research and/or whether a Financial Conflict of Interest exists.

5. The Office of General Counsel (or designated Subcommittee) may involve the Investigator, Vice President, Designated Administrator, and others, as provided herein, in the determination of whether a Significant Financial Interest is related to PHS-Funded Research and/or whether a Financial Conflict of Interest exists.

6. If it is determined that (a) a Significant Financial Interest is related to PHS-Funded Research and (b) a Financial Conflict of Interest exists, the Office of General Counsel shall communicate the determination to the Investigator and the relevant Vice President.

7. If the Office of General Counsel and other relevant parties cannot agree on a satisfactory resolution of the matter giving rise to the conflict or if the matter is, in the reasonable judgment of any one of them, significant, any one of them may refer the matter to a committee comprised of the President, the General Counsel, the Vice President and Chief Financial Officer and Treasurer, and the Vice President and Chief Operating Officer, or the designee of any one of them. Any one of these individuals may refer the matter to the Audit Committee for final resolution. If the affected individual is a Vice President, that person shall recuse himself or herself from the discussions, and the matter shall go directly to the President, or his or her designee, and the General Counsel, and may be referred to the Audit Committee.

E. Management of Financial Conflicts of Interest / Management Plan

1. If it is determined that a Financial Conflict of Interest exists, Brookings will undertake such actions as are deemed necessary to Manage the FCOI.

2. The Office of General Counsel will work with the Investigator, the Investigator’s supervisor and relevant Vice President(s) to develop an appropriate Management Plan. The purpose of the Management Plan is to establish rules and procedures that provide a reasonable expectation that the PHS-Funded Research associated with the Investigator’s Financial Conflict of Interest will be free from bias. The Management Plan must specify the actions that have been, and shall be, taken to Manage any Financial Conflict of Interest in accordance with the Policy and the PHS Regulations.

3. The Investigator, supervisor, or Vice President shall forward the Management Plan to the Office of General Counsel for review and recommendation for approval.

4. The Office of General Counsel may require additional information from the Investigator, supervisor and/or Vice President and may seek input and advice from others, as provided herein, in connection with the development and/or implementation of a Management Plan.

5. Actions, conditions, or restrictions that may be required under the Management Plan may vary depending upon the nature and extent of the Financial Conflict of Interest. Examples of actions, conditions, or restrictions that might be imposed to Manage a Financial Conflict of Interest include but are not limited to:

a. Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the Research);

b. For Research projects involving human subjects, disclosure of financial conflicts of interest directly to participants;

c. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the Research against bias resulting from the Financial Conflict of Interest;

d. Modification of the Research plan;

e. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the Research;

f. Reduction or elimination of the Significant Financial Interest (e.g., sale of an equity interest); and/or

g. Severance of relationships that create financial conflicts.

6. The Investigator’s Vice President is responsible for: (a) ensuring that steps set forth in the Management Plan are implemented; and (b) taking reasonable steps to ensure the Investigator’s compliance with the Management Plan.

F. Reporting of Financial Conflicts of Interest

1. Brookings’s Grants Administration department shall be responsible for ensuring that all Financial Conflict of Interest reports and other information are submitted to the PHS Unit, as required by the PHS Regulations.

2. Such FCOI reports must be filed:

a. Prior to Brookings’s expenditure of funds under a PHS-Funded Research project;

b. Within sixty (60) days, with respect to any Significant Financial Interest that is identified as a Financial Conflict of Interest subsequent to the initial FCOI report during an ongoing PHS-Funded Research project (e.g. upon the participation of an Investigator who is new to the PHS-Funded Research project); and

c. Annually with respect to any Financial Conflict of Interest previously reported with regard to an ongoing PHS-Funded Research project.

G. New Significant Financial Interests during Ongoing PHS Funded Research

1. This Section applies: (a) whenever an Investigator discloses a Significant Financial Interest that was developed or acquired after Research under a PHS-funded award had begun; or (b) whenever, in the course of an ongoing PHS-Funded Research project, an Investigator who is new to participating in the Research project discloses a Significant Financial Interest.

2. In any such event, within sixty (60) days of the disclosure, the Office of General Counsel (or designated Subcommittee) shall: (a) review the disclosed interest; (b) determine whether it is related to the PHS-Funded Research; and (c) if so, determine whether a Financial Conflict of Interest exists.

3. If a Financial Conflict of Interest exists, Brookings shall implement, on at least an interim basis, a Management Plan that shall specify the actions that have been, and will be, taken to Manage such Financial Conflict of Interest going forward. The Office of General Counsel shall report to the PHS Unit as required by the PHS Regulations.

4. Depending on the nature of the disclosed interest, additional interim measures may be taken with regard to the Investigator’s participation in the PHS-Funded Research between the date of disclosure and the completion of the review process.

H. Retrospective Review and Mitigation Report

1. If a Significant Financial Interest is not disclosed in a timely manner by an Investigator or, for whatever reason, was not previously reviewed by Brookings during an ongoing PHS-Funded Research project (e.g., was not timely reviewed or reported by a subrecipient), the Office of General Counsel (or designated Subcommittee) shall, within sixty (60) days of the disclosure: (a) review the disclosed interest; (b) determine whether it is related to the PHS-Funded Research; and (c) if so, determine whether a Financial Conflict of Interest exists.

a. If a Financial Conflict of Interest exists, Brookings shall implement, on at least an interim basis, a Management Plan that shall specify the actions that have been, and will be, taken to Manage such Financial Conflict of Interest going forward. The Office of General Counsel shall report to the PHS Unit as required by the PHS Regulations.

b. Depending on the nature of the Financial Conflict of Interest, the Office of General Counsel may determine that additional interim measures are necessary with regard to the Investigator’s participation in the PHS-Funded Research project between the date that the Financial Conflict of Interest or the Investigator’s non-compliance is determined and the completion of the retrospective review process.

2. In addition, whenever a Financial Conflict of Interest is not identified or Managed in a timely manner (including failure by the Investigator to disclose a Significant Financial Interest that is determined to constitute a Financial Conflict of Interest; failure by Brookings to review or Manage such a Financial Conflict of Interest; or failure by the Investigator to comply with a Management Plan), the Office of General Counsel shall, in concert with the Investigator’s supervisor and/or Vice President, within one hundred twenty (120) days of the determination of non-compliance: (a) complete a retrospective review of the Investigator’s activities and the PHS-Funded Research, or portion thereof, conducted during the time period of the non-compliance; and (b) determine whether or not there was bias in the design, conduct, or reporting of the PHS-Funded Research. The Office of General Counsel shall document the retrospective review as required by the PHS Regulations.

a. Based on the results of the retrospective review, if appropriate, the Office of General Counsel shall update the previously submitted Financial Conflict of Interest report, specifying the actions that will be taken to Manage the Financial Conflict of Interest going forward. If bias is found, the Office of General Counsel shall notify the PHS Unit promptly and submit a mitigation report to the PHS Unit, in accordance with the PHS Regulations. Thereafter, the Office of General Counsel shall submit Financial Conflict of Interest reports annually.

I. Monitoring / Internal Reporting

Whenever a Management Plan is implemented, the Investigator’s supervisor and/or Vice President shall be responsible: (a) to monitor and to take reasonable steps to ensure Investigator compliance with the Management Plan on an ongoing basis until the completion of the PHS-Funded Research project; and (b) to report to the Office of General Counsel or designee any non-compliance with the Management Plan.

J. Public Accessibility

1. Brookings shall maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with PHS regulations and make such policy available via a publicly accessible Web site.

2. Prior to Brookings’s expenditure of any funds under a PHS-Funded Research project, Brookings shall ensure public accessibility of information concerning any disclosed Significant Financial Interest that meets the following three criteria: (a) the Significant Financial Interest was disclosed and is still held by Senior/Key Personnel; (b) Brookings determines that the Significant Financial Interest is related to the PHS-Funded Research; and (c) Brookings determines that the Significant Financial Interest is a Financial Conflict of Interest.

3. Such information shall be made accessible via written response to any requestor within five (5) business days of the Office of General Counsel’s receipt of a written request. Such information shall include at a minimum the information required by the PHS Regulations, specifically: the Investigator’s name; the Investigator’s title and role with respect to the research project; the name of the entity in which the significant financial interest is held; the nature of the significant financial interest; and the approximate dollar value of the significant 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. The response will note that the information provided is current as of the date of the response and is subject to updates, on at least an annual basis and within sixty (60) days of Brookings’s identification of a new Financial Conflict of Interest, and that such updates should be requested subsequently by the requestor.

4. Information concerning the Significant Financial Interests of an individual subject to this section shall remain available for responses to written requests, for at least three (3) years from the date that the information was most recently updated.

K. Subrecipient Collaborations (Brookings as Prime Recipient)

1. If Brookings carries out PHS-Funded Research through a subrecipient (e.g., subcontractors, or consortium members), Brookings shall be responsible to ensure that there is a written agreement with the subrecipient which contains terms that establish whether the Policy or the financial conflicts of interest policy of the subrecipient will apply to the subrecipient’s Investigators.

a. If the subrecipient’s Investigators must comply with the subrecipient’s financial conflicts of interest policy, the agreement shall require that the subrecipient certify as part of the agreement that its policy complies with the Policy and the PHS Regulations. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the Policy for disclosing Significant Financial Interests that are directly related to the subrecipient’s work for Brookings;

b. Additionally, if the subrecipient’s Investigators must comply with the subrecipient’s financial conflicts of interest policy, the agreement shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to Brookings. Such time period(s) shall be sufficient to enable Brookings to provide timely Financial Conflict of Interest reports, as necessary, to the PHS Unit as required by the Policy and the PHS Regulations;

c. Alternatively, if the subrecipient’s Investigators must comply with Brookings’s financial conflicts of interest policy, the agreement shall specify time period(s) for the subrecipient to submit all Investigator disclosures of Significant Financial Interests to Brookings. Such time period(s) shall be sufficient to enable Brookings to comply timely with its review, management, and reporting obligations under the Policy and the PHS Regulations.

2. The Office of General Counsel shall be responsible to provide Financial Conflict of Interest reports to the PHS Unit regarding all financial conflicts of interest of all subrecipient Investigators consistent with the Policy and the PHS Regulations, i.e., prior to the expenditure of funds and within sixty (60) days of any subsequently identified Financial Conflict of Interest.

L. Brookings as a Subrecipient

1. If Brookings is a subrecipient of PHS-Funded Research where another entity is the prime recipient, the Office of General Counsel shall be responsible to ensure that there is a written agreement with the prime recipient which contains terms that establish whether the Policy or the financial conflicts of interest policy of the prime recipient will apply to Brookings’s Investigators

2. If the agreement specifies that Brookings’s Investigators must comply with the prime recipient’s financial conflicts of interest policy, then Brookings’s Investigators shall so comply with the prime recipient’s policy, and the Policy shall not apply.

3. If the agreement specifies that Brookings’s Investigators must comply with the Policy, then Brookings’s Investigators shall so comply with the Policy, and the Policy shall apply.

M. Record Retention

1. The Office of General Counsel shall retain all records relating to Investigator disclosures of financial interests; the review of and response to such disclosures (whether or not a disclosure resulted in the determination of a Financial Conflict of Interest); and all actions under the Policy or retrospective review, if applicable.

2. Such records shall be retained for at least three (3) years from the date of submission of final expenditure reports to PHS for each PHS-funded project (or where applicable from other dates specified in the PHS Regulations for different situations).

3. Such records may be destroyed within ninety (90) days following the expiration of the three (3) year retention period, unless there is relevant pending or active administrative or legal action or otherwise required by applicable law or Brookings policy.

N. Noncompliance

1. It shall be considered a violation of Brookings policy, subject to disciplinary action in accordance with applicable policies, if an Investigator: (a) fails to disclose a Significant Financial Interest as required herein; (b) fails to comply with an established Management Plan; (c) fails to provide timely annual report information or other required information; or (d) fails to comply with any other requirement of the Policy.

2. If the failure of an Investigator to comply with the Policy or a Management Plan appears (in the reasonable judgment of the Office of General Counsel) to have biased the design, conduct, or reporting of PHS-Funded Research, the Office of General Counsel shall be responsible to promptly notify the PHS Unit of the corrective action taken or to be taken, as required by the PHS Regulations.

3. In the event that the U.S. Department of Health and Human Services determines that a PHS-Funded Research project involving clinical Research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a Financial Conflict of Interest that was not Managed or reported by Brookings in accordance with the PHS Regulations and the Policy, such Investigator shall be required to disclose the Financial Conflict of Interest in each public presentation of the results of the Research and to request an addendum to previously published presentations.

Questions regarding the Policy and its application should be directed to Brookings’s Office of General Counsel.