Financial Conflict of Interest Implementation Procedures for U.S. Public Health Service and National Science Foundation Funded Research

The University of Waterloo (“Waterloo”) adopts these Procedures as an addendum to its Policy 69: Conflict of Interest: Appendix A: United States’ Public Health Service and National Science Foundation Funded Research Financial Conflict of Interest Requirements to implement and to comply with:

Public Health Service (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) for PHS-funded research
National Science Foundation (NSF) Proposal & Award Policies & Procedures Guide for NSF-funded research

The purpose of Policy 69 Appendix A and these Procedures are to comply with U.S. regulatory requirements and their goal of promoting objectivity in Federally-funded research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research from U.S. Federally-funded grants, cooperative agreements and contracts will be free from bias resulting from Investigators’ Conflict of Interest (COI), including Financial Conflict of Interest (FCOI).

II. Applicability

Policy 69 Appendix A and these Procedures apply to each Investigator that is part of any application for, or in receipt of, research funding from PHS and NSF, whether such funding is by means of a grant, cooperative agreement, or contract.

III. Definitions

A. Conflict of Interest (“COI”): As defined by Waterloo Policy 69 and, for PHS Funded Research and NSF Funded Research, includes Financial Conflict of Interest as defined in these Procedures.

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

C. FCOI Committee: Associate Vice-President, Research Oversight and Analysis, and Director, Funding Agencies & Non-profit Sponsors, as appointed by the Vice-President, Research and International. The FCOI Committee may include the FCOI Official where warranted.

D. FCOI Official: Waterloo’s Vice President, Research and International.

E. Institution: Any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, U.S. Federal Research funding.

F. Institutional Responsibilities: An Investigator’s professional responsibilities on behalf of Waterloo 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 research ethics boards or health and safety committees.

G. 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 U.S. Funded Research, or proposed for such funding, which may include, for example, co-applicants, collaborators or consultants.

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

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

J. NSF Funded Research: Any Research funded by the National Science Foundation (NSF).

K. PHS Funded Research: Any Research funded by the Public Health Service (PHS), including any PHS Awarding Component.

L. PHS Regulations: PHS regulations promoting objectivity in research (set forth at 42 C.F.R. Part 50, Subpart F and 45 C.F.R. Part 94), as they may be amended, supplemented, or replaced from time to time, and any other similar PHS regulations that may arise.

M. PHS Awarding Component: The organizational unit of the PHS that funds PHS Funded Research. PHS Awarding Components 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 the: (1) Agency for Healthcare Research and Quality (AHRQ), (2) Agency for Toxic Substances and Disease Registry (ATSDR), (3) Centers for Disease Control and Prevention (CDC), (4) Food and Drug Administration (FDA), (5) Health Resources and Services Administration (HRSA), (6) Indian Health Service (IHS), (7) National Institutes of Health (NIH), and (8) Substance Abuse and Mental Health Services Administration (SAMHSA).

N. Research: A systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioural 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 the U.S. Federal Government through a grant, cooperative agreement, or contract, or a related subaward or subcontract.

O. Significant Financial Interest (“SFI”):

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 Institutional Responsibilities:

a. 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 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. 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 or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);

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

d. 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 Waterloo to the Investigator if the Investigator is currently employed or otherwise appointed by Waterloo, including intellectual property rights assigned to Waterloo and agreements to share in royalties related to such rights;

b. Any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization;

c. 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;

d. 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;

e. 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 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.

3. For clarity, Waterloo applies the definition of Significant Financial Interest as used in the PHS Regulations to NSF Funded Research.

P. Signing Official: An Office of Research Grants and Contracts Manager (or Senior Manager), as appointed from time to time by the Director, Funding Agencies and Non-profit Sponsors, or Director, Research Partnerships, on behalf of the Vice President, Research and International.

Q. Supervisor:The immediate supervisor of the Waterloo individual who may be declaring a Significant Financial Interest. This is usually the department chair or director in an academic department or school/centre/institute or a similar official in an academic support unit, unless a different individual is designated by proper authority. The Investigator’s Supervisor may consult with their own supervisor, as appropriate. In cases where the Investigator is external to Waterloo (e.g., consultant or subrecipient collaborator) Waterloo’s Vice President, Research and International or designate shall serve as the Supervisor.

R. U.S. Funded Research: Research funded by the U.S. Federal Government through a grant, cooperative agreement, or contract, or a related subaward or subcontract. Within these Procedures, U.S. Funded Research refers to both PHS Funded Research and NSF Funded Research.

S. U.S. Regulations: Include but are not limited to the:

Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards (“Uniform Guidance”, 2 C.F.R. Part 200) for grants and cooperative agreements;
Federal Acquisition Regulation (FAR) for contracts;
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); and
NSF Proposal & Award Policies & Procedures Guide.

IV. Requirements

A. Financial Conflict of Interest Training (PHS Funded Research Only)

1. Each Investigator who is planning to participate in, or is participating in, PHS Funded Research must complete training related to FCOI regardless of whether or not an FCOI exists.

2. Access to such training shall be provided by Waterloo.

3. 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 Waterloo, prior to engaging in PHS Funded Research;

d. Whenever Waterloo revises its 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 Policy 69 Appendix A and these Procedures, or any Management Plan.

B. Disclosure of Significant Financial Interests

1. The FCOI Official is designated as Waterloo’s institutional official with overall responsibility for the solicitation and review of disclosures of SFI from each Investigator who is planning to participate in, or is participating in, PHS or NSF Funded Research.

2. The FCOI Committee is responsible for making determinations regarding SFI, FCOI and Management Plans, as provided herein.

3. The Signing Official is responsible for coordinating and facilitating the processes established to implement these Procedures and shall coordinate such efforts with Waterloo’s FCOI Committee, as appropriate.

4. Each Investigator who is planning to participate in, or who is participating in, PHS or NSF Funded Research shall disclose any SFI (including of the Investigator’s spouse and dependent children) to the FCOI Official or designee, if it reasonably appears that SFI is related to the Investigator’s Institutional Responsibilities. Such disclosures shall be made as part of the application submission process. Alternatively, if no such SFI exists, the Investigator shall so certify as part of the application submission process.

5. Disclosures of SFI (or certifications that no such SFI exist) shall be made by each Investigator as follows:

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

b. At least annually during the period of the PHS or NSF Funded Research award;

i. The annual disclosure shall include: (a) any new information that was not disclosed to the FCOI Official or designee either initially or subsequently (e.g., any FCOI identified on a PHS or NSF Funded Research project that was transferred from another institution); and (b) updated information regarding any previously disclosed SFI (e.g., the updated value of a previously disclosed equity interest);

ii. Annual updates shall be required of all Investigators participating in a PHS or NSF Funded Research project, regardless of whether or not SFI was previously disclosed.

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

6. 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 location (i.e., country) 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.

7. The Signing Official shall notify the Investigator if further information is needed, including without limitation a determination or disclosure of monetary value, in order for the FCOI Committee to decide whether the disclosed SFI constitutes FCOI with the PHS or NSF Funded Research. The Investigator shall provide any such additional information, as requested.

C. Determination of Financial Conflicts of Interest

1. Prior to Waterloo allowing expenditure of any funds under a PHS or NSF Funded Research project, all Investigator disclosures of SFI shall be reviewed and the following determinations shall be made, as applicable, and consistent with Waterloo’s Policy 69 Appendix A and the applicable U.S. Regulations.

2. The FCOI Committee shall determine, in its reasonable discretion, whether any SFI is related to PHS or NSF Funded Research.

a. SFI is related to PHS or NSF Funded Research if (as reasonably determined by the FCOI Committee):

(i) the SFI could be affected by the PHS or NSF Funded Research; or

(ii) the SFI is in an entity whose financial interest could be affected by the PHS or NSF Funded Research.

3. If the SFI is related to PHS or NSF Funded Research, the FCOI Committee, in its reasonable discretion, shall then determine whether FCOI exists.

a. FCOI exists if the SFI could directly and significantly affect the design, conduct, or reporting of PHS or NSF Funded Research.

4. The FCOI Committee may designate a Subcommittee to conduct any review and/or determination regarding whether SFI is related to PHS or NSF Funded Research and/or whether FCOI exists.

5. The FCOI Committee (or designated Subcommittee) may involve the Investigator, Investigator’s Supervisor, Supervisor’s Supervisor, and others, as provided herein, in the determination of whether the SFI is related to PHS or NSF Funded Research and/or whether FCOI exists.

6. If it is determined that (a) the SFI is related to PHS or NSF Funded Research and (b) FCOI exists, the FCOI Committee shall communicate the determination to the Investigator and the Investigator’s Supervisor.

D. Management of Financial Conflicts of Interest/ Management Plan

1. If it is determined that FCOI exists, Waterloo will undertake such actions as are deemed necessary to Manage the FCOI.

2. The FCOI Committee, with the Signing Official, will work with the Investigator and the Investigator’s Supervisor 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 U.S. Funded Research associated with the Investigator’s FCOI will be free from bias. The Management Plan must specify the actions that have been, and shall be, taken to Manage any FCOI in accordance with Policy 69 Appendix A and the applicable U.S. Regulations.

3. The Supervisor shall forward the Management Plan to the Signing Official who shall submit it to the FCOI Committee for review and recommendation as to approval. The recommendation of the FCOI Committee shall be subject to approval by the FCOI Official.

4. The Signing Official, FCOI Committee, and/or FCOI Official may require additional information from the Investigator and/or Supervisor 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 FCOI. Examples of actions, conditions, or restrictions that might be imposed to Manage FCOI include but are not limited to:

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

b. For Research projects involving human subjects, disclosure of FCOI 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 FCOI;

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 SFI (e.g., sale of an equity interest); and/or

g. Severance of relationships that create financial conflicts.

6. The Investigator’s Supervisor 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.

E. Reporting of Financial Conflicts of Interest

1. For PHS Funded Research, the Signing Official shall be responsible for ensuring that all FCOI reports and other information are submitted to the PHS Awarding Component, as required by the PHS Regulations. Such FCOI reports must be filed:

a. Prior to Waterloo’s allowing expenditure of funds under a PHS Funded Research project;

b. Within sixty (60) days, with respect to any SFI that is identified as FCOI 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 FCOI previously reported with regard to an ongoing PHS Funded Research project.

d. The FCOI report will contain, at minimum, the following required elements:

i. project number

ii. project director/principal investigator (PD/PI), or contact PD/PI if a multiple PD/PI model is used

iii. name of the investigator with the FCOI

iv. name of the entity with which the investigator has an FCOI

v. nature of the SFI (e.g., equity, consulting fee, travel reimbursement, honorarium)

vi. value of the SFI (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

vii. description of how the SFI relates to the PHS Funded Research and why the Institution determined that the SFI conflicts with such research

viii. description of the key elements of the institution’s Management Plan, including a) role and principal duties of the conflicted Investigator in the Research project; conditions of the Management Plan; c) how the Management Plan is designed to safeguard objectivity in the Research project; d) confirmation of the Investigator’s agreement to the Management Plan; e) how the Management Plan will be monitored to ensure Investigator compliance; and f) other information as needed

2. For NSF Funded Research, the Signing Official shall report to the Office of the General Counsel if Waterloo is unable to satisfactorily manage a Conflict of Interest, including an FCOI.

F. New Significant Financial Interests

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

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

3. If FCOI exists, Waterloo 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 FCOI going forward. For PHS Funded Research, the Signing Official shall report to the PHS Awarding Component as required by the PHS Regulations. For NSF Funded Research, the Signing Official shall report to the Office of the General Counsel if Waterloo is unable to satisfactorily manage a Conflict of Interest, including an FCOI.

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 or NSF Funded Research between the date of disclosure and the completion of the review process.

G. Retrospective Review and Mitigation Report

1. If SFI is not disclosed in a timely manner by an Investigator or, for whatever reason, was not previously reviewed by Waterloo during an ongoing PHS or NSF Funded Research project (e.g., was not timely reviewed or reported by a subrecipient), the FCOI Committee (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 or NSF Funded Research; and (c) if so, determine whether FCOI exists.

i. If FCOI exists, Waterloo 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 FCOI going forward. For PHS Funded Research, the Signing Official shall report to the PHS Awarding Component as required by the PHS Regulations. For NSF Funded Research, the Signing Official shall report to the Office of the General Counsel if Waterloo is unable to satisfactorily manage a Conflict of Interest.

ii. Depending on the nature of the FCOI, the FCOI Committee, in consultation with the Supervisor, may determine that additional interim measures are necessary with regard to the Investigator’s participation in the PHS or NSF Funded Research project between the date that the FCOI or the Investigator’s non-‐compliance is determined and the completion of the retrospective review process.

2. For PHS Funded Research, whenever FCOI is not identified or Managed in a timely manner (including failure by the Investigator to disclose SFI that is determined to constitute FCOI; failure by Waterloo to review or Manage such FCOI; or failure by the Investigator to comply with a Management Plan), the FCOI Committee shall, 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 FCOI Committee shall document the retrospective review as required by the PHS Regulations.

i. Based on the results of the retrospective review, if appropriate, the Signing Official shall update the previously submitted FCOI report, specifying the actions that will be taken to Manage the FCOI going forward. If bias is found, the Signing Official shall notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component, in accordance with the PHS Regulations. Thereafter, the Signing Official shall submit FCOI reports annually.

H. Monitoring/ Internal Reporting

Whenever a Management Plan is implemented, the Investigator’s Supervisor shall be responsible for: (a) monitoring and taking reasonable steps to ensure Investigator compliance with the Management Plan on an ongoing basis until the completion of the U.S. Funded Research project; and (b) reporting to the FCOI Official or designee any non-‐compliance with the Management Plan.

I. Public Accessibility of Information (PHS Funded Research Only)

1. Prior to Waterloo allowing the expenditure of any funds under a PHS Funded Research project, Waterloo shall ensure public accessibility of information concerning any disclosed SFI that meets the following three criteria: (a) the SFI was disclosed and is still held by Investigator; (b) Waterloo determines that the SFI is related to the PHS Funded Research; and (c) Waterloo determines that the SFI is a FCOI.

2. Such information shall be made accessible via written response to any requestor within five (5) business days of the Signing Official’s receipt of a written request. Such information shall include at a minimum the information required by the PHS Regulations: Investigator’s name and title, Research project role, name of the entity in which the SFI is held, and the nature and approximate value of the SFI. 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 Waterloo’s identification of a new FCOI, and that such updates should be requested subsequently by the requestor.

3. Information concerning the SFI 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.

J. Subrecipient Collaborations: Waterloo as Pass-Through-Entity

1. If Waterloo carries out U.S. Funded Research through a subrecipient (e.g., subcontractors or consortium members), Waterloo’s Office of Research shall be responsible for ensuring that there is a written agreement with the subrecipient which contains terms that establish whether Waterloo Policy 69 Appendix A and these Procedures or the conflict 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 conflict of interest policy, the agreement shall require that the subrecipient certify as part of the agreement that its policy complies with appropriate U.S. Regulations. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to Waterloo Policy 69 Appendix A and these Procedures for disclosing SFI that are directly related to the subrecipient’s work for Waterloo;

b. Additionally, if the subrecipient’s Investigators must comply with the subrecipient’s conflict of interest policy, the agreement shall specify time period(s) for the subrecipient to report all identified FCOI to Waterloo. For PHS Funded Research, such time period(s) shall be sufficient to enable Waterloo to provide timely FCOI reports, as necessary, to the PHS Awarding Component as required by the PHS Regulations;

c. Alternatively, if the subrecipient’s Investigators must comply with Waterloo’s conflict of interest policy, the agreement shall specify time period(s) for the subrecipient to submit all Investigator disclosures of SFI to Waterloo. Such time period(s) shall be sufficient to enable Waterloo to comply timely with its review, management, and reporting obligations under the applicable U.S. Regulations.

2. For PHS Funded Research, the Signing Officer, in coordination with the FCOI Committee, shall be responsible for providing FCOI reports to the PHS Awarding Component regarding all FCOI of all subrecipient Investigators consistent with this Policy and the PHS Regulations, i.e., prior to allowing the expenditure of funds and within sixty (60) days of any subsequently identified FCOI.

K. Subrecipient Collaborations: Waterloo as Subrecipient

1. If Waterloo is a subrecipient of U.S. Funded Research from another institution acting as the pass-through-entity, Waterloo’s Office of Research shall be responsible for ensuring that there is a written agreement with the pass-through-entity that contains terms that establish whether Waterloo Policy 69 Appendix A and these Procedures or the conflict of interest policy of the pass-through-entity will apply to Waterloo’s Investigators.

2. If the agreement specifies that Waterloo’s Investigators must comply with the pass-through-entity’s conflict of interest policy, then Waterloo’s Investigators shall so comply with the pass-through-entity’s policy, and Appendix A of Waterloo’s Policy 69 and these Procedures shall not apply.

3. If the agreement specifies that Waterloo’s Investigators must comply with Waterloo Policy 69 Appendix A, then Waterloo’s Investigators shall so comply with Waterloo Policy 69 Appendix A and these Procedures shall apply.

L. Record Retention

1. The Office of Research shall retain all records relating to Investigator disclosures of SFI; the review of and response to such disclosures (whether or not a disclosure resulted in the determination of an FCOI); and all actions under Waterloo Policy 69 Appendix A and these Procedures 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 the U.S. federal sponsor for each U.S. Funded Research project (or where applicable from other dates specified in the applicable U.S. Regulations for different situations) or until the resolution of any U.S. federal sponsor action involving those records, whichever is longer.

M. Non-compliance

1. It shall be considered a violation of Waterloo policy, subject to disciplinary action in accordance with applicable policies and procedures, if an Investigator: (a) fails to disclose a SFI 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 Policy 69 Appendix A and these Procedures.

2. If the failure of an Investigator to comply with Policy 69 Appendix A and these Procedures or a Management Plan appears (in the reasonable judgment of the FCOI Official or designate) to have biased the design, conduct, or reporting of U.S. Funded Research, the FCOI Official or designate shall be responsible to promptly notify U.S. federal sponsor as required by the applicable U.S. 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 an FCOI that was not Managed or reported by Waterloo in accordance with the PHS Regulations and these Procedures, such Investigator shall be required to disclose the FCOI in each public presentation of the results of the Research and to request an addendum to previously published presentations.