University of Maryland Procedures on Financial Conflicts of Interest in Public Health Service Funded Research

The University of Maryland (“the University”) adopts the University of Maryland Procedures on Financial Conflicts of Interest in Public Health Service Funded Research (“this Policy”) as required to implement and to comply with U.S. 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). The purpose of this 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 (FCOIs).

1. “COI Administrator” means the individual appointed by the University’s Vice President for Research to support the implementation of the University’s COI/COC Policy and to oversee the work of the Disclosure Office and COI Committee.
2. “COI Committee” means the advisory committee appointed by the President of the University, in accordance with the University’s COI/COC Policy and based on the authority granted by the Maryland State Ethics Commission (SEC) regarding conflicts associated with Research or development.
3. “COI Official” means the University’s Vice President for Research.
4. “Financial Conflict of Interest (FCOI)” means a Significant Financial Interest that affects, or could appear to affect, the design, conduct, or reporting of Research.
5. “Disclosure(s)” means information that is required to be provided on all outside professional activities, external relationships, and/or Significant Financial Interests.
6. “Institutional Responsibilities” means an Investigator’s primary duties and responsibilities at the University, as defined in their contract job duties, offer letter, or other comparable documentation.
7. “Investigator” means 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 proposed for such funding, which may include, for example, collaborators or consultants.
8. “Management Plan” means a written plan provided by the University that describes how a conflict or potential conflict will be managed.
9. “PHS Funded Research” means any Research that is funded by PHS, including any PHS Unit.
10. “PHS Regulations” means 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.
11. “PHS Unit” means 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 (FDA), (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 the Office of the Inspector General (OIG).
12. “Research” means 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.
13. “Senior/Key Personnel” 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.
14. “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:
       1. 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);
       2. Any equity interest in any entity including any stock, stock option, or other ownership interest;
       3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests;
       4. 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
       5. 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:
       1. Salary, royalties, or other remuneration paid by the University to the Investigator if the Investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalties related to such rights;
       2. 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;
       3. 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;
       4. 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;
       5. Income from service on advisory committees or review panels of: 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
       6. 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.
15. “Unit” means a department, center, institute, division, or non-departmentalized College or School.
16. “Unit Head” means the administrator(s) responsible for a Unit and the individual(s) to whom a University Employee reports. A Unit Head may be a Director, Department Chair, Dean, Vice President, or a similar official in a non-academic Unit.

1. This Policy applies to any application for or receipt of Research funding from PHS, including without limitation the National Institutes of Health (“NIH”), whether such funding is by means of a grant, cooperative agreement, or contract. However, this Policy shall only apply to PHS Funded Research with an issue date of the Notice of Award on or after August 24, 2012.
2. This Policy applies to each Investigator of PHS Funded Research.
3. Any Investigator conducting PHS Funded Research is also subject to:
   1. The University System of Maryland (USM) Policy on Conflicts of Interest in Research or Development (III-1.11);
   2. The University of Maryland Policy on Conflict of Interest and Conflict of Commitment (II-3.10(A)(“the COI/COC Policy”)); and
   3. The University’s Disclosure and Conflict Management Guidelines.
4. Notwithstanding anything contained herein, this Policy does not apply to any Small Business Innovation Research Program (“SBIR”) or Small Business Technology Transfer (“STTR”) Program Phase I applications.

1. Designation
   1. The COI Official is designated as the University’s institutional official with 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 COI Committee is responsible for making determinations regarding Significant Financial Interests, FCOIs and Management Plans, as provided herein.
   3. The COI Administrator is responsible for coordinating and facilitating the processes established to implement this Policy and Procedures and shall coordinate such efforts with the University’s Office of Research Administration (ORA), the Disclosure Office, and/or the COI Committee, as appropriate.
   4. Input and advice may be solicited throughout such processes, as appropriate, from the Office of General Counsel, other University and USM personnel, federal agencies and from others unaffiliated with the University who may have relevant expertise.
2. Training
   1. Each Investigator who is planning to participate in, or is participating in, PHS Funded Research must complete training related to FCOIs regardless of whether or not an FCOI exists.
   2. Such training must be completed:
      1. Prior to engaging in PHS Funded Research;
      2. At least every four (4) years;
      3. If the Investigator is new to the University, within sixty (60) days of the commencement of employment but not later than the beginning of PHS Funded Research by the Investigator;
      4. Whenever the University revises this Policy in a manner that affects the requirements of Investigators; and/or
      5. When so directed as a result of an Investigator’s non-compliance with this Policy or any Management Plan.
   3. Training, or access to training, shall be provided by the University and shall include information regarding this Policy, PHS regulations, and the Investigator’s responsibilities under this Policy and the PHS Regulations to disclose Significant Financial Interests of the Investigator (and those of the Investigator’s spouse and dependent children).
3. 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 those of the Investigator’s spouse and dependent children). 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:
      1. At or before the time of submission of an application for PHS Funded Research;
      2. At least annually during the period of the PHS Funded Research award;
         1. The annual Disclosure shall include: (a) any new information that was not disclosed to the University either initially or subsequently (e.g., any FCOI 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);
         2. 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.
      3. Within thirty (30) days of the discovery or acquisition (e.g., through purchase, marriage, or inheritance) of a new Significant Financial Interest.
   3. The Disclosures shall include without limitation the following information:
      1. The nature and amount of remuneration received from any entity in the twelve (12) months preceding the Disclosure;
      2. The name and address of the entity;
      3. If there is an equity interest in the entity, any value as of the date of Disclosure; and
      4. 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 COI Administrator shall notify the Investigator and/or Unit Head 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 an FCOI with PHS Funded Research. The Investigator and/or Unit Head shall provide any such additional information, as requested.
4. Determination of a Financial Conflicts of Interest
   1. Prior to the University’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 this Policy and PHS Regulations.
   2. The COI Committee shall determine, in its reasonable discretion, whether any Significant Financial Interest is related to PHS Funded Research.
      1. A Significant Financial Interest is related to PHS Funded Research if, as reasonably determined by the COI Committee:
         1. the Significant Financial Interest could be affected by the PHS Funded Research; or
         2. 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 COI Committee, in its reasonable discretion, shall then determine whether an FCOI exists.
      1. An FCOI exists if the Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of PHS Funded Research.
   4. The COI Official may authorize the Chair of the COI Committee to designate a Subcommittee to conduct any review and/or determination regarding whether a Significant Financial Interest is related to PHS Funded Research and/or whether an FCOI exists.
   5. The COI Committee, or designated Subcommittee, may involve the Investigator, Unit Head, and others, as provided herein, in the determination of whether a Significant Financial Interest is related to PHS Funded Research and/or whether an FCOI exists.
   6. If it is determined that (a) Significant Financial Interest is related to PHS Funded Research and (b) an FCOI exists, the COI Committee shall communicate the determination to the Investigator and the Unit Head.
5. Management of Financial Conflicts of Interest / Management Plans
   1. If it is determined that an FCOI exists, the University will undertake such actions as are deemed necessary to manage the FCOI.
   2. The COI Administrator and COI Committee will work to develop an appropriate Management Plan, in accordance with the COI/COC Policy and the Disclosure and Conflict Management Guidelines. 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 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 this Policy and the PHS Regulations.
   3. The COI Administrator, COI Committee, and/or COI Official may require additional information from the Investigator, supervisor and/or Unit Head and may seek input and advice from others, as provided herein, in connection with the development and/or implementation of a Management Plan.
   4. 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 an FCOI include but are not limited to:
      1. Public disclosure of FCOIs (e.g., when presenting or publishing the Research);
      2. For Research projects involving human subjects, disclosure of FCOIs directly to participants;
      3. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the Research against bias resulting from the FCOI;
      4. Modification of the Research plan;
      5. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the Research;
      6. Reduction or elimination of the Significant Financial Interest (e.g., sale of an equity interest); and/or
      7. Severance of relationships that create financial conflicts.
   5. The Investigator’s Unit Head 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.
6. Reporting of Financial Conflicts of Interest
   1. The COI Administrator shall be responsible for ensuring that all FCOI reports and other information are submitted to the PHS Unit, as required by PHS Regulations.
   2. Such FCOI reports must be filed:
      1. Prior to the University’s expenditure of funds under a PHS Funded Research project;
      2. Within sixty (60) days, with respect to any Significant Financial Interest that is identified as an 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
      3. Annually with respect to any FCOI previously reported with regard to an ongoing PHS Funded Research project.
7. 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 COI Committee, 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 an FCOI exists.
   3. If an FCOI exists, the University 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 the FCOI going forward. The COI Administrator shall report the FCOI and Management Plan to the PHS Unit as required by 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.
8. 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 the University during an ongoing PHS Funded Research project (e.g., was not timely reviewed or reported by a subrecipient), the COI 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 Funded Research; and (c) if so, determine whether an FCOI exists.
      1. If an FCOI exists, the University 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 the FCOI going forward. The COI Administrator shall report to the PHS Unit as required by the PHS Regulations.
      2. Depending on the nature of the FCOI, the COI Official 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 FCOI or the Investigator’s non-compliance is determined and the completion of the retrospective review process.
   2. In addition, whenever an FCOI 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 an FCOI; failure by the University to review or manage an FCOI; or failure by the Investigator to comply with a Management Plan, the COI Administrator 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 COI Administrator shall document the retrospective review as required by PHS Regulations.
      1. Based on the results of the retrospective review, if appropriate, the COI Administrator 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 COI Administrator shall notify the PHS Unit promptly and submit a mitigation report to the PHS Unit, in accordance with PHS Regulations. Thereafter, the COI Administrator shall submit FCOI reports annually.
9. Monitoring / Internal Reporting
   Whenever a Management Plan is implemented, the Investigator’s Unit Head 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 PHS Funded Research project; and (b) reporting to the COI Official or designee any non-compliance with the Management Plan.
10. Public Accessibility
    1. Prior to the University’s expenditure of any funds under a PHS Funded Research project, the University 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) the University determines that the Significant Financial Interest is related to the PHS Funded Research; and (c) the University determines that the Significant Financial Interest is an FCOI.
    2. Such information shall be made accessible via written response to any requestor within five (5) business days of the COI Administrator’s receipt of a written request.  Such information shall include at a minimum the information required by PHS Regulations. 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 the University’s identification of a new FCOI, and that such updates should be requested subsequently by the requestor.
    3. 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.
11. Subrecipient Collaborations (the University as Prime Recipient)
    1. If the University carries out PHS Funded Research through a subrecipient (e.g., subcontractors, or consortium members), ORA shall be responsible for ensuring that there is a written agreement with the subrecipient which contains terms that establish whether this Policy or the FCOI policy of the subrecipient will apply to the subrecipient’s Investigators.
       1. If the subrecipient’s Investigators must comply with the subrecipient’s FCOI policy, the agreement shall require that the subrecipient certify as part of the agreement that its policy complies with this Policy and PHS Regulations. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to this Policy for disclosing Significant Financial Interests that are directly related to the subrecipient’s work for the University;
       2. Additionally, if the subrecipient’s Investigators must comply with the subrecipient’s FCOI policy, the agreement shall specify time period(s) for the subrecipient to report all identified FCOIs to the University. Such time period(s) shall be sufficient to enable the University to provide timely FCOI reports, as necessary, to the PHS Unit as required by this Policy and PHS Regulations;
       3. Alternatively, if the subrecipient’s Investigators must comply with the University’s FCOI policy, the agreement shall specify time period(s) for the subrecipient to submit all Investigator Disclosures of Significant Financial Interests to the University. Such time period(s) shall be sufficient to enable the University to comply timely with its review, management, and reporting obligations under this Policy and PHS Regulations.
    2. The COI Official, in coordination with the COI Administrator and ORA, shall be responsible for providing FCOI reports to the PHS Unit regarding all FCOIs of all subrecipient Investigators consistent with this Policy and PHS Regulations, i.e., prior to the expenditure of funds and within sixty (60) days of any subsequently identified FCOI.
12. The University as a Subrecipient
    1. If the University is a subrecipient of PHS Funded Research where another entity is the prime recipient, ORA shall be responsible for ensuring that there is a written agreement with the prime recipient that contains terms that establish whether this Policy or the FCOI policy of the prime recipient will apply to the University’s Investigators.
    2. If the agreement specifies that the University’s Investigators must comply with the prime recipient’s FCOI policy, then the University’s Investigators shall so comply with the prime recipient’s policy, and this Policy shall not apply.
    3. If the agreement specifies that the University’s Investigators must comply with this Policy, then the University’s Investigators shall so comply with this Policy, and this Policy shall apply.
13. Records Retention
    1. The COI Administrator 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 an FCOI); and all actions under this 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 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 University policy.
14. Noncompliance
    1. It shall be considered a violation of University 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 this Policy.
    2. If the failure of an Investigator to comply with this Policy or a Management Plan appears, in the reasonable judgment of the COI Official, to have biased the design, conduct, or reporting of PHS Funded Research, the COI Official shall be responsible for promptly notifying the PHS Unit of the corrective action taken or to be taken, as required by 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 an FCOI that was not managed or reported by the University in accordance with PHS Regulations and this Policy, 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.

Questions regarding this Policy and its application should be directed to the Disclosure Office in the Division of Research.