99¾Ã¾Ã¾«Æ·

Policy Statement

The 99¾Ã¾Ã¾«Æ· (99¾Ã¾Ã¾«Æ·) recognizes the importance of promoting objectivity in research which is sponsored by federal funding.  99¾Ã¾Ã¾«Æ· has established this policy regarding significant financial conflicts of interest (FCOI) for sponsored research; 99¾Ã¾Ã¾«Æ· and its investigators will be responsible for managing and eliminating any actual or prospective conflicts of interest that may occur. 

This policy reflects the requirements of the following agencies:

PHS, including the National Institutes of Health, Agency for Health Research and Quality, the Health Resources and Services Administration and other PHS agencies.

Policies specific to other agencies, where they differ from this policy, are described in 99¾Ã¾Ã¾«Æ·â€™s ‘Other Agencies’ addendum to this policy.

Policy Purpose

The federal Department of Health And Human Services (HHS) has determined, pursuant to  and , as revised on August 25, 2011, that effective no later than August 24, 2012, Public Health Services (PHS)-sponsored investigators shall be subject to specific requirements regarding the disclosure and management of conflicts of interest with regard to research in order to provide a reasonable expectation that PHS-sponsored Activities will be conducted free of bias resulting from Investigator financial conflicts of interest.

These regulations require the University to maintain a written policy on conflict-of-interest disclosure as a condition for receiving PHS awards. Therefore, this Policy implements the 2011 PHS regulations on Promoting Objectivity in Research and applies to all Investigators supported by PHS [National Institutes of Health (NIH), Centers for Disease Control (CDC), Food and Drug Administration (FDA), etc.] awards and other non-federal sponsors that adopt the PHS policy. (See ).

This policy applies to all grants and cooperative agreements with an issue date of the Notice of Award on or after August 24, 2012 (including noncompeting continuations), and to solicitations issued and contracts awarded after August 24, 2012 that are for research. These federal requirements are applicable to all proposals for extramural awards submitted to PHS. Please note that financial conflicts of interest do not prohibit research or funding, as long as they are properly disclosed and managed.

Policy Table of Contents

99¾Ã¾Ã¾«Æ· Entities to review and manage conflicts.

Definitions.

Responsibilities and Procedures.

1. Disclosure.
2. Training/Education.
3. Review of Disclosures; Management Plan.
4. Reporting to PHS.
5. Monitoring.
6. Public Access to Information.
7. Records.
8. Sanctions.

99¾Ã¾Ã¾«Æ· Entities to review and manage conflicts

Conflict of Interest Advisory and Oversight Committee (COIC)

Make the final determination on FCOI and whether it can be managed; informs Investigator on determination and next steps. The committee is charged by the Chancellor. The members of the COIC are the designated institutional officials.

Designated Administrator (DA)

Collects Disclosures, makes relatedness determinations, maintains records, reports FCOI to PHS. The DA considers Investigator’s disclosure, determines whether the SFI is related to the research; and where it is related, submits disclosure to COIC. At 99¾Ã¾Ã¾«Æ· the DO is the Preaward manager.

Designated Institutional Official(s)  (IO)

Members of the COIC. The IOs are appointed by the Chancellor.

Definitions

Financial Conflict of Interest (FCOI)

A Significant Financial Interest that is related to the PHS-funded activity in which the Investigator is engaged and that could directly and significantly affect the design, conduct or reporting of PHS Activity. COIC make the FCOI determinations.

Institution of Higher Education

An Institution of higher education is defined at 20 U.S.C. 1001(a) as :

an educational institution in any State that—

1. Aadmits as regular students only persons having a certificate of graduation from a school providing secondary education, or the recognized equivalent of such a certificate, or persons who meet the requirements of section 1091(d) of this title;
2. Is legally authorized within such State to provide a program of education beyond secondary education;
3. Provides an educational program for which the institution awards a bachelor’s degree or provides not less than a 2-year program that is acceptable for full credit toward such a degree, or awards a degree that is acceptable for admission to a graduate or professional degree program, subject to review and approval by the Secretary;
4. Is a public or other nonprofit institution; and
5. Is accredited by a nationally recognized accrediting agency or association, or if not so accredited, is an institution that has been granted pre-accreditation status by such an agency or association that has been recognized by the Secretary for the granting of pre-accreditation status, and the Secretary has determined that there is satisfactory assurance that the institution will meet the accreditation standards of such an agency or association within a reasonable time.

Note that this definition excludes for-profit and foreign education institutions.

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 research funded by the PHS (e.g., NIH), or proposed for such funding, which may include, for example, collaborators or consultants. It may also (depending on the role being performed) include graduate or undergraduate students, research assistants and research staff.
NOTE: The Investigator designation is based on the role, rather than the title, and the degree of independence with which those individuals work.  

Institutional Responsibilities

The investigator’s professional responsibilities on behalf of 99¾Ã¾Ã¾«Æ· including: research, research consultation, teaching, professional practice, Institutional committee memberships, and service on panels such as Institutional Review Boards or Institutional Animal Care and Use Committees, Data and Safety Monitoring Boards. 

Senior/Key personnel

The Project Director/Principal Investigator (PD/PI) and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the NIH by 99¾Ã¾Ã¾«Æ· under the regulation.

Significant Financial Interest (SFI)

A financial interest consisting of one or more of the following interests of the Investigator or the Investigator’s spouse or registered domestic partner and any dependent children for the following categories:

1. With regard to any publicly-traded entity, a Significant Financial Interest exists if the value of any remuneration (other than remuneration described in Paragraph E, below) 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. Included are salary (other than salary described in Paragraph E, below), consulting fees, honoraria, and the equity interest value at the date of disclosure as determined by public prices or other reasonable measure of fair market value;
2. With regard to any non-publicly traded entity, an SFI 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 an individual or his or her family holds any equity interest (e.g., stock, stock option, or other ownership interest); or
3. Intellectual property rights and interests (e.g., patents, copyrights) meeting or exceeding the de minimis threshold $5,000, upon receipt of income related to such rights and interests.
4. Any reimbursed or sponsored travel of aggregate value meeting or exceeding $5,000 (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education 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.  This disclosure will include the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.  In accordance with the Institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
5. The term significant financial interest does not include the following types of financial interests:
1. Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution 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. 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; or
4. 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
5. Any paid for or reimbursed travel determined by the 99¾Ã¾Ã¾«Æ· not to constitute an SFI (See Item D above.)

Responsibilities and Procedures

A. Disclosure

1. Investigators
   1. Investigators must disclose all Significant Financial Interests related to their Institutional Responsibilities, no later than at the time of application for federal funding.
   2. Investigators who are engaged in PHS-funded Activities have an ongoing responsibility to update their disclosures throughout the period of support:
      1. Within thirty (30) days of acquiring or discovering any new SFI (with the exception of travel disclosures explained below, see section A.1.d.); and
      2. At least annually throughout the period of the award.
   3. New Investigators must complete a disclosure of SFI before joining an ongoing PHS funded Activity.
   4. Sponsored or reimbursed travel may be disclosed:
      1. Prospectively listing all anticipated travel (including information about the purpose of the trip, the identity of the sponsor/organizer, the destination and the duration of the trip, as well as any other relevant information as defined by the COIAC) for the 12-month period following the filling of the Investigator's annual disclosure form; and/or
      2. Within 30 days of the occurrence of travel that either was not listed on the prospective annual travel report pursuant to paragraph i) or that significantly varied in the threshold reporting details from what was listed in the prospective report.
2. Principal Investigators (PIs):
   In addition to submitting disclosures as described in A.1., Principal investigators with a PHS-funded award must also
1. Identify all Investigators on the award (that is, all individuals who will have responsibility for designing, conducting, or reporting the research, including 99¾Ã¾Ã¾«Æ· employees, students, and consultants)
2. Ensure that all investigators file and update disclosures as described in A.1. before commencing/continuing work on the award. (In the case of employees of subrecipient institutions, procedures in paragraph 3, below will be followed.)
3. Collaborators/Subrecipients
   1. Investigators from other institutions who will be conducting research under a subaward from 99¾Ã¾Ã¾«Æ· are expected to comply with the policies and procedures of the organization at which they are employed, if those policies are in compliance with the relevant federal regulations. Before issuing a subaward, 99¾Ã¾Ã¾«Æ· will ask the subrecipient institution to certify that its policy is in compliance with Department of Health and Human Services (HHS) conflict of interest regulations, or, if it is not, to agree to abide by 99¾Ã¾Ã¾«Æ·â€™s policy.
   2. If the subrecipient institution certifies that its FCOI policies comply with the regulations, the subaward will include a term requiring the subrecipient institution to report any financial conflict of interest to 99¾Ã¾Ã¾«Æ· before the expenditure of funds, or in the case of newly discovered conflicts, in a time frame that permits 99¾Ã¾Ã¾«Æ· to report identified FCOI’s to the awarding agency within the required time frame.
   3. If the subrecipient institution agrees to abide by 99¾Ã¾Ã¾«Æ·â€™s policy, the subaward will include a clause requiring investigators follow this policy’s requirements for training and disclosure, and 99¾Ã¾Ã¾«Æ· will identify, manage and report identified FCOI’s to the federal agency.
   4. Investigators who are not employed by 99¾Ã¾Ã¾«Æ· and who will participate in research under an independent consulting agreement issued by 99¾Ã¾Ã¾«Æ· should be identified as Investigators by the 99¾Ã¾Ã¾«Æ· PI and must complete the 99¾Ã¾Ã¾«Æ· disclosure forms. If, upon review, 99¾Ã¾Ã¾«Æ· determines that these SFI could directly and significantly affect the design, conduct, or reporting of the research to be performed under the agreement, these collaborators will be expected to adhere to the mitigation plans put in place to manage the identified conflicts of interest.
4. Disclosure of Significant Financial Interests form is a Qualtrics survey at . In addition to providing for initial, changed, and annual updates of SFIs, this form provides a place to upload your FCOI training certificate.

B. Training/Education

1. Investigators must complete on Financial Conflicts of Interest, the responsibilities to disclose and the PHS regulations. Investigators receiving extramural funding must be current on their training in order to access their extramural funds. All Investigators must be complete the training every four years. Investigators should print their training certificate and upload it when completing their disclosure of Significant Financial Interests (See section A).
2. The above requirement applies to investigators who are 99¾Ã¾Ã¾«Æ· employees, consultants, and employees of subrecipient institutions that have agreed to abide by 99¾Ã¾Ã¾«Æ·â€™s policy. Investigators who are employees of subrecipients who have certified that their policy is in compliance with the regulations, will follow the training requirements of their institution’s policy.
3. Investigators must provide copy of their certificates to 99¾Ã¾Ã¾«Æ· OSP for retention and with every proposal submission to PHS.
4. All PHS-supported Investigators must complete FCOI training immediately if
   1. An Investigator is new to 99¾Ã¾Ã¾«Æ·
   2. An Investigator is not in compliance with the policy or management plan
   3. 99¾Ã¾Ã¾«Æ· revises is FCOI policy in a way that affects requirements of Investigators
5. The Preaward office shall ensure that investigators applying for PHS awards are aware of the policy and its requirements through a combination of:
   1. Direct communication with PIs proposing to PHS agencies
   2. Form fields on internal proposal documents for investigators to certify their familiarity with 99¾Ã¾Ã¾«Æ·â€™s policy, and their completion of training
   3. Publication of FCOI requirements at least twice/year in newsletters
   4. ‘Quick start’ training offered once/year and as requested, to orient faculty and staff researchers to the policy, its requirements, training, and resources.

C. Review of Disclosures; Management Plan

1. With each PHS proposal, progress report, incremental funding or extension, when a new Investigator participates in the PHS Activity, and when an Investigator reports a new Significant Financial Interest, Investigator’s Significant Financial Interests disclosures will be reviewed by the Designated Administrator (or designee) to determine whether there are any Significant Financial Interest that reasonably appear to be related to PHS Activities in which the Investigator is engaged.
2. In the event that the Designated Administrator (or designee) concludes that an Investigator's Significant Financial Interest reasonably appears related to the PHS Activity, the Disclosure and appropriate documentation shall be forwarded to the COIC for review.
3. The COIC will review the documentation and the Disclosure to determine whether:
   1. The SFI related to the PHS Activity appears to directly and significantly affect the design, conduct, or reporting of the PHS Activity;
   2. Whether the SFI could be affected by the PHS-funded research; or
   3. The SFI is in an entity whose financial interest could be affected by the research.

If one of these is the case, it thereby constitutes a FCOI that needs to be managed.

4. The COIC makes final determination on FCOI and whether it can be managed; informs Investigator on determination and next steps. The COIC may consult with the Office of General Counsel to make the determination.
5. The COIC, consulting as needed with the Offices of Human Resources, General Counsel, Technology and Commercialization, and Research Integrity and Compliance, will create a plan to manage the FCOI.
6. The management plan is to be implemented prior to expenditure of PHS funds awarded for the project, and shall specify the actions that are required to manage the FCOI, and may include:
   1. The role and principal duties of the conflicted Investigator;
   2. Conditions of the management plan;
   3. How the plan will safeguard objectivity in the research activity;
   4. Confirmation of the investigator’s agreement to the plan; and
   5. How the plan will be monitored.

D. Reporting to PHS

1. Initial Reports: Prior to expenditure of any funds provided under a PHS award, the Designated Administrator (or designee) must provide to the PHS funding agency an initial report regarding Investigator Financial Conflict of Interest. If Financial Conflicts of Interest are eliminated before research funds are expended, 99¾Ã¾Ã¾«Æ· is not required to submit a report to the PHS funding agency.
2. Additional FCOI reports must be submitted to PHS by the DA under the following circumstances:
   1. Within sixty (60) days of determining that a FCOI exists based on disclosure of a newly acquired or newly discovered SFI by an Investigator during the course of an ongoing PHS Research Activity;
   2. Within sixty (60) days of determining that a FCOI exists for an Investigator who joins an ongoing PHS Research Activity;
   3. Throughout the lifetime of an award when progress reports are submitted, or at the time that an award is extended (either through extension notification or an NIH prior approval request) to provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project. When during the course of an ongoing PHS Activity a FCOI ceases to exist, updated information about the status of that FCOI should be provided with the subsequent progress report;
   4. In any case which the Department of Health and Human Services (HHS) determines that a PHS-sponsored project of 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 99¾Ã¾Ã¾«Æ· as required by this policy and Federal regulation may require the Investigator to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.
   5. If 99¾Ã¾Ã¾«Æ· determines that an Investigator has failed to comply with this FCOI policy, or with a management plan, in a way that appears to have biased the design, conduct or reporting of PHS-funded research.
3. In-process and Retrospective Review (of new/previously undisclosed FCOI)
   1. When during the course of an ongoing PHS Research Activity, 99¾Ã¾Ã¾«Æ· identifies a potential SFI that was not disclosed in a timely manner by an Investigator, or which was not previously reviewed, the Designated Administrator and the COIC will review the SFI within sixty (60) days to determine whether it is related to PHS Activities and whether a FCOI exists. If a FCOI is identified after such a review, a management plan must be implemented, at least on an interim basis.
   2. In addition, whenever a FCOI is not identified or managed in a timely manner, regardless of whether the Investigator did not disclose a SFI that was later determined to be a FCOI, or 99¾Ã¾Ã¾«Æ·â€™s failure to review or manage the FCOI, or because the Investigator failed to comply with a previously implemented management plan 99¾Ã¾Ã¾«Æ· must within one hundred twenty (120) days of the determination of non-compliance complete a retrospective review of the Investigator's activities and the PHS Activities. The purpose of the retrospective review is to determine if the ongoing PHS Activity was biased in its design, conduct or reporting
      1. Based on the results of the retrospective review, the previously submitted FCOI report must be updated to specify the actions that 99¾Ã¾Ã¾«Æ· will take to manage the identified FCOI going forward.
      2. If bias was found during the retrospective review, 99¾Ã¾Ã¾«Æ· will promptly notify the PHS funding agency, The CIOC will draft a mitigation report that at a minimum document the key elements of the retrospective review, describes the impact of the bias on the research, and outlines 99¾Ã¾Ã¾«Æ·â€™s plans to eliminate or mitigate the effect of the bias.
      3. 99¾Ã¾Ã¾«Æ· will document the retrospective review; such documentation will include the project number; project title; name of Investigator with the FCOI; name of entity with which the Investigator has a FCOI; the reasons for the retrospective review; detailed methodology used for the retrospective review; findings and conclusions.

E. Monitoring

Management plans put in place by 99¾Ã¾Ã¾«Æ· will specify how the Investigator's compliance with the management will be monitored on an ongoing basis until completion of the PHS-funded project.

F. Public Access to Information

99¾Ã¾Ã¾«Æ· is required to respond within five (5) business days to any request for information about FCOIs of senior/key personnel for research grants and cooperative agreements and key personnel for research contracts. The 5-day response shall start from the date the request for information is received at the campus designated email address (uaa_oric@alaska.edu).

G. Records

Records of financial disclosures, Designated Administrator’s determinations, COIC determinations, and University action regarding management of a conflict of interest will be retained for at least three (3) years beyond the date of submission of the award's final expenditure report, or until the resolution of any actions by PHS involving the records, whichever is longer. Records relating to unfunded projects need not be retained.  See 45 CFR Part 75.361.

H. Sanctions

Failure by an individual to file a complete and truthful financial disclosure for pending proposals, or when a new interest is obtained, or failure to comply with any conditions or restrictions directed or imposed, including failure to cooperate with appointed project monitoring bodies, will be grounds for discipline pursuant to the University of Alaska Policy and Regulations on Faculty Conduct and/or other applicable employee or student disciplinary policies.

Agreements with consultants who either fail to file a complete disclosure or fail to comply with any conditions or restrictions imposed may be terminated for cause. Similarly, agreements with subrecipient organizations may be terminated for cause if that organization fails to comply with its obligations under the PHS regulations. In addition, federal regulations may require reports to the federal sponsor of any violations of federal regulations and University policy.