POLICY AND PROCEDURES ON FINANCIAL CONFLICTS OF INTEREST IN PUBLIC HEALTH SERVICE FUNDED RESEARCH
Effective August 24, 2012
This policy implements the requirements of certain federal regulations, specifically “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 applies to all projects funded, directly or indirectly through a subaward from another organization, by the Public Health Service of the U.S. Department of Health and Human Services (PHS) other than Phase One SBIR or STTR awards. These PHS specific regulations supplement Northeastern University’s Policy on Conflict on Commitment and Interest as stated in the Faculty Handbook.
PHS regulations differ, in some respects, from Northeastern University’s Policy. It is imperative, therefore, that every Northeastern University Investigator that accepts PHS funding, whether directly or indirectly, becomes familiar with, and abides by, the provisions of these PHS regulations.
PHS includes the National Institutes of Health (NIH) and many other components, including but not limited to, the Administration for Children and Families (ACF), Administration on Aging (AoA), Agency for Healthcare Research and Quality (AHRQ), Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), Federal Occupational Health (FOH), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), and Substance Abuse and Mental Health Services Administration (SAMHSA).
Under the revised PHS regulations, the term Investigator includes not only the principal investigator and co-principal investigator for a project, but also other individuals, who are independently responsible for the design, conduct, or reporting of PHS funded research. These individuals may be referred to as “key personnel” on NIH grants and contracts. The principal investigator is responsible for identifying the Investigators on a project. While a title alone cannot determine who is an Investigator for purposes of the PHS regulations, postdoctoral appointees and graduate students would rarely be considered independently responsible for a project. An investigator matrix designed to assist Principal Investigators in identifying individuals who are Investigators can be found on the Northeastern University Financial Conflict of Interest website.
The other definitional difference is that Significant Financial Interest takes into account travel expenses that are reimbursed or sponsored by an outside entity or organization. The difference is discussed in more detail under TRAVEL DISCLOSURES below.
Full and prompt disclosure is critical to Northeastern University’s ability to identify, manage, and eliminate Financial Conflicts of Interest. There are three types of disclosures:
- Annual Disclosures. Investigators must disclose their Significant Financial Interests to Northeastern University on an annual basis, and must also disclose certain information with respect to conflicts of commitment and interest as prescribed in the Faculty Handbook.
- Proposal-related Disclosures. Prior to submitting a proposal for funding, the Principal Investigators identified in the proposal and, if requested by the Institutional Official or the Designated Official, other Investigators associated with the proposal must disclose whether the Investigator’s Significant Financial Interests may be related by the proposal. If there is a potential relationship, the Investigator must file a full disclosure with additional information regarding the relationship of the project to the Related Company prior to submission of the proposal to the sponsor.
- Ad hoc Disclosures.
- An Investigator must disclose on an ad hoc basis any new Significant Financial Interest within 30 days following the date on which the Significant Financial Interest is acquired or arises. This 30 day requirement is specific to the PHS regulations.
- An Investigator must disclose on an ad hoc basis his or her Significant Financial Interests prior to the Investigator commencing participation in an existing research project.
In addition to the disclosures required by Northeastern University Policy, PHS regulations now require Investigators to disclose to Northeastern University any reimbursed or sponsored travel undertaken by the Investigator related to his or her Institutional Responsibilities, and for Northeastern University to determine if the travel has the potential to bias PHS funded research.
Note that travel that is reimbursed through Northeastern University does not need to be disclosed under the PHS policy.
Travel disclosures must be made if travel is reimbursed or sponsored by an organization other than:
- Northeastern University
- U.S. Federal, state or local governmental agencies
- U.S. Institutions of higher education
- Research institutes affiliated with Institutes of higher education, and
- Academic teaching hospitals and medical centers.
Such disclosures must be made by the Investigator within 30 days following reimbursement or within 30 days following the completion of the trip if the organization or entity funds the travel directly. The travel disclosure must include at a minimum, the purpose of the trip, the identity of the organization or entity funding the travel, the destination, and the duration of the trip (usually measured in days). The Designated Official will determine if additional information is needed to determine whether the travel constitutes a Financial Conflict of Interest.
REPORTING TO PHS
The PHS regulations require Northeastern University to provide information regarding Financial Conflicts of Interest at specified times:
- if a Financial Conflict of Interest exists prior to award, prior to expenditure of funds;
- if a Financial Conflict of Interest arises during the term of the award, then within 60 days following the Investigator’s disclosure of the Significant Financial Interest (see Disclosure Requirements above);
- as part of the University’s annual progress report on the Research;
- as part of any requests for an extension of the award; and
- following a retrospective review as discussed in more detail under RETROSPECTIVE REVIEW below.
Each report Northeastern University provides to PHS must include sufficient information to enable PHS to understand the nature and extent of the potential financial conflict and to assess the appropriateness of the management plan. The required information includes:
- project number;
- Principal Investigator or Contact Principal Investigator if there are multiple Principal Investigators on the project;
- name of the Investigator with the Financial Conflict of Interest;
- name of the entity with which the Investigator has a Financial Conflict of Interest;
- nature of the Significant Financial Interest (e.g., Equity, consulting fees, travel reimbursement, honorarium);
- value of the Significant Financial Interest, which value may be expressed as being within a range($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, if the value of the interest cannot be readily determined through reference to public prices or other reasonable measures of fair market value, a statement confirming that fact;
- a description of the relationship of the Significant Financial Interest to the PHS-funded research and the basis for Northeastern University’s determination that the Significant Financial Interest conflicts with the research; and
- a description of the key elements of the management plan, including:
- the role and principal duties of the conflicted Investigator in the research;
- the conditions of the management plan;
- how the management plan is designed to safeguard the objectivity of the research;
- confirmation of the Investigator’s agreement to the management plan;
- how the management plan will be monitored to ensure Investigator compliance; and
- other relevant information.
PHS requires Northeastern University to make information regarding Financial Conflict of Interests reported to PHS, available to the public upon request. The information that must be made available includes the following, at a minimum:
- Investigator’s name;
- Investigator’s title and role with respect to the research;
- name of the entity in which the Significant Financial Interest is held or from which it is received;
- nature of the Significant Financial Interest; and
- approximate value of the Significant Financial Interest, which value may be expressed as being within a range as described above or if the value of the interest cannot be readily determined through reference to public prices or other reasonable measures of fair market value, a statement confirming that fact.
Northeastern University may also disclose information regarding the management of the Financial Conflict of Interest. Instructions for requesting information about a reported Financial Conflict of Interest can be found on Northeastern University’s Financial Conflict of Interest website.
SUBAWARDS ISSUED BY NORTHEASTERN UNIVERSITY UNDER PHS FUNDED PRIME AWARDS
When Northeastern University issues a subaward to another organization to carry out a portion of a PHS funded project, the subawardee must comply with the PHS conflict of interest regulations. Northeastern University, therefore, will only grant subawards under PHS funded awards to institutions that have financial conflict of interest polices that comply with the PHS regulations. This requirement will be set forth in the Northeastern University subaward.
If a subawardee Investigator has a Financial Conflict of Interest, Northeastern University is responsible for reporting the Financial Conflict of Interest to the PHS on behalf of the subawardee. As a result, subawardees must report Financial Conflicts of Interest to Northeastern University within 45 days of discovering the Financial Conflict of Interest so that Northeastern University may report it to the PHS in a timely manner. In addition, Northeastern University is required by PHS to make information regarding subawardee Financial Conflicts of Interest available to the public. Northeastern University uses the same method it uses to disclose Northeastern University Financial Conflicts of Interest and notifies the subawardee of any requests for information. Questions regarding the specifics of subawardee Financial Conflicts of Interest are directed to the subawardee.
SUBAWARDS ISSUED TO NORTHEASTERN UNIVERSITY UNDER PHS FUNDED PRIME AWARDS
When Northeastern University makes a proposal for or receives a subaward from another organization to carry out a portion of a PHS funded project, Northeastern University must comply with the PHS regulations regarding conflicts of interest. Northeastern University’s Policy and these PHS regulations apply to these proposals and awards rather than the policies of the subawarding organization. Northeastern University provides reports of Financial Conflicts of Interest to the subawarding organization for reporting to PHS as specified in the PHS regulations. Reports are provided in the same form and format as Northeastern University uses in connection with its direct awards from PHS. The subawarding organization is also responsible for the public accessibility reporting (see above). The subawarding organization may choose to do so either by posting Northeastern University’s report to a publicly available website or responding to written requests within 5 business days.
INVESTIGATOR NON-COMPLIANCE - RETROSPECTIVE REVIEW
In cases where a Financial Conflict of Interest is not identified or managed in a timely manner, including due to 1) failure by the Investigator to disclose a Significant Financial Interest that is determined by the Institution to constitute a Financial Conflict of Interest; 2) failure by Northeastern University to review or manage such a Financial Conflict of Interest; or 3) failure by the Investigator to comply with a Financial Conflict of Interest management plan, Northeastern University must, within 120 days of its determination of noncompliance, complete a retrospective review of the Investigator’s activities and the PHS-funded research to determine whether the design, conduct, or reporting of the PHS-funded research, or any portion thereof, conducted during the period of noncompliance, was biased. Retrospective reviews will be conducted by the respective Dean’s Office in consultation with Office of General Counsel and Office of Research Administration and Finance.
Northeastern University is required to document the retrospective review and report detailed findings to PHS, including at least the following key elements:
- project number;
- project title;
- Principal Investigator or contact Principal Investigator if there are multiple Principal Investigators on the project;
- name of the Investigator with the Financial Conflict of Interest;
- name of the Entity with which the Investigator has a Financial Conflict of Interest;
- reason(s) for the retrospective review;
- detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
- findings of the review; and
- conclusions of the review.
Based on the results of the retrospective review, Northeastern University will update the previously submitted Financial Conflict of Interest report, if appropriate, specifying the actions that will be taken to manage the Financial Conflict of Interest. If bias is found, Northeastern University must notify PHS promptly and submit a mitigation report. The mitigation report must include, at a minimum:
- the elements documented in the retrospective review above;
- a description of the impact of the bias on the research; and
- Northeastern University’s plan of action or the actions taken to eliminate or mitigate the effect of the bias (e.g., extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research is salvageable).
Thereafter, Northeastern University will submit Financial Conflict of Interest reports annually, as specified under the PHS regulations. Depending on the nature of the Financial Conflict of Interest, Northeastern University may determine that additional interim measures are necessary with regard to the Investigator’s participation in the PHS funded research between the date that the Financial Conflict of Interest or the Investigator’s noncompliance is determined and the completion of Northeastern University’s retrospective review.
Northeastern University must provide training regarding Northeastern University’s Policy and the PHS regulations to Investigators. Investigators must complete the training prior to engaging in research related to any PHS-funded grant, and at least every four years thereafter. Investigators must also complete training immediately when (i) the Northeastern University FCOI policy is substantively amended in a manner that affects the requirements of Investigators or (ii) Northeastern University determines that the Investigator has not complied with this FCOI policy or with a management plan related to his or her research, or (iii) a PHS funded Investigator is new to Northeastern University.
Training will be provided through the Collaborative Institutional Training Initiative (CITI). More information can be found at Northeastern University’s Investigator Training webpage.
The Designated Official will retain all disclosures, conflict management plans, and related documents for a period of at least seven years following submission of the final expenditure report for the applicable project to the PHS or the prime PHS awardee, unless any litigation, claim or negotiation, audit, or other action involving the records is commenced before expiration of the seven-year period, in which case, records will be retained until completion of the action and resolution of all issues.
In part, this policy statement is based on one approved by the Faculty at the Massachusetts Institute of Technology in July, 2012.