1) INTRODUCTION TO FINANCIAL CONFLICT OF INTEREST POLICY
The U.S. Department of Health and Human Services (HHS) has issued a final rule in the Federal Register that amends the 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). An Institution applying for or receiving PHS funding from a grant or cooperative agreement must be in compliance with all of the revised regulatory requirements no later than August 24, 2012, and immediately upon making the Institution’s Financial Conflict of Interest policy publicly accessible as described in 42 CFR part 50.604(a).
The purpose of the policy described herein is to implement the revised PHS regulation. This policy governs PHS financial conflict of interest and applies to all Investigators at Applied Biotechnology Institute who are planning to participate in or who already are participating in PHS-funded research. The Grants Administrator is the Institutional Official responsible for ensuring implementation of this policy and has the authority to suspend all relevant activities until a given financial conflict of interest is resolved or other action deemed appropriate by the Institutional Official is implemented.
Family means any member of the Investigator’s immediate family, specifically, any dependent children and spouse.
Financial Interest means anything of monetary value received or held by an Investigator or an Investigator’s Family, whether or not the value is readily ascertainable, including, but not limited to: salary or other payments for services (e.g., consulting fees, honoraria, or paid authorships for other than scholarly works); any equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights and interests (e.g., patents, trademarks, service marks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests.
Financial Interest does NOT include:
a) salary, royalties, or other remuneration from the Institution;
b) income from the authorship of academic or scholarly works;
c) income from seminars, lectures, or teaching engagements sponsored by or from advisory committees
or review panels for U.S. Federal, state or local governmental agencies; U.S. institutions of higher education; U.S. research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers; or
d) equity interests or income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in these vehicles.
For Investigators, Financial Interest also includes any reimbursed or sponsored travel undertaken by the Investigator and related to his/her institutional responsibilities. This includes travel that is paid on behalf of the Investigator rather than reimbursed, even if the exact monetary value is not readily available. It excludes travel reimbursed or sponsored by U.S. Federal, state or local governmental agencies, U.S. institutions of higher education, research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers.
Significant Financial Interest means a Financial Interest that reasonably appears to be related to the Investigator’s Institutional Responsibilities, and:
a) if with a publicly traded entity, the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure, and the value of any equity interest during the 12 month period preceding or as of the date of disclosure, exceeds $5,000; or
b) if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure exceeds $5,000; or
c) if with a non-publicly-traded company, is an equity interest of any value during the 12 month period preceding or as of the date of disclosure; or
d) is income related to intellectual property rights and interests not reimbursed through the Institution.
Financial Conflict of Interest means a Significant Financial Interest (or, where the Institutional Official requires disclosure of other Financial Interests, a Financial Interest) that the Institution reasonably determines could directly and significantly affect the design, conduct or reporting of Institutional and or PHS funded research. Institution means Applied Biotechnology Institute.
Institutional Official means the individual within the Institution that is responsible for the solicitation and review of disclosures of significant financial interests including those of the Investigator’s Family related to the Investigator’s institutional responsibilities. For the purposes of this policy, the Institutional Official is designated the Grants Administrator.
Institutional responsibilities means the Investigator’s responsibilities associated with his or her Institutional appointment or position, such as research, teaching, clinical activities, administration, and institutional, internal and external professional committee service. Investigator means any individual who is responsible for the design, conduct, or reporting of PHS sponsored research, or proposals for such funding. This definition is not limited to those titled or budgeted as principal investigator or co-investigator on a particular proposal, and may include postdoctoral associates, senior scientists, or graduate students. The definition may also include collaborators or consultants as appropriate.
Public Health Service or PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to, the Administration for Children and Families, Administration on Aging, Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Federal Occupational Health, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and Substance Abuse and Mental Health Services Administration.
Research means a systematic investigation, study, or experiment designed to 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).
CONFLICT OF INTEREST
This policy is predicated on the expectation that Investigators should conduct their affairs so as to avoid or minimize conflicts of interest, and must respond appropriately when conflicts of interest arise. To that end, this policy informs investigators about situations that generate conflicts of interest related to Research, provides mechanisms for Investigators and the Institution to manage those conflicts of interest that arise, and describes situations that are prohibited. Every Investigator who applies for or receives PHS funding has an obligation to become familiar with, and abide by, the provisions of this policy. If a situation raising questions of conflict of interest arises, an Investigator should discuss the situation with the Institutional Official.
1) DISCLOSURE OF FINANCIAL INTERESTS
All Investigators are required to disclose their outside financial interests, as relates to their Institutional responsibilities, to the Institution at the time of application for PHS funded research, on an annual and on an ad hoc basis, as described below. The Institutional Official or designee as applicable is responsible for the distribution, receipt, processing, review and retention of disclosure forms. Regardless of the disclosure requirements, the Investigator, in his or her own best interest, is encouraged to disclose any other financial or related interest that could present an actual conflict of interest or be perceived to present a conflict of interest.
a) Application Disclosure
All Investigators must disclose their Significant Financial Interests to the Institution, at the time of application for PHS funding.
b) Annual Disclosures
All Investigators must disclose their Significant Financial Interests to the Institution, at least annually while supported by PHS funding.
c) Ad hoc Disclosures
In addition to annual disclosure, certain situations require ad hoc disclosure. All Investigators must disclose their Significant Financial Interests to the Institution, through the Institutional Official, within 30 days of their initial appointment or employment.
Prior to entering into sponsored projects or applications for sponsored projects for PHS funded research, where the Investigator has a Significant Financial Interest, the Investigator must submit to the Institutional Official an ad hoc updated disclosure of his or her Significant Financial Interests with the outside entity. The Institution will not submit a research proposal for PHS funded research unless the Investigator(s) have submitted such ad hoc disclosures. In addition, all Investigators with PHS funded research must submit to the Institutional Official an ad hoc disclosure of any Significant Financial Interest they acquire during the course of the year within thirty (30) days of discovering or acquiring the Significant Financial Interest.
Investigators must also disclose reimbursed or sponsored travel, related to their institutional responsibilities, as defined above in the definition of Financial Interest. A disclosure of all sponsored travel other than that specifically exempted by the FCOI rules must be submitted to the Institution when travel sponsored by a single entity or company is valued at more than $5,000 in the 12 months preceding disclosure, or within 30 days of reaching the $5,000 threshold. Such disclosures must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value. The Institutional Official will determine if additional information is needed (e.g., the monetary value if not already disclosed) to determine whether the travel constitutes a Financial Conflict of Interest with the Investigator’s PHS funded research.
2) REVIEW AND DECISION OF THE INSTITUTIONAL OFFICIAL
If the disclosure form reveals a Significant Financial Interest, it will be reviewed promptly by the Institutional Official for a determination of whether it constitutes a Financial Conflict of Interest. If a Financial Conflict of Interest exists, the Institutional Official will take action to eliminate, reduce, or manage the conflict, as appropriate. A Financial Conflict of Interest will exist when the Institutional Official determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of PHS supported research. If the Institutional Official determines that there is a Financial Conflict of Interest that can be managed, he or she must require and approve a written management plan before any related PHS supported research goes forward. The affected Investigator is responsible for developing and submitting a proposed management plan, in consultation with the Institutional Official.
3) SUB-RECIPIENT REQUIREMENTS
Subrecipient requirements shall be established via a written agreement between the Institution and the subrecipient and where applicable shall address whether subrecipient will follow the Financial Conflict of Interest policy of the awardee institution or the Financial Conflict of Interest policy of the subrecipent. If the latter, the subrecipient will certify that the subrecipient’s Financial Conflict of Interest policy complies with the regulation, and will provide any additional information that may be necessary to allow the prime awardee to fulfill their reporting obligations to the PHS.
4) REPORTING TO PHS
Should any reported financial conflict of interest or non-compliance require reporting to PHS, the Institutional Official or designee will report in accordance with PHS regulations. If the funding for the Research is made available from a prime PHS awardee, such reporting shall be made available to the prime awardee such that they may fulfill their reporting obligations to the PHS.
5) INVESTIGATOR NON-COMPLIANCE
a) Disciplinary Action
In the event of an Investigator’s failure to comply with this Policy, the Institutional Official may suspend all relevant Research activities or pursue other disciplinary action, following established University procedures, until the matter is resolved or other action deemed appropriate by the Institutional Official is implemented. An Institutional Official’s decision to impose sanctions on, or pursue other action via established University Procedures against, an Investigator because of failure to comply with this policy, or failure to comply with the decision of the Institutional Official, will be described in a written explanation of the decision to the investigator, and, where applicable, other administrative areas of the Institution, and will notify the individual of the right to appeal the decision.
b) Retrospective Review
In addition, if the Institutional Official determines that a Financial Conflict of Interest was not identified or managed in a timely manner, including but not limited to an Investigator’s failure to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, or failure by an Investigator to materially comply with an approved management plan for a Financial Conflict of Interest, the Institutional Official will complete a retrospective review of the Investigator’s activities and the research project to determine whether the research conducted during the period of non-compliance was biased in the design, conduct or reporting of the research.
This retrospective review shall be completed and documented within 120 days of the retrospective review and shall include the project number, project title, PI, name of Investigator with the Financial Conflict of Interest, name of the entity with which the Investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review. The Institutional Official or designee will update any previously submitted report to the PHS or the prime PHS awardee relating to the research, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward. If bias is found, the report will include a mitigation report in accordance with the PHS regulations, including a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias. Should the Institutional Official determine that a PHS funded research 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 an FCOI that was not managed or reported by the Institution as required by the regulation, the Institution shall require the Investigator involved to disclose the FCOI in each public presentation of the results of the research, and to request an addendum to previously published presentations.
Each Investigator must complete training on this Policy prior to engaging in research funded by PHS, and at least every four years thereafter. They must also complete training within a reasonable period of time as determined by the Institutional Official in the event that this Policy is substantively amended in a manner that affects the requirements of Investigators, or if it is determined that the Investigator has not complied with this policy or with a management plan related to their activities. http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm
7) RECORD RETENTION
The Institutional Official or designee will retain all disclosure forms, conflict management plans, and related documents for a period of three years from the date the final expenditure report is submitted to the PHS or to the prime PHS awardee or from other dates specified in 45 CFR 74.53(b) and 92.42(b), where applicable.
To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential. However, the Institution may make such information available to an agency funding research of the faculty member, to a requestor of information concerning financial conflict of interest related to PHS funding or to the primary entity who made the funding available to the Institution, if requested or required. If the Institution is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this disclosure.
9) PUBLIC ACCESSIBILITY
The Institution shall respond to any requestor within five business days of the request, with information concerning any Significant Financial Interest that meets the following criteria:
a) The Significant Financial Interest was disclosed and is still held by the Investigator;
b) A determination has been made that the Significant Financial Interest is related to the PHS funded research; and
c) A determination has been made that the Significant Financial Interest is a Financial Conflict of Interest. The information to be made available shall be consistent with the requirements of the PHS policy.
10) REGULATORY AUTHORITY
This policy implements the requirements of 42 CFR 50 and 45 CFR 94; where there are substantive differences between this policy and the requirements, the requirements shall take precedence.