Office of Vice President of Research Conflict of Interest Information
To address situations when outside financial interests may overlap or conflict with an employee's activities at the University of Alabama in Huntsville, the University has adopted policies regarding financial conflicts of interest. Generally, see Appendix I, UAHuntsville Faculty Handbook and Ethical Duties, UAHuntsville Staff Handbook. Real or perceived conflicts of interest, when not appropriately disclosed and addressed, can undermine confidence in the integrity of University research and sponsored programs.
Due to recent changes in federal regulations, UAHuntsville policy and practices for addressing conflicts of interest in research have been updated. UAHuntsville on August 24, 2012 adopted the Interim Policy on Promoting Objectivity in Research which is applicable to all Investigators (as defined in the policy) working on research projects or sponsored programs funded by the National Science Foundation or the U.S. Department of Health and Human Services Public Health Service and its component agencies or involving human subject research. PHS agencies include the National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Indian Health Service (IHS), Health Resources and Services Administration (HRSA), Substance Abuse and Mental Health Services Administration (SAMHSA), Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare & Medicaid Services (CMS), Administration for Children and Families (ACF), or Administration on Aging (AOA).
In the near future, it is the intention of the University to transition the applicability of this Interim Policy to all sponsored research projects. The Office of Vice President for Research will keep you informed of the transition as it is scheduled. Until then, non-PHS and non-NSF Investigators will continue to disclose financial interests through the revised questionnaire located within the OSP Internal Coordination Sheet which is executed with each proposal.
What is a Conflict of Interest?
Conflicts of interest in research occur when university members are in a position to influence research and their extramural activities are such that they or their family may receive a financial benefit or improper advantage from the research. Conflicts of interest have the potential to inappropriately influence many aspects of research - from how a study is designed, how data is collected, analyzed and reported, to what individuals/suppliers are involved in the work. In a university setting, especially one that promotes technology transfer and entrepreneurial activity, conflicts of interest are inevitable.
"Conflict of Interest" means a significant financial interest related to research or sponsored programs activities that could directly and significantly affect the design, conduct, or reporting of research or a sponsored program. Perceived conflicts of interest can be as harmful as real conflicts of interest. University policy requires that researchers disclose certain financial interests.
What is a Financial Interest?
"Financial Interest" is defined as anything of monetary value, whether or not the value is readily ascertainable, or serving in an executive position with an entity, i) that reasonably appears to be related to the Investigator's institutional responsibilities or, (ii) in entities whose financial interests would reasonably appear to be affected by, or could affect, such institutional responsibilities. There are exceptions to what constitutes a Financial Interest. You should refer to the Interim Policy on Promoting Objectivity in Research for further information in this regard.
What is Meant by "Related to your Institutional Responsibilities"?
"Related to your institutional responsibilities' means an interest or relationship that relies upon the same expertise as does your ability to carry out your University responsibilities; as well as any interest or relationship that has the potential to influence the duties that the University considers to be a part of your work. In this regard, "Institutional Responsibilities" are the professional responsibilities (e.g., academic or research area of interest or expertise) of an Investigator on behalf of the University to perform duties and/or activities that are undertaken to fulfill one's research, teaching, or service responsibilities within the University.
The policies of UAHuntsville and the applicable federal regulations recognize that the existence of a potential conflict of interest does not necessarily mean that the outside interest or activity must be avoided or discontinued. Often, potential and actual conflicts of interest can be addressed effectively by disclosure or other steps to resolve or manage the conflict.
Who Must Disclose:
- All Investigators conducting research funded by the PHS or NSF are required to disclose their financial interests and those of family members to the University on an annual and on an event basis, as described below.
- All Investigators conducting human subject research subject to Institutional Review Board review.
- "Investigator" means the principal investigator, any co-principal investigators and any senior/key personnel. For PHS-funded research only, the term also includes University faculty and staff who have independent responsibility, as determined by the PI or Co-PI, for designing, conducting, or reporting research, regardless of title or position and may include, for example, post-doctorals paid on research grants, collaborators or consultants.
- "Family Members" is defined to include spouse or any dependent.
When and How to Disclose:
- Instructions: All disclosure forms are accessed through Banner. Opening a disclosure form by clicking on its Title in the upper right-hand box on this Home page will take you to the Banner log-in page. You should log in with your A-number, open the Employee section and then scroll down to and open the "Investigator Research Portal". The three financial interest disclosure forms discussed below will appear within the box labeled "Forms and Certifications". Please note that a partially completed form cannot be submitted, nor will it be saved for later completion. Each question and sub-part must be answered. However, new External Entities may be added at a later time by directly accessing that form.
- Investigators with active PHS or NSF awards or proposals should complete the Investigator's Annual Financial Interest Disclosure and Certification (see link to that form on this Home page.) as soon as possible in order to ensure that information is on file for financial interests and it is current and accurate. This annual disclosure will be updated on or before March 1 of each year. The first disclosure will be of a partial year.
- Investigators must submit another disclosure of financial interests (using the External Entity Disclosure form linked on this Home page) within 30 days of acquisition of a new financial interest or elimination of a reportable financial interest for the Investigator and family, or a change in, or the initiation of, an executive position or a sponsor, or any change that might affect a current conflict of interest management plan.
- Investigators that are new to their role in PHS or NSF research must complete a disclosure of financial interest (using the annual form) prior to undertaking any PHS or NSF research, even if there are no financial interests to report.
- At the time of submitting a proposal, Investigators must submit (a) a certification of no change in his/her annual disclosure, and (b) a proposal-specific updated disclosure of his or her financial interests, including any sponsor-required information. (This disclosure is accomplished by completion of the Proposal Certification and Financial Interest Disclosure in the OSP Internal Coordination Sheet on this portal if senior/key personnel.)
- Investigators for Institutional Review Board ("IRB") protocol which are subject to review are required to report their project-related financial interests to the IRB at the time they submit a protocol. (This disclosure may be accomplished by completion of the Proposal Certification and Financial Interest Disclosure questionnaire linked on this Home page.)
- Investigators are required to file or update their annual disclosure at the time the Office of Technology Commercialization begins to negotiate a license for technologies for which the Investigator is named as inventor.
Failure to Complete Disclosures
Principal responsibility for implementation and enforcement of the Interim Policy on Promoting Objectivity in Research resides with the VPR. As with any University policy, sanctions may apply for an Investigator's non-compliance with this Policy. The responsibility for initiating disciplinary action resides with the Investigator's supervisor. The VPR may report instances of non-compliance with this Policy to the Investigator's applicable supervisor who may initiate disciplinary action in accordance with University policies and procedures. In addition, the funding agency will be notified, if applicable.
Summary of Financial Interest Review
Financial interest disclosures are reviewed first by the University Chief Compliance Officer to determine if an Investigator's financial interest meets the threshold of being a significant financial interest. If that threshold is met, the significant financial interest is secondly reviewed by the applicable Department Chair or Center Director, Chief Compliance Officer, College Dean and VPR to determine (i) if the significant financial interest is related to the sponsored research activities, and (ii) could it directly and significantly affect the design, conduct or reporting of research or a sponsored program activity. Any financial interests of Investigators proposing research involving human subjects are initially reviewed by the IRB and subsequently by the foregoing officials. The Investigator may be consulted as needed for these reviews. The designated officials may consult the Conflict of Interest in Research Committee for guidance in specific cases, or in the application of the policy to particular circumstances. The Vice President for Research has final approval of all financial interest reviews.
DISCLOSURE AND REVIEW PROCESS
Conflict of Interest Resolution and Management
If a conflict of interest is determined to exist, the VPR, through the Department Chair, College Dean and/or Research Center Director and Chief Compliance Officer, is required to reduce, eliminate or manage the conflict through the development and implementation of a written management plan. The Investigator must develop and initially propose a written management plan for approval. Conditions that might be imposed on an Investigator or a research or sponsored project in such management plan include public disclosure of the conflict, modification of the research design, monitoring of the research by independent reviewers, disqualifying participation in all or a portion of the research, divesting significant financial interests, or severing relationships that create actual or potential conflicts of interest. The VPR may consult with the Conflict of Interest in Research Committee.
Conflict of Interest in Research Committee
The Conflict of Interest in Research Committee consists of at least five members selected from full time, tenured faculty and senior research staff members who are experienced with the administration of Federal contracts/grants and sponsored programs appointed by the Vice President for Research, and others as deemed appropriate by the Vice President for Research.
When Investigators outside the University participate in research as a sub-grantee, contractor, or collaborator, the University, at least to the extent required by the research sponsor, will take reasonable steps to ensure that sub-grantees, sub-contractors, or collaborators are adequately informed of their obligation to comply with all applicable conflict of interest reporting, review, and disclosure requirements as required by federal and state law, as well as all conflict of interest policies of research sponsors.
When the University makes a proposal for or receives a sub-award from another organization to carry out a portion of a PHS-funded project, the University must comply with the regulations regarding conflicts of interest. University policy applies to these proposals and awards rather than the policies of the sub-awarding organization.
Each Investigator must complete, at a minimum, web-based training regarding promoting objectivity in research prior to engaging in research and at least every four years thereafter. (On line training may be accessed at the FCOI Tutorial link on this Home page.) It is the responsibility of each Investigator to complete training and transmit a the Certificate and a Training Certification form (linked at the upper right of this page) to the database administrator, Ms. Woodonna Deerman at firstname.lastname@example.org.
Who should I contact for assistance regarding a conflict of interest issue?
Office of Counsel – Chief Compliance Officer