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Administration and Operatio...
2.10 Objectivity in Research and Investigator...
College Hall 106
Last Revised: September 2021
Refer Questions to: Special Assistant to the Provost for Research
This policy applies to Gallaudet University employees who serve as investigators and who apply for funding through Gallaudet from the Public Health Service (PHS), which includes: the National Institutes of Health (NIH) the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Food and Drug Administration (FDA) and the Agency for Healthcare Research and Quality (AHRQ) or the National Science Foundation (NSF) or other funding agencies with similar requirements. This policy may also be extended to any federal sponsor that has similar requirements with regard to investigator financial disclosure according to the scope of their regulation. The term “investigator” includes the principal investigator, co-principal investigator, and any other person at Gallaudet University who is responsible for the design, conduct, or reporting of research (this may include, for example, consultants and unpaid collaborators) funded by the above funding agencies or an agency with similar requirements as the Public Health Service agencies.
The University complies with Public Health Service, National Science Foundation and other federal agency disclosure regulations in order to maintain eligibility to submit applications for grant, cooperative agreement or contract funding to those agencies. Additionally, and most importantly, the regulations are designed to promote objectivity in research and to ensure that the design, conduct and reporting of research conducted at Gallaudet University and sponsored with federal funds are not biased by any perceived or real financial conflict of interest (FCOI) of an investigator. The NIH Office of Extramural Research Conflict of Interest Website contains more information at https://grants.nih.gov/grants/policy/coi/index.htm as well as a link to the current regulation “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” (42 C.F.R. Part 50, Subpart F) which is the basis for this policy and provides a more extensive definition of what a Significant Financial Interest (SFI) includes. The National Science Foundation’s Award and Administration Guide has more information for NSF investigators at http://www.nsf.gov. The body which will determine if an SFI constitutes an FCOI and be responsible for management plans and review of FCOIs will be the Objectivity in Research Committee (ORC) under the auspices of the Dean’s Office of the Graduate School and Professional Programs. The ORC will provide a report to the Dean as each FCOI is determined initially and provide an annual report on all FCOIs.
The Gallaudet University Office of Sponsored Programs (OSP) shall be responsible for ensuring that each investigator is informed about this policy and made aware of the required training through the university’s Collaborative Institutional Training Initiative (CITI). The OSP will ensure that each investigator has completed the CITI FCOI training prior to engaging in research related to any PHS or NSF-funded grant, cooperative agreement, or contract and at least every (4) years thereafter, and immediately when any of the following applies: (1) this FCOI Policy, the SFI Disclosure Form, or the University’s procedures are materially revised in any manner that affects the requirements of the investigators; (2) an investigator is newly appointed to the University; or (3) the University ORC finds that an investigator is not in compliance with this policy or their FCOI management plan. “Immediately” shall mean the training is provided or made available and the investigators participate in the training expeditiously following the event that triggers the training requirement. The Gallaudet University Institutional Review Board (IRB) for the Protection of Human Subjects will be responsible for maintaining the CITI subscription, ensuring access to CITI training, and retaining records of training completed on behalf of the University.
Disclosure, Review and Monitoring
The term “Significant Financial Interest” does not include: salary, royalties, or other remuneration paid by Gallaudet to the investigator if the investigator is currently employed or otherwise appointed by Gallaudet, including intellectual property rights assigned to Gallaudet and agreements to share in royalties related to such rights; 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; 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 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.
With respect to human subjects research, the term “Significant Financial Interest” shall include cases involving any type of remuneration and any type of equity ownership. See also Administration and Operations Manual Policy 3.03 for Gallaudet’s Protection of Human Subjects in Research Projects.
“Institutional Responsibilities” means an investigator’s professional responsibilities on behalf of Gallaudet, including activities such as research, teaching, clinical or other professional practice, academic activities, scholarly events, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Committees.
Management of Financial Conflicts of Interest
Enforcement and Sanctions
The University, through the ORC, is required pursuant to the PHS and NSF FCOI Regulations to maintain all SFI Disclosure Forms and all related records of actions taken by the University with respect to disclosures of financial interests for a period of three years from the date of submission of the final expenditures report to the PHS as governed by Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) or the NSF Award Administration Guide. The OSP will maintain records of the initial disclosure of SFIs via the routing and approval form for submission of proposals. The IRB will maintain records related to training. The GSPP Dean’s Office will retain records related to annual SFI disclosures. The ORC will maintain records related to SFIs determined to be FCOIs, subsequent management plans, and any other related materials connected to oversight of the management plan.
Approved by: Gallaudet University Administration
Approval – A conflict has been identified for which a management plan can be developed by the ORC and implemented by an oversight committee designated by the ORC.
Approval with Conditions or Restrictions – A conflict has been identified, and a management plan can be developed only for parts of the conflict with conditions or restrictions. The management plan with conditions or restrictions will be implemented by an oversight committee designated by the ORC.
Prohibition – A conflict has been identified for which a management plan cannot be developed.
CITI / Collaborative Institutional Training Initiative – The CITI Program is a subscription service providing research ethics education to all members of the research community. Learners must be affiliated with a CITI participating organization such as Gallaudet University. CITI is a subscription based service and includes an FCOI course among other responsible conduct of research topics.
FCOI / Financial Conflict of Interest – A significant financial interest that the University’s designated official has reasonably determined could directly and significantly affect the design, conduct, or reporting of research project.
FCOI report – An Institution’s report of a financial conflict of interest to a PHS Awarding Component or to another agency with similar requirements or regulations such as the NSF.
Financial Conflict of Interest (FCOI) – A significant financial interest that could directly and /or significantly affect the design, conduct, or reporting of PHS-funded research.
Financial interest – Anything of monetary value, whether or not the value is readily ascertainable.
Institutional Responsibilities – “Institutional Responsibilities” means an investigator’s professional responsibilities on behalf of Gallaudet, including activities such as research, teaching, clinical or other professional practice, academic activities, scholarly institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Committees.
ORC / Objectivity in Research Committee – The body overseen by the office of the Dean, Graduate School and Continuing Studies. The ORC will be comprised of two standing members (the Assistant Dean for Graduate Education and one other faculty or staff member) and one additional researcher in a related field.
Oversight Committee – The committee designated by the ORC to manage conflicts which are approved and for which a management plan has been developed. Ordinarily, the oversight committee will be comprised of one member of the ORC, the Department Chair or Budget Unit Head of the investigator, the Dean of the College or Unit of the investigator.
SFI / Significant Financial Interest – See section Disclosure C.
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