Policy Regarding Disclosure of Significant Financial Interests

NERI has instituted a policy for the disclosure of significant financial interests that are related to a staff member’s institutional responsibilities. This policy applies to all NERI research staff at Level 8 or above and to immediate family members of those staff members. The policy also applies to external investigators and research staff who collaborate on the study design, conduct and reporting of results. The policy and procedures are provided in an institutional operating procedure (OP) and are designed to comply with Public Health Service (PHS) regulations in 42 CFR Part 50, 45 CFR Part 94, and 21 CFR 54.

The policy requires that specified research staff complete training on the OP prior to engaging in research related to any PHS-funded grant or contract and at least every four years thereafter, and immediately if:

• NERI’s financial conflict of interest (FCOI) policy changes in a manner that affects Investigator requirements;
• An investigator is new to NERI; and
• NERI finds an Investigator noncompliant with this OP or with the management plan for an identified FCOI.

Each specified research staff is responsible for disclosing any significant financial interest of his/her own, or of his/her immediate household, that might constitute a FCOI with their institutional responsibilities. Financial disclosure is also obtained from external investigators and research staff collaborating on a funded study.

NERI’s Research Integrity Officer or his/her designee is responsible for reviewing each Significant Financial Interest Disclosure Form obtained and for implementing any and all actions required to resolve or manage identified FCOIs.

A Conflict of Interest Management Committee is responsible for reviewing potential FCOI identified by the Research Integrity Officer, based on submitted disclosure forms. The Committee determines whether the significant financial interest identified in the disclosure process could affect the design, conduct, or reporting of the research of the affected investigator(s), and determine what conditions or restrictions, if any, should be imposed by NERI to manage such conflicts.

The Research Integrity Officer will notify the PHS awarding component or other research sponsor(s), as may be required by the sponsor’s policies or agreements between NERI and the sponsor(s), of FCOI(s). Information regarding the FCOI will be incompliance with the reporting requirements of 42 CFR Part 50, 45 CFR Part 94, and 21 CFR 54.

The Research Integrity Officer will make information concerning identified FCOIs available by written response to any requestor within five business days of a request.