Policies, Procedures and Guidelines

FCOI Education Requirements

Introduction

The WUSTL Research COI Policy states “A covered individual must complete training in regard to this policy and applicable federal regulations as established by the University and/or applicable federal regulations.” Central to Washington University’s mission of fostering excellence in research is a commitment to ensure that individuals responsible for the design, conduct, or reporting of research receive education regarding financial conflicts of interest (FCOI) that is appropriate to help assure the ethical and objective conduct of research. FCOI education includes information regarding WUSTL’s policy on financial conflicts of interest, an individual’s responsibilities regarding disclosure of financial interests, and federal regulations governing financial conflicts of interest.

Procedure

This document further defines the procedures governing the FCOI education requirements as addressed in the Research Conflicts of Interest Policy.

Applicability

Educational requirements apply to all “covered individuals,” those individuals required to submit a Financial Disclosure Statement, examples include:

  1. All faculty with an academic appointment of instructor or higher on tenure or non-tenure tracks, and
  2. Any other individual who, regardless of title or position, is independently responsible for the design, conduct, or reporting of research at WUSTL.

Requirements/Frequency

Completion of the education is required within the next 12 months or prior to the start date of any new, competitive, or non-competitive awards supporting research activities, whichever occurs first. For example, if your research funding is due to start September 1, 2012, the education must be completed prior to September 1, 2012, to prevent delays in the award set-up.

  1. Renewal of the education will be required every four years.
  2. Education will also be required in WUSTL revises its FCOI policy that affects the requirements of covered individuals and/or when an investigator is not compliant with a FCOI management plan.

Process

Education shall be provided through a web-based education module available via Learn@Work​. The module should take approximately 15 minutes to complete. Click here to access FCOI Education via Learn@Work.

Roles and Responsibilities

Principal Investigator/Project Director
The PI/PD is responsible for assuring that covered individuals involved with their research projects complete the appropriate education requirements.

School, Department, or Program Administration
Schools, departments, and programs should monitor compliance with FCOI education requirements by:

  1. Working with the PI/PD to help inform appropriate individuals of their need to comply with this requirement;
  2. Verifying appropriate individuals have complied with this requirement within the applicable timeline for completion. The completion data is available via the Compliance Module; and
  3. Implementing necessary internal procedures to assure that issues of noncompliance are identified and resolved.

Office of Sponsored Research Services (OSRS)
The OSRS is responsible for providing institutional assurance of compliance with the education requirements for all applicable research sponsors. Should the necessary education not be completed by the covered individuals, OSRS may delay the set-up of the award in accordance with federal regulations and/or institutional policies or processes.

Research Ethics and Compliance Office (RECO)
The RECO is responsible for working with the Conflict of Interest Review Committee (CIRC) to develop and deliver education that complies with institutional policies and federal regulations. The RECO may also monitor for compliance.

Monitoring

As outlined here or as required, compliance with the educational requirements will be monitored.

Compliance

Issues of non-compliance with the educational requirements that are identified through ongoing monitoring activities will be forwarded to the vice chancellor for research who, as institutional official, is responsible for imposing sanctions.

Failure to gain compliance within a specified timeline and/or circumstances of repeated or egregious noncompliance may result in corrective actions or sanctions, which may include the restriction of access to all project funds until compliance is obtained and/or removal of allocated salaries for the non-compliant individual from the research funds.