Common Rule: Human Subjects Protections Update

After five years of effort, federal agencies have published the final rules for the Federal Policy for the Protection of Human Subjects, more commonly known as the Common Rule. The new rule was published on January 19, 2017, with most changes going into effect one year later on January 19, 2018. The federal Office for Human Research […]

Uniform Guidance

On December 26, 2013, the Office of Management and Budget (OMB) released the “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Rewards,” also known as the Uniform Guidance; the Uniform Guidance consolidated and superseded eight OMB Circulars, including Circulars A-21, A-110 and A-133.The OMB’s Uniform Guidance became effective December 26, 2014. Please send any comments or questions […]

Rights and Responsibilities of Individuals Involved in Research Misconduct Proceedings

December 10, 2010 Complainant/Witness Respondent Individuals providing requested information Research Integrity Officer Members on the Committee on Research Integrity Research Ethics and Compliance Office (RECO) Vice Chancellor for Research Deans Department Heads Office of the Executive Vice Chancellor and General Counsel (OGC) Legal counsel/advisor for the respondent Complainant/Witness Rights Protection from retaliation for his/her activities […]

Financial Disclosure Procedure

Washington University Annual Financial Disclosure Statement is required: For all covered individuals who have any type of WUSTL appointment, the disclosure statement can be accessed through RMS at https://rms.wustl.edu. System instructions are available on the Financial Disclosure System page. If the individual is transferring to Washington University, an appointment can be entered into the Human Resources Management […]

Monitoring Procedures

Washington University (WUSTL) shall monitor compliance with FCOI management plans related to Public Health Services (PHS)-funded research on an ongoing basis until the completion of the PHS-funded research project, in accordance to PHS regulations, 42 CFR Part 50 and 45 CFR part 94. Monitoring of management plans for PHS-funded research will occur as prescribed below. 1. Monitoring […]

Request Information Available to the Public

Washington University (WUSTL) shall provide to any requestor written information about Financial Conflicts of Interest, which were determined to be a Financial Conflict of Interest related to Public Health Services (PHS)-funded research on or after August 24, 2012, in accordance with 42 CFR Part 50 and 45 CFR Part 90 and this procedure. Information concerning Financial […]

Material Financial Interest

The following outlines the CIRC’s Threshold for Reviewing Financial Interests Type of Research Funding: PHS/NIH All Non PHS (e.g. NSF, industry, etc.) Includes: ≥$5,000 in remuneration from an entity (includes non-profits), in aggregate ≥$5,000 equity in publicly traded entity Holding of any ownership interest or equity in a non-publicly traded entity (includes non-profits) Travel reimbursed […]

Dispute Resolution/Appeals Procedure

Introduction The WUSTL Research Conflicts of Interest Policy states “Unresolved disagreements concerning the application of this policy shall ultimately be referred for final resolution to a committee established by the chancellor or representative appointed by the chancellor.” This procedure outlines the necessary steps individuals shall take to resolve disagreements and, if needed, seek an appeal regarding […]

Determining and Managing Research FCOIs Procedures

1. Introduction The following describes the Conflicts of Interest Review Committee’s (CIRC) procedures and considerations for a) reviewing individuals’ personal financial interests, b) determining whether there is a material financial interest, c) evaluating its relatedness to the research and risks, to determine if a financial conflict of interest exists. It also provides guidelines and examples for managing […]

Timing of Disclosures

Covered individuals should update their Financial Disclosure Statement: at least annually; within 30 days of acquiring a new financial interest (which includes travel for individuals involved in PHS funded research – see above); or when they initiate new research projects. a. Sponsored Research Projects (e.g. grants or contacts) For Proposals: Annual Financial Disclosure Statements (FDS) or […]