Boston University
Charles River Campus IRB
Policies and Procedures
Title: Researcher Financial Conflicts of Interest
Date: October 9, 2015

Purpose

The purpose of this policy is to describe the process for reviewing researcher or research staff financial conflicts of interest that are related to human subjects research.

Policy

The Charles River Campus (CRC) IRB requires that researchers and research staff confirm in the IRB Application that all those responsible for the design, conduct, or reporting of the proposed program, including at minimum, all Senior/key personnel in the grant application, have completed the financial interest disclosure forms, submitted them to the Conflict of Interest (COI) office, and completed training as dictated at: bu.edu/researchsupport/training-how-to/conflict-of-interest-training/, and as provided under the Boston University Policy on Investigator’s Conflicts of Interest:

In addition, the Principal Investigator must indicate in the IRB Application if he/she or any of the research staff disclosed a financial interest in the financial interest disclosure forms.

The Principal Investigator must complete these COIConflict of Interest Learn about BU's Financial Conflict ... sections in the original IRB Application forms, the Continuing Review Application form, and the Study Staff Amendment form.

The IRB Director serves as a non-voting member of the Charles River Campus (CRCCharles River Campus) Conflicts of Interest Committee.

Procedures

  1. The IRB staff will review the IRB Applications for positive financial interest disclosures. If the Principal Investigator indicates that there was a financial interest disclosure on the COI Unit forms, the IRB Staff will forward the IRB Application to the IRB Director.
  2. The IRB Director will contact the COI Manager to discuss the interests disclosed.
  3. If it was determined that there is a financial conflict of interest (FCOI) related to the research, the IRB Director will communicate this information to the IRB Chair and the IRB reviewer for the study. If the study is being reviewed by the convened Board, the information will be presented at the convened meeting.
  4. Even if the Faculty Review Committee on Research COIs determines that there is no financial conflict of interest and/or no management plan is necessary, and the Associate 2 Vice President for Research Compliance, as Designated Official, confirms this, the IRB may request additional requirements.
  5. The COI Manager will notify the IRB Director of any FCOI management plan that is related to human subjects research. The IRB Director will forward this information to the IRB Chair and IRB reviewer and/or convened Board as applicable.
  6. The IRB may approve the research pending review and approval of the Designated Official. Following the final determination of the Designated Official, the IRB receives the COI management plan for review.
  7. In the assessment of risks and benefits, the IRB will determine if it is necessary that the conflict be disclosed to subjects in the consent form. The IRB will make the final determination of what may be additionally required to assure that subjects are protected and fully informed. The IRB cannot remove anything from the Faculty Review Committee’s management plan.
  8. The IRB will notify the Principal Investigator directly of any additional requirements regarding the financial conflict of interest.

Boston University Policy on Investigator Conflict of Interest

 

Title: Researcher Conflict of Interest

Author: Cynthia Monahan

Effective Date: October 9, 2015

Last Review/Update Date:

Revision #:

Approved: Cynthia Monahan, IRB Director Kathryn Mellouk, Associate Vice President-Research Compliance

View all posts