HRPP policies & procedures manual

801: Conflict of interest (investigator)

1. Purpose

In the environment of research, openness and honesty are indicators of integrity and responsibility, characteristics that promote quality research and can only strengthen the research process. Therefore, conflicts of interest should be eliminated when possible and effectively managed and disclosed when they cannot be eliminated.

2. Policy

It is the policy of WSU Institutional Review Board (IRB) that all conflicts of interest be disclosed and reviewed by the IRB to ensure elimination of any conflict of interest, or to appropriately manage and disclose the conflict of interest to the subjects in human subjects research.

3. Specific policies

3.1 Conflict of interest

The protection of human subjects requires objectivity in communicating risks, selecting subjects, promoting informed consent, gathering, analyzing, and reporting data. Therefore, the IRB considers financial and other conflict of interest issues in its deliberations of applications.

3.2 Reporting

All investigators whose projects require full-board or expedited review must reveal on their application to the IRB whether they or any other person responsible for the design, conduct, or reporting of the research has an economic interest in, or acts as an officer or a Office of Research Assurances (ORA) director of any outside entity whose financial interests would reasonably appear to be affected by the research.

When a conflict of interest is reported, the WSU Conflict of Interest Committee (COIC) will review the conflict. If, upon review, a conflict is determined, the COIC will design a conflict management plan. The plan will be reviewed by the IRB, at which time the IRB will decide whether the research can be approved.

WSU investigators

WSU investigators are required to adhere to the WSU policy on financial conflict of interest (Objectivity in Research).

All investigators are required to complete an annual disclosure of conflict of interest by principal investigators (pdf). This form is reviewed by the COIC. If a conflict of interest is identified, the institutional official or the conflict of interest coordinator notifies the ORA director. The ORA director checks all open studies to determine if the conflict of interest needs to be addressed. This process is in addition to completing the conflict of interest questions on the IRB application.

3.3 Management

The IRB, at a convened meeting, will review the management plan and will consider:

  • Risks to subjects
  • Anticipated benefits, if any, to subjects
  • The scientific or the scholarly integrity of the research
  • The selection of subjects
  • The possibility of coercion or undue influences during the consent process
  • The information provided to subjects
  • Provisions for monitoring the data collected to provide for safety of subjects
  • Provisions to protect the privacy interests of subjects
  • Provisions to maintain the confidentiality of identifiable data.

The IRB may accept the management plan or require additional management including, but not limited to:

  • Public disclosure of significant financial interest
  • Monitoring of research by independent reviewers
  • Modification of the research plan
  • Disqualification from participation in all or a portion of the research
  • Divestiture of significant financial interests
  • Severance of relationships that create actual or perceived conflicts

3.4 Approval

The IRB will withhold approval until the determination and/or management plan is reviewed by the convened IRB. The IRB has the final authority to approve the research or to require modification to the research given the management plan. A copy of the IRB approval and any additions to the management plan will be sent to the Conflict of Interest Committee chair.

3.5 Changes in the conflict of interest status during the course of the study

If there is a change in the conflict of interest status of an investigator during the course of a study, the investigator is required to notify the IRB within ten (10) working days of the change. The IRB will review the change as a modification to the protocol.

3.6 Annual review

At the time of continuing review, the investigator will be asked whether there has been any change in the conflict of interest status relating to the research. The IRB will review conflict of interest as part of its continuing review.

3.7 FDA COI requirements

In 1998, the Food and Drug Administration issued its revised regulations (21 CFR 54) with respect to financial disclosure by clinical investigators. The FDA’s definitions and what constitutes a conflict of interest vary from those of the U.S. Public Health Service. For the purposes of its regulations, the FDA has established the following concepts:

  • Compensation made to the investigator in which the value of compensation could be affected by study outcome. This requirement applies to all covered studies, whether ongoing or completed as of February 2, 1999.
  • A proprietary interest in the tested product, including, but not limited to, a patent, trademark, copyright or licensing agreement. This requirement applies to all covered studies, whether ongoing or completed as of February 2, 1999.
  • Any equity interest in the sponsor of a covered study, i.e., any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices. This requirement applies to all covered studies, whether ongoing or completed;
  • Any equity interest in a publicly held company that exceeds $50,000 in value. These must be disclosed only for covered clinical studies that are ongoing on or after February 2, 1999. The requirement applies to interests held during the time the clinical investigator is carrying out the study and for 1 year following completion of the study; and
  • Significant payments of other sorts, which are payments that have a cumulative monetary value of $25,000 or more made by the sponsor of a covered study to the investigator or the investigators’ institution to support activities of the investigator exclusive of the costs of conducting the clinical study or other clinical studies, (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for 1 year following completion of the study. This requirement applies to payments made on or after February 2, 1999.

4. Applicable regulations and guidelines

WSU financial conflict of interest (Objectivity in Research)

National Institutes of Health Guide, “Objectivity in Research”

5. Forms

Significant financial interest disclosure

6. Procedures employed to implement this policy & assignment of responsibility

ORA directorReview potential conflicts of interest and forward to WSU Conflict of Interest Committee or other individuals as appropriate.
COI committeeReview conflict of interest and make determination and/or recommend management plan.
IRB membersReview conflict of interest determination, management plan, and all supplemental materials at convened IRB meeting.
IRB coordinatorDistribute communications to and from investigators to appropriate IRB staff and members in a timely manner.