HSPP Conflicts of Interest in Research
Individuals are considered to have an institutional responsibility and are required to disclose financial interests in research if they are involved in any of the following:
- The design, conduct, or reporting of research
- Research consultation
- Professional practice
- Institutional committee memberships
- Service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards
All members of the research team involved in human research are required to disclose financial interest in the iStar application that are related to the research. A financial interest is related to the research when the interest is in:
- A sponsor of the research;
- A competitor of the sponsor of the research;
- A product or service being tested; or
- A competitor of the product or service being tested.
All members of the research team must also provide details of their financial interest(s) through the diSClose system. The iStar application includes questions regarding the financial interests of each study team member. If a conflict is indicated, the application links to the content in that person’s diSClose account. Conflict of interest disclosures are reviewed by the CHLA Conflict of Interest in Research Committee (COIRC) in advance of the IRB’s review of the new research studies. The COIRC reviews the financial interest(s) and determines whether a Conflict Management Plan is required.
Conflict Management Plans may include:
- Specific wording to be added to the consent documents to disclose a financial conflict to subjects
- Limitations on which members of the research team may obtain consent
- Changes to the research regarding whether researchers may participate in the research at all
- Specific wording to disclose the conflict when the results of the research are disseminated
- Financial divestiture by the researcher with the conflict
- Appointment of an independent safety monitoring committee
- Shorter study approval periods
The relevant components of the Conflict Management Plan must be incorporated into the application (e.g. revision to the consent or study team composition) before the protocol may be approved by the IRB. The approved conflict management plan must be uploaded to the iStar study application.
The IRB reviews the executed conflict management plans for personal financial conflicts of interest. The IRB reviews the executed conflict management plans for personal financial conflicts of interest. The IRB may determine that additional requirements (above and beyond those described in the conflict management plan) are necessary to manage the conflict. The IRB may determine that additional requirements (above and beyond those described in the conflict management plan) are necessary to manage the conflict.