Investigators

This area of our site helps investigators better understand the responsibilities involved with clinical trials and the role IRB’s play in the clinical trial process.

Topics include:

Conflict of Interest

Concerns have grown that financial conflicts of interest in research, derived from financial relationships and the financial interests they create, may affect the rights and welfare of human subjects in research. Financial interests are not prohibited, and not all financial interests cause conflicts of interest or affect the rights and welfare of human subjects.

Investigator Conflict of interest can be defined as any situation which may bias the professional judgment of the investigator and lead to inappropriate decisions being made for the research participant.

Financial interests determined to create a conflict of interest may be managed by eliminating them or mitigating their impact. A variety of methods or combinations of methods may be effective. Some methods may be implemented by institutions engaged in the conduct of research, and some methods may be implemented by IRBs or investigators. Some of those may apply before research begins, and some may apply during the conduct of the research.

The Department recommends that investigators conducting human subjects research consider the potential effects that a financial relationship of any kind might have on the research or on interactions with research subjects, and what actions to take.

Actions to consider:
  • Including information in the informed consent document, such as
    • the source of funding and funding arrangements for the conduct and review of research, or
    • information about a financial arrangement of an institution or an investigator and how it is being managed.
  • Using special measures to modify the informed consent process when a potential or actual financial conflict exists, such as
    • having a another individual who does not have a potential or actual conflict of interest involved in the consent process, especially when a potential or actual conflict of interest could influence the tone, presentation, or type of information presented during the consent process.
    • Using independent monitoring of the research.

For more information, see the 2004 final guidance document entitled Financial Relationships and Interests in Research Involving Human subjects: Guidance for Human Subject Protection.

Although the main focus on current discussions regarding conflict of interest center on financial concerns of the investigator or close family members. Included in this area are financial incentives or subject recruitment bonuses, stock or options held in a sponsor company, ownership interest in a healthcare facility where research is conducted and consulting relationships with research sponsors.

Other than financial interests, other personal areas that may pose a concern include tenure, peer pressure and professional recognition and promotions.

If you can’t find the answer to your questions, contact us for more information.

For Sponsor/CRO and Investigator feedback, concerns, or suggestions contact Copernicus Group Independent Review Board (CGIRB) at 1-888-303-2224 (toll free) or irb@cgirb.com.