Definition of Conflict of Interest
A conflict of interest can be any situation in which financial interests or other personal considerations have the potential to compromise an investigator’s professional judgment and objectivity in the design, conduct or reporting of research (AAMC, 1990). Conflicts of interest are usually associated with situations where KEP members have a financial or non-financial interest in the research being reviewed or the investigators/institution has a financial or non-financial interest in the research to be carried out.
In research involving human subjects, conflict of interest may harm the well-being of the subjects. A conflict of interest may lead to injury or harm to particular study participants. On a larger scale, a conflict of interest can damage an entire research enterprise by reducing the trust and confidence that people generally have in research.
Individuals directly involved in the conduct, design, or reporting of research involving human subjects should not have more than a minimal personal financial interest in a company that sponsors the research or owns the technology being studied. Investigators submitting protocols using human subjects must disclose all interests that may be perceived as a conflict with the best interest of the subject in order to be considered for approval.
According to the 2011 KEPPKN (Komisi Etik Penelitian dan Pengembangan Kesehatan Nasional/National Health Research and Development Ethics Commission) Guidelines, conflicts of interest can arise from the interests of sponsors, public organizations, or government agencies. These conflicts include:
To ensure that the potential risk has been considered, Investigators ought to complete the disclosure form and submit it to the KEP-LPEM (Financial Interest Disclosure Letter). Based on the information submitted by the investigator for review, the KEP-LPEM may determine that:
Conflict of Interest Management
If it is proven that there is a conflict of interest in the research team, the investigator needs to provide an explanation of the plan to minimize the risk of the impact of the conflict of interest on the objectivity of the research and the protection of human subjects. KEP may request additional management plans if needed. Conflict of interest management can be done in various ways. Here are some examples:
Financial Conflict of Interest
Financial Conflict of Interest means a significant financial interest and for Investigators that could directly and significantly affect the design, conduct, or reporting of research. In considering whether specific financial relationships create financial interests in research studies that may adversely affect the rights and welfare subjects, KEP-LPEM can include the following questions in their deliberations:
Managing Conflict of Interest at the Individual Level
In handling individual investigator conflicts of interest, specific steps might include:
Depending on the complexity of the conflict, other management strategies could include:
Conflict of Interest at the Institutional Level
Institutional conflict of interest is when financial interests of the institution or of an institutional official might affect or reasonably appear to affect institutional processes including the conduct, review, or oversight of human research. Strategies are emerging to manage institutional conflicts of interest:
Conflict of Interest at the KEP Level
A KEP member is said to have a conflict of interest if the KEP member, or his/her spouse, domestic partner or relative (e.g. children, siblings, or parents):
Managing Conflict of Interest at the KEP Level
Download this guide: Conflict of Interest Policy Guide