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Conflict of Interest Policy

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:

  1. Funds owned by Investigators or their family members for research costs.
  2. Payments to Investigators for speed in obtaining subjects or reporting research results.
  3. Restrictions or restrictions for Investigators in analyzing and publishing results.

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: 

  1. No conflict of interest exists, or 
  2. A conflict of interest exists and must be disclosed to the subjects in the informed consent statement, or 
  3. A conflict of interest exists and the investigator must resolve the conflict before the research can be approved.

 

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:

  • Add independent supervisors to the study team to ensure that research procedures are transparent.
  • Create a safe environment for each member of the research team and/or students to report any perceived conflicts of interest that may occur during the course of the study.
  • Disclose potential conflicts of interest to the subject in the Consent After Explanation (PSP) form.
  • Reduce the role of the investigator in the research if the investigator has a conflict of interest (less interaction with the subject, less data analysis, etc.).
  • Ensure careful study design, which may include randomization and blinding.
  • Disclosure of conflicts of interest, including in publication or presentation of study results.
  • Notify other members of the research team if there is a conflict of interest.
  • Change a member’s role in research if there is a conflict of interest.

 

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:

  • Does the research involve a financial relationship that could create potential or actual conflicts of interest?
    • How is the research supported or financed?
    • Where and by whom was the study designed?
    • Where and by whom will the resulting data be analyzed?
    • What interests are created by the financial relationships involved in the situation?
  • Do individuals or institutions receive any compensation that may be affected by the study outcome?
  • Do individuals or institutions involved in the research:
    • Have any proprietary interests in the product, including patents, trademarks, copyrights, or licensing agreements?
    • Have an equity interest in the research sponsor and, if so, is the sponsor a publicly held company or non-publicly held company? 
    • Receive significant payments of other sorts? (e.g., grants, compensation in the form of equipment, retainers for ongoing consultation, or honoraria)
    • Receive payment per participant or incentive payments, and are those payments reasonable?
  • Given the financial relationships involved, is the institution an appropriate site for the
    research?

 

Managing Conflict of Interest at the Individual Level 

In handling individual investigator conflicts of interest, specific steps might include:

  • The investigator discloses their financial interest to the KEP-LPEM FEB UI;
  • The investigator’s financial interests with the sponsor of the research could be fully disclosed to any research subjects;
  • The investigator’s financial relations to the sponsor should be included in all written and oral presentations, publications, and abstracts.

 

Depending on the complexity of the conflict, other management strategies could include:

  • Modifying the research plan, including changing the site(s) of the research.
  • Monitoring of research by independent reviewers. This could include special oversight on participant recruitment and enrollment, the PSP process, analysis of the study data, and the subsequent reporting to the sponsor.
  • Divestment of significant financial interests.
  • Severance of relationships that create (potential) conflicts.
  • Disqualification of the investigator from part or all of the research project

 

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: 

  • Encourage transparency via disclosure of conflicts of interest among trustees and former trustees as well as university officials who often have close connections with boards of companies doing business with the institution.
  • Set a limit on involvement of faculty members and institutional officials in the company.
  • Be careful when an official’s remuneration is related to stock values, as personal biases can influence judgments regarding stock sales or the acceptance of sponsored research agreements.
  • Manage and review conflicts of interest using independent sources and external reviewers.
  • Build organizational firewalls so that potentially conflicted parties do not interact. 
  • Anticipate situations that could be perceived as compromising research and fiduciary integrity.

 

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):

  • is an investigator or key-personnel on the protocol under consideration;
  • acts as an officer or a director of the sponsor or an agent of the sponsor; 
  • is involved in the research as a coordinator, protocol consultant and/or primary advisor; 
  • has received any entity whose financial interests would reasonably appear to be affected by the outcome of the research;
  • Has identified him/herself for any other reason as having a conflicting interest (e.g., having a close personal or professional association with the submitting investigator, serving as co-investigator and/or the primary mentor for a student or postdoc investigator).

 

Managing Conflict of Interest at the KEP Level

  • Each member of the KEP is responsible to disclose any COI in a study submitted to the KEP and recuse him/herself from the review of that protocol.  
  • No member may participate in the discussion for initial or continuing review of any research project in which the member has a conflict of interest, except to provide information or answer questions from the KEP as requested. 
  • Members with a conflict of interest for a protocol may not be present during KEP voting for the research protocol.

Download this guide: Conflict of Interest Policy Guide

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