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COI is a set of conditions, in which professional judgment concerning a primary interest (patient's welfare or the validity of research) tends to be or appears to be unduly influenced by a secondary interest (financial or non-financial gain).
The payments made thereof do not include payments for the conduct of the clinical trial of the product under consideration or clinical trials of other products, under a contractual arrangement, but do include other payments made directly to the investigator or to an institution for direct support of the investigator and institution.
Financial interest related to the research means financial interest in the sponsor, product, or service being tested, or competitor of the sponsor or product or service being tested.
Compensation affected by the outcome of clinical studies means compensation that could be higher for a favorable outcome than for an unfavorable outcome, such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.
COI of interest in clinical research extends to all stakeholders. Principal investigator (PI), ethics committee (EC), and the institution.
Main Area of Concern is the Industry-sponsored research.
In case of sponsored research, if immediate family members of the PI or of institutional heads, and/or human research protection programme (HRPP) board are a part of the board of directors, and/or medical advisors, and/or ethics committee members, and/or who have financial interests and/or who hold major share in the sponsor company should be probed and should be declared before the acceptance of the research protocol.
COI of interest in clinical research extends to all stakeholders. PI, EC, and the institution
Its relative weight in professional decisions on meeting recruitment targets may pose problems, due to which may compromise patient care.
Personal: Preference for family and friends.
Desire for prestige, power, and faculty advancement, interest in obtaining positive results, pressure/desire to publish.
Commercial: Industry influence.
Financial: Financial gain.
Favoring pharmaceutical company to receive favors.
Political: Institutional COI
Principles of accountability and transparency whereby, the research or experiment will be conducted in a fair, honest, impartial, and transparent manner after full disclosure is made by those associated with the study of each aspect of their interest in the study, and any conflict of interest that may exist; and whereby, subject to the principles of privacy and confidentiality and the rights of the researcher, full and complete records of the research inclusive of data and notes are retained for such reasonable period as may be prescribed or considered necessary for the purposes of post-research monitoring, evaluation of the research, conducting further research (whether by the initial researcher or otherwise) and in order to make such records available for scrutiny by the appropriate legal and administrative authority, if necessary.
To avoid COI in the research conducted at Manipal Hospitals and prioritize the interests of science and integrity of the data generated and protection of subject.
This policy and procedure is to the EC members and PIs, research staff, and HRPP members.
The institution has its own policy for conflict of interest; however, we follow US FDA regulations with reference to COI.
It is the policy of MHB that investigators and all research personnel involved in the design, conduct, or reporting of research must complete a “Researcher and Research Staff Conflict of Interest Disclosure” worksheet at initial review, continuing review, and any time financial or circumstances change, and disclose whether the researcher or immediate family members (spouse/dependent children/dependent parents) have any of the following:
When the convened IRB determines a conflict exists, it will review a researcher's proposed management plan, or require specific actions to manage the conflict. Disclosure of conflicts to participants is not sufficient by itself to manage conflicts. Examples of actions the convened IRB may take to manage conflicts include requiring:
Before beginning any trail, the PI has to complete the “checklist for COI” and submit the same to the EC. The EC members will evaluate the response and take legal opinion whether there could be conflict of interest; if anything amounts to COI, the PI is asked to give up the non-financial interest till the period of trial.
There is a checklist for COI, which the PI has to fill and submit to the ethics committee.
The EC will review the COI form [Financial disclosure form] and a statement that he would recruit subject without any coercion or undue pressure from the sponsor. If the sponsor induces him, he will promptly report to the EC and will withhold recruitment. Propose a plan to prevent the financial interest from interfering with the design, conduct, or reporting of the research, including interfering with the protection of participants, and submit this information for review by the convened EC. The convened EC has final authority to determine whether the management plan is adequate. The convened EC will evaluate disclosures using the “Researcher and Research Staff Conflict of Interest Disclosure” worksheet and determine if they represent a conflict that might adversely affect the protection of participants or the credibility of the HRPP, and will evaluate proposed management plans to determine if they are adequate. The criteria to evaluate conflicts do not vary by funding or regulatory oversight. The EC will determine whether:
Every EC member, whether internal or external, have to give a declaration that they do not have any COI in the new protocols that will be taken up for approval.
Apart from this,
Source of Support: Nil
Conflict of Interest: None declared.