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Perspect Clin Res. 2013 Jan-Mar; 4(1): 41–44.
PMCID: PMC3601703
Conflict of interest and its importance
Pratibha Pereira
Department of Quality and department of clinical research, Manipal Clinical Research Centre, Manipal Hospital, Bangalore, Karnataka, India
Address for correspondence: Dr. Pratibha Pereira, Manipal Clinical Research Centre, Manipal Hospital, Bangalore, Karnataka, India. E-mail: ppatta08/at/gmail.com
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.
The non-financial interest
  • Academic: Desire for prestige, power, and faculty advancement, interest in obtaining positive results, pressure/desire to publish.
  • Political: Institutional COI.
  • Personal: Preference for family and friends; desire to alleviate human pain and suffering.
  • Compromise in appointment or promotion.
The financial interest
  • Its relative weight in professional decisions on meeting recruitment targets may pose problems.
  • Commercial: Industry influence, patents.
  • Financial: Financial gain.
COI of interest in clinical research extends to all stakeholders. PI, EC, and the institution
For the PI
Non-Financial
  • Academic: Desire for prestige, power, and faculty advancement, interest in obtaining positive results, pressure/desire to publish.
  • Personal: Preference for family and friends; desire to alleviate human pain and suffering.
  • Compromise in appointment or promotion.
Financial
Its relative weight in professional decisions on meeting recruitment targets may pose problems, due to which may compromise patient care.
  • Investigators may ignore AEs, which can harm health of patients in the trial.
  • These results (where AEs are under-reported) can be responsible for licensing - thereby endangering the health of public.
For EC Members
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.
For the institution
Favoring pharmaceutical company to receive favors.
Political: Institutional COI
Indian council of medical research guidelines
  • XII Principles of accountability and transparency. Full disclosure is made by those associated with the research or experiment of each aspect of their interest in the research, and any conflict of interest that may exist.
  • In all situations where there is likely to be conflict of interest, it must be ensured that the interest of the individuals involved in the study are protected at all cost.
  • Guidelines developed to handle situations where there is COI between an individual and that of family and society at large.
  • A member must voluntarily withdraw from the EC while making a decision on an application which evokes a conflict of interest, which should be indicated in writing to the chairperson prior to the review and should be recorded so in the minutes.
Indian good clinical practice guidelines
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.
ADDRESSING COI INTEREST IN MANIPAL HOSPITAL BANGALORE
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.
  • As per the HRPP plan, the institution will conduct, probe into possible conflicts of interest between scientific/professional responsibilities of researchers and business interests.
  • In cases where the Ethics Committee Manipal Hospital determines that a conflict of interest may damage the scientific integrity of a project or cause harm to research participants, the board should advise accordingly.
  • In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits, and potential risks of the study and the discomfort it may entail.
  • The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal.
  • After ensuring that the subject has understood the information, the physician should then obtain the subject's freely given informed consent, preferably in writing.
For the PI
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:
  • i) 
    Ownership interest, stock options, or other financial interest related to the research, unless the financial interest:
    • Does not exceed INR 1, 00,000 when aggregated for the immediate family.
    • Is publicly traded on a stock exchange.
    • No arrangement is entered into where the value of the ownership interests will be affected by the outcome of the research. [e.g., an arrangement has been made where the value of the interest will change depending on the outcome of the research.]
    • Does not exceed 5% interest in any one single entity when aggregated for the immediate family.
  • ii) 
    Compensation related to the research, unless compensation:
    • Does not exceed INR 1, 00,000 in the past year when aggregated for the immediate family.
    • No arrangement is entered into where the amount of compensation will be affected by the outcome of the research. [e.g., an arrangement has been made where the value of the interest will change depending on the outcome of the research.]
  • iii) 
    Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright, or licensing agreement.
  • iv) 
    Board or executive relationship related to the research, regardless of compensation.
  • v) 
    Any interest that could be affected by the outcome of the research.
    • The financial interest will adversely affect the protection of participants in terms of the criteria for IRB approval.
    • The financial interest will adversely affect the integrity of the research.
    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:
    • Partial or complete divestiture of financial or other interests (not just those related to a particular research study).
    • An independent researcher to obtain informed consent.
  • vi) 
    Frequent continuing review.
  • vii) 
    Disclosure of conflicts and their management to participants in research.
  • viii) 
    Disapproval of research if the convened IRB determines the conflict cannot be managed.
  • ix) 
    The convened IRB's determination will be communicated to the researcher [describe the process; e.g., through a letter].
  • x) 
    The likelihood that judgment will be influenced while trying to meet the recruitment targets, which appear to be influenced, by the secondary interest i.e. research payment; this is addressed by auditing the patient's background and conducting ad hoc interviews.
  • xi) 
    The participants are given a questionnaire to address whether there has been any conflict of interest. The seriousness of the harm or wrong that is likely to result from such influence or its appearance, statement of conflicts of interest affecting appropriate recruitment of patients, which includes,
    • Proprietary interest
    • Compensation other than PI fees
    • Significant payment
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:
MHB policy for COI for institution…
  • If Institution has financial interest in a compound and investigator from that hospital conduct clinical trial on it – may compromise trial (biased design/data-collection or recording, statistical analyzes, or reporting and interpretation of the data).
  • To improve the revenue generation in the area of diagnostics. To avoid this, the compliance committee.
  • Budget: PI fees and to research staffs are mentioned in the budget, and copy is sent to EC and financial department of the institution. If the compensation paid to PI is high as paid to the trial process, the institution will ask the PI to clarify the same. All financial transactions have to be routed through the institution. The institution will also look into the budget if it has concerns any in significant payment of sorts. Any consultation fee other than PI fees is not allowed. The institution makes sure that the resources given for the trial process is documented through the MHBRC and will be used for the trial purpose.
  • Fabrication of Data: The institution keeps a record of all the data and puts a policy in place where in the source documents of the participants have to be the CRF of the hospital. Each visit is captured in this hospital-based source document. This is done to avoid fabrication of data, which would otherwise affect the integrity of the data.
Ethics committee and COI
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,
  • The ethics committee members who are prospective PIs and whose protocol is for review will not participate in the review of the protocol and abstain from voting.
  • Consultants may not participate in the review of any protocol, in which they have a conflicting interest, except to provide information requested by the ethics committee.
  • A member should withdraw from the meeting during the decision procedure concerning an application where a conflict of interest arises, and this should be indicated to the chairperson prior to the review of the application and recorded in the minutes.
  • Conflict of interest should be declared by members of the EC.
  • At the opening of all EC meetings, the chairperson will remind EC members or consultants in attendance at the meeting to declare any conflicting interests with items on the agenda.
INTERNAL AUDITS AND MONITORING
  • Internal audits are conducted by the QA team who will identify the internal auditors to conduct the audits. To identify if participants recruited or screened meet the eligibility criteria in trials where the recruitment is heavy.
  • Budget of the trial will be reviewed pre-trial and periodically to assess the remuneration that the staffs receives.
  • The PI and the concerned research staff should also submit to the committee, for review, information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest, and incentives for subjects.
INTERNAL MONITORING
  • Internal reviews of patient care and research by an EC, ad hoc committee which will be selected by the QA team.
  • In institutional COI: Have to ensure independence of the committee by the HRPP board.
INTERNAL MONITORING BY ETHICS COMMITTEE
  • Independent of institution,
  • No direct financial interest in hospital (should declare),
  • Have members from outside the institution,
  • Has a mandate to review research protocols.
Footnotes
Source of Support: Nil
Conflict of Interest: None declared.
Articles from Perspectives in Clinical Research are provided here courtesy of
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