How to Regulate Company Gifts to Clinical Investigators

The relationship between clinical investigators and pharmaceutical and medical device companies can be symbiotic.

Clinical investigators work for universities or large medical centers, although there are independent researchers. The sponsoring pharmaceutical or medical device company contracts with the clinical investigator to test the company's drug or device to confirm that it is safe and that it works. A conflict of interest is created when researchers or staff accept gifts, services or favors from the sponsoring company. These might suggest the the researcher is biased in favor of the company. Conflicts of interest are problematic because serious and substantiated allegations of lack of impartiality and objectivity can end the clinical investigator's career.

Instructions

1. 

   Accepting frequent catered lunches from the sponsoring company could give the appearance of a conflict of interest.

   Develop a comprehensive policy manual that includes a financial interest disclosure statement, a clearly stated policy regarding conflicts of interest arising from acceptance of gifts from the sponsoring company, and the likely consequences of policy violations. Transparency, impartiality and objectivity are as important as reliability and validity in research.

2. Submit to review by an institutional review board a study's protocols and policies. Research projects involving human or animal subjects utilize an institutional review board, which is a committee of other clinical investigators, specialists in research, mathematics and science; and community members.The IRB will assist the researcher in the development of comprehensive policies regarding gifts from sponsoring companies to avoid conflicts of interest, as well as performing oversight for the safety of research participants and research staff.

3. 

   Keep all signed statements of financial disclosure and conflict of interest policies with the research protocol paperwork.

   Direct current and newly hired research and support staff to complete a financial disclosure statement and sign a statement that they have read and understand the policy on accepting gifts from companies sponsoring the investigative study.

4. 

   Generate a "paper trail" to document due diligence in avoiding all conflicts of interest.

   Review and update the policy manual periodically and as new issues arise. Submit modifications and additions of the policy manual to the institutional review board for approval and those approvals of policies with the research protocols documents.

5. 

References

• MedicationSense: The Medical Professions's Culture of Corruption, Part 1
• GPO Access: Codes of Conduct

Resources

• FDA 101: Clinical Trials and Institutional Review Boards
• FDA: Model COI Policy: Third Party Inspection Program