CYIL vol. 14 (2023)

CYIL 14 (2023) CONFLICT OF INTEREST IN MEDICAL RESEARCH for serving as a speaker or on a speakers’ bureau, for serving on an advisory board, for enrolling patients in clinical trials. 25, 26 With regard to medical research, the financial relationships of researchers (clinical investigators) and the industry are specifically covered by the Code of Federal Regulations (further also to be referred to as the CFR), Title 21: Food and Drugs 27 and Title 42: Public Health 28 . The CFR provides some substantial definitions and regulates the disclosure and other management of financial conflict of interest, including, among others, what is known as conflict of commitment regarding an abroad affiliation. 29 Whilst Title 21 of the CFR provides the legal framework for clinical trials’ evaluation by the Food and Drug Administration (further referred to as FDA), Title 42 of the CFR, besides other public health issues, focuses on regulating the National Institutes of Health’s (further referred to as the NIH) 30 responsibilities regarding their funding of research projects. 31 Conflict of interest disclosure and management from the perspective of FDA Under the 21 CFR § 54.1(a), FDA evaluates clinical studies submitted in marketing applications, required by law, for new human drugs and biological products and marketing applications and reclassification petitions for medical devices. Under the 21 CFR § 54.1(b), FDA may consider clinical studies inadequate and the data inadequate if, among other things, appropriate steps have not been taken in the design, conduct, reporting, and analysis of the studies to minimize bias. One potential source of bias in clinical studies is a financial interest of the clinical investigator in the outcome of the study, because of the way payment is arranged (e.g., a royalty), or because the investigator has a proprietary interest in the product (e.g., a patent), or because the investigator has an equity interest in the sponsor of the covered study 32 . 25 CAMPBELL, E. G., GRUEN, R. L., MOUNTFORD, J., MILLER, L. G., CLEARY, P. D., BLUMENTHAL, D. a National Survey of Physician-Industry Relationships. The New England Journal of Medicine . 2007;356(17): 1742-1750. doi:10.1056/NEJMsa064508. 26 What is euphemistically called a constructive collaboration between physicians and industry is now regulated by the 2013 Physician Payments Sunshine Act, incorporated into the Affordable Care Act and other laws, e.g., Stark Law and Anti-Kick Back Statute. 27 To be further referred to as the 21 CFR § 54.1 or following. Available online https://www.ecfr.gov/current/ title-21/chapter-I/subchapter-A/part-54. Accessed August 15, 2023. 28 To be further referred to as the 42 CFR § 50.601 or following. Available online https://www.ecfr.gov/current/ title-42/chapter-I/subchapter-D/part-50/subpart-F. Accessed August 15, 2023 29 PRITT, S. L., NOTO, M. Typology of conflict of commitment (COC) in the era of inappropriate foreign influence in research. Accountability in Research . 2022;0(0):1-16. 30 The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency. Accessed August 15, 2023. https://www.nih.gov/about-nih/who-we-are. 31 Financial interest of FDA or NIH employees and their next of kin (i.e., public employees and their spouses and children) are in general regulated by the Criminal Conflict of Interest Stature, 18 U.S.C. § 208, and additionally by Standards of Ethical Conduct for Employees of the Executive Branch contained in the 5 CFR § 2635 and ff., and Supplemental Standards for Ethical Conduct of Employees of the Department of Health and Human Services contained in the 5 CFR § 5501 and ff. Additionally, employees might be subjected to what is known as a cooling-off period and other post-employment restrictions. In: https://www.fda.gov/media/134461/ download. Accessed August 15, 2023. 32 Covered clinical study is defined by the 21 CFR § 54(2)(e) any study of a drug or device in humans submitted in a marketing application or reclassification petition subject to this part that the applicant or FDA relies on to establish that the product is effective (including studies that show equivalence to an effective product), or any study in which a single investigator makes a significant contribution to the demonstration of safety.

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