Maintaining a stringent regulatory oversight of financial interests and disclosures is pivotal in clinical research ethical standards. The public well-being is always at stake when a new product is in the market. Ultimately, the primary objective of a regulatory agency’s purview on financial disclosure requirements’ is to protect the best interest of human subjects while negotiating the best possible common grounds that meets a safe introduction of new medicinal product in the marketplace. Under the International Conference on Harmonization (ICH) guidelines, all the regulatory agencies worldwide, requires provisional financial disclosures to the sponsor company from the principal investigators (PIs), research institutions, etc. involved in conducting the clinical trials (ICH, 1997).
Financial disclosure is a necessary tool in clinical trials when the efforts in innovation focus on obtaining statistical and clinical significance of a medicinal product. Also, financial disclosure processes and evaluations are multi-faceted with ethical concerns. Thus, financial disclosure or invested financial interest evaluation processes are essential to understanding the level of the impacts and implications on the willingness to participate, enrollment process, recruitment decision-making process, trust, patient-physician relationships, and quality of the research (Weinfurt et al., 2008). In addition, human participants’ level of education, informed consent’s clarity, and the interpretative structure of the financial disclosure information could affect the outcome of a clinical trial or the enrollment process.
For instance, individuals with terminal health conditions would not care much whether a PI had equity or is the inventor/co-inventor of the medicinal product under investigation because the patients’ primary goal is an outcome reach. Hence, the expected potential benefits or claims from the medicinal product are the most invaluable decision-making factors for participation. Perhaps, the multi-complexity in the clinical trial’s participation decision-making process for persons with terminal health conditions may be coerced or biased even when there are serious financial conflicts or undue influences. For this reason, regulatory agencies and the institutional review boards (IRBs) or the Ethic Committees (ECs) require financial or vested interest disclosures from PIs prior to the onset of the clinical trials.
Conflict of interest or undue influence is a “risk” factor in itself against innovation and product development, which should be eschewed by all means in clinical trials. The lack of stringent conflict of interest regulations both on individual and organizational levels would facilitate the drive for biased clinical trials. In such cases, the “art of science” would become the “art of disaster” capable of yielding irreproducible data at the expense of serious health risks on public health well-being. For instance, the fraudulent violation that cost Pfizer a federal penalty of $2.3 billion with a “felony” citation was the fourth settlement with Pfizer, or its subsidiaries since 2002 over series of illegal marketing (Arnst, 2009). The fines on Pfizer for other illegal activities prior to the $2.3 billion settlement summed up to about $513 million (Arnst, 2009). Such practices of coercion of medical practitioners betray the trust and patient-physician relationships bestowed upon physicians. Even with a “felony” citation for known ethical violations against Pfizer, the conduct is an action that reminds the scientific community the level of the implications of conflict of interests.
Arnst, C. (2009, September 3). Feds hit Pfizer with a $2.3 billion fine. BusinessWeek Online. Retrieved from http://www.businessweek.com/bwdaily/dnflash/content/sep2009/db 2009092_913433.htm
International Conference on Harmonization. (ICH) (1997). ICH Guidelines. Retrieved from http://www.ich.org/products/guidelines/
Weinfurt, K. P., Hall, M. A., Dinan, M. A., DePuy, V., Friedman, J. Y., Allsbrook, J. S., et al. (2008). Effects of disclosing financial interests on attitudes toward clinical research. JGIM: Journal of General Internal Medicine, 23(6), 860–866. Retrieved from http://ezp. waldenulibrary.org/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=a9h&AN=32486389&site=ehost-live&scope=site