Financial Disclosure Requirement by Federal Regulatory Authorities

Ethics and Financial Disclosure

One of the most important or core goals of trial registries is transparency within the clinical research process. Transparency is an important goal because of the significance of the objectivity of research, given its role in gaining and maintaining public trust. As a result, several measures have been undertaken by federal regulatory authorities to ensure the objectivity of research, especially in relation to transparency in clinical research process. These measures are also geared towards dealing with increasing complexities of financial interests by various researchers. Actually, objectivity and transparency of research is crucial because of the subsequent interactions among research institutions, the government, and the private sector after a clinical research is carried out.

In light of measures undertaken to promote objectivity and transparency within the clinical research process, federal regulatory agencies have established some rules and regulations that relate to financial interests. One of these regulations is the requirement by federal regulatory authorities that the principal investigator disclose any financial interest in a sponsor company that he/she is carrying out clinical trials for. It is appropriate for federal regulatory authorities to establish the requirement because of the likelihood of any conflicting financial interests on the principal investigator's part. In case the principal investigator has conflicting financial interests in a sponsor company that he/she is conducting clinical trials for, he/she is likely to be compromised, which enhances the possibility of generating incorrect results.

Disclosure of these financial interests helps in lessening the potential for bias that could emerge from such financial interests and/or arrangements ("Guidance for Clinical Investigators," 2013). This in turn helps in enhancing the credibility, objectivity, and transparency within the clinical research process. Through disclosure of such financial interests and arrangements, the principal investigator works with due diligence, which helps in building public trust and the credibility of the research process. Therefore, this requirement by federal regulatory authorities is appropriate with regards to enhancing the objectivity, transparency, and credibility of the clinical trial in a manner that obtains and maintains public trust.

Given the suitability of the requirement of disclosure of financial interests and/or arrangements on the part of the principal investigator in a clinical trial, there are situations where financial disclosure could create a problematic ethical dilemma. When conducting their work, principal investigators in a clinical trial subscribe to three fundamental elements i.e. patient safety, scientific integrity, and investigator objectivity. While scientific integrity and patient safety are important aspects of financial disclosure, the requirement for disclosure of financial interests largely focus on ensuring investigator objectivity. However, principal investigators are increasingly likely to experience conflicts of interest because of the need to maintain balance across these three delicate elements. This is exacerbated by the increased concerns regarding bias and decreased objectivity in the clinical research setting.