Know-How about PHS Regulations Regarding Financial Conflict of Interests

Financial conflict of interest means financial interest in the research conducted by PHS. Actions that have an inappropriate influence on the design, review, conduct, and research results. It entails those actions in which a researcher has a considerable financial interest. It has the potential to compromise the investigation process. PHS regulations were formulated in August 2012. PHS regulations identify financial conflict of interest in projects funded by PHS.

This article by The Academic Papers UK aims to clarify PHS regulations about the financial conflict of interests. It will also highlight the importance of these regulations.

Difference between Financial Interest and Financial Conflict of Interest

Financial interest refers to anything which has monetary value. It is regardless of its exact determined value. Financial conflict of interest means a researcher’s financial interest that could affect the research process. Let’s take an overview of PHS regulations on financial conflict of interests.

PHS Regulations Related To Financial Conflict Of Interest

Following PHS regulations pertain to financial conflict of interest.

• Disclosure of personal financial interest by researchers participating in research funded by PHS. Researchers participate in the formulation, conduct and reporting of research.
• It requires an annual submission of the Outside Disclosure Form (OIDF). Researchers submit it in electronic format before submitting research proposals for PHS-funded research.
• Proposals sent before the e-submission of OIDF will be unacceptable
• Researchers who take part in PHS funded research projects must disclose travel expenses funded by an outside entity
• If the sponsored travel expenses hit the ceiling of $5000 by an outside entity. Researchers have to submit an E-report  to explain the travel sponsored by that entity
• Conflict of interest training is mandatory before engaging in any PHS funded project
• Researchers will enrol in training again if they fail to disclose outside interests. Failures to follow PHS regulations also need enrolling for training again
• Disclosure of discovery of new outside interests and sponsored travel within 30 days.
• New researchers added by Principal Investigator have to submit OIDF form. They will also have to enrol in training.
• The training program for financial conflict of interest lasts for four years. Noncompliance with it may result in termination from PHS funded research projects

Recognition of Significant Financial Interests

PHS regulations need detailed scrutiny of financial conflict of interests. It encompasses those financial interests that can directly impact the research process. PHS regulations need full Disclosure of financial interests. They relate to the researcher’s institutional responsibilities. It includes compensation from non-profit entities and sponsored travel.

Other financial interests which may cause a financial conflict of interest as per PHS regulations

• Earnings from publicly or non-publicly traded entities
• Earnings from equities such as stocks and bonds
• Pension benefits or post-employment benefits
• Disclosure of income received from intellectual property rights such as patents and copyrights
• The gifts received from clients, vendors, and other healthcare-related entities

PHS excludes some of the following financial interests, and they do not amount to financial conflict of interests.

• Salary and wages earned from PHS funded research projects
• Travel expenses paid or reimbursed by PHS or associated agencies
• The compensation received from mutual funds and retirement accounts
• Income received from affiliation with higher education institutions. It could be income received for seminars, lectures or teaching engagements
• The compensation received from providing services to advisory committees or review panels. The compensation received from association with government agencies or institutions of higher education

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Management of Financial Conflict of Interest 

PHS regulations require management and monitoring of PHS funded projects. To ensure that the research conducted is objective and impartial constant monitoring is necessary. It has the following features.

• Financial interests of the research are required to be publically available
• Disclosure of the financial interests of a research investigator will be made after notifying and consulting the concerned researcher
• Research projects which involve human subjects financial conflict of interest will be disclosed to the participants involved in the research process
• Research projects will be monitored by those researchers who do not have any actual or apparent financial conflict of interest. They are better able to monitor and implement the measures to ensure the objectivity and impartiality of the research process
• Disqualification of personnel who fail to comply with PHS regulations about a financial conflict of interest

Conclusion

Public Health Service (PHS) introduced regulations of research projects in the light of increased public scrutiny. The purpose was to alleviate the grievances of the public regarding some projects at the research institutions which had a financial conflict of interest. The aim is to standardize such practices, ensuring objectivity and impartiality in the research process. These regulations ensure that the design, conduct or reporting of research funded by PHS or associated organizations will not be biased by any conflicting financial interest.