Loading...

Designing a Research Compliance Program

Term Paper 2017 10 Pages

Medicine - Public Health

Excerpt

Content

HOW THE RESEARCH COMPLIANCE DEPARTMENT WILL FIT INTO THE ORGANIZATIONAL STRUCTURE

THE PRIMARY ETHICAL CONCERNS AFFECTING THE PROCESS

HOW THE COMPLIANCE DEPARTMENT WOULD MAINTAIN OVERSIGHT OF RESEARCH OPERATIONS

TOOLS AND APPROACHES USABLE IN THE ORGANIZATION AND THEIR EFFECTIVENESS

HOW TO INDUCT THE PERSONNEL INVOLVED INTO THE NOTION OF ADDITIONAL LAYERS OF OVERSIGHT

CONCLUSION

Works Cited

After the management of a healthcare organization tasks the VC of healthcare systems with forming a research compliance department, there are many consideration the executive must make in order to be effective in that capacity. As part of the large organization involved in among other activities healthcare, various ethical issues arise that necessitate the creation of such a department. However, the process is not easy as many considerations have to be made. This paper follows the process of the creation of a Research Compliance Program through an investigation of the process or designing and implementing a Research Compliance Department. The process intends to use a distinct set of considerations that not only form the basic processes of forming the department, but also understanding the operations of the Program. These considerations include who the compliance department answers to, the primary ethical issues involved, how the department intends to maintain oversight, the tools and approaches applicable as well as their applicability, and to assimilate all personnel involved into the notion of additional oversight.

HOW THE RESEARCH COMPLIANCE DEPARTMENT WILL FIT INTO THE ORGANIZATIONAL STRUCTURE

Many business organizations dealing with healthcare face additional ethical issues because of the sensitivity in the matter (Wallace 15). Such importance is part of the reason why the formation of a Compliance Department is crucial especially when research is being undertaken. However, for any compliance and oversight practice to be effective in its mandate and operations, it must be fitted into the main entity’s organizational structure. The process and results of such a consideration are as important as the compliance department’s mandate.

Most large considerations assume the common organizational structure that includes a Chief Operations Officer (COO). This executive is responsible for the coordination of all the firm’s operational departments and their coordinative efforts in achieving the organization’s objective. Consequently, the formation of a Research Compliance Department for the organization this paper targets would obviously involve the identification and recruitment of a Chief Compliance Officer (CCO). This executive would be in charge of the entire Research Compliance Department and its operations in a manner that the Chief Executive Officer (CEO) is to the entire organizations. However, with regard to whom the Compliance Department answers to in the main organization or organizational structure, the CCO would be answerable to the COO, who is in turn answerable to the CEO.

Some business organizations are not as large meaning that they do not include a Chief Operations Officer (COO). Such business organizations have executives that manage entire departments as Managing Directors and sit at Boards of Directors. Some examples of these executives include the Chief Finance Officer (CFO), Chief Technical Officer (CTO), and the Chief Marketing Officer (CMO). All these executives are directly answerable to the CEO. Applying this rationale to the main organization the intended Research Compliance Department intends to serve, one discovers that the Chief Compliance Officer who will head this new department must be directly answerable to the CEO.

Other business organizations might decide to create entirely new department to serve new interests brought about by expansion, mergers or even research. In such circumstances, the team tasked with identifying and recruiting the heads of these departments must also create unique spaces according to the roles the new departments will serve in the main organization. Therefore, a newly created Research Compliance Department would be stationed in the main organization’s head quarters where the department would operate from a C-suite. Applying this rationale to the main organization the paper focuses on, one find that the Research Compliance Department would be stationed at the firm’s headquarters in the wing aptly named the C-suite. This department’s head would be a Chief Compliance Officer (CCO), whose mandate as head of a completely independent department would be to manage the oversight and compliance issues related to the main organization’s research activities.

THE PRIMARY ETHICAL CONCERNS AFFECTING THE PROCESS

During the formation of the Research Compliance Department intended to provide additional oversight to the organization intent on healthcare research, the executives must carefully consider certain ethical concerns pertinent to the process. The first ethical concern that the Chief Compliance Officer and his team must consider is the entry of bad management into the research ranks (Wallace 53). Research activity, especially those targeting the healthcare industry, is a critical process that demands personnel with the highest integrity. Therefore, the CCO must make appropriate action to prevent the entry of researchers that have demonstrated unethical behavior in the past. Some characteristics the CCO might need to check out for among the team involved in the research endeavor include dishonesty, recklessness, and disrespect.

The second ethical concern that the Research Compliance Department’s head might need to consider revolves around training and education (Tsan and Tsan 224). Most large companies that declare an intention to carry out research attract a large pool of professionals drawn by the opportunities for growth, innovation, and attractive remunerations. Many cases have come up in the past where some of these prospective employees have cheated the Human Resources and Compliance Departments about their training and education in order to gain entry into these attractive opportunities.

Another ethical concern that the CCO must check during his tenure as head of the organization’s Research Compliance Department is unfair performance incentives and rewards. Some organizations attempt to inspire their research personnel using unfair or even untenable performance incentives and rewards that may include bribes and promises. Such practices constitute unethical behavior given the sensitivity of the industry the research endeavor targets. Research activity and process in the healthcare sectors must be allowed its fair share of time in order to ensure that no corners are cut or mistakes missed (Wallace 15). Therefore, the CCO must watch out for unethical issues related to unfair performance incentives and rewards to prevent compromising both the process and results of the research process.

All research endeavors that aim to introduce new innovations or make significant improvement in the healthcare industry rely on a solid financial backing. However, the creation of a large pool of resources for processes of innovation introduces ethical issues related to financial integrity because researchers can get away with unforeseen costs. Therefore, the head of the Research Compliance Department must liaise with the Financial Department to ensure that auditing and financial oversight is done well. Many research processes or initiatives in the past have suffered large financial losses and compromised ethical standing due to reckless auditing. Therefore, as head of research compliance, the CCO must be keen to ensure no ethical issued related to finances arise.

No compliance and oversight practice is complete until it creates, communicates and implements solid disciplinary measures for all wrong doers as part of its ethical sustainability strategy. The organization that is keen to engage in research and tasks a Research Compliance Department with the job must also include some strategy to ensure that all disciplinary issues are tackled accordingly. Mishandling such issues introduces serious ethical concerns in the process where large pools or resources and strict objectives are involved. Therefore, the CCO must identify, communicate, and implement a strict disciplinary regime to prevent such ethical concerns from becoming reality.

[...]

Details

Pages
10
Year
2017
ISBN (eBook)
9783668455252
ISBN (Book)
9783668455269
File size
472 KB
Language
English
Catalog Number
v366636
Grade
2
Tags
Research Compliance Compliance Departemtnt

Author

Share

Previous

Title: Designing a Research Compliance Program