Protection and Confidentiality of Data, Coursework Example

Introduction

Conducting a research study is a complex process that requires a number of steps to support desirable outcomes. This process influences the manner in which individual researchers perform their duties and treat all study subjects with the utmost respect and consideration at all times. It is important for researchers to have the appropriate background knowledge and understanding of research involving human subjects so that their needs and interests are protected from unnecessary risks at all times. From this perspective, it is important to identify the challenges and considerations that are likely to impact human subjects if all tasks are not performed in the required manner. As a result, the Collaborative Institutional Training Initiative (CITI) has been adopted universally by many institutions in order to ensure that all activities related to research are conducted properly and that researchers have the proper training and insight regarding the protection of human subjects (CITI Program, 2013). The CITI program offers training in a number of areas related to research, including conflict of interest and animal welfare; however, human subjects is a critical area of interest that impacts a large segment of the research population that should be examined further (CITI Program, 2013).

Analysis

One of the critical factors associated with the CITI program is its emphasis on ethical frameworks and principles that govern all areas of research (University of Wisconsin Milwaukee, 2014). All persons involved in a research project are required to take this training as part of their knowledge base and to support their understanding of human subjects research and the ethical principles that govern this type of research (University of Wisconsin Milwaukee, 2014). This program is instrumental in providing the knowledge background and framework that is necessary to ensure that human subjects are protected throughout all phases of a research project (University of Wisconsin Milwaukee, 2014). It is necessary for researchers to have this background because it conveys the critical nature of ethical responsibility in research and the capacity to understand the need for Institutional Review Boards (IRBs) that govern and approve research protocols that involve human subjects (Princeton, 2014). IRBs provide expert knowledge, oversight, and detailed review of all areas of a given research project so that human subjects protection is maximized and supported by this governing body at all phases (Princeton, 2014). As part of the research protocol, therefore, it is necessary for all research staff members, from the Principal Investigator to technicians, to complete the CITI training to expand their knowledge and understanding of human subjects research (Princeton, 2014).

It is also necessary for all research staff members to complete the required CITI training because it provides a much-needed background regarding the history of human subjects research and some of the challenges that emerged in past research studies that have posed significant risks to participants (Albert Einstein College of Medicine, 2014). Some of these studies are somewhat disturbing because the researchers in question did not take into account the potential lasting damage and fatal consequences that their subjects might endure; therefore, these studies posed significant risks to patients that were not closely considered until IRBs and other frameworks were established. It was important for governing bodies to take a closer look at human subjects research in order to address the potential risks associated with these studies and to ensure that prospective participants were also aware of these risks.

The history of human subjects research is somewhat surprising to the novice because several prominent studies have been captured in the CITI training that demonstrate the lack of support for the protection of human subjects from a historical point of view. In past decades, human subjects faced unnecessary risks on a continuous basis in some studies because there was a lack of governance over these protocols and a clear understanding of these risks and how they impacted participants. Upon review of the different modules offered in the CITI training component, there was a significant lack of understanding of the risks posed to some subjects, thereby leading to the development of comprehensive IRBs and new levels of training and protection to ensure that human subjects were not placed at unnecessary risk. Methods such as informed consent evolved from these past errors in judgment and demonstrated the importance of new approaches to ensure that human subjects were protected at all costs. These elements remain a critical component of all modern research studies involving human subjects in order to protect these subjects from any type of unnecessary risk or harm that could lead to permanent consequences.

Conclusion

The implementation of mandatory CITI training on a universal basis for all research personnel working with human subjects has provided a positive and lasting framework for the research community to perform their due diligence and protect all human subject participants from unnecessary risk or harm. This training is critical in the development and sustainability of any research protocol and supports the acknowledgement of risks associated with human subjects research. At the same time, it is important for researchers to recognize these risks and to take the steps that are necessary to support positive outcomes for all subjects at all times. The CITI training initiative provides a positive framework for enabling all research study staff members to understand the need for human subjects protections and the risks that are involved in all phases of a research project. Protecting human subject participants at all times is critical to the success of research protocols throughout the world.

References

Albert Einstein College of Medicine (2014). Human Subjects Research Education (CITI). Retrieved from http://www.einstein.yu.edu/administration/institutional-review-board/education/human-subjects.aspx

Collaborative Institutional Training Initiative (2013). Human subjects research (HSR) series. Retrieved from https://www.citiprogram.org/citidocuments/forms/Human%20Subjects%20Research%20%28HSR%29%20Catalog.pdf

Princeton University (2014). Human research education program. Retrieved from http://www.princeton.edu/ria/human-research-protection/training/

University of Wisconsin Milwaukee (2014). Human subjects research training. Retrieved from http://www4.uwm.edu/usa/irb/researchers/training.cfm