Introduction
Everyone has the right to privacy and security, even when it comes to science. Protection of Human Research Participants plays an essential role in Human Research and regulates the field of human research. The objective of protecting participants is to minimize or avoid harm to the participant in the conduct of the study. In addition, protection implies the preservation of a person’s personal space. The reasons for Protecting Human Research Participants are the excessive striving of scientists to achieve their goals (White, 2020). It leads to ignoring the fundamental human rights mentioned above. The rules and laws developed to protect the participants during human research allow them to draw critical scientific conclusions without harming the participant.
Institutional Review Board and Purpose
Institutional Review Boards were created as a structure for the Protection of Human.
Research Participants. IRB is an organization in the United States of America. According to White (2020), “institutional review boards (IRBs) have the federally mandated responsibility to review human subjects to ensure that a proposed protocol meets the appropriate ethical subjects before they may be enrolled in the study” (p. 16). The IRB also regulates the ethics of human research. The establishment of a regulatory board like the IPB is necessary and timely, as it allows only research that complies with all ethics and human rights.
Ethical Principles
As was mentioned above, IRB is a committee that evaluates future research from an ethical standpoint. To better understand the functioning of IRB, it is helpful to highlight three ethical principles of IRB that are fundamental to human subject protection. They are Respect for persons, Beneficence, and Justice (White, 2020). As mentioned at the beginning, respect for persons is an essential part of regulation and implies respect for all individual rights. Beneficence involves minimizing the risks to human health during research (Wolinetz & Collins, 2017). At the same time, Justice ensures compliance with legal actions in conducting the study and its compliance with the stated purpose.
Research and Quality Improvement
IRB regulates research process that has some consequences. On the one hand, human rights and all ethical standards of research are preserved. On the other hand, it also has some impact on scientific activities and results. However, in addition to research, there is still quality improvement (QI). According to Bass and Maloy (2020), “at a basic level, research is about the discovery of new information, while quality improvement is the application of known knowledge.” (p. 57). It is important to note that because of this, quality improvement puts people at minimal risk when conducting research. However, the risk of conducting such a scientific activity remains and this fact is confirmed by IRB (Bass and Maloy, 2020). This gives potential research participants food for thought, take part in quality improvement or not.
Types of IRBs
In order to achieve quality assessment of ethical aspects and research safety, the IRB uses different reviews in its work. According to Arynchyna et al. (2019), “there are four types of IRB reviews that exist to guide investigators to conduct proper research” (p. 201). They are Not Human Subjects Research, Exempt Review, Expedited Review, and Full Board Review. They use different tools to evaluate the research. Based on these, the IRB concluded whether the study was legitimate and whether it would violate the personal space of the participants.
The Belmont Report
One of the most important documents concerning the ethical component of Protecting.
Human Research Participants is the Belmont Report. According to White (2020), “this document, widely regarded as the landmark analysis of ethics in human subjects research, serves as the foundation for discussion of ethical concerns in research ethics involving human subjects…” (p. 20). It defines the three primary principles, such as respect for persons, beneficence, and justice, which also form the basis of IRB (Miracle & Vickie, 2016). According to the Belmont Report, respect for persons is defined as “the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy” (p.21). The beneficence, emphasizes the importance of minimizing harm to humans. As an example of the value of beneficence, the words from the Bible can be quoted: “And be ye kind one to another, tenderhearted, forgiving one another. …” (King James Version, 1611, Eph. 4:31–32). The meaning of these words reveals the essence of the concept of beneficence in the Belmont report. Bible related to Protecting Human Research as guidelines for respecting and valuing every person’s life. Justice, as noted earlier, emphasizes the importance of conducting research safely in order to achieve the desired result.
Conclusion
In conclusion, it will be useful to re-emphasize the importance of Protecting Human.
Research Participants. All the above-mentioned organizations and materials, such as the IRB and Belmont report, are required to reduce risks in Human Research. It applies not only to threats in violation of the privacy and dignity of the person. The regulation of these studies also ensures the safety and health of participants. The importance of Protecting Human Research Participants cannot be overestimated. Basic principles of human protection, according to IRB and The Belmont Report, are similar to the teachings of the Bible, as was shown by the example of beneficence. Literacy and ethical standards during Human Research provide the opportunity to obtain the necessary scientific findings and save participants’ lives. Following these rules will also help avoid mistakes of the past, such as Nazi medical war crimes.
References
Arynchyna, Putney, S. B., & Peter Iafrate, R. (2019). Institutional review boards: General regulations, institutional obligations, and personal responsibility. A Guide to the Scientific Career, 193–210. Web.
Bass, P.F. & Maloy J. W. (2020). How to determine if a project is human subjects research, a quality improvement project, or both. Ochsner Journal March, 20(1), 56-61. Web.
King James Version. (1611). Cambridge Univ. Press & BFBS. Web.
Miracle, A., & Vickie, A. (2016). Dimensions of Critical Care Nursing, 35(4), 223-228. Web.
White, G. M. (2020). Why human subjects research protection is important. Ochsner Journal March, 20(1), 16-33. Web.
Wolinetz, C. D. & Collins, F. S. (2017). Single-Minded Research Review: The Common Rule and Single IRB Policy. American Journal of Bioethics, 17(7), 34-36. Web.