Institution Review Board in Nursing Research

IRB in Nursing

An Institutional Review Board (IRB) is a constituted group designated to review and monitor biomedical research involving human subjects per federal regulations (Smith & Anderson, 2022). The main purpose of the IRB group is to protect the rights and welfare of human research participants by examining in advance the steps set aside to protect the rights of human participants in any research (White, 2020). The IRB decisions are regulated by various ethical principles, including respect for individuals, beneficence, and justice which should be adequately addressed in a researcher’s informed consent, compliance assurances, and IRB provisions (Smith & Anderson, 2022). Unlike typical nursing research that does not engage human participants, the review of an exempt or expedited protocol is more rapid and requires a full board review (White, 2020). The protocols that require a full board review often involve vulnerable groups such as children, pose a greater risk to subjects such as clinical trials, or collect sensitive information. The rationale of this essay is to explore the essence and importance of protecting human subjects and how patient subjects are involved in research.

Protection of Human Subjects

In nursing research, such as clinical trials, participants may be asked to engage in a study that does not have benefits or substantial risks (placebo), while others may be exposed to a study that may have significant benefit ad significant risks (intervention group) (Smith & Anderson, 2022). In this context, protecting human subjects means accessing the proposed protocols to ensure they meet the appropriate ethical standards and promote the utmost well-being of participants. Protection of human subjects also entails giving participants informed consent, which entails knowledge of the purpose of research, potential risks and benefits, and their role in the research. The researchers should also ensure patients are not subjected to any harm, either physical, emotional, or psychological, while participating in any clinical research (White, 2020).

Importance of Human Subject Protection in Research

Human subject protection is critical in research, for research subjects will not volunteer if they fear harm. According to White (2020), protecting human subjects in research guarantees adherence to ethical principles, including respect for persons, beneficence, and justice throughout the research process. Respect for persons requires that research subjects are treated as autonomous agents where their opinions and choices are considered. Persons with diminished autonomy, such as children and mentally ill participants, are entitled to additional protection. Respect for persons is important, for it ensures participants understand the risks and potential benefits of participating in research (Mick, 2019). According to the Belmont principle of respect for persons, participants’ decisions should not be influenced by coercion or excessive compensation, which guarantees that the research findings are authentic and reliable.

Besides respecting participants’ decisions, the beneficence ethical principle guarantees that participants are protected from any harm. Therefore, the researchers strive to maximize possible benefits and minimize possible harm to respondents. Justice, on the other hand, ensures that the procedures and outcomes are fair to research subjects. According to Mick (2019), maintaining justice ensures that participants’ inclusion and exclusion criteria are fair and equal. That is, respondents are not considered based on their availability, vulnerability, or compromised positions but for reasons directly related to the subject being studied. Therefore, protecting human subjects in research enhances the research findings’ relevance and maximizes the respondents’ benefit from the research.

Participation in Research

Admission for care in a healthcare environment does not imply that patients have subjected themselves to research studies in the institution. While patient subjects may fall under the target population suitable for the research, patients have a right to decide whether to participate in the research or not. Strini et al. (2021) argue that patients must receive informed consent to determine whether to participate in research or not. Informed consent entails a detailed discussion of the purpose, risks, and benefits of participating in research and the risks and benefits of the alternative interventions (Strini et al., 2021). Informed consent also ensures that participants are competent to make a voluntary decision on whether to undergo the procedures (Strini et al., 2021). The healthcare provider is obligated to clarify that patients are participating in the decision-making process and avoid making the patients feel forced to agree to participate in the research.

Conclusion

Patients have a right to know their state of health, diagnosis, treatments available, and the risks and benefits associated with choosing any treatment alternative. The accuracy of healthcare providers or researchers in informing the patients on the necessary elements dictates the ability of patients to make the most convenient and beneficial decision for their well-being. The role of the IRB is to guarantee that the rights and welfare of participants are protected and validate the value of the research to patients and healthcare practice. IRB also ensures ethical principles are followed based on the set federal and institutional guidelines.

References

Mick, J. (2019). Protecting the rights of patients, nurses, and others participating in research. Nursing2021, 49(7), 26–34. https://doi:/10.1097/01.NURSE.0000559916.31202.4e

Smith, E., & Anderson, E. E. (2022). Reimagining IRB review to incorporate a clear and convincing standard of evidence. Accountability in Research, 29(1), 55–62. https://doi.org/10.1080/08989621.2021.1880902

Strini, V., Schiavolin, R., & Prendin, A. (2021). The Role of the Nurse in Informed Consent to Treatments: An Observational-Descriptive Study in the Padua Hospital. Clinics and Practice, 11(3), 472-483. https://doi.org/10.3390/clinpract11030063

White, M. G. (2020). Why human subjects research protection is important. Ochsner journal, 20(1), 16-33. https://doi.org/10.31486%2Ftoj.20.5012