Introduction
It is important to note that research involving human subjects must adhere to the strictest rules to safeguard their safety and informed consent. The latter is achieved by following the core ethical principles of justice, non-maleficence, beneficence, and respect for all persons. My approach ensured that the rights of my subjects were protected at every step of the process, which included informed consent, safety, fairness, beneficence, and respect.
Role and Purpose of the Institutional Review Board (IRB)
Firstly, an Institutional Review Board (IRB) serves an integral role in the realm of scientific research. The IRB’s primary purpose is “to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research” (FDA, 2019, para. 3). The given protection is achieved through an initial review of the research proposal and subsequent periodic assessments. The IRB acts as a safeguard by assuring that ethical considerations are paramount when involving human participants in research.
Ensuring the Protection of Human Subjects’ Rights
Secondly, the protection of human subjects’ rights in research is of paramount importance. It ensures the safety and dignity of the individuals participating in the research. When participants feel safe, they are more likely to engage authentically and contribute valuable data to the study (U.S. Department of Health and Human Services, 2018)—proper protection safeguards the subjects’ physical and emotional well-being and the research’s integrity. As a result, ensuring that my participants in the research feel safe at every step of the process will be my top priority.
Confidentiality and Data Security Measures
Thirdly, in this research, all data collection will remain confidential. All demographic data, questionnaires, and consent forms on the paper form will be secured and locked in a file cabinet at the outpatient clinic. Once all the data collected on paper has been analyzed, it will be shredded. Any electronic data collected will be secured in a locked laptop with password protection, and only the principal investigator will have access to that password. A coding system with a 1-to 2-digit PIN will be assigned to each participant to protect their privacy.
Participants will be advised not to use any names or identifiers on the forms. Participants will be assigned a random number in the order they agree to participate. For example, the first PIN will begin with one and end with 25, depending on the number of participants. All data collected will be held for 3 years per IRB requirements and then destroyed.
Importance of Informed Consent in Research
Fourthly, informed consent is an essential aspect of respecting the autonomy of research subjects. I allowed subjects to make educated decisions regarding their participation in research. The given process entailed a detailed explanation of the study to the participants, which included informing them about potential risks and benefits (respect, beneficence, and fairness). They were provided with an explicit explanation that any participants involved would not experience any anticipated risks, discomforts, or stressors. In addition, the voluntary nature of participation was emphasized, which affirmed that subjects could withdraw from the study at any time.
Ethical Principles Guiding Human Subject Protection
Fifthly, I applied a trifecta of ethical principles, which included respect, beneficence, and fairness, because they guided the approach to protecting subjects’ rights. The principle of respect involves acknowledging the autonomy of subjects and offering special protection to those with diminished autonomy (U.S. Department of Health and Human Services, 2018). Beneficence is essentially an obligation to prevent harm and promote the participants’ well-being (U.S. Department of Health and Human Services, 2018). Fairness, as a principle of justice, ensures equal treatment and just distribution of research burdens and benefits, a critical component in ethical research (U.S. Department of Health and Human Services, 2018). In other words, the research is primarily based on and guided by the ethical principles of respect, beneficence, and fairness.
Conclusion
In conclusion, informed consent, safety, equity, beneficence, and dignity were the key pillars of my approach when working with my human subjects. It was critical to ensure they knew and felt safe about their involvement in the study. The entirety of the research is built based on respect for my human subjects as persons, justice for the participants, and beneficence for each individual.
References
FDA. (2019). Institutional Review Boards frequently asked questions. Web.
U.S. Department of Health and Human Services. (2018). Read the Belmont Report. Web.