Original Work Less Than 20% Plagiarism APA Format

Original Work Less Than 20 Plagiarism APA Formatfor This Project Y

Research the Institutional Review Board (IRB) and detail the important factors for the ethical protection of research participants. Identify and discuss what an IRB is, the historical development of IRBs, and the three types of IRB review, including criteria for each level and examples. Explain the ethical and legal issues in research, such as informed consent, confidentiality, and voluntary participation. Include details on protections for vulnerable populations. Using a library database, locate one historical example of unethical research from the past 100 years and analyze the ethical issues involved. Discuss the consequences of not adhering to ethical standards and the role of IRB review. Incorporate relevant ethical standards from the Code of Ethics for the National Organization for Human Services. Also, relate Saint Leo’s core values of Integrity and Community to the ethical protection of research participants. The paper should be typed, double-spaced, and formatted in APA style, including in-text citations and a reference page, utilizing the textbook and at least two outside sources.

Paper For Above instruction

The Institutional Review Board (IRB) plays a crucial role in ensuring the ethical protection of human subjects involved in research. As a designated entity within research institutions, IRBs are responsible for reviewing research proposals to ensure they adhere to ethical standards that respect the dignity, rights, and welfare of participants. The origin and development of IRBs trace back to unethical research practices in the early 20th century, leading to the establishment of formal review processes (Appelbaum, 2012). The primary purpose of IRBs is to evaluate research protocols to minimize risks and ensure ethical standards are met, thereby safeguarding participants from harm.

IRBs operate under three distinct levels of review: exempt, expedited, and full board review. Exempt review applies to research involving minimal risk and fitting specific Federal criteria, such as anonymous surveys or educational tests, which do not require continuing review (Department of Health and Human Services [HHS], 2018). For example, research involving the analysis of existing publicly available data may qualify for exempt review. Expedited review is suitable for research involving no more than minimal risk but does not qualify for exemption, such as collection of hair or tissue samples from volunteers. An example here would be a study collecting blood samples for research with adult volunteers, requiring review by a single IRB member (45 CFR 46.110). Full board review is necessary for studies posing more than minimal risk or involving vulnerable populations, such as prisoners or children, requiring a convened IRB quorum to evaluate the ethical considerations thoroughly. An example is a clinical trial testing a new drug on pediatric patients.

Ethical and legal issues in research are integral to protecting participants. Informed consent stands as a fundamental principle, emphasizing transparency and ensuring participants voluntarily agree after understanding risks, benefits, and procedures (Beauchamp & Childress, 2019). Confidentiality protects personal information, requiring researchers to secure data and limit access. Voluntary participation underscores that consent must be given freely without coercion, emphasizing respect for autonomy. Special populations, such as children, prisoners, or individuals with cognitive impairments, require additional protections due to their vulnerability. The IRB evaluates specific safeguards, including consent procedures tailored to these populations, to prevent exploitation or undue harm (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979).

Historical unethical research exemplifies the importance of strict ethical standards. The Tuskegee Syphilis Study (1932-1972) remains one of the most infamous violations, where treatment was intentionally withheld from African American men with syphilis without their informed consent, leading to avoidable suffering and death (Jones, 1993). This study violated principles of respect for persons, beneficence, and justice outlined by the Belmont Report (1979). Its unethical nature prompted significant reforms in research ethics, emphasizing the necessity of IRBs to prevent such abuses.

Failure to adhere to ethical standards can have devastating consequences, including harm to participants, loss of public trust, and legal repercussions. The IRB acts as a safeguard, providing oversight that ensures research aligns with ethical principles and legal requirements. Regular review and monitoring process help protect vulnerable populations and maintain research integrity (Resnik, 2018).

Ethical standards from the Code of Ethics for the National Organization for Human Services emphasize the importance of respecting human dignity, ensuring confidentiality, and promoting social responsibility (National Organization for Human Services, 2015). These ethical principles resonate with core values of Saint Leo University, particularly Integrity and Community. Acting with integrity involves honesty and adherence to ethical guidelines, ensuring participants are protected and research is conducted responsibly. The value of community emphasizes collective responsibility, promoting ethical practices that serve the broader society’s well-being (Saint Leo University, 2023).

In conclusion, the IRB plays an essential role in maintaining ethical standards in research by overseeing protocols and safeguarding participants, particularly vulnerable populations. Learning from past unethical practices, such as the Tuskegee Syphilis Study, underscores the importance of strict adherence to ethical principles like informed consent, confidentiality, and voluntary participation. Incorporating institutional ethical standards and university core values further enhances the commitment to integrity and community. By continuously upholding these standards, researchers can contribute to ethically sound and socially responsible science, fostering trust and respect within society.

References

• Appelbaum, P. S. (2012). The history of research ethics. The Hastings Center Report, 42(1), 21-28.
• Beauchamp, T. L., & Childress, J. F. (2019). Principles of biomedical ethics (8th ed.). Oxford University Press.
• Department of Health and Human Services. (2018). 45 CFR 46.110. Federal Policy for the Protection of Human Subjects ('The Common Rule').
• Jones, J. H. (1993). Bad blood: The Tuskegee Syphilis Study, 1932-1972. Free Press.
• National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report. U.S. Department of Health, Education, and Welfare.
• National Organization for Human Services. (2015). Code of Ethics.
• Resnik, D. B. (2018). The ethics of research with vulnerable populations. Accountability in Research, 25(4), 186-193.
• Saint Leo University. (2023). Core Values. https://www.saintleo.edu/about/mission-and-values