NURS FPX 5005 Assessment 1 Protecting Human Research Participants

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

Name

Capella university

NURS-FPX 5005 Introduction to Nursing Research, Ethics, and Technology

Prof. Name

Date

Protecting Human Research Participants

Human subject protection encompasses ethical and regulatory measures designed to safeguard the safety, rights, and welfare of individuals involved in research studies (White, 2020). The field has evolved significantly, influenced by historical events and the establishment of guidelines such as Institutional Review Boards (IRBs) and the informed consent process. These frameworks prioritize the dignity and well-being of research participants, particularly those from vulnerable populations. By aligning scientific inquiry with respect for human dignity, these protections ensure ethical and responsible research practices.

Historically, unethical research practices led to significant harm and exploitation, particularly of vulnerable populations like children and prisoners. The Nuremberg Code of 1947 was one of the first ethical frameworks, emphasizing voluntary participation and informed consent in response to Nazi medical experiments during World War II. Another critical case was the Tuskegee Syphilis Study, where African American men were denied treatment to study disease progression, sparking public outrage and the National Research Act of 1974 (Spellecy & Busse, 2021). These historical milestones highlight the necessity of ethical oversight in research. Modern frameworks such as the Belmont Report emphasize respect for persons, beneficence, and justice, setting ethical standards that continue to guide research today (White, 2020).

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

The evolution of research activities has brought new challenges and opportunities for protecting human subjects. Observational studies, such as cohort studies examining smoking behaviors, and interventional studies, like clinical trials for cancer treatments, require robust safeguards. Ethical considerations include ensuring informed consent, minimizing risks, and protecting participant confidentiality (National Institute of Dental and Craniofacial Research, 2022). Behavioral research, such as studies on mindfulness techniques, underscores the importance of participant welfare in all research types. These measures build trust, reduce dropouts, and enhance the validity of research outcomes.

Protecting vulnerable populations is a cornerstone of ethical research. IRBs ensure that studies involving groups such as children, prisoners, and economically disadvantaged individuals meet rigorous ethical standards. Special measures include obtaining consent from legal guardians for children and avoiding coercion for prisoners (Office for Human Research Protections, 2024). Researchers must balance ethical obligations with practical considerations, tailoring study designs to ensure fairness and minimize risks (Shaw et al., 2020). Ethical standards, such as those outlined in the Belmont Report, continue to evolve, fostering trust and integrity in research while ensuring the safety and dignity of all participants.

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

Heading Details References
History and Importance The evolution of ethical standards began with the Nuremberg Code, emphasizing informed consent after unethical Nazi experiments. The Tuskegee Syphilis Study highlighted the need for oversight, leading to the National Research Act and the Belmont Report’s ethical principles: respect, beneficence, and justice. White, 2020; Spellecy & Busse, 2021; Shaw et al., 2020
Research Activities Observational studies, such as cohort studies, and interventional studies, like clinical trials, require safeguards like informed consent, risk mitigation, and participant confidentiality. Behavioral research further emphasizes participant welfare, ensuring ethical and valid research practices. National Institute of Dental and Craniofacial Research, 2022; White, 2020
Protections for Vulnerable Populations IRBs oversee studies involving vulnerable groups, requiring measures like legal guardian consent for children and avoiding coercion for prisoners. Ethical guidelines, such as the Belmont Report, ensure fairness and safety while balancing ethical obligations with research feasibility. Office for Human Research Protections, 2024; Shaw et al., 2020

References

CITI Program. (n.d.). Homepage.

National Institute of Dental and Craniofacial Research. (2022, June). Human subjects research overview.

Office for Human Research Protections. (2024). The Belmont Report.

Shaw, R. M., Howe, J., Beazer, J., & Carr, T. (2020). Ethics and positionality in qualitative research with vulnerable and marginal groups. Qualitative Research, 20(3), 146879411984183. https://doi.org/10.1177/1468794119841839

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

Spellecy, R., & Busse, K. (2021). The history of human subjects research and rationale for institutional board review oversight. Nutrition in Clinical Practice, 36(3), 560–567. https://doi.org/10.1002/ncp.10623

White, M. G. (2020). Why human subjects research protection is important. The Ochsner Journal, 20(1), 16–33. https://doi.org/10.31486/toj.20.5012