NURS FPX 5005 Assessment 1 Protecting Human Research Participants

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Capella university

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

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Protecting Human Research Participants

Human subjects in research must be protected so that the scientific community can comply with the law and ethics. This essay examines the moral obligations, legal concerns, and historical evolution of research involving human subjects. This report outlines important human participant protection principles, research types that require participation, risk-reduction techniques, and particular safeguards for vulnerable populations, all based on CITI Social-Behavioral-Educational (SBE) training and academic sources. 

History and Significance of Protecting Human Subjects

One of the biggest advancements in the last century has been protecting research subjects. The unethical experiments conducted during World War II, particularly by Nazi physicians, which led to the creation of the Nuremberg Code (1947), are among the most significant events in this history. The document greatly focused on voluntary consent and the right to withdraw from studies. This was the birth of formalized ethical standards in human research (Barrow et al., 2022). 

Another historic instance of African American males with syphilis being misled and refused treatment without informed consent occurred during the Tuskegee Syphilis Study (1932–1972), even after penicillin became the accepted therapy. This egregious violation of human rights stirred public outrage, resulting in the National Research Act (1974) and the Belmont Report (1979). The CITI SBE training reinforces three core ethical principles of current research ethics: beneficence, fairness, and respect for individuals (Nagai et al., 2022), which were established in the Belmont Report.

The next influential case was the study of hepatitis at Willowbrook (1956–1970), in which institutionalized children were purposefully exposed to hepatitis to track the development of the illness (Barrow et al., 2022). Despite obtaining parental consent, the population was vulnerable, and the tension regarding coercion was quite high. Today, Institutional Review Boards (IRBs), stricter informed consent protocols, and continuing ethical training continue to protect. These concerns are just some of the reasons for increased vigilance and the evolution of approaches to protecting human subjects from the use of data for purposes like genetic research, data privacy, or use in behavioral studies by AI.

Types of Human Subjects Research Activities

Research involving human subjects includes activities in which people are actively or indirectly involved.  According to the CITI program, any systematic study involving real people in which the researcher gathers data by interaction, intervention, or identifiable private information is considered human subjects research (CITI Program, 2023). The first and the main type of research is intervention research, for example, clinical trials, behavioral interventions, or educational programmes in which researchers actively manipulate some part or other of the environment or introduce some variable. For instance, a study evaluating a new mental health therapy for adolescents involves human participants being treated with that therapy and then evaluated for outcomes.

Observational research is another category in which subjects are observed without active intervention (Kim, 2023). For example, researchers’ observations of nurses’ routines and responses to survey questions, for instance, would record how nurses cope with stress on 12-hour shifts. Survey and interview-based studies also require human subjects when collecting sensitive or identifiable data. One would be to interview transgender individuals structurally about their experiences in accessing healthcare. Finally, ethnographic or field research, such as studying cultural practices within a community, depends heavily on interaction with participants and thus requires human subjects protections (Balkin et al., 2023). The range of human subject research (HSR) activities demonstrated the need for ethical oversight and informed consent. 

Strategies to Minimize Potential Risks 

The ethical responsibility of HSR includes minimizing possible dangers that participants might face during their involvement in research. 

1. Before accepting participation, researchers must educate subjects about the study goals, procedures, possible dangers, and potential advantages. The participants chose to participate in the study because the CITI Program (2020) provided them with complete information about its purpose and procedures. 
2. Security protocols for data protection, along with confidentiality measures, function as an additional strategy. Researchers must ensure the security of personal identification data and maximum anonymous data storage to prevent privacy breaches (Kang & Hwang, 2023). Researchers can decrease the vulnerability of sensitive personal information through either de-identified data or coding of identifiers. 
3. The intervention should have the least possible level of intrusiveness. The researcher should select noninvasive observational methods, which include surveys, focus groups, and interviews (Kim, 2023). When researchers analyze pre-anonymized datasets, they reduce participant involvement and related risks. Combining such methods results in minimal disruption for research participants, enables ethical compliance, and maintains research credibility. 

Protections for Vulnerable Populations

The federal government has determined specific vulnerable populations including pregnant women as well as inmates and youngsters and people with impaired capacity which requires enhanced protective measures due to their increased risk of coercion and exploitation. Additional safety measures to defend ethical research practices were established through the Belmont Report and subsequent HHS regulations. The set of regulations in Subpart D of 45 CFR part 46 provides multiple safeguards for children in research studies including IRB review and risk assessment as well as both parent permission and child assent which together ensure research participation poses no dangerous risks to children (HHS, n.d.). Researchers need to examine possible risks to pregnant women and their fetuses while taking all possible measures to prevent injury.

Prisoners require protection from coercive influences that develop because they feel compelled to participate in studies. Research participants must decide freely after getting proper information (Simpson et al., 2025). Research participants who have cognitive disabilities need their representatives to give consent, while the researchers must ensure they face no excessive risks. The requirement for extra safeguards depends directly on the level of significance. The research requires extensive review from the IRB because of its high-risk category (HHS, n.d.). The research structure and its extent depend on ethical requirements, including providing proper informed consent procedures, maintaining low-risk levels, and monitoring continuously.

Ethical Standards Applied in Research

Research with participants is ethically conducted following highly regarded ethical standards, including respecting them as persons and acting with fairness and dignity. The Belmont Report is a document that describes and includes primary ethical guidelines like beneficence, fairness, and respect for people. Throughout the research process, they safeguard the rights and welfare of participants (Barrow et al., 2022). Another essential component of ethical research is informed consent, which guarantees that participants are completely aware of the study’s goals, methods, risks, and rewards before participating. It has to be voluntary, and participants should be able to withdraw without penalty. The procedure entails answering queries or concerns and delivering understandable information (CITI Program, 2020). 

Personal and medical data of participants are protected under regulatory privacy protections, such as the Health Insurance Portability and Accountability Act (HIPAA)  (Edemekong et al., 2024). The data needs to be anonymized, stored securely, and shared only with authorized personnel; researchers must ensure this. The privacy protections ensure there is little risk of data breaches or the participants’ confidentiality being violated. The development of these ethical standards greatly affects the research design by influencing study protocols. Thus, for example, informed consent forms in clear, detailed forms of consent, data protection measures must be applied, and studies that minimize potential risks must be designed. This compliance is partly maintained by IRBs that offer ethical oversight to ensure that research is done fairly and follows the standards of conduct for human subjects research.

Conclusion

Protecting human research participants is crucial to maintaining ethical standards in scientific research. Researchers can adhere to historical lessons, moral principles, and regulatory guidelines to minimize risks, protect vulnerable populations, and respect participants’ rights, thereby advancing responsible and trustworthy research.

References

 Balkin, E. J., Kollerup, M. G., Kymre, I. G., Martinsen, B., & Grønkjær, M. (2023). Ethics and the impossibility of the consent form: Ethnography in a Danish nursing home. Journal of Aging Studies, 64, 101110. https://doi.org/10.1016/j.jaging.2023.101110 

Barrow, J. M., Khandhar, P. B., & Brannan, G. D. (2022). Research Ethics. National Library of Medicine; StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK459281/

CITI Program. (2023, August 23). On tech ethics podcast – human subjects research ethics in space. CITI Program. https://about.citiprogram.org/blog/on-tech-ethics-podcast-human-subjects-research-ethics-in-space/

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

CITI Program. (2020). Informed consent and clinical investigations. In citiprogram.org. https://about.citiprogram.org/course/informed-consent-and-clinical-investigations-a-focus-on-the-process/

Edemekong, P. F., Haydel, M. J., & Annamaraju, P. (2024). Health Insurance Portability and Accountability Act (HIPAA). National Library of Medicine; StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK500019/ 

HHS. (n.d.). Research with children FAQs. HHS.gov. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/children-research/index.html 

Kim, S. (2023). Overview of clinical study designs. Clinical and Experimental Emergency Medicine, 11(1). https://doi.org/10.15441/ceem.23.036

Kang, E., & Hwang, H.-J. (2023). The importance of anonymity and confidentiality for conducting survey research. Journal of Research and Publication Ethics, 4(1), 1–7. http://dx.doi.org/10.15722/jrpe.4.1.202303.1 

Nagai, H., Nakazawa, E., & Akabayashi, A. (2022). The creation of the Belmont report and its effect on ethical principles: A historical study. Monash Bioethics Review, 40(2), 157–170. https://doi.org/10.1007/s40592-022-00165-5

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

Simpson, P. L., Guthrie, J., Jones, J., Haire, B., & Butler, T. (2025). Ethical issues in conducting health research with people in prison: Results of a deliberative research project conducted with people in Australian prisons. Social Science & Medicine, 367, 117751–117751. https://doi.org/10.1016/j.socscimed.2025.117751