The focus of this assignment is to apply the principles detailed in the Belmont Report to case studies involving human subjects in research or a quality improvement project.
The focus of this assignment is to apply the principles detailed in the Belmont Report to case studies involving human subjects in research or a quality improvement project.
Utilize the “Ethical Conduct of Scholarly Activities” document to complete this assignment.
While APA style is not required for the body of this assignment, solid academic writing is expected, and documentation of sources should be presented using APA formatting guidelines, which can be found in the APA Style Guide, located in the Student Success Center.
This assignment uses a rubric. Please review the rubric prior to beginning the assignment to become familiar with the expectations for successful completion.
You are required to submit this assignment to LopesWrite. A link to the LopesWrite technical support articles is located in Class Resources if you need assistance.
Benchmark Information
This benchmark assignment assesses the following programmatic competencies and professional standards:
RN-BSN
4.3: Promote the ethical conduct of scholarly activities [AACN ]
American Association of Colleges of Nursing Core Competencies for Professional Nursing Education
This assignment aligns to AACN Core Competency 1.2, 4.3, 9.1, 10.2
Sample Expert Answer
Application of the Belmont Principles: Case Study 1
| Belmont Report principles and the components of each principle | Explain how the case meets the components of each principle. | Explain how the case does not meet the components of each principle. | What steps can the nurse researcher or quality improvement manager take to adhere to the ethical principles identified in the Belmont Report? |
Respect for Person
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The woman has the right to decide about her treatment, even if her cultural background places decision-making with her spouse. Respect means giving her full information about the risks and benefits so she can make an informed choice (Millum, 2020). The researchers provided a careful consent process, which shows respect for her autonomy. However, they must also consider the cultural influence on her decision. Participation should remain voluntary and free from pressure. Protecting her choice means balancing respect for her beliefs with her individual right to decide her own care. | The case does not fully meet respect for persons because the woman’s cultural background limits her ability to make her own decision. Even though she completed the informed consent process, her spouse’s refusal creates pressure that weakens her autonomy. She may not be truly free to choose if family or cultural rules override her wishes. While information was given, respect for personal beliefs also includes protecting her right to act on them (Omutoko et al., 2023). In this situation, the woman’s independence is not fully honored, making the principle incomplete. | The nurse researcher should ensure the woman has the final say in her treatment decision. This means reinforcing that participation is voluntary and her right to choose is protected, even if cultural traditions suggest otherwise (Omutoko et al., 2023). The researcher can provide additional counseling to both the woman and her spouse, helping them understand that her autonomy is central in research ethics. Using interpreters or cultural mediators may also help explain the importance of her informed consent. Respecting her decision requires creating an environment where she feels empowered to act freely without fear of family or cultural opposition. |
Beneficence
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The experimental therapy offers some hope, though the chance of success is small and the risks are serious. Beneficence requires researchers to minimize the possibility of harm, such as explaining clearly about the risk of sudden cardiac failure. At the same time, they should maximize possible benefits, since the woman’s illness is advanced and options are limited. Her well-being should come before scientific progress, and she should not be treated as only a subject for data collection. The focus should stay on her safety, dignity, and comfort while receiving the therapy. | The case does not fully meet beneficence because the risks of the experimental therapy are extremely high compared to the low chance of benefit. Some participants in trials have experienced sudden cardiac failure, which raises concerns about safety. While hope is given, there is no guarantee of effectiveness, and exposing her to such danger may cause more harm than good. The balance between potential benefit and risk is not clear. This means her well-being may not be protected above the scientific value of testing the experimental drug in more patients. | The nurse researcher should take steps to minimize harm while offering the best chance of potential benefit (Millum, 2020). This can include thorough medical screening to ensure the woman is a safe candidate for the therapy, close monitoring during treatment, and quick intervention if complications arise. All information about risks, such as sudden cardiac failure, should be explained clearly and honestly. Emotional support should also be given to reduce stress and help her make informed choices (Omutoko et al., 2023). Beneficence means keeping her health and dignity first, not using her only for research outcomes, and prioritizing her safety above all scientific goals. |
Justice
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Justice requires fairness in how participants are selected and treated (Nagai et al., 2020). The woman is asking to join voluntarily, which means she is not being exploited as a vulnerable person. Researchers must make sure she is not pressured by her cultural setting or her spouse’s disagreement. The risks and benefits of this trial must be shared equally with all patients, not just those with certain backgrounds. No group should carry more burden than another. Fairness means avoiding conflicts of interest and ensuring that participants are included because of medical need, not convenience. | The case does not fully meet justice because cultural pressure may prevent the woman from having the same access as others who can decide freely. Her spouse’s disapproval could unfairly block her from joining, even though she qualifies medically. This limits fair selection of participants. Vulnerable groups, such as those influenced by cultural or family authority, risk being excluded or silenced. The burdens and benefits of the trial are not equally shared if some patients cannot participate due to outside control. Therefore, justice is not fully achieved in this situation. | The nurse researcher should guarantee fair and equal access to the trial. This means ensuring the woman is considered based on her medical needs and not excluded unfairly due to cultural or family influences (Nagai et al., 2020). The researcher must guard against coercion by making sure her spouse’s disagreement does not prevent her participation. Clear procedures should be in place to prevent vulnerable individuals from being overlooked or denied care. Justice also requires transparency in how participants are selected and ensuring that risks and benefits are fairly distributed, without any group carrying more burden than another in the trial process. |
Application of the Belmont Principles: Case Study 2
| Belmont Report principles and the components of each principle. | Explain how the case meets the components of each principle. | Explain how the case does not meet the components of each principle. | What steps can the nurse researcher or quality improvement manager take to adhere to the ethical principles identified in the Belmont Report? |
Respect for Person
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The case meets respect for persons by ensuring participants are properly identified and included with their consent. Fingerprint scanning protects against mistaken identity and ensures the right person receives the medication. Providing mobile phones with reminders supports participants in keeping appointments, which respects their ability to stay engaged in care. The technology also helps maintain communication, giving participants more control over their involvement. By reducing confusion and missed treatments, researchers show respect for each person’s role in the study. Participation is voluntary, and informed consent is assumed before agreeing to fingerprinting and monitoring. | The case does not fully meet respect for persons because fingerprint scanning, GPS tracking, and phone monitoring may invade privacy and reduce personal freedom. Even if participants consent, they may feel pressured to accept these conditions to gain access to treatment. This creates a risk that participation is not truly voluntary (Millum, 2020). Continuous tracking may also conflict with cultural or personal values. While the intention is to improve follow-up, it may instead feel like control. Respect requires balancing research needs with dignity, and here, technology could limit the participant’s ability to act independently (Sivasubramaniam et al., 2021). | The nurse researcher should make sure participation is truly voluntary by clearly explaining how fingerprint scanning, phone use, and GPS tracking work. Informed consent must be detailed, including possible privacy risks, so participants can decide freely (Nagai et al., 2020). Extra time should be given for questions, and participants should know they can withdraw without losing access to standard care. The researcher should also provide clear options for those uncomfortable with technology, offering support or alternatives where possible. Respecting participants means protecting their dignity, honoring their personal beliefs, and ensuring they feel in control of their decisions throughout the study (Sivasubramaniam et al., 2021). |
Beneficence
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The case supports beneficence by aiming to minimize harm and maximize benefits. Mobile phones and reminders help participants follow treatment schedules, lowering the risk of missed doses and failed therapy. GPS tracking allows researchers to find participants quickly, making sure they continue receiving medication and medical care (Sivasubramaniam et al., 2021). These steps protect participants’ health and support the best chance of effective treatment. Fingerprint scanning also reduces the risk of misuse, ensuring drugs reach the intended patient. Overall, these methods prioritize participant well-being, protect against treatment interruptions, and support the research goal of improving HIV care in a high-need population. | The case does not fully meet beneficence because the technology introduces new risks. Phones with GPS tracking could expose participants to stigma or harm if discovered by others in their community. There is also the risk of data breaches, which could reveal HIV status and cause discrimination. The stress of constant monitoring might negatively affect participants’ mental well-being. While the goal is to improve care, these risks may outweigh the intended benefits for some individuals. Beneficence requires careful weighing of risks and benefits, and here, the balance may not always favor the participant’s safety and dignity.
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To uphold beneficence, the nurse researcher should minimize risks by protecting all personal data collected through phones, GPS, and fingerprint systems. Confidentiality safeguards, such as encryption and secure storage, must be used (Omutoko et al., 2023). The researcher should also consider the mental and social risks of stigma and ensure participants are not exposed through visible tracking tools (Omutoko et al., 2023). Benefits should be maximized by using reminders to support treatment adherence and continuity of care. Regular monitoring and ounselling can help address fears or stress related to the technology. Beneficence is maintained when participant well-being, safety, and dignity take priority over research goals.
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Justice
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Justice is met because the study addresses a population with a high burden of HIV and seeks fair ways to provide care while conducting research. By giving phones and using fingerprint identification, researchers ensure equal access and prevent unfair distribution of medication. These methods help protect participants from losing treatment due to mobility, relocation, or family interference. The technology also helps ensure that benefits and risks are shared fairly among all participants. The selection of participants is based on health needs, not convenience or privilege, which supports fairness and reduces the chance of exploitation or discrimination.
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The case does not fully meet justice because not every participant may have equal comfort or ability to use the technology provided. Some may lack digital skills or fear surveillance, which could exclude them from fair participation. Giving phones only to study participants may also create tension in communities where many lack access, leading to perceptions of unfairness. Vulnerable groups might feel compelled to accept conditions to receive treatment, raising concerns of coercion. Justice requires equal access without undue burden, yet here, technology may unintentionally create inequalities and place extra burdens on those who are less technologically literate. | The nurse researcher should guarantee that technology use does not create unfair barriers. Training should be provided for participants unfamiliar with mobile phones, ensuring equal opportunity to benefit from the intervention (Sivasubramaniam et al., 2021). Participation should not depend only on willingness to accept tracking; instead, alternative ways of support must be offered. Fair selection of participants is essential, focusing on health needs rather than convenience. To prevent resentment in the community, clear communication about why phones are provided is needed. Justice is maintained when benefits and burdens are shared equally, and no group feels excluded, exploited, or unfairly pressured to participate (Sivasubramaniam et al., 2021).
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Personal Reflection
| In less than 250 words, discuss how the ethical principles from the Belmont Report align with the Christian worldview. Reflect on your current nursing practice and describe how these ethical principles align with your nursing practice. |
| The Belmont Report emphasizes respect for persons, beneficence, and justice, principles that align closely with the Christian worldview. Christianity teaches the inherent dignity and worth of every individual as created in the image of God (New International Version Bible, 2011, Genesis 1:27). Respect for persons reflects this truth by affirming autonomy, protecting the vulnerable, and ensuring informed consent. Beneficence parallels Christ’s command to love one another (NIV, 2011, John 13:34), calling us to act in ways that promote health, healing, and safety. Justice connects to biblical teachings on fairness and equity, such as Micah 6:8, which urges believers to act justly and show mercy. Together, these principles uphold ethical decision-making grounded in compassion, fairness, and reverence for human life.
In my nursing practice, I see these principles expressed daily. Respect for persons guides how I honor patients’ choices, even when cultural or family influences complicate their decisions. Beneficence drives my commitment to minimize harm, provide safe care, and advocate for treatments that prioritize well-being over convenience. Justice is evident in how I strive to give fair care to every patient, regardless of background, financial means, or social status. My Christian faith deepens these commitments, reminding me that caring for patients is more than a job—it is a calling to serve with integrity, humility, and love. By integrating the Belmont principles with biblical values, I can uphold professional standards while reflecting Christ’s compassion in every interaction. |
References
Millum J. (2020). International Clinical Research and Justice in the Belmont Report. Perspectives in Biology And Medicine, 63(2), 374–388. https://doi.org/10.1353/pbm.2020.0025
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
New International Version Bible. (2011). Zondervan Publishing. (Original work published 1978)
Omutoko, L., Amugune, B., Nyawira, T., Inwani, I., Muchoki, C., Masika, M., … & Jaoko, W. (2023). Strengthening research ethics oversight in Africa: The Kenyan example. South African Journal of Bioethics and Law, 16(1), 19-22. https://hdl.handle.net/10520/ejc-m_sajbl_v16_n1_a5
Sivasubramaniam, S., Dlabolová, D. H., Kralikova, V., & Khan, Z. R. (2021). Assisting you to advance with ethics in research: An introduction to ethical governance and application procedures. International Journal for Educational Integrity, 17(1), 14. https://doi.org/10.1007/s40979-021-00078-6
NRS-445 Topic 2: Benchmark – Ethical Conduct of Scholarly Activities
For this assignment, students will read the two case studies that follow and then complete the application of the Belmont Principles case study tables for each case study as well as a personal reflection at the end.
Background: The Belmont Report is a foundational document in the field of research ethics. It was created in response to ethical concerns raised by the Tuskegee Syphilis Study and other research studies that exploited vulnerable populations. The Belmont Report outlines three core ethical principles for research involving human subjects: respect for persons, beneficence, and justice. Institutional review boards (IRBs) are responsible for ensuring that research studies comply with these ethical principles. The Belmont Report has had a significant impact on the formation and function of IRBs.
IRBs use the principles outlined in the Belmont Report as a framework for understanding and evaluating the ethical implications of research studies. The principles of respect for persons, beneficence, and justice are used to guide decision-making around issues such as informed consent, risk-benefit analysis, and the selection of human subjects. Overall, the Belmont Report has played a crucial role in shaping the ethical standards for research involving human subjects.
Assignment Focus: The focus of this assignment is to allow the student to apply the principles detailed in the Belmont Report to case studies involving human subjects in research or a quality improvement project. Emphasis is placed on developing and demonstrating an understanding of the role of the nurse researcher or quality improvement project manager as an effective facilitator of ethical principles in human-subjects research or quality improvement projects.
Resources: Review the “NRS-445 The Belmont Report Lecture” to gain a better understanding of the Belmont Report and the role it plays in conducting research.
Case Study 1: An Experimental Trial Worth Taking?
Life-threatening cancers can end a person’s life within a matter of weeks to months. Experimental procedures such as a combination of immunotherapy and the novel medication guadecitabine are currently being investigated in a clinical trial. In 8% of cases, the treatment has been highly successful. In one documented case, a woman with breast, colon, and lung cancers with poor odds of survival agreed to partake in receiving the experimental therapy. The experimental therapy compellingly treated the tumors; she has been cancer-free for six years. Regrettably, the treatment does not affect most people, and significant risk is involved: in some trials, the patients suffered immediate cardiac failure.
Another woman diagnosed with aggressive cancer, who doctors estimate will live for five months, has inquired about pursuing this therapy. In an extensive informed consent process over a three-week period, she and her spouse are given all the evidence-based background, the risks and benefits, and more. Once the informed consent process is completed, the woman wants to seek the experimental treatment, but her spouse does not support the decision. The woman and her spouse are from a cultural background in which the male partner of the family decides the important choices, and the pair are devoted to their cultural beliefs.
Reflection Points: Should researchers accept this woman into the clinical trial to receive the experimental therapy?
Case 2: Send Me a Message When You Can!
In an African nation, one in seven adults has HIV. Treatment is not accessible to everyone who needs it, and researchers are engrossed in creating effective, economical treatment methods for patients with HIV. The research of new drugs for HIV encounters the issue of the mobility of many African people because many people move from one area to another due to employment, political unrest, or the need to find housing.
This issue makes regular contact with research participants challenging. Often, researchers are concerned that their participants will instruct their family members to obtain the experimental drugs they are supposed to have, rather than obtaining the drugs themselves, to split the treatment. This jeopardizes the research and curative value of the medication, which should be taken regularly.
Researchers suggest the use of technology to remedy multiple issues. They will scan the participants’ fingerprints and include them in an electronic database for proof that each participant is included in the research study before obtaining treatments. Researchers will also give participants mobile phones to allow the researchers to send text message reminders to participants about their study appointments and to allow rescheduling of visits. GPS tracking will be on the phones to allow researchers to locate participants when necessary, so that they can see the participants in person.
Reflection Points: Should research be conducted as described above explained? Is technology the only way to mitigate the impact of equity issues in research?