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.
Researchers in a boardroom discussing
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?
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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
Respect the right to choose, hold views, and act according to personal beliefs.
Protect those with decreased capacity to make their own choice.
Ensure voluntary participation.
Provide informed consent, explaining harms and benefits.
Beneficence
Minimize the harm/risks to the greatest extent possible.
Maximize the potential benefits.
Ensure that the rights and well-being of the patient take precedence over the needs of science.
Justice
Justly distribute the benefits and burdens of the research. Guard against using vulnerable populations.
Ensure a fair selection of research participants.
Guard against coercion and undue influence.
Avoid potential financial or other conflicts of interest.
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
Respect the right to choose, hold views, and act according to personal beliefs.
Protect those with decreased capacity to make their own choice.
Ensure voluntary participation.
Provide informed consent, explaining harms and benefits.
Beneficence
Minimize the harm/risks to the greatest extent possible.
Maximize the potential benefits.
Ensure that the rights and well-being of the patient take precedence over the needs of science.
Justice
· Justly distribute the benefits and burdens of the research. Guard against using vulnerable populations.
· Ensure a fair selection of research participants.
· Guard against coercion and undue influence.
· Avoid potential financial or other conflicts of interest.
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.
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