Applying Belmont Principles: Ethical Case Studies in Research
School
Moi University**We aren't endorsed by this school
Course
STATISTICS 316
Subject
Nursing
Date
Dec 12, 2024
Pages
12
Uploaded by francisonduto
NRS-445 Topic 2: Benchmark – Ethical Conduct ofScholarly ActivitiesFor 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 and a personal reflection at the end. Background: The Belmont Report is a foundational document in 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. Institutionalreview boards (IRBs) are responsible for ensuring that research studies comply with these ethicalprinciples. The Belmont Report has significantly impacted 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 guide decision-making around 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 facilitatorof ethical principles in human-subjects research or quality improvement projects. Resources: Review the "NRS-445 The Belmont Report Lecture" to better understand the Belmont Report and its role in conducting research. © 2023. Grand Canyon University. All Rights Reserved.
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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 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 patientssuffered 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 three weeks, 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 makes the important choices, and the pair is 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 willbe done on the phones to allow researchers to locate participants when necessary so that they cansee them 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?3
Application of the Belmont Principles: Case Study 1Belmont Report principles and thecomponents of each principleExplain how the case meetsthe components of eachprinciple.Explain how the case doesnot meet the components ofeach principle.What steps can the nurseresearcher or qualityimprovement manager take toadhere to the ethicalprinciples identified in theBelmont Report?Respect for PersonRespect the right to choose, hold views,and act according to personal beliefs.Protect those with decreased capacity tomake their own choice. Ensure voluntary participation. Provide informed consent, explaining the harms and benefits.Followingathoroughinformed consent procedure,the woman's decision toparticipate in the trial showsher autonomy, a crucialaspect of respect for people.Thespouse'sobjectionchallenges the woman'sautonomy, which is foundedon cultural views. If thewoman's decision is nothonored, this dispute couldcompromise the concept ofrespect for people.The patient's choice toreceiveexperimentalWhileconsideringthecultural background, ensurethe woman's autonomy ispreserved. This can entailconsultinganethicalcommitteeorculturaladvisor.Nurse researchers shouldwork with the patient to4
treatment in spite of thepoorprognosiscouldindicate a weakened abilitytomakeindependentdecisions.identify the best way tocommunicatemedicalinformation and align it withher values when speakingwith her family or spousebefore discussing the risksand benefits of aggressivetherapy for a patient withaggressive cancer. The patient can provideinsightful insight into howher family and husbandmight better understand themedical facts. Even if shedecides not to tell her familydirectly, they can discusshow to let them know that5
shewantstopursueaggressive therapy.BeneficenceMinimize the harm/risks to the greatest extent possible.Maximize the potential benefits.Ensure that the patient's rights and well-being take precedence over science's needs.The prior successful caseillustratesthepossibleadvantagesoftheexperimentaltreatment,which are consistent with thebeneficence principle.The beneficence principlemay be called into question ifthe considerable dangers ofthetreatment—suchassuddenheartfailure—outweighanypotentialadvantages.Perform a comprehensive risk-benefit analysis and ensure thewoman and her partner knowthe results. This shouldencompass possible hazards,advantages, and solutions.According to the principle ofbeneficence, researchers havea duty to protect participantsfrom exploitation.Justice Notwithstanding her dismalIt can be considered aEncourage the woman to6
Justly distribute the benefits and burdens of the research. Guard against usingvulnerable populations.Ensure a fair selection of research participants.Guard against coercion and undue influence. Avoid potential financial or other conflicts of interest.prognosis,thewoman'seligibilityfortheexperimentaltherapyisconsistent with the justiceprinciple, which promotesequitableaccesstoopportunities.The woman in the firstinstance benefited fromexperimentalcancertreatment since she wascancer-free for six years,which is an example of theethical concept of justice.breach of the justiceprinciple if the woman'scultural beliefs prohibit herfrom receiving the therapy.Despite having a poorchance of survival, thepatient took part in the trialeven though she benefitedfrom the experimentalcancer treatment.receive the experimentaltherapy, but keep in mind thebroader ramifications forother patients in comparablecircumstances.Withinthepracticallimitations, nurse researchersmustensurethatthehardships experienced by thesubjects are commensuratewith the possibility that theywould benefit from thestudy's findings.7
Application of the Belmont Principles: Case Study 2Belmont Report principles and thecomponents of each principle.Explain how the case meetsthe components of eachprinciple.Explain how the case doesnot meet the components ofeach principle.What steps can the nurseresearcher or qualityimprovement manager take toadhere to the ethicalprinciples identified in theBelmont Report?Respect for PersonRespect the right to choose, hold views,and act according to personal beliefs.Protect those with decreased capacity tomake their own choice. Ensure voluntary participation. Provide informed consent, explaining the harms and benefits.Within practical limitations,nurse researchers must ensurethat the difficulty experiencedbythesubjectsiscommensuratewiththepossibility of gaining fromthe study's findings. More focus should be placedon obtaining as much datafrom studies as possible priortoevaluatingtheWhen technical tools such asGPS tracking and mobilephone alerts attempt to reachthe goal of encouragingphysical activity or any othergoal compromise people'sprivacy, it is against theirvalue of respecting others. Inturn, it results in anxiety andconstant checking, which isotherwise known as theUsing cutting-edge technology-enabled methods to distributestudy materials,guaranteecomprehension,andtrackongoing consent and opt-outchoices, nurse researchers mayfoster respect for people. Theresearcher is responsible forassessingacandidate'scompetency,comprehension,8
experimentaltherapy'sefficacy.panopticon phenomenon.and fit for the study.BeneficenceMinimize the harm/risks to the greatest extent possible.Maximize the potential benefits.Ensure that the patient's rights and well-being take precedence over science's needs.Adherence to the treatmentplan under evaluation may beimproved using technology,such as text messagereminders for study meetings,visit rescheduling capabilitiesand GPS tracking. As aresult,this raises thepossibilityoffavorableresults. Ingeneral,theruralcommunity needs to learnmore about GPS technology,which could obscure thepatients' or participants' needsand preferences To adhere to the beneficenceprinciple, nurse researchersmust use new technology toperform several tasks, includingpatient recruitment, informedconsent, data extraction frompatientrecords,follow-upappointments, and patient safetythroughout the study.Justice Justly distribute the benefits and burdens of the research. Guard against using vulnerable populations.Ensure a fair selection of research The ethical concept of justicemay be upheld if patientsagree to be tracked via GPSand get text messagereminders. Doing this willFinding and managing studyvolunteers with technologymay lead to unjustifiedstigma, discrimination, andThe nursing researchers shouldthoroughly inform the generalpublic about the planned use oftechnology in the study and itsjustification before recruiting9
participants.Guard against coercion and undue influence. Avoid potential financial or other conflicts of interest.make the study successfuland advantageous for theparticipantsandtheresearcher.exclusion. study participants begins. They should put appropriatesafeguards in place to protectthe system's security. In the end,consent to participate shouldonly be given to people whofully understand the purposeand ramifications of the study.Personal ReflectionIn 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.Because they encourage the acceptance of shared values, the ethical tenets of the Belmont Report—respect for others,beneficence, and justice—are grounded in the Christian worldview. According to Millum (2020), ethical standards prioritize carersexhibiting compassion, honesty, and an understanding of the intrinsic worth of every person, regardless of their differences,histories, or skills. From a Christian perception, all the values hold the word of God, which advocates for care, love, and respect for10
human beings. In the nursing practice, these guidelines are helpful to ensure that the patient receiving care meets his/her needs. Iensure patients' self-governance is approved by strictly honoring the respect tradition. In my unprofessional work, I have alwaysadvocated for patients' autonomy to receive medical or healthcare decisions. The aspirational goal of acting in a way that is mostlikely to produce the best outcome while avoiding the worst possible outcome evidences beneficent actions. Altruism is a Christianvalue that best suits this thought (Schupmann & Moreno, 2020). The justice concept nurses must embrace requires deserving clientsto gain the necessary treatment. Encouraging equitable access to healthcare resources is another aspect of the idea. Compassion is encouraged by the Christian worldview as the moral cornerstone of justice in nursing. It also encourages away of thinking that goes beyond one's work responsibilities. In my current practice, I put this idea into reality by seeing patients asdistinct individuals who should be treated with respect and empathy rather than just as medical cases (Earl, 2020). In addition, Iconstantly value taking patients' physical, emotional, and spiritual needs into empathetic consideration. 11
ReferencesEarl, J. (2020). The Belmont Report and Innovative Practice. Perspectives in Biology and Medicine, 63(2), 313–326. https://doi.org/10.1353/pbm.2020.0021Millum, 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.2020.0025Schupmann, W., & Moreno, J. D. (2020). Belmont in Context. Perspectives in Biology and Medicine, 63(2), 220–239. https://doi.org/10.1353/pbm.2020.002812