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DNP 706 Replies

Please reply this student Jacqueline, Juliet, Anthony and Nicholas discussion each in a paragraph of 170 – 200 words with APA and References. One reply for each student for a total of 4 replies.

1. Jacqueline Licauco 

Ethics and Role of IRB

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Ethics and Role of IRB

The Tuskegee Study was conducted from 1935 through 1972 in Tuskegee, Alabama, and involved hundreds of African American men who had latent syphilis who were studied over a period of 40 years to evaluate the effects of untreated syphilis (Jones & Reverby, 2022).  The patients were not given informed consent and was lied upon by the researches that they were being treated for a “bad blood” (Jones & Reverby, 2022). Many have died untreated, and many passed the diseases to their sexual partners and children (Jones & Reverby, 2022).

There were moral and ethical violations in this study.  First is the lack of moral and ethical obligation to treat the disease. The subjects were left untreated intentionally to evaluate the disease process over forty years in untreated subjects.  The subjects were not fully aware of the condition they were being treated for. They were not given informed consent about the disease and the treatment.  Second, patients were not given full disclosure about the risks and harms the study might develop. Subjects were unaware that they were contagious and had passed the disease to their loved ones. They were also not informed that they had the right not to participate. 

The Institutional Review Board (IRB) at the University of Massachusetts is responsible for reviewing and approving research involving human subjects to ensure that the study follows ethical and professional standards (Brandman University, 2019). The IRB ensures that the study is morally and ethically sound and that it follows specific standards to ensure that the study is conducted in a manner that does not inflict harm on the individuals. It assures that informed consent is given to participants that describes all measures and procedures to be done as part of the study. Informed consent must state a description of foreseeable risks and benefits to the subjects as well as alternative procedures or courses of treatment, if any (Resnik, 2021). It is also the right of the subjects to know how health information and privacy will be protected and how they will be compensated for their participation (Resnik, 2021).

In application of IRB standards to the clinical scholarly project to improve the response rate of FIT testing through follow-up messaging, there is minimal risk to subjects because it is non-invasive research.  The study will involve patients who undergo FIT testing and will be sent reminder messages to complete the test and to return the kits back to complete the screening process.  There is no harm anticipated and there is intent to treat.

 

 

References

            Brandman University. (2019).  Institutional Review Board.

            Jones, J. H., & Reverby, S. M. (2022). 50 years after the tuskegee revelations: Why does the mistrust linger?  American Journal of Public Health112(11), 1538–1540.  https://doi.org/10.2105/ajph.2022.307088

            Resnik, D. B. (2021). Informed consent, understanding, and trust.  The American Journal of Bioethics21(5), 61–63.  https://doi.org/10.1080/15265161.2021.1906987

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2. Juliet Nwana

WK 8: Ethics and the Role of IRB

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Ethics and the Role of IRB

Reflection of Tuskegee Syphilis Study

          Although nothing can be done about the fact that the Tuskegee Syphilis Study occurred, it is crucial to reflect on why and how it occurred to highlight its ethical implications to prevent a possible repetition. The Tuskegee Syphilis Study is a renowned clinical research conducted in Macon County, Alabama, USA, from 1932 to 1972 on approximately six hundred black men. Four hundred out of them were infected with syphilis, while the other uninfected two hundred were more like the control group (Tobin, 2022). The Tuskegee Syphilis Study aimed to find out whether black people react to syphilis in a similar way as Caucasians and to evaluate how long humans can live with untreated syphilis. In the study, most of the men were uneducated sharecroppers and were left untreated with syphilis. They suffered immensely at the hands of medical practitioners from the US Public Health Service. The study participants were never told that they had been injected with syphilis. The researchers coined the term “bad blood” to falsely portray the participant’s medical situation. These men were informed that they were sick and would receive free care. Surprisingly, they believed that they were receiving treatment for “bad blood” (Tobin, 2022).

           From the details of the Tuskegee syphilis study, it is clear that the researchers violated the rights of research participants, raising various ethical issues like informed consent, maleficence, unfair subject selection, autonomy, and justice (Varkey, 2021). In any research involving human subjects, seeking their consent through deception, as seen in the Tuskegee syphilis study, is unethical and may discourage individuals from participating. From the very start of participant selection, the real intention of the experiment was not disclosed to them to ensure they cooperated, thus violating their autonomy (Varkey, 2021). Besides, disregarding fair subject selection, as seen in the Tuskegee study, where only black men were selected, violated the principle of justice (Varkey, 2021). The participants in the Tuskegee syphilis study were denied treatment, putting them at risk of severe complications, including death, thus violating the principle of malefence.

The Ethical Failings and the Change the Brandman IRB website Could have Made

          Adhering to the Brandman IRB guidelines would have compelled better and transparent communication. The participants would have been informed about the nature of the study, including potential risks and benefits. Additionally, the researchers would ensure participants had access to appropriate medical care. Also, they could withdraw from the study at any time, which would have prevented any further harm and spread.

The Potential Risks to Subjects in CSP

          Regarding the CSP, potential risks may include wrong data collection and interpretation which may lead to unwarranted treatment and unprecedented side effects of medication, that may range from mild to severe. Sometimes, the experimental technology may fail (Scanlon et al., 2021). Besides, some physical tests may accelerate the chance of fall-related injuries. Again, the confidentiality of CSP data may not be guaranteed because other individual sponsors may have access to medical information (Scanlon et al., 2021).

References

Scanlon, J. K., Wofford, L., Fair, A., & Philippi, D. (2021). Predictors of participation in clinical research.  Nursing Research70(4), 289-297. https://doi.org/10.1097/nnr.0000000000000513

Tobin, M. J. (2022). Fiftieth anniversary of uncovering the Tuskegee syphilis study: The story and timeless lessons.  American Journal of Respiratory and Critical Care Medicine205(10), 1145-1158. https://doi.org/10.1164/rccm.202201-0136SO

Varkey, B. (2021). Principles of clinical ethics and their application to practice.  Medical Principles and Practice30(1), 17-28. https://doi.org/10.1159/000509119

12 hours ago

3.Anthony Castro 

wk 8 DB AC IRBs

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The innovator role is characterized by the person who brings new ideas, constructs, technologies, or work processes to the fore allowing for advancement of ideas or the field writ large. Endemic to this role is a degree of novel or non-conventional thinking which can be utilized to reorganize the available information or identify a hole in present practices or understandings such that new opportunities are borne off of the innovative approaches they take. As with any unique strength necessarily comes unique potential weaknesses. This week’s readings attest to prior instances of novel thinking an practice which sought to earnestly expand information, however in each instance some degree of inhumane behavior occurred or unchecked variable was allowed to run express itself to the detriment of the subjects who had not signed on to be so exploited. Some of these studies will be explored presently with the hope of gleaning what wisdom that can be gleaned from their review.

We will start by order of the most evil and least benevolent studies, starting at the obvious genesis point of the Tuskegee Syphilis Experiment. In this case there can be little benevolent intention toward the subject’s experience on as the researchers were aware of their action and the probable effect on their subjects (irreversible tissue damage, dementia, and death). Whatever benevolent intent might be theorized must be toward the field at large, the general public, and humanity. This “ends justify the means” understanding of experimental medical and psychological research is precisely why IRB’s are needed.

In the Second study in order of least benevolent intent to greatest, the Milgram Electroshock Study subject were not physically harmed, however there was deception which subjected them to the high risk/reality of vicarious trauma as the result of listening to another (purported to subject) pain, and to be the inflictor of said pain response. This is unique in that there was strong coercion and fundamental failures of informed consent however what was being tested was theoretically a willingness, thought in truth and with what we know of compulsion and conformist behavior in the post WWII era population there was little choice for many/most subjects. Distilled to its elemental sense, the Milgrim study is a case study in coercion, and coercive control, and perhaps probabilistically so as it was seeking answer questions of conformity in Nazi Germany, however in doing so the harm or potential harm to subjects was not remotely considered.

The final study, that of the Stanford Prison Experiment, was a study in ingroup outgroup dynamics, paranoia, and control in the form of an empowered smaller group placed in role of jailer of a slightly larger group placed in opposite role of inmates. Role assignment and its effect on behavior in light of very few concrete instructions gave rise to physical and phycological abuse of subjects and did so in a way that was at least partially known to researchers and yet was not immediately corrected or stopped. Here there is a form of curiosity which is unethical, not wholesome, and does not live up to the best traditions of medicine or psychological research in that it definitely did not first “do no harm”. Thus, what is left is what to be learned.

No physical harm nor deception would come to subjects given my own experimental design (the only administration is self-guided mindfulness practice, practice demonstrated vis a vie CBT interventions to be safe and an EBP for anxiety and mood disordered Sx, and appreciable as antecedents to compassion fatigue and elevated workplace stress. Physical harm would be hard stretch, though I suppose outlier conditions might be sought for which self-guided mindfulness practice would be harmful. What is clear upon review of these studies is that coercive control can exist in the presence of power differential. This could have been avoided, or at least the harm resulting in it as with the Zimbardo study if informed consent was stronger. Thus as this would be applied to nurses in a labor force, all coercive control must be examined and special attention put into not motivating subject to participate who would be made to do so out of obligation or compulsion. Lastly, I am not aware upon review of any use of force to push subjects past their willing thresholds however a build in part of the study, as clinical check-ins are written in might be the freedom the subject had to discontinue participation with no adverse outcomes awaiting them. This might be a positive way of stressing only willing participation. These are the only thoughts I could come up with given the very divergent nature of this research to the ones examined, however all feedback is welcomed.

 

References

Sivasubramaniam, S.D., Cosentino, M., Ribeiro, L., & Marino, F. (2021). Unethical

practices within medical research and publication: an exploratory study. International Journal for Educational Integrity, 17 (7), 265-269.  https://edintegrity.biomedcentral.com/articles/10.1007/s40979-021-00072-y#citeas

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4. Nicholas Nsiah 

IRB Week 8 DB

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The integrity of scientific research is of utmost importance, not only for the advancement of knowledge but also for the protection of individuals who participate in studies. Unfortunately, there have been historical instances where ethical guidelines have been neglected, resulting in tragic consequences, particularly impacting vulnerable populations like African American communities. The Tuskegee Syphilis Study is one such instance that has left a lasting distrust in healthcare among many African Americans, affecting their willingness to participate in potentially beneficial health-related research (Jones & Brown, 2021).

More recently, there have been concerns about ethical standards, as seen in weight loss experiments targeting African American adolescents, a group that is already disproportionately affected by obesity and its related health issues. Given these precedents, the role of ethical oversight bodies becomes crucial. The Institutional Review Board (IRB) at the University of Massachusetts Global sets forth comprehensive guidelines designed to prevent such ethical violations and ensure the protection and respect of all research participants (Garcia & Lee, 2022).

The importance of rigorous ethical oversight becomes even more apparent when considering historical abuses in medical research involving vulnerable populations. The Tuskegee Syphilis Study and unethical weight loss experiments targeting African American adolescents serve as stark reminders of the consequences when ethical standards are ignored. These examples highlight not just a breach of ethical conduct but also the profound impact such breaches can have on community trust and individual well-being (Johnson et al., 2019). Strict adherence to IRB protocols ensures that research practices are conducted with utmost respect for human dignity and autonomy. This includes ensuring informed consent is thoroughly obtained and understood, a fundamental practice designed to protect participants from deception or coercion (Smith, 2020).

In adherence to ethical standards, strict protocols will be implemented to ensure the proper conduct of research involving African American adolescents in the weight loss program. The Institutional Review Board (IRB) guidelines will be rigorously followed to safeguard participants' rights, welfare, and confidentiality. Prior to the commencement of the study, informed consent will be obtained from both the adolescents and their legal guardians, emphasizing the voluntary nature of participation and the potential risks and benefits involved (Robinson, 2018).

Additionally, measures will be taken to ensure culturally sensitive approaches, considering the unique needs and backgrounds of African American adolescents. Continuous monitoring and oversight will be exercised throughout the study to uphold ethical standards and promptly address concerns. By adhering to IRB protocols, the research aims to uphold the integrity of the study while prioritizing the well-being and dignity of all participants (Taylor, 2023).

 

References

Garcia, A., & Lee, B. (2022). Ensuring Ethical Conduct in Adolescent Weight Loss Programs: A Guide for Practitioners. Journal of Adolescent Health, 45(2), 78-86.

Johnson, R., et al. (2019). Informed Consent in Adolescent Health Research: Ethical Considerations and Recommendations. Pediatrics, 136(2), 197-203.

Jones, K., & Brown, D. (2021). Understanding and Applying Institutional Review Board Protocols in Adolescent Health Studies. Journal of Adolescent Research, 24(3), 124-132.

Robinson, L. (2018). Culturally Sensitive Approaches to Adolescent Health Research: A Review of Best Practices. Journal of Cultural Diversity, 37(1), 56-64.

Smith, M. (2020). The Role of Institutional Review Boards in Protecting Adolescent Participants: A Comprehensive Overview. Journal of Adolescent Health, 42(4), 189-197.

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