NUR 550 Translational Research Framework and Legal/ Ethical Considerations
NUR 550 Translational Research Framework and Legal/ Ethical Considerations
NUR 550 Translational Research Framework and Legal/ Ethical Considerations
Topic 3 DQ 1
Description:
Discuss the ethical guidelines that would need to be implemented when conducting translational research. What are the ethical and legal considerations related to translating research into practice? Discuss what steps you would take as a member of a translational research team in order to establish ethical guidelines for conducting translational research.
Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research (FDA, n.d).
From a public health perspective, it is important to recognize an ethical standard that respects community autonomy. This standard can be achieved by requiring community collaboration (ie, at a minimum, establishing a community advisory board) to protect against exploiting vulnerable populations, to ensure fair terms of cooperation, to ratify that the interventions to be tested are acceptable to community members, and to minimize potential misunderstandings about the research. Such community advisory boards should have responsibility for determining whether the research goals are valuable to local community members and the methods are acceptable before the research is allowed to proceed (Buchanan & Miller, 2006).
In this era of translational research, social injustice is one of the crucial ethical concerns. Resource-rich countries conducting translational medical research in resource-poor countries are common and if the results of the research are not expected to be beneficial/less beneficial to the resource-poor country, then arises the issue of social injustice and disparity. Examples include research undertaken on diseases that are rare or the resulting intervention/product is too expensive to implement, in developing countries (Mandal et al., 2017).
Read Also: NUR 550 DQ Translational Research Application in Global Disease
NUR 550 Translational Research Framework and Legal/ Ethical Considerations
References
Buchanan, D. R., & Miller, F. G. (2006). A public health perspective on research ethics. Journal of medical ethics, 32(12), 729–733. https://doi.org/10.1136/jme.2006.015891
Mandal, J., Ponnambath, D. K., & Parija, S. C. (2017). Ethics of translational medical research. Tropical parasitology, 7(2), 62–64. https://doi.org/10.4103/tp.TP_47_17
FDA (n.d). Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials. Retrieved from https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials
RESPOND HERE (150 WORDS, 2 REFERENCES)
Re: Topic 3 DQ 2
Unfortunately, many countries, including the United States, have previously conducted unethical clinical trials, and as a result, policies and regulations to protect human participants have been implemented. The Institutional Review Board (IRB) was formed to ensure the safety of these clinical trials. They are guided by three fundamental ethical principles: individual respect, beneficence, and justice (Qiao, 2018).
Individual dignity is preserved by ensuring patient autonomy. This is where informed consent comes into play. Patients must be fully informed about the trial in which they are participating, including their expectations and any potential side effects. They must agree to participate in the trial voluntarily and be informed that they may withdraw at any time (Pietrzykowski & Smilowska, 2021).
The beneficence is concerned with the patient’s or study participant’s safety (Qiao, 2018). At all stages of the trial, patient safety is of the utmost importance. Justice will be kept in check by ensuring equity. Health equity has recently become a hot topic, with many minorities lacking access to clinical trials or the knowledge to participate confidently.
References
Pietrzykowski, T., & Smilowska, K. (2021). The reality of informed consent: Empirical studies on patient comprehension—systematic review. Trials, 22(1). https://doi.org/10.1186/s13063-020-04969-w
Qiao, H. (2018). A brief introduction to institutional review boards in the united states. Pediatric Investigation, 2(1), 46–51. https://doi.org/10.1002/ped4.12023
RESPOND HERE (150 WORDS, 2 REFERENCES)
Re: Topic 3 DQ 2
The Food and Drug Administration (FDA) established an Institutional Review Board (IRB) to review and monitor translational research involving human subjects. The IRB has several responsibilities, including approving or rejecting research proposals (Nurunnabi, 2014). For example, in order for a study to be approved by the IRB, some ethical requirements must be met, such as informed consent, scientific validity, fair subject selection, subject respect, and many others. If the research lacks or fails to meet IRB requirements, the study may be disapproved or the design may be modified. Furthermore, the IRB has been tasked with providing training on how investigators can protect human subjects from harm during research (Nurunnabi, 2014). In addition, before investigators submit research proposals for funding, the IRB must review the proposals to determine whether or not ethical principles have been followed. Fidelity, nonmaleficence, and beneficence are among the ethical research considerations specific to population health (DeCamp et al., 2018). Fidelity entails an individual’s respect, trust, and autonomy, which should be considered by the investigator before beginning the research. Non-maleficence implies that the study should not cause harm to human subjects, whereas beneficence implies that the study should act in the best interests of the patients (DeCamp et al., 2018).
Topic 3 DQ 2
Description:
Discuss the role of the Institutional Review Board. Discuss ethical research considerations specific to population health. How are respect for the persons, potential benefits and burdens of the research, and justice kept in balance? Provide an example.
Topic 3 Participation
Description:
NA
Topic 3: Translational Research Framework and Legal and Ethical Considerations
Description
Objectives:
1. Discuss ethical guidelines for conducting translational research.
2. Examine ethical considerations related to translating research into practice .
3. Examine legal considerations related to translating research into practice.
4. Discuss ethical research considerations specific to population health.
Study Materials
Advanced Practice Nursing: Essential Knowledge for the Profession
Description:
Read Chapter 26 in Advanced Practice Nursing: Essential Knowledge for the Profession.
Description:
View “What is Evidence-Based Practice?” by Lippincott NursingCenter.com, located on YouTube (2016).
Course Code Class Code Assignment Title Total Points
Indeed, investigators must ensure that people, potential benefits, and the burden of the research are all respected, and that justice is maintained throughout translation research. Individuals, for example, should be treated as autonomous subjects with the right to absolute protection from harm. Investigators should ensure that the research is in the best interests of the patients, and that the findings will improve population health. Once again, the cost of research should be reasonable and affordable. Following the research, participants’ research benefits should be distributed fairly and equitably. When an investigator takes all of these factors into account, the research is balanced from an ethical standpoint.
Timeline ten percent There is no description of the timeline. A timeline description is either incomplete or incorrect. The timeline is described but there is no evidence. The timelines are fully described and supported by sufficient evidence. The timeline is described in detail and supported by substantial evidence.
20.0 percent PICOT The PICOT statement is left out. The PICOT statement is deficient. The PICOT statement is presented, but there are some errors. The PICOT statement is given. Some specifics are required. The PICOT statement describes the problem succinctly and accurately.