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DQ: Discuss the role of the Institutional Review Board

NUR 550  Topic 3 DQ 2

DQ: Discuss the role of the Institutional Review Board

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).

DQ: Discuss the role of the Institutional Review Board

References

Buchanan, D. R., & Miller, F. G. (2006). A public health perspective on research ethics. Journal of medical ethics32(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 parasitology7(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

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RESPOND HERE (150 WORDS, 2 REFERENCES)

Re: Topic 3 DQ 2

Unfortunately, many countries including the United States have conducted unethical clinical trials in the past and because of that, we

DQ Discuss the role of the Institutional Review Board
DQ Discuss the role of the Institutional Review Board

have implemented policies and regulations to keep human participants safe. The Institutional Review Board (IRB) was implemented to keep safeguards in place for these clinical trials. They have three basic ethical principles to stand by; respect for person, beneficence, and justice (Qiao, 2018).

Respect for persons is kept in balance by ensuring patient autonomy. This is where informed consent comes to play. Patients need to be fully informed about the trial they are participating in, including requirements expected of the patient and any adverse effects the patient may experience. They have to voluntary agree to participate in the trial and be informed that they can choose to drop out of the trial at any time (Pietrzykowski & Smilowska, 2021).

The beneficence is focused on protecting the patient or study participant (Qiao, 2018). Ensuring patient safety is at utmost importance during every step of the trial. Justice will be kept in balance by ensuring equity. Health equity has been a hot topic recently where many of the minority population may not have access to clinical trials or the knowledge to be comfortable with becoming a participant.

DQ: Discuss the role of the Institutional Review Board

DQ: Discuss the role of the Institutional Review Board

References

Pietrzykowski, T., & Smilowska, K. (2021). The reality of informed consent: Empirical studies on patient comprehension—systematic review. Trials22(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 Investigation2(1), 46–51. https://doi.org/10.1002/ped4.12023

RESPOND HERE (150 WORDS, 2 REFERENCES)

Institutional Review Board (IRB) was formed under the Food and Drug Administration (FDA) to review and monitor translational research using human beings as subjects. IRB plays several roles not limited to approving or disapproving research proposals (Nurunnabi, 2014). For instance, for a study to be approved by IRB, some of the ethical requirements must be met, including informed consent, scientific validity, fair subject selection, respect for subjects, and many others. If the research lacks or fails to meet IRB requirements, the study can be disapproved or required to modify the design. Further, IRB has been assigned to offer training on how investigators can protect human subjects against harm during the research (Nurunnabi, 2014). Also, before investigators submit research proposals for funding, IRB must review the research proposals to determine whether ethical principles have been followed or not. Among the ethical research considerations specific to population health include fidelity, non-maleficence, and beneficence (DeCamp et al., 2018). Fidelity entails an individual’s respect, trust, and autonomy that the investigator should consider before starting the research. Non-maleficence means do no harm to human subjects, and beneficence implies that the study should act in the patients’ best interests (DeCamp et al., 2018).

Indeed, investigators should ensure respect for the persons, potential benefits, and burden of the research, and justice is kept balance during translation research. For example, selected individuals should be treated as autonomous subjects and are entitled to absolute protection from harm. Investigators should ensure the research is in the patients’ best interests; that is, the findings will improve population health. Again, the cost associated with research should be reasonable and affordable. After the research, participants should be distributed with benefits of research fairly and equitably. Once an investigator puts all these factors into consideration, the research has been kept balance from an ethical point of view.

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