NUR 550 DQ: Ethical Research Considerations to Population Health
Institutional Review Board (IRB) is an administrative body creates with the aim of protecting the rights and welfare of human research participants in research activities carried under the auspices of an organization with which it is associated. The role of the IRB is to review, before its initiation, all research involving human subjects to ascertain that it does not create harm (Suri, 2020). The IRB focuses on protection of the welfare, rights, and privacy of human subjects and has the authority to approve, disapprove, monitor, and request for any changes in research activities within its jurisdiction. The IRB ensures that researchers comply with all ethical and legal provisions to validate their studies and make them credible and reliable.
Ethical considerations during research studies include ascertaining that subjects are doing sit at their own will (Al Tajir, 2018). The implication is that researchers must seek consent from the participants and should not recruit minors unless with express permission from parents or guardians. Secondly, the researchers should ensure that participants’ information and data collected is kept confidential. They should give priority to sensitive information and treat research participants with utmost respect and ensure that there is no discrimination.
Respect for individuals, possible benefits and burdens in research are balanced by ensuring that researchers comply with ethical principles and professional considerations based on existing regulations. Such compliance and knowledge of research and ethical principles ensure that research studies confer benefits to participants while risks and conflicts are mitigated and neutralized to attain the goals of the study (Barrows et al., 2021). The implication is that ethical principles and rules set by Institutional Review Board and other legal frameworks should be followed during research studies.
Al Tajir, G. K. (2018). Ethical treatment of participants in public health research. Journal of
Public Health and Emergency, 2(1), 1-10. doi: 10.21037/jphe.2017.12.04
Barrows, J. M., Brannan, G. D. & Khandhar, P. B. (2021). Research Ethics. StatPearls [Internet].
Suri, H. (2020). Ethical considerations of conducting systematic reviews in educational research.
Systematic Reviews in Educational Research, 41-54.
Topic 3 DQ 2
Discuss the role of the Institutional Review Board. Discuss ethical research considerations specific to population health. How is respect for the persons, potential benefits and burdens of the research, and justice kept in balance? Provide an example
PICOT (Population/Problem, Intervention, Comparison, Outcome, and Time to achieve the outcome) is a method that helps clarify the qualities needed to create a good question out of a practice issue or problem affecting a population of focus.
The purpose of this assignment is to complete your PICOT for your selected nursing practice problem. Refer to your “Evidence-Based Practice Project Proposal: Identification of Nursing Practice Problem” assignment from Topic 1 to complete this assignment. If your nursing practice problem or PICOT required revision, include those revisions in this assignment. The final PICOT you develop in this assignment will provide the framework for developing your evidence-based practice project proposal. Use the “PICOT-Final” template to complete this assignment.
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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.
Re: Topic 3 DQ 2
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).
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)
I agree with you that it the institutional review board (IRB) is mandated to carry out assessment and standardization of any biomedical or biotechnological research that works with human subjects. One of the key pillars considered by the IRB is the autonomy of the subjects. It is imperative to have a research framework that is built on community engagement and participation at free will without coercion or intimidation (Das & Sil, 2017). The information shared to the subjects should be truthful and no crucial information should be obstructed or hidden from them. Additionally, the research project should be of general good and valuable to the entire pubic. Clinical trials procedure should be strictly adhered to and the human trials should only be used at the appropriate stage and only on volunteers who have not been pushed to take part because of being taken advantage of or being paid in order to take part. It should be out of their self-consciousness and willingness (Landray et al., 2017).
Landray, M. J., Bax, J. J., Alliot, L., Buyse, M., Cohen, A., Collins, R., Hindricks, G., James, S. K., Lane, S., Maggioni, A. P., Meeker-O’Connell, A., Olsson, G., Pocock, S. J., Rawlins, M., Sellors, J., Shinagawa, K., Sipido, K. R., Smeeth, L., Stephens, R., & Stewart, M. W. (2017). Improving public health by improving clinical trial guidelines and their application. European Heart Journal, 38(21), 1632–1637. https://doi.org/10.1093/eurheartj/ehx086
Das, N., & Sil, A. (2017). Evolution of ethics in clinical research and ethics committee. Indian Journal of Dermatology, 62(4), 373. https://doi.org/10.4103/ijd.ijd_271_17
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 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.
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)
I agree with you that unfortunately, the United States of America has in the past been involved in unethical practices in the field of clinical and medical research. One of the most heinous act of bioethics neglect is the Tuskegee Study on untreated syphilis among the African American men in Tuskegee (“Learning from Tuskegee in Recognizing COVID-19 Vaccine Hesitancy | HealthCity”, 2021). The research was done between 1932 and 1972, for all these 40 years, the subjects in the study were given false information that they were being offered treatment of the disease. The Tuskegee Experiment was a gross violation of human rights and dignity until it prompted a public apology from the US government by President Clinton on May 15th 1997. This issue led to reduced level of trust especially by the black minority when it comes to clinical and medical interventions. It was evident, in the first roll out of Covid-19 vaccines. There was a lot of distrust about the vaccines among the black community in the initial phase of the vaccination program (Journal, 2021).
Journal, J. W. | P. by L. W. for T. W. S. (2021, February 25). History Drives Distrust in Covid-19 Vaccines for Black Americans in Tuskegee. Wall Street Journal. https://www.wsj.com/articles/history-drives-distrust-in-covid-19-vaccines-for-black-americans-in-tuskegee-11614269633
Learning from Tuskegee in Recognizing COVID-19 Vaccine Hesitancy | HealthCity. (2021, March 15). Boston Medical Center. https://www.bmc.org/healthcity/population-health/learning-tuskegee-recognizing-covid-19-vaccine-hesitancy
Refer to the “Evidence-Based Practice Project Proposal – Assignment Overview” document for an overview of the evidence-based practice project proposal assignments.
You are required to cite at least four peer-reviewed sources to complete this assignment. Sources must be published within the last 5 years and appropriate for the assignment criteria and nursing content.
While APA style is not required for the body of this assignment, solid academic writing is expected, and documentation of sources should be presented using APA formatting guidelines, which can be found in the APA Style Guide, located in the Student Success Center.
This assignment uses a rubric. Please review the rubric prior to beginning the assignment to become familiar with the expectations for successful completion.
You are not required to submit this assignment to LopesWrite.
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.
Advanced Practice Nursing: Essential Knowledge for the Profession
Read Chapter 26 in Advanced Practice Nursing: Essential Knowledge for the Profession.
Population Health: Creating a Culture of Wellness
Read Chapter 10 in Population Health: Creating a Culture of Wellness.
A Few Ethical Issues in Translation Research for Gene and Cell Therapy
Read “A Few Ethical Issues in Translation Research for Gene and Cell Therapy,” by Riva and Petrini, from Journal of Translational Medicine (2019).
The Underappreciated and Misunderstood PICOT Question: A Critical Step in EBP Process
Read “The Underappreciated and Misunderstood PICOT Question: A Critical Step in EBP Process,” by Gallagher-Ford and Melnyk, from Worldviews on Evidence-Based Nursing (2019).
Life After PICOT: Taking the Next Step in a Clinical Inquiry Project
Read “Life After PICOT: Taking the Next Step in a Clinical Inquiry Project,” by Granger, from AACN Advanced Critical Care (2020).
Read “The Belmont Report,” by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, located on the U.S. Department of Health and Human Services website (1979).
PICO: A Model for Evidence-Based Research
View “PICO: A Model for Evidence-Based Research,” by Binghamton University Libraries, located on YouTube (2017).
What is Evidence-Based Practice?
View “What is Evidence-Based Practice?” by Lippincott NursingCenter.com, located on YouTube (2016).