NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
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An Institutional Examine Board is a body that the FDA has explicitly authorized to review and oversee human biomedical research. The goal of an IRB review is to ensure that adequate safeguards are in place to protect research subjects’ rights and welfare both in advance and on a regular basis. NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health. IRBs use a group procedure to evaluate study protocols and related materials (such as informed consent forms and investigator brochures) to ensure the rights and welfare of research subjects (FDA, n.d).
Acceptance of an ethical standard that prioritizes local autonomy is essential for public health. This standard can be met by requiring community participation (at a minimum, the formation of a community advisory board) to protect vulnerable populations, ensure equitable working conditions, confirm that the interventions being tested are acceptable to community members, and reduce potential research misunderstandings.NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
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Before any research can begin, these community advisory committees must determine whether the study’s objectives and procedures will benefit the neighborhood’s residents (Buchanan & Miller, 2006). NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
Social injustice is one of the most important ethical issues in this era of translational research. It is usual for resource-rich countries to perform translational medical research in resource-poor countries, but this can lead to social injustice and unfairness if the research’s findings are not expected to be beneficial to or are less advantageous to the resource-poor country. Examples include studies conducted in impoverished nations on rare diseases or studies whose interventions or products are too expensive to use (Mandal et al., 2017).
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. NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
Re: Topic 3 DQ 2 NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
An Institutional Review Board is a group that has been formally designated by the FDA to review and monitor biomedical research involving human subjects. The purpose of IRB review is to ensure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research, both in advance and through periodic review.
IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure the rights and welfare of human subjects of research are protected (FDA, n.d).NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
From the standpoint of public health, it is critical to recognize an ethical standard that respects community autonomy. This standard can be met by requiring community collaboration (i.e., establishing a community advisory board) to protect vulnerable populations, ensure fair terms of cooperation, ratify that the interventions to be tested are acceptable to community members, and reduce potential misunderstandings about the research.
Before allowing the research to proceed, such community advisory boards should determine whether the research goals are valuable to local community members and whether the methods are acceptable (Buchanan & Miller, 2006).NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
Social injustice is a critical ethical concern in this era of translational research. It is common for resource-rich countries to conduct translational medical research in resource-poor countries, and if the research results are not expected to be beneficial/less beneficial to the resource-poor country, the issue of social injustice and disparity arises. Examples include research on rare diseases where the resulting intervention/product is prohibitively expensive to implement in developing countries (Mandal et al., 2017).
ALSO READ: NUR 550 Topic 4 DQ 1 Distinguish between reliability and validity in research design
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RESPOND HERE (150 WORDS, 2 REFERENCES)
Hello,NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
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.NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
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). NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
References
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.ijd27117
Re: Topic 3 DQ 2
Unfortunately, many countries, including the United States, have previously conducted unethical clinical trials, and as a result, we have implemented policies and regulations to protect human participants. The Institutional Review Board (IRB) was established to maintain safeguards for these clinical trials. They are guided by three fundamental ethical principles: respect for the individual, 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 safety of the patient or study participant (Qiao, 2018). Patient safety is of the utmost importance at all stages of the trial. By ensuring equity, justice will be maintained in balance. Health equity has recently become a hot topic, with many minorities lacking access to clinical trials or the knowledge to feel comfortable participating.
Name: Assignment Rubric
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Summarize your interpretation of the frequency data provided in the output for respondent’s age, highest school grade completed, and family income from prior month.
32 (32%) – 35 (35%)
The response accurately and clearly explains, in detail, a summary of the frequency distributions for the variables presented.
The response accurately and clearly explains, in detail, the number of times the value occurs in the data.
The response accurately and clearly explains, in detail, the appearance of the data, the range of data values, and an explanation of extreme values in describing intervals that sufficiently provides an analysis that fully supports the categorization of each variable value.
The response includes relevant, specific, and appropriate examples that fully support the explanations provided for each of the areas described.
28 (28%) – 31 (31%)
The response accurately summarizes the frequency distributions for the variables presented.
The response accurately explains the number of times the value occurs in the data.
The response accurately explains the appearance of the data, the range of data values, and explains extreme values in describing intervals that provides an analysis which supports the categorization of each variable value.
The response includes relevant, specific, and accurate examples that support the explanations provided for each of the areas described.NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
25 (25%) – 27 (27%)
The response inaccurately or vaguely summarizes the frequency distributions for the variables presented.
The response inaccurately or vaguely explains the number of times the value occurs in the data.
The response inaccurately or vaguely explains the appearance of the data, the range of data values, and inaccurately or vaguely explains extreme values.
An analysis that may support the categorization of each variable value is inaccurate or vague.
The response includes inaccurate and irrelevant examples that may support the explanations provided for each of the areas described.
0 (0%) – 24 (24%)
The response inaccurately and vaguely summarizes the frequency distributions for the variables presented, or it is missing.
The response inaccurately and vaguely explains the number of times the value occurs in the data, or it is missing.
The response inaccurately and vaguely explains the appearance of the data, the range of data values, and an explanation of extreme values, or it is missing.
An analysis that does not support the categorization of each variable values is provided, or it is missing.
The response includes inaccurate and vague examples that do not support the explanations provided for each of the areas described, or it is missing.
Summarize your interpretation of the descriptive statistics provided in the output for respondent’s age, highest school grade completed, race and ethnicity, currently employed, and family income from prior month.
45 (45%) – 50 (50%)
The response accurately and clearly summarizes in detail the interpretation of the descriptive statistics provided.
The response accurately and clearly evaluates in detail each of the variables presented, including an accurate and complete description of the sample size, the mean, the median, standard deviation, and the size and spread of the data.
40 (40%) – 44 (44%)
The response accurately summarizes the interpretation of the descriptive statistics provided.
The response accurately explains evaluates each of the variables presented, including an accurate description of the sample size, the mean, the median, standard deviation, and the size and spread of the data.
35 (35%) – 39 (39%)
The response inaccurately or vaguely summarizes the interpretation of the descriptive statistics provided.
The response inaccurately or vaguely evaluates each of the variables presented, including an inaccurate or vague description of the sample size, the mean, the median, the standard deviation, and the size and spread of the data.
0 (0%) – 34 (34%)
The response inaccurately and vaguely summarizes the interpretation of the descriptive statistics provided, or it is missing.
The response inaccurately and vaguely evaluates each of the variables presented, including an inaccurate and vague description of the sample size, the mean, the median, the standard deviation, and the size and spread of the data, or it is missing.NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
Written Expression and Formatting – Paragraph Development and Organization:Paragraphs make clear points that support well-developed ideas, flow logically, and demonstrate continuity of ideas. Sentences are carefully focused—neither long and rambling nor short and lacking substance. A clear and comprehensive purpose statement and introduction is provided which delineates all required criteria.
5 (5%) – 5 (5%)
Paragraphs and sentences follow writing standards for flow, continuity, and clarity.
A clear and comprehensive purpose statement, introduction, and conclusion is provided which delineates all required criteria.
4 (4%) – 4 (4%)
Paragraphs and sentences follow writing standards for flow, continuity, and clarity 80% of the time.
Purpose, introduction, and conclusion of the assignment is stated, yet is brief and not descriptive.
3 (3%) – 3 (3%)
Paragraphs and sentences follow writing standards for flow, continuity, and clarity 60%–79% of the time.
Purpose, introduction, and conclusion of the assignment is vague or off topic.
0 (0%) – 2 (2%)
Paragraphs and sentences follow writing standards for flow, continuity, and clarity < 60% of the time.
No purpose statement, introduction, or conclusion was provided.
WrittenNUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health Expression and Formatting – English writing standards:Correct grammar, mechanics, and proper punctuation
5 (5%) – 5 (5%)
Uses correct grammar, spelling, and punctuation with no errors.
4 (4%) – 4 (4%)
Contains a few (1 or 2) grammar, spelling, and punctuation errors.
3 (3%) – 3 (3%)
Contains several (3 or 4) grammar, spelling, and punctuation errors.
0 (0%) – 2 (2%)
Contains many (≥ 5) grammar, spelling, and punctuation errors that interfere with the reader’s understanding.
Written Expression and Formatting – The paper follows correct APA format for title page, headings, font, spacing, margins, indentations, page numbers, parenthetical/in-text citations, and reference list.
5 (5%) – 5 (5%)
Uses correct APA format with no errors.
4 (4%) – 4 (4%)
Contains a few (1 or 2) APA format errors.
3 (3%) – 3 (3%)
Contains several (3 or 4) APA format errors.
0 (0%) – 2 (2%)
Contains many (≥ 5) APA format errors.
Total Points: 100
Regulatory bodies that ensure ethics is upheld in research include human research protection programs, institutional review boards (IRBs), federal U.S. groups like the FDA, and codes/reports such as the Belmont Report (Rabinak, 2017). I agree with the roles that these regulatory bodies have in the research process because they uphold proper and ethical/legal standards and protect the rights of research participants.NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
Research must maintain respect for persons- which includes informed consent and confidentiality, beneficence, and justice (Rabinak, 2017). When these principles and rights are violated, it can have negative effects on the research participants as we have seen happen in the past. Having third-party regulatory bodies reviewing and guiding research studies ensures that human participants are protected and ethical standards are complied with.
Reference Rabinak, Christine. (2017, July 7). Ethical considerations in clinical research [Video]. YouTube. NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
I watched the video on ethical considerations in clinical research and I completely agree with the governing bodies role in the safety of clinical trial participants. First off the participants must know that their safety is our number one concern. After all the clinics trials ultimate outcome is to improve patient safety or patient care to the population. They need to know we will keep their participation confident.
Also, they need to know that we appreciate their willingness to participate and we show that by beneficence, that the benefit will outweigh the risk. Lastly is justice, if we are not committed to being fair and honest there is really no point in doing research at all. We need our research to be valid and trustworthy in order for people to allow us to make these positive changes in their care, be it healthcare or other areas of their lives.NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
Rabinak, Christine. (2017, July 7). Ethical considerations in clinical research [Video]. YouTube.
Regulatory agencies play an integral role in clinical research programs. They were developed as a result of issues that occurred in the past. Human Research Protection Agency protects the rights and wellbeing of human subjects who are involved in clinical research that are conducted by the US Department of Health and Human Services. This goal is accomplished through guidelines and protocols regulations.
This is vital to the success of the research. As stated in the Belmont Report, human subjects should be voluntarily consented to being apart of clinical research after adequate information was related to them.NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
Rabinak, Christine. (2017, July 7). Ethical considerations in clinical research [Video]. YouTube. NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
Three regulatory bodies that insure that ethical guidelines are followed during research involving human subjects are Human Research Protection Programs (HRPPs), Food and Drug Administration (FDA), and the Institutional Review Board (IRB). There is also a Office for Human Research Protections that oversees research conducted by the federal government through the Health and Human Services Department (Health and Human Services, n.d.). I feel that these regulatory bodies and the roles they play are vial in protecting people during the research process.
Medical research is necessary for the development and improvement of medications, medical treatment options and procedures, but history has proven that, if not regulated, great harm can be done in the name of research.NUR 550 Topic 3 DQ 2 Discuss ethical research considerations specific to population health
References:
Health and Human Services. (n.d.). Office for Human Research Protections. https://www.hhs.gov/ohrp/index.html
Rabinak, Christine. (2017, July 7). Ethical considerations in clinical research [Video]. YouTube.
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