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Posted: February 11th, 2024

Assessment requires you to visit the The Research Clinic

Overview

This assessment requires you to visit the The Research Clinic:

https://ori.hhs.gov/TheResearchClinicVideo/

You will click to play Jan Klein, RN. Work your way through the brief videos, choosing the best response as the RN assisting in research.

Upon completing the videos, you will submit a Word file that summarizes the essential elements of informed consent, special populations that require special legal and ethical research considerations, and the nurse’s role in advocating for the patient in research situations. Also, provide a summary of your personal thoughts on Jan’s actions during the activity.

Your summary should be between 300-400 words. Provide a minimum of 2 references, in 7th edition APA format, supporting your summary.

Objectives

Understand the history behind the development of Human Subjects Protection guidelines
To identify and describe the three principles of ethical human subjects research identified in the Belmont Report
To identify risks associated with participation in research and appropriate protections against risks, vulnerable populations that need specific protections, and situations in which research involving humans is exempt from regulatory requirements
Identify the essential elements of an informed consent form
Describe the nurse’s role as patient advocate in research situations
QUESTUION 2Textbooks:Godshall (2020).
Chapter 7 – Finding the Evidence
Chapter 8 – Evaluating the Evidence
OverviewThis assignment must follow the template provided.
This assessment requires you to explore the literature. Using the PICOT you developed at the beginning of the course, search the literature (library database) to find 2 research articles that are examples of 2 different levels on the levels of evidence hierarchy. The pyramid that illustrates the levels of hierarchy is provided in instructional materials. Please read about the levels of evidence to ensure you understand them before selecting your articles.
Develop your title page
Page 1: Provide your APA 7th edition reference for your 1st article at the top of the page.
In paragraph 1, identify the level of evidence on the hierarchy, summarize the design, sample, hypothesis/research question and any other components of the study itself
In paragraph 2, discuss the findings and the relevance/importance of the study to nursing practice (ie. why is this information important to know?)
NO CONCLUSION is needed.
On a new page, Provide your APA 7th edition reference for your 2nd article at the top of the page.
Repeat steps 3 and 4 for the second article. Again, no conclusion is needed.
Your studies MUST be less than 5 years old (no exceptions).Objectives
Understand the research levels of evidence hierarchy (pyramid)
Demonstrate effective data base search strategies
Identify studies by level of evidence
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nformed Consent in Research
Ethical research involving human subjects requires that participants provide voluntary informed consent. The three core principles outlined in the 1979 Belmont Report – respect for persons, beneficence, and justice – established informed consent as a fundamental aspect of ethical research (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Informed consent aims to respect individual autonomy and protect vulnerable populations by ensuring research participants understand the purpose, risks, and benefits of studies before agreeing to participate.
Essential elements of informed consent include a description of the research purpose, procedures, risks and discomforts, benefits, alternatives, confidentiality protections, compensation for injury, contact information for questions, and a statement clarifying participation is voluntary with the right to withdraw at any time (Office for Human Research Protections, 2021). Consent forms must be written in clear, understandable language at an appropriate reading level for participants (Office for Human Research Protections, 2021). Additional protections are required when involving special populations like children, prisoners, pregnant women, or those with impaired decision-making capacity.
Nurses play a key role in the informed consent process by educating potential participants and advocating for their wellbeing (American Nurses Association, 2015). As frontline healthcare providers, nurses are well-positioned to assess a person’s understanding of consent materials and address any questions or concerns. It is important nurses clarify any medical terminology, avoid coercion, and confirm voluntary participation (American Nurses Association, 2015). During the study, nurses continue advocating by monitoring for adverse events or changes in a participant’s condition that could impact the risk-benefit analysis (American Nurses Association, 2015).
Special populations requiring additional protections in research include children, prisoners, pregnant women, and those with impaired decision-making capacity. For children and others unable to consent, assent and permission from parents or guardians is required in addition to consent from those able to provide it (Office for Human Research Protections, 2021). Additional safeguards aim to protect potentially vulnerable prisoners from coercion. Pregnant women require consideration of risks to both mother and fetus. Those with impaired cognition need simplified consent processes and involvement of legally authorized representatives (Office for Human Research Protections, 2021).
In the video scenario, Jan the nurse advocated appropriately for her patient’s understanding and voluntary participation in the research study. By taking time to explain the consent form, answering questions, and confirming understanding, Jan respected the patient’s autonomy and fulfilled her role in ensuring truly informed consent (American Nurses Association, 2015; Office for Human Research Protections, 2021). While the scenario portrayed only a brief interaction, Jan’s patient-centered approach sets an example for how nurses can uphold ethical standards in research through compassionate advocacy.
In summary, informed consent and protection of vulnerable populations are cornerstones of ethical human subjects research. Nurses play a vital role in safeguarding participant rights and welfare during both the consent process and study conduct. By taking the time for thorough education, question-answering and assessment of understanding, nurses like Jan in the video fulfill their advocacy duties and help ensure research respects the dignity and autonomy of all individuals.
American Nurses Association. (2015). Code of ethics for nurses with interpretive statements..
American Nurses Association. (2015). Code of ethics for nurses with interpretive statements. Silver Spring, MD: Nursesbooks.org.
Office for Human Research Protections. (2021, January 15). The Belmont Report. HHS.gov. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

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