Protecting Human Research Participants
Capstone in Applied Practice II
(NIH) Protecting Human Research Participants
You will explore and investigate the history and relevance of human subject protection by completing the National Institutes of Health’s (NIH) Protecting Human Research Participants course. This certificate is required for IRB submission for South University. Submit a copy and keep this in a file for your IRB submission.
You will explore and investigate the history and relevance of human subject protection by completing the ethics course found at this link (free of charge without CEs)
Submit evidence of completion. This is not graded but is required for submission and for IRB.
Training on Ethical Practice in Research with Human Subjects
ACRP has a free option for this training if you select “Pricing Without Contact Hours.” You will need to create an account in order to take the course.
NSG8105 Capstone in Applied Practice II
Week 4 Project
Overview of Project Methods
During this course, you will complete a multipart paper, with different pieces due in various weeks.
Overview
During this course, your Methods section will be broken down into two sections to allow you to focus specialized attention on and develop methods that will be ready for implementation in the next course. Section 1 will include an overview of the approach/design, site, agency, or participant information and methods. Section 2 will include any instruments, data collection methods, and the data analysis plan. The purpose of the substantive drafts is to develop a solid plan for your DNP project and develop a final project deliverable that incorporates faculty feedback and is ready for implementation during your next course, NSG8110.
In Week 6, you will submit a substantive draft of Section 1 of your Methods section. Remember that Section 1 includes the following information:
Overview of the Approach/Design: This section should make clear to the reader the manner in which you intend to approach the clinical question and the techniques and logic that you will use to address it.
Site, Agency, or Participant Information: This section should include a description of key information related to the practicum site and key variables that describe any participants (often called the sample) whom you wish to include in your project.
Methods: What will you do? Nurses or other healthcare professionals may wish to replicate your work in their settings. When others replicate your work, it allows for verification of your findings, an opportunity for improved quality, safety, or finances in another setting, or the potential for collaboration with colleagues who share your same interests. To make results verifiable, you need to give a complete and accurate description of the techniques that you will be using for your project. This section should be clear, direct, and to the point, while including all information. Ensure that your methods describe a clear and feasible time frame.
In Week 7, you will submit a draft of Section 2 of your Methods section of your project. Remember that Section 2 includes the following information:
Instruments: What instruments will you use? What evidence or research exists for the instruments? Have they been determined to be valid or reliable? If so, for what groups? If you are using an instrument or tool that has not been well studied, ensure that you provide evidence to justify its use in your project.
Data Collection: Are there any other points of data that you will be collecting that have not previously been mentioned? The emphasis in this section should be on fully describing specifically what data you will be using in your study. Part of the purpose of doing this is to detect flaws in the plan before they become problems in the research.
Data Analysis Plan: How will you analyze your data? This section should explain in some detail how you will manipulate the data that you assembled to get at the information that you will use to answer your question. When describing statistical tests, ensure that you have specified the appropriate information, such as the significance level and type of confidence interval (one- or two sided). Additionally, describe what meaning the output of any statistical tests will help answer and how it relates to your PICOT/clinical problem.
In Week 8, you will resubmit Section 1 of your Methods section on the basis of faculty feedback that you have received.
In Week 9, you will resubmit Section 2 of your Methods section on the basis of faculty feedback that you have received.
In Week 10, you will submit your final course paper. Your final course paper should include the totality of your Methods section and your introduction (with any revisions suggested by previous faculty). To download a suggested format and minimum expectations for your final course paper, click here.
Assignment
This week, you will submit a 1–2-page overview of your Methods section. Include information about data collection tools that you would like to use and the process you will follow for your DNP project.
NSG8105 Capstone in Applied Practice II
Week 5 Project
Final IRB Submission
By the due date assigned, submit your rough IRB submission based on the feedback you received from your instructor to the Submissions Area. This will be a another review to ensure that you are ready to move forward with submission to the IRB. After receiving confirmation from your instructor, you will continue to refine the applications before submission, which will assist with submission to the IRB.
You must attach all elements required for IRB submission in a zipped file including the following:
Completed IRB application
Participant Consent Form (and child assent form if needed)
Recruitment Materials-flyer, online email, script
Tools
Permission to use tools
Education materials (ALL)
Letter of permission to conduct study at site (and statement that there is no IRB) *IF site has IRB- this must be done first
Student ACRP human subjects certificate
Chair/Professor’s ACRP/CITI human subjects certificate
NSG8105 Capstone in Applied Practice II
Week 8 Project
Methods: Revision of Section 1
This week, you will submit a revised version of Section 1 of your Methods section on the basis of faculty feedback. Remember that Section 1 should include the following information:
Overview of the Approach/Design: This section should make clear to the reader the way that you intend to approach the clinical question and the techniques and logic that you will use to address it.
Site, Agency, or Participant Information: This section should include a description of key information related to the practicum site and key variables that describe any participants (often called the sample) that you wish to include in your project.
Methods: What will you do? Nurses or other healthcare professionals may wish to replicate your work in their settings. When others replicate your work, it allows for verification of your findings, an opportunity for improved quality, safety, or finances in another setting, or the potential for collaboration with colleagues who share your same interests. To make results verifiable, you need to give a complete and accurate description of the techniques that you will be using for your project. This section should be clear, direct, and to the point while writing your methodology.
NSG8105 Capstone in Applied Practice II
Week 3 Assignment
IRB Application
Early in the week, speak with someone from your clinical site about your project and human subject protection. After assessing what type of submission will be needed (either your clinical site’s IRB or the South University IRB), complete all relevant paperwork and submit it for faculty review. The South University IRB application can be downloaded here. Depending on what type of data you are collecting, you will likely need to use an informed consent document.
Remember, this is a draft. Please be sure to review the videos posted on the IRB process before completing this.
Submit your documents to the Submissions Area by the due date assigned.
NSG8105 Capstone in Applied Practice II
Week 6 Assignment
Methods Development
As discussed in Week 4, during this course, your Methods section will be broken down into two sections to allow you to focus specialized attention on and develop methods that will be ready for implementation in the next course. Section 1 will include an overview of the approach/design, site, agency, or participant information and methods. Section 2 will include any instruments, data collection methods, and the data analysis plan. The purpose of the substantive drafts is to develop a solid plan for your DNP project and develop a final project deliverable that incorporates faculty feedback and is ready for implementation during your next course, NSG8110.
This week, you will submit a substantive draft of Section 1 of your Methods section. Remember that Section 1 includes the following information:
Overview of the Approach/Design: This section should make clear to the reader the manner in which you intend to approach the clinical question and the techniques and logic that you will use to address it.
Site, Agency, or Participant Information: This section should include a description of key information related to the practicum site and key variables that describe any participants (often called the sample) whom you wish to include in your project.
Methods: What will you do? Nurses or other healthcare professionals may wish to replicate your work in their settings. When others replicate your work, it allows for verification of your findings, an opportunity for improved quality, safety, or finances in another setting, or the potential for collaboration with colleagues who share your same interests. To make results verifiable, you need to give a complete and accurate description of the techniques that you will be using for your project. This section should be clear, direct, and to the point while writing your methodology.
*For a thorough understanding of the entire Methods section assignment and final course paper, see W6 Final Paper—Working Ahead.
NSG8105 Capstone in Applied Practice II
Week 7 Assignment
Section 2 of Methods
This week, you will submit a draft of Section 2 of the Methods section of your project. Remember that Section 2 includes the following information:
Instruments: What instruments will you use? What evidence or research exists for the instruments? Have they been determined to be valid or reliable? If so, for what groups? If you are using an instrument or tool that has not been well studied, ensure that you provide evidence to justify its use in your project.
Data Collection: Are there any other points of data that you will be collecting that have not previously been mentioned? The emphasis in this section should be on fully describing specifically what data you will be using in your study. Part of the purpose of doing this is to detect flaws in the plan before they become problems in the research.
Data Analysis Plan: How will you analyze your data? This section should explain in some detail how you will manipulate the data that you assembled to get at the information that you will use to answer your question. When describing statistical tests, ensure that you have specified the appropriate information, such as significance level and type of confidence interval (one or two sided). Additionally, describe what meaning the “output” of any statistical tests will help answer and how it relates to your PICOT/clinical problem.
NSG8105 Capstone in Applied Practice II
Week 9 Assignment
Methods: Revision of Section 2
This week, you will submit a revision of Section 2 of your Methods section on the basis of feedback received from your instructor. Remember that Section 2 should include the following information:
Instruments: What instruments will you use? What evidence or research exists for the instruments? Have they been determined to be valid or reliable? If so, for what groups? If you are using an instrument or tool that has not been well studied, ensure that you provide evidence to justify its use in your project.
Data Collection: Are there any other points of data that you will be collecting that have not previously been mentioned? The emphasis in this section should be on fully describing specifically what data you will be using in your study. Part of the purpose of doing this is to detect flaws in the plan before they become problems in the research.
Data Analysis Plan: How will you analyze your data? This section should explain in some detail how you will manipulate the data that you assembled to get at the information that you will use to answer your question. When describing statistical tests, ensure that you have specified the appropriate information, such as the significance level and type of confidence interval (one- or two sided). Additionally, describe what meaning the output of any statistical tests will help answer and how it relates to your population/patient, intervention, comparison, outcome, and time (PICOT)/clinical problem.
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