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Wk 8 – IRB Human Research Worksheet [Due Saturday]

DOC/741 v6
IRB Human Research Worksheet
DOC/741 v6
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IRB Human Research Worksheet
 
This assignment is designed to allow you and your dissertation chair an opportunity to plan for your IRB submission and to address issues related to the protection of human subjects.
Provide a substantive response to each of the questions below.
Note: This assignment references several resources ( GUIDANCE and FORMS ) that are available on the IRBNet website (left menu > “Forms and Templates” tab). You are also encouraged to review the required and/or optional CITI modules associated with the “Social / Behavioral Research Investigator and Key Personnel” course you previously completed.
Recruitment

GUIDANCE – Recruitment

GUIDANCE – Relationship to Research

GUIDANCE – Permissions

1. Describe both the population and sample of potential participants for your study. Include the size of each group and indicate the inclusion and exclusion criteria you are using to define and select your sample.
Click or tap here to enter your response.
2. Locate and review the following article for information on what it means to be a vulnerable subject in research:
· Sieber, J. E. (2008). Protecting the vulnerable: Who are they? Journal of Empirical Research on Human Research Ethics: An International Journal, 3(1), 1-2. doi:10.1525/jer.2008.3.1.1
Are participants in your research project considered vulnerable? Explain what makes them vulnerable. What will you do to mitigate any risks associated with the vulnerability of this group?
Click or tap here to enter your response.
3. Outline the specifics for recruiting individuals for your study. What materials will be used to conduct the recruitment?
Click or tap here to enter your response.
4. Do you need any permissions to access and recruit these individuals? Why or why not?
Click or tap here to enter your response.
5. What will you do if you are unable to obtain permission to access and recruit these individuals for research? In other words, what is your backup plan?
Click or tap here to enter your response.
Informed Consent

GUIDANCE – Informed Consent

FORMS – Informed Consent

1. What is meant by informed consent?
Click or tap here to enter your response.
2. How do you plan to gather informed consent from your study participants?
Click or tap here to enter your response.
3. Will you:
a. Use a regular informed consent procedure;
b. Request to waive or alter the regular informed consent procedure; or
c. Request to waive documentation of informed consent?
Explain your decision.
Click or tap here to enter your response.
Data Collection

GUIDANCE – Data Access and Use Permissions

GUIDANCE – Pilot Studies, Field Tests & IRB Review

GUIDANCE – Privacy, Confidentiality & Anonymity

1. Describe the instruments needed to collect your data (i.e., surveys, interview questionnaires, observation protocols, and so forth).
Click or tap here to enter your response.
2. Is permission needed to use any of the instruments in your study? If so, how do you intend to obtain permission?
Click or tap here to enter your response.
3. Do your instruments need to be validated using a pilot test or field study? Explain whether this activity will take place before or after your IRB review?
Click or tap here to enter your response.
4. If your data already exists (archived data), what permissions are needed to access this data for research purposes?
Click or tap here to enter your response.
5. What makes your data anonymous or confidential?
Click or tap here to enter your response.
6. Where will you collect your data (i.e., where will interviews, observations, or surveys take place)? Do you need to implement any strategies to ensure the confidentiality of participants during data collection? If so, describe these plans.
Click or tap here to enter your response.
Data Management

GUIDANCE – Data Management

1. Will your data include individual identifiers? Can you remove these identifiers to protect confidentiality? If so, describe when the identifiers will be removed and how they will be destroyed.
Click or tap here to enter your response.
2. Is your data going to be collected and maintained as hard copies or as electronic files? Do your data management plans adequately describe how this particular data will be securely maintained?
Click or tap here to enter your response.
Ethical Principles
Review your recruitment plans, informed consent process, data collection strategies, and data management plans as outlined above and respond to the following questions.
1. How do your plans reflect your understanding of the ethical principle of “Respect for Persons”?
Click or tap here to enter your response.
2. How do your plans reflect your understanding of the ethical principle of “Beneficence”?
Click or tap here to enter your response.
3. How do your plans reflect your understanding of the ethical principle of “Justice”?
Click or tap here to enter your response.
Copyright 2020 by University of Phoenix. All rights reserved.
Copyright 2020 by University of Phoenix. All rights reserved.
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