Address issues related to the protection of human subjects.

IRB Human Research Worksheet

This worksheet is designed to allow you and your dissertation chair to plan for your IRB submission and to address issues related to the protection of human subjects.

Respond to each item below. Start each answer on a new line.

Note: This worksheet references several resources (Guidance and Forms) thatare availablefromIRBNet(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

Describe 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.
- 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? If so, explain what makes them vulnerable. What will you do to mitigate any risks associated with the vulnerability of this group?
Outlinethe specifics for recruiting individuals for your study. What materials will be used to conduct the recruitment?
Do you need any permissions to access and recruit these individuals? Why or why not?
What will you do if you are unable to obtain permission to access and recruit these individuals for research? In other words, what isyour backup plan?

Informed Consent

Guidance> Informed Consent

Forms> Informed Consent

What doesinformed consentmean?
How do you plan to gather informed consent from your study participants?
- Will you:
  - Use a regular informed consent procedure?
  - Request to waive or alter the regular informed consent procedure?
  - Request to waive documentation of informed consent?

Data Collection

Guidance> Data Access and Use Permissions

Guidance> Pilot Studies, Field Tests, and IRB Review

Guidance> Privacy, Confidentiality, and Anonymity

Describe the instruments needed to collect your data (i.e., surveys, interview questionnaires, observation protocols, and so forth).
Is permission needed to use any of the instruments in your study? If so, how do you intend to obtain permission?
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.
If your data already exists (archived data), what permissions are needed to access this data for research purposes?
What makes your data anonymous or confidential?
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.

Data Management

Guidance> Data Management

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.
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 data will be securely maintained?

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:

How do your plans reflect your understanding of the ethical principle of “Respect for Persons”?

How do your plans reflect your understanding of the ethical principle of “Beneficence”?

· How do your plans reflect your understanding of the ethical principle of “Justice”?

Answer preview to Address issues related to the protection of human subjects.

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