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IRB Considerations

 

Human subjects research is subject to approval by OU's Institutional Review Board (IRB). This approval includes reviewing your informed consent document. The informed consent form should explain how you are going to protect the privacy and confidentiality of your study participants. However, you don't want to overly restrict or prohibit sharing or preserving of the data created in the research project.

 

Overly restrictive language for informed consent forms

"Your responses will only be seen by the research team"

"All data will be destroyed after project completion"

"Your data will only be shared in aggregate form or in statistical tables"

Source: University of Minnesota IRB Approval and Considerations

 

 

Recommended language for informed consent forms*

"We will make our best effort to protect your statements and answers, so that no one will be able to connect them with you. These records will remain confidential. Federal or state laws may require us to show information to university or government officials [or sponsors], who are responsible for monitoring the safety of this study. Any personal information that could identify you will be removed or changed before files are shared with other researchers or results are made public."

"The information in this study will only be used in ways that will not reveal who you are. You will not be identified in any publication from this study or in any data files shared with other researchers. Your participation in this study is confidential. Federal or state laws may require us to show information to university or government officials [or sponsors], who are responsible for monitoring the safety of this study."

Source: ICPSR Recommended Informed Consent Language for Data Sharing

 

*As a researcher, you need to write the informed consent form so that your study participants can understand it. Therefore, the recommended language above may need to be modified for your research project.

 

 

 

Make a plan for your data

Library contact

Joanna Thielen

Joanna Thielen

Assistant Professor
Research Data Librarian
Science Librarian for Biological Sciences, Chemistry, and Physics
jthielen@oakland.edu

Created by Name / Updated on March 15, 2017 by Name

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