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Research Data Support

Guidance for planning, organizing, securing and sharing research data.

IRB considerations

Human subjects research is subject to approval by OU's Institutional Review Board (IRB). This approval includes reviewing your informed consent document. From the standpoint of research data, the informed consent form should include language to explain to study participants:

  • the potential future uses of their data
  • how you plan to protect the privacy and confidentiality of your study participants.

However, you don't want to overly restrict or prohibit sharing or preservation of the data created in the research project.

Examples of 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

Examples of less restrictive language for informed consent forms*

"...De-identified data may be used or distributed to another investigator for future research use without additional informed consent from you..."

Source: Oakland University IRB, Template "Consent form for expedited research" revised 03/2023

 

"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.

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