Sample IRB Application Text

This page provides sample language that can be used as a model for some responses in the ARROW application and consent documents. The examples provided are to be used as a guide only and should be edited appropriately to fit your study design.

Study Summary
  • 1.1: "From time of final IRB approval until ____________."
NOTE: Include time to conduct data analysis.
Risks and Benefits: General
  • 1.1: "There are no direct benefits." If Study Teams want to provide additional detail, preface with "However..."
NOTE: Compensation is NOT considered a benefit.
Risk/Benefit Analysis
  • 4.1: Though not all-inclusive, these are examples of common risks in education and social/behavioral research:
    • "There is a risk of a confidentiality breach."
    • "Participants may be upset by aspects of the research."
    • "Participants may reveal personal, sensitive, or identifiable information when responding to open-ended questions."
    • "Participants may reveal illegal behaviors due to the nature of the questions."
    • "Participants may become fatigued or frustrated due to the length of the study."
  • 4.2:  Though not all-inclusive, these are examples of common methods to minimize risks listed above:
    • "Data will be stored securely according to campus policy; when necessary, identifiable or sensitive information will be stored separately from other study data and participant identities will be masked in publication."
    • "Participants will be informed about all aspects of the study during consent and have the option to skip or withdraw from any activities that make them upset or uncomfortable."
    • "Personal, sensitive, or identifiable information will either be removed from the research record or, if such information is necessary to answer the research question, it will be stored separately from other study data or coded with the decryption key stored in a separate location."
    • "If a participant reveals illegal behavior, it will either be removed from the research record or, if necessary to answer the research question, a Certificate of Confidentiality will be obtained."
    • "Participants will be informed of the approximate length of study activities during the consent process and will be offered the opportunity to take breaks during the study activities if needed."
  • 4.4: "The Study Team will work with the PI and the IRB to address any unanticipated problems that may occur."
Privacy and Confidentiality
  • 1.1: Though not all-inclusive, these are examples of the type of responses the IRB would expect in this section:
    • "Interactions with study participants will be conducted in a private room or a location chosen by the participant."
    • "Data collection will be limited to the amount necessary to achieve the aims of the research.  In the event that unnecessary personal, sensitive, or identifiable information is provided by the participant, it will either not be recorded or removed from the research record as soon as possible."
    • "All communications regarding research activities will either be directly with the consented participant and from a location where privacy can be maintained or be general enough to protect the personal/private information of the participant (e.g. phone conversations with/about participants should be limited to private spaces or language should be limited to non-identifiable information; written communications such as letters, emails or texts should not contain personal or sensitive information)."
  • 1.3: Though not all-inclusive, these are examples of the type of responses the IRB would expect in this section:
    • "Paper files and consent forms will be stored in a locked file in the PI's campus office."
    • "Video files will be stored on UW Box."
    • "Audio files are for transcription purposes only and will be permanently destroyed as soon as transcription is complete."
    • "Transcriptions will be stored on UW Box indefinitely."
    • "Electronic files will be stored on a secure department server."
    • "Data will be coded to remove direct identifiers and the link to the code will be stored in a separate file accessible only via password."
    • "Only approved personnel will have access to study data."
Privacy and Confidentiality: Continued
  • 2.1.1: "Data will be temporarily stored on a password protected laptop and transferred to UW-Box for long-term storage.  Data stored on a laptop will not contain direct identifiers."

NOTE: More stringent data protection measures may be requested by the IRB, depending on the sensitivity of the subject matter.

Audio Recordings
  • 2.1.1: "Transcription will be done by a member of the Study Team or by a campus-approved professional transcription service."
Interviews, focus groups, surveys, questionnaires, assessments: Continued
  • 3.1.2:  "Sensitive, stigmatizing, or psychologically disturbing information will be stored separately from information that could be used to identify the participant.  Additionally, a Certificate of Confidentiality will be obtained or, if a Certificate will not be obtained, such information will be coded and the decryption key will be stored separately."
  • 3.2:  "Participants will be informed prior to the beginning of the focus group that confidentiality cannot be guaranteed in a group setting, however, participants will be asked to keep information shared during the session private."
  • 3.3:  "The researcher will inform participants prior to the home visit that he/she is required to abide by local law regarding reporting of child or elder abuse/neglect and that in such cases confidentiality may need to be broken.  The researcher will then abide by local laws concerning such matters."
Consent Language
  • Confidentiality in focus groups
    • "Although the research team will strive to maintain your confidentiality, due to the group setting, confidentiality cannot be guaranteed.  However, all focus group members are asked to keep information shared during the session private."
  • Reporting Language
    • Research conducted in homes by University of Wisconsin System affiliates (including all student researchers)
      • "Researchers may be required to break confidentiality if abuse or neglect of a minor is suspected or witnessed while in your home."
    • Mandated Reporters by State Statute (required to report based on professional duties, such as social workers or counselors)
      • "If the researchers learn that you, your child, or someone else is in serious danger or at risk of being harmed, they will make the disclosures necessary to protect your and/or other persons.  If concerns arise about the welfare of you, your child, or your family, the researchers will make every effort to talk with you before disclosing information."
    • Research topics that could potentially reveal sensitive information
      • "Researchers may be required to break confidentiality if it is revealed that the safety of you or someone else is at risk."
  • Voluntary participation
    • "Your participation in this research is voluntary.  You may choose not to participate or to withdraw from the research at any time."
  • Access to audio recordings
    • "Only authorized personnel will have access to the audio recordings."




Keywords:wording, complete, guidance, ARROW, protocol   Doc ID:68242
Owner:Kamie L.Group:Education and Social/Behavioral Science IRB
Created:2016-11-02 12:47 CSTUpdated:2019-01-17 12:17 CST
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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