IRB Application Instructions - Subject Privacy / Confidentiality

Help Information

A. Privacy (22A: Expedited / Full Board, 11A: Exempt)

  • Privacy means having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

  • Anonymity means that no one, including the principal investigator, is able to associate responses or other data with individual subjects.  Investigators may promise anonymity only under this condition.  Face to face interviews are not considered anonymous.

  • See HRPP Manual Section 6-6, Privacy, Confidentiality, and Anonymity for considerations

B. Data Storage (22A: Expedited / Full Board, 11A: Exempt)

  • Records relating to the research, such as signed informed consent documents, must be maintained for at least three years following completion of the research; please note that other regulations or requirements (e.g. contract), may have longer retention periods

  • See HRPP Manual Section 4-7, Recordkeeping for requirements

C. Access to Data (22A: Expedited / Full Board, 11A: Exempt)

  • Will identifiable data be shared outside the research team?

  • Is the project subject to data sharing requirements?

D. Confidentiality / Anonymity (22D: Expedited Full Board / 11B: Exempt)

  • Confidentiality means treatment of information that an individual has disclosed in a relationship of trust with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission.

  • See HRPP Manual Section 6-6, Privacy, Confidentiality, and Anonymity for considerations

E. Monitoring Plan (Expedited / Full Board Only)

  • If it is appropriate for your project to have a monitoring plan, the plan will depend upon the nature, size, risk, and complexity of the study

  • See HRPP Manual Section 6-7, Data and Safety Monitoring, for considerations and requirements

Helpful HRPP Manual Sections

Question Number

  • Initial Application (Exempt) - Question 11A, 11B

  • Initial Application (Expedited and Full Board) - Question 22A, 22B, 22C, 22D, 22E