You are required to ensure human research includes adequate provisions to protect the privacy of participants and confidentiality of data, as required by federal regulations.

• Privacy refers to a person’s desire to control the access of others to themselves. For example, research participants may not want to be seen entering a place that might stigmatize them, such as a pregnancy counseling center that is clearly identified as such by signs on the front of the building.
• Confidentiality refers to the researcher’s agreement with the participant about how the research participant’s identifiable private information will be handled, managed, and disseminated.

For the IRB to assess privacy and confidentiality protections, you must describe how you will protect participant privacy and data confidentiality in your protocol or application. The IRB will assess whether the participants’ privacy interests and confidentiality of data are protected in ways commensurate with the benefits to participants and the risks of everyday life.

For more information, refer to HRP 314-WORKSHEEET-Criteria for Approval.