Federal regulations require that the IRB review anything that a potential participant might see or hear related to the research study.
Only the investigator(s) or individuals of the research team can identify the responses of individual subjects. However, the researchers must make every effort to prevent anyone outside of the project from connecting individual subjects with their responses.
Personal identifying information must be kept separate from research data, and both sets of data should be stored in an encrypted or locked format.
Anonymity of information collected from research participants means that either the project does not collect identifying information of individual subjects, or the project cannot link individual responses with participants’ identities.
It is important to limit the amount of identifying information you collect. Only collect data that is necessary for achieving the goals of your research. However, if you need to collect and link identifying information to subjects’ responses, researchers must do their best and may need to be creative to provide the utmost confidentiality of subject data. The following are examples of practices that may be implemented to increase the level of confidentiality:
Study codes may be used on data collection instruments in place of identifying information to protect participant responses and data. Also, in the event that a data document is lost, stolen, etc. having the data protected by a study ID will prevent anyone who may view the data from determining the participant's identity. On a separate document / file type each participant's name along with their unique study ID (ex: 001). Store this document separately from data documents.
Examples of Identifying Information: