Data security and confidentiality protections are an essential aspect of the ethical conduct of research. Data security measures for human subjects research must comply with federal regulations for the protection of human subjects and institutional policies regarding the protection of data. Researchers must have adequate confidentiality protections for storage and transmission of paper and electronic records and biospecimens, particularly when data are more sensitive.

Consult with your departmental IT representative for help to prepare an effective data security plan based on the sensitivity of data collected in the study. For additional guidance, see the UI Information Technology Services (ITS) web page Protecting Sensitive Data (overview and how to and support) and/or consult with IT Research Services (

The Data Security Guidance tool provides issues to consider and institutional policy regarding research data security. This tool also distinguishes between privacy and confidentiality protections and includes best practices to protect privacy at the point of data collection and to protect confidentiality during data storage and transmission.

Protected Health Information 

Researchers must implement additional confidentiality protections for medical records that are used for research purposes. Protected Health Information (PHI) includes health information that:

  • Is transmitted or maintained in any form (electronic, oral, paper) by a covered entity
  • Identifies the individual or could reasonably be used to identify the individual, including name, contact information, date of birth, dates of service, account numbers, and full-face photographic images (see the list of 18 HIPAA identifiers)
  • Relates to past, present, or future, physical or mental, health condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual

Confidentiality Protections

Researchers protect subjects by restricting access to study materials and by the way these materials are identified. Data may be recorded or stored in the following manner:

  • Anonymous – Study data are anonymous if no identifying information is collected from subjects. This is the highest level of protection for subject privacy.
  • ID code with no link to subject identifiers – This is similar to anonymous data. In some cases, researchers ask subjects to answer a series of questions to create a unique ID code for themselves that can be used for data collection at future timepoints.
  • ID code with link to subject identifiers – Researchers may assign an ID code and store the link between the code and identifying information about the subject. The research team must have a robust data security plan for storage of that key.
  • Identified – Some data, such as photographs or videotapes, will by nature be identifiable. In this case, researchers protect subjects by establishing a robust data security plan for storage, transmission and transport of these data.

Paper Records

Paper records include any paper documents that contain study data or other research-related records. Signed Informed Consent Documents are considered paper records with identifiable information (subject name). The research team is responsible for maintaining confidentiality protections for all paper records, including signed consent documents, during transport and storage of these records. Some common confidentiality protections for paper records include: locked file cabinet, locked office, transporting documents in a folder, envelope or locked briefcase.

Electronic Records

Electronic records include all electronic files and digital recordings or images that are collected and/or stored for research purposes. The confidentiality protections for these records depends on the sensitivity of the data and can include:

  • Password protected files
  • Limited access folders on a shared drive
  • Encryption


Researchers must also maintain data security for biospecimens collected and stored for research purposes. This can be done by labeling samples with an ID code rather than subject identifiers. Another method is to restrict access to the specimen storage location, so it is only accessible to research team members.