The protection of subjects in ALL STUDIES requires the assurance that privacy, security and confidentiality are appropriately managed. Principal investigators must ensure that studies include provisions for security and for ensuring the privacy and confidentiality of participants. The strategies to ensure privacy, security and confidentiality during and after the research shall be evaluated by the IRB which acts as the Privacy Board for HIPAA-related purposes, and the appropriateness of these strategies shall be a prerequisite for its study approval.
Strategies for privacy must ensure each participant’s right to be free from unauthorized or unreasonable intrusion into his/her private life and the right to control access to personal information. Research procedures should be carefully designed to limit the personal information to be acquired to that which is minimally necessary and should be administered using procedures that will protect the subject's privacy.