Secondary Data Analysis Informed Consent Waiver Request
Project Title
Principal Investigator Name
Study Description
Briefly describe the purpose and objectives of your study.
Description of Data Source
Describe the data set(s) to be analyzed, including source, content, and identifiers if any.
Justification for Waiver of Informed Consent
Explain why it is not practical to obtain informed consent from data subjects. Address all required criteria for waiver (minimal risk, rights/welfare, practicability, additional information if appropriate).
Risks to Subjects and Minimization Procedures
Describe risks to subjects and how these risks are minimized.
Privacy & Confidentiality Protections
Describe procedures for safeguarding data confidentiality and privacy (e.g. storage, access, de-identification).
Will the data include any direct identifiers?
Is the data publicly available?
Additional Information
Provide any additional information relevant to the waiver request.