Institutional Review Board

Please refer to the following templates and samples for guidance with developing materials for your project.

Study Protocol

Your protocol must follow the protocol template in order to be considered for review.

• Protocol template

Informed Consent

• Introduction to Informed Consent
  
  
• Informed consent template
  
  
• California Experimental Subject's Bill of Rights
  
  
• California Experimental Subject's Bill of Rights (Spanish)

Parent/Guardian Permission and Minor Assent

• Parent/Guardian Permission Form template

• Child Assent Form (Ages 7-12) template

• Teen Assent Form (Ages 13-17) template

HIPAA Authorization

If your project will obtain HIPAA authorization, you must use the following HIPAA Authorization form. If you have any questions regarding whether your data includes Protected Health Information (PHI), please review your institution's HIPAA policy and/or contact the Privacy Officer at your institution.

• HIPAA PHI Individual Authorization Form

The IRB reviews any DPH-related research project that involves the collection or analysis of data from or about human subjects.

Research projects may include…

• Clinical trials

• Focus groups

• Data abstraction from medical records

• Surveys

Though IRB procedures allow exemption for some data collection projects that are classified as routine public health activity rather than research, the IRB must make the determination that a project is exempt.