IRB HIPAA-Related Forms

IRB HIPAA-Related Forms

• Oath of Confidentiality, revised 5/5/09 (DOC)
  • Researchers sign this oath when they conduct studies involving the collection or analysis of confidential information about individuals without obtaining their permission.
  • Sources of information are usually medical records or clinical databases. This information is also referred to under the federal privacy rules (HIPAA) as protected health information (PHI).
• Oath of Confidentiality: Recruitment, revised 5/5/09 (DOC)
  • Researchers based at Children’s sign this oath when they need to review confidential (protected) health information about Children’s patients for the sole purposes of identifying patients eligible for a research study.
  • This Oath is used to obtain the minimum necessary information needed for recruitment purposes only. After recruitment efforts are completed, any information collected on patients who did not take part in the research must be destroyed.
• HIPAA Authorization Form: Permission to Use, Create and Share Health Information for Research, revised 6/09/09 (DOC)
• Also available in the following languages:
• Traditional Chinese (PDF)
• Simplified Chinese (PDF)
• Hindi (DOC)
• Korean (PDF)
• Russian (PDF)
• Somali (PDF)
• Spanish (DOC)
• Vietnamese (PDF
• Use this form for all research studies that use, create, or share protected health information.
• This form is used in addition to the research study consent form. The form contains all the elements needed to be compliant with the federal privacy rules known as HIPAA.
• Electronic Research Disclosure Tracking Form (for use within Children’s network)
• Printable Research Disclosure Tracking Form (PDF) (for use outside Children’s network)
  • Use this form when a Children’s patient's health information (PHI) is accessed electronically (e.g. CIS, Invision, department databases) for use in an IRB-approved research study, where use of the information has not been authorized by the patient/parent (IRB approved a waiver of authorization) and when the research team contains members who are not part of Children’s workforce.
  • Employees of Children’s, CUMG, and residents and fellows working at Children’s are part of Children’s workforce.
  • Your data will automatically feed into Children’s disclosure tracking system when you enter it into the electronic Research Disclosure Tracking Form. Children’s must track all disclosures of PHI that were made without an authorization.