Research Authorization Instructions
The attached research authorization is required to obtain or collect Protected Health Information for research purposes unless:
- The IRB has waived HIPAA authorization; or
- Only deidentified data is collected (see De-identification); or
- The data is a limited data set collected under a data use agreement (see Limited datasets); or
- The study is of decedents and has been approved by the privacy official (see Decedent research application); or
- The data is being collected for purposes preparatory to research, and has been approved by the privacy official (see Research preparation application).
The filled-out form must be signed by the research subject prior to collecting any data, and filed in the chart in the consents section.
The following authorization is the appropriate form for the University of California. If you want to use a different form for the authorization, and the PHI is being obtained at or from a University of California facility, you must have the form approved by Teresa Porter (916) 734-8808.
Other entities may require their own specific authorization form when you collect PHI there. If you are collecting data from an entity in another state, the form will definitely be different, as this form has sections addressing California state laws.
As of January 1, 2004, the authorization's font size must be at least 14 points.
The form is only available in English. If the subject's primary language is not one for which an authorization has been prepared or if there are other language barriers that would prevent the subject from reading and understanding the authorization, a reader or an interpreter who is fluent in the subject's primary or spoken language may, if the subject agrees, read the full authorization to the individual. The interpreter will sign the interpreter's statement at the end of the authorization. The interpreter or reader may be a family member or friend if the subject agrees.
Oral authorizations are not normally allowed. If you need to obtain those, you will need to apply to the IRB for an alteration of authorization requirements.
Customizing the Form
You can either use the form as-is (the pdf format is useful for that), or customize it for your project as follows:
There are blank areas (underlined) that you need to replace with the study title, sponsor, and IRB project number. You should replace open boxes in section "B" with pre-checked boxes as appropriate. The two blank areas in "B" and "C" may be replaced with specific text if applicable.
In the section marked "Permission for Specific Uses", ensure that the subject initials the proper line for any of those conditions that apply. A general authorization for release of information is insufficient to allow release of those specific pieces of data: drug and alcohol abuse diagnosis or treatment, mental health diagnosis or treatment, HIV/AIDS testing information, and genetic testing information.
Do not delete any language from the form as provided here. This information is required by law or UC Davis policy.
If you have questions about this form or if a research sponsor wants you to use a different form, please contact Teresa Porter (916) 734-8808.