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THE COMMITTEE ON HUMAN RESEARCH
REQUIRED ELEMENTS OF AN AUTHORIZATION
Background:
To comply with HIPAA requirements, the HIPAA
authorization must satisfy the general requirements as well as
specific elements.The authorization must be:
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written in plain language, |
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be in 14 pt font, |
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contain all of the elements listed below, and |
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a signed copy must be provided to the individual signing
it, if the covered entity itself is seeking the authorization. |
Note that all of these requirements are already covered when the
standard Subject's Authorization for Research Access to Health
Information form is filled out correctly.
Required elements:
| 1. |
A specific and meaningful
description of the PHI to be used or disclosed. |
| 2. |
The names or class of persons
(e.g. “the research team”) who will use or disclose
the PHI. |
| 3. |
The names or other specific
identification of anyone else to whom the PHI may be disclosed. |
| 4. |
A description of the research
purposes of the use or disclosure. |
| 5. |
A statement of when the authorization
will expire. At UC, this is stated as “when study is
completed”. |
| 6. |
A statement of the subject’s
right to cancel the authorization, a description of how to
do so, and a description of any exceptions to the right to
cancel authorization. |
| 7. |
A statement that there is a
potential risk that PHI will be re-disclosed by one of the
parties to which it is initially disclosed. This may be a general
statement that although normal standards for protecting confidentiality
will still apply, HIPAA may no longer protect health information
after the initial disclosure for research purposes. |
| 8. |
A statement of the consequences
of not signing the authorization, including whether or not
a patient’s treatment (including research-related treatment),
enrollment in a study, or eligibility for benefits will be
affected by not signing the authorization. |
| 9. |
A signature and date line for
the subject: if a legally authorized representative signs the
authorization, a description of the representative’s
authority must be included. |
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