+-----------------------------------------------------------------------+
| Required Information in **Bold** (Please unbold text before           |
| submitting).                                                          |
|                                                                       |
| Suggested wording in *Italics* (Please add and delete text to fit     |
| your study).                                                          |
|                                                                       |
| Authorization must be written in lay language.                        |
|                                                                       |
| Please delete this box before submitting.                             |
|                                                                       |
| IT IS THE RESPONSIBILITY OF THE RESEARCH TEAM TO GIVE THE SUBJECT A   |
| COPY OF THE PRIVACY NOTICE, EVEN IF THEY HAVE ALREADY RECEIVED ONE.   |
| THIS MUST BE DONE BEFORE THE SUBJECT PARTICIPATES IN THE STUDY.       |
+-----------------------------------------------------------------------+

##### HR# 

Ralph H. Johnson VAMC

**Health Insurance Portability and Accountability Act (HIPAA)**

**Authorization to Use or Disclose**

### Protected Health Information (PHI) for Research Purposes

{Study Title}

**HIPAA is a federal law that requires the protection of information
that can identify you. Protected Health Information includes information
that pertains to your past, present or future physical and mental health
conditions, or the provision of health care. You are being asked to sign
this Authorization because you are in the research study listed above.**

**The researchers (add study sponsor if applicable) agree to protect
your protected health information by using and disclosing it only as
permitted by you in the Authorization and as directed by state and
federal law.**

# A. What is the purpose of the use and/or disclosure of your protected health information?

Discuss why the disclosures are being made. Text from the Purpose
section of the Informed Consent may be inserted if it answers this
question.

**B. What protected health information will be used or disclosed?**

*You may be asked for health-related information relevant to the study.
Your medical or health records may be reviewed and researchers may need
to discuss your health information with your treating physicians (if
applicable). Researchers will also generate new information about you as
a result of the research procedures, tests, visits and
questionnaires/interviews. The information that will be*

*used or disclosed to others includes (results of lab tests, medical
record notes, etc.)*

**HR#**

*(Text from #2 Sources of Research Material of the Human Subjects
document could be inserted here.)*

*The VA specifically wants you to disclose if you are requesting release
of information regarding:*

-   *Drug Abuse*

-   *Alcoholism or Alcohol*

-   *Testing for or Infection with Human Immunodeficiency Virus (HIV)*

-   *Sickle cell anemia*

##### C. Who will disclose your protected health information?

*By signing this document, you will authorize the Veterans Health
Administration (VHA) to provide (**insert name of Principal**
**Investigator**) and **his or her** research team to use and disclose
your medical/health information for this study.*

##### D. Who will receive your protected health information? 

*Your protected health information may be used or shared with others
outside of the VHA for purposes directly related to the conduct of the
research.* **Once this information leaves VHA, we cannot guarantee that
it will be protected by this authorization.**

***(This is a list of potential recipients -- add/delete groups as
applicable)***

*Your protected health information may be shared with the following:*

-   ***Sponsor of the research study, or its agents such as data
    repositories or contract research organization;***

-   ***Other medical centers / institutions/ investigators outside of
    the VHA participating in the research study;***

-   **Federal and state agencies and VHA committees that have authority
    over the research, such as:**

    -   ***The Institutional Review Board (IRB) that oversees human
        research at the MUSC***

    -   ***Committees with oversight or quality improvement
        responsibilities***

    -   ***Office of Human Research Protections (ORHP)***

    -   *Food and Drug Administration (FDA)(If drug/device study)*

    -   *National Institutes of Health (NIH)*

    -   *Department of Health and Human Services (DHHS)*

    -   *Department of Social Services (DSS)*

    -   *Other governmental offices as required by law*

    -   *Hospital or other accrediting agencies*

    -   *Data Safety Monitoring Board, if applicable*

##### HR#

-   *Clinical staff not involved in the study who may become involved in
    your care if it is potentially relevant to treatment*

**E. Do you have to sign this authorization?**

**You do not have to sign this authorization. If you choose not to sign
the authorization, it will not affect your treatment, payment or
enrollment in any health plan or affect your eligibility for benefits.
You will not be allowed to participate in the research study.**

**F. If you sign the Authorization, can you change your mind?**

**You have the right to withdraw your authorization to allow VHA to use
or share your protected health information collected for this research
study. Protected health information that has already been used or
disclosed cannot be withdrawn. Your protected health information may
still be used and disclosed if you have an adverse event. Once
authorization is withdrawn and you are no longer participating in the
study, no more protected health information will be collected. If you
want to withdraw your permission, you must do so in writing to the
investigator. The investigator's address is:**

**{Insert name and address here}**

**If you withdraw your authorization, you will not be allowed to
participate in the research study.**

G. Include one of the following options:

*{Option 1}* **You have a right to see and copy the information
described on this authorization form.**

OR

*{Option 2}* **You will not be allowed to see or copy the information
described on this form as long as the research is in progress. When the
study is over, you will have the right to see and copy the information
described on this authorization form.**

**H. Authorization:**

You authorize (add PI name) and his/her staff, your doctors and other
health care providers to use and disclose your protected health
information for the purposes described above.

##### HR#

**I. Privacy Notice:**

You have been given a copy of the Privacy Notice that describes the
practices of VHA regarding your protected health information. Please
initial here: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

If you have any questions or concerns about your privacy rights, you
should contact the VAMC Privacy Officer at (843) 789-7833.

**You will be given a signed copy of this form.**

**There is no expiration date for this authorization.**

Signature of Research Subject Date

## \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

## Research Subject's Personal Representative Date 

## (if applicable) 

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Printed Name of Research Subject

or Research Subject's Personal Representative (if applicable)

## 

##### Representative's Relationship to Research Subject

-   Personal Representative: A person authorized under state or other
    law to act on behalf of the individual in making health-related
    decisions. Examples: Court-appointed guardian with medical
    authority, a health care agent under a health care proxy, and a
    parent acting on the behalf of an unemancipated minor.

-   The execution of this form does not authorize the release of
    information other than that specifically described. The information
    requested on this form is solicited under Title 38, U.S.C. The form
    authorizes release of information that you specify in accordance
    with the Health Insurance Portability and Accountability Act, 45 CFR
    Parts 160 and 164, 5 U.S.C. 552a and 38 U.S.C.5701 and 7332. Your
    disclosure of information requested on this form is voluntary.
    However if the information, including Social Security Number
    (SSN)(the SSN will be used to locate records for release) is not
    furnished completely and accurately, Department of Veterans Affairs
    will be unable to comply with the request.