LA HIPPA - English

Attachment 8A-2

LOS ANGELES COUNTY PUBLIC HEALTH IRB AUTHORIZATION FOR

USE AND DISCLOSURE OF HEALTH INFORMATION

IN CONNECTION WITH RESEARCH STUDY

The Health Insurance Portability and Accountability Act (HIPAA) and California Law:

A federal law known as the Health Insurance Portability and Accountability Act (HIPAA) protects how your health information is used for certain purposes.

HIPAA requires that you give your written permission to release your “Protected Health Information” to members of the research team to use for this research study. “Protected Health Information” is any identifiable health information about your past, present or future physical or mental health condition or payment for health care. Examples of protected health information include: medical or dental records, billing records, identifiable tissue samples and x-rays. State law also gives you certain protections regarding the use and release of your health information.

This form authorizes your health care providers to release your health information to members of the research team and others for research purposes. It also describes how your health information will be used. You must sign this form to participate in the study.

Authorization to Obtain and Use Health Information From Provider for Research Study:

By signing this document, you authorize (give permission to) your health care provider(s) listed or described as:

__________________________________________________________________________________

To release the following information: [check the box that applies]

• All of your medical or other patient records and other protected health information that the provider has in his or her possession, including information relating to any patient history, mental or physical condition and any treatment you received. (This section does not include HIV test results, certain inpatient mental health records, and drug and alcohol treatment records protected under federal law, which require your separate authorization below).

• Only the following records or types of health information: (Insert dates of treatment, types of treatment or other designation.) ______________________________________________________________________

• Any and all health information that is generated in the course of the research study

To the following individuals or entities for the following purposes:

• Researchers (those individuals in charge of the study), research staff, including nurses, technicians and administrators, students involved with the research project, such as graduate assistants, medical or professional trainees and other members of the research team for purposes of the research study as described in the attached informed consent

• The research sponsor, its affiliates, subcontractors and representatives for purposes of conducting, evaluating, overseeing or otherwise assisting with this research study and the related research activities of the sponsor

• The Los Angeles County Department of Public Health Institutional Review Board (IRB), funding agencies and relevant government national and international oversight agencies such as the Food and Drug Administration and the Office for Human Research Protections and as otherwise required by law

Authorization to Use Health Information for a Research Database:

Health care researchers will often review existing health information from large groups of patients in order to test or validate theories that the researcher develops. This is sometimes called records research or database research. Los Angeles County Department of Public Health maintains such databases, often grouping together patient information for purposes of future medical or other health research. This authorization also permits Public Health to include the health information about you that Public Health has in its possession in Public Health research databases for the purpose of future medical or other health research.

This authorization only allows Los Angeles County Department of Public Health to use your health information for purposes of entering the data and maintaining the research databases. The Los Angeles County Department of Public Health will not allow researchers further access to the Public Health database for research purposes unless the Los Angeles County Department of Public Health obtains a specific authorization from you or unless such use or disclosure is specifically required or permitted by law.

This section of the Authorization will remain in effect indefinitely from the date of this Authorization.

You are not required to agree to this section in order to participate in the study.

Limits of this Authorization:

Under the Los Angeles County Department of Public Health policies, personnel identified above who have access to your health information as part of this study, may not use the information for purposes other than this study, except as otherwise permitted by law. In addition, while health information that is shared with others outside the Los Angeles County Department of Public Health may not be protected by HIPAA once disclosed, it may nonetheless remain protected under relevant California or other state privacy laws.

Right to Deny Access to Health Information:

During the course of this study, you may be denied access (to inspect or copy) to some or all information generated for this research study. Subject to applicable law, you are entitled to access this health information once the research study is completed.

Term of this Authorization:

Except for database research, if applicable, this authorization for Los Angeles County Department of Public Health to use your health information described above for purposes of the research study expires 3 (THREE ) years from the date of your signature or at the end of the research study (including all data collection and analysis), whichever is sooner, unless you revoke this authorization as described in the next section.

Refusal to sign/Right to Revoke:

You must sign this Authorization in order to participate in this research. You may change your mind and revoke (e.g., withdraw or cancel) this authorization and your participation in this research study at any time. To do so, your revocation must be in writing to the Los Angeles County Department of Los Angeles County Department of Public Health Institutional Review Board (IRB) and include: (1) the title of the research study; (2) the name of the Principal Investigator; and (3) your name and telephone number or address. Please send the revocation to the following IRB address: Los Angeles County Department of Public Health IRB, 313 N. Figueroa St, Suite 127, Los Angeles, CA 90012.

From and after the date your notice of revocation is received, you will not be allowed to participate any further in the research and we will stop collecting your health information. However, even if you revoke

this authorization and your participation in this research study, we may still use and share your health information already obtained as necessary to maintain the integrity of the research study.

Questions regarding your privacy rights:

The address of the Los Angeles County Department of Public Health IRB is 313 N. Figueroa Street, Suite 127, Los Angeles, CA 90012, and you may contact the IRB by telephone at 213-250-8675.

Agreement:

I have read (or someone has read to me) the information provided above. I have been given the opportunity to ask questions and all of my questions have been answered to my satisfaction. My signature below indicates that I authorize the use and disclose my health information as described in this document.

____________________________________________________________________________________

Name of Subject Signature Date of Birth Date Signed

If Individual is unable to sign this Authorization, please complete the information below:

________________________________________________________________________________

Name of Legal Guardian/ Signature Date

Legal Relationship

Personal Representative

You will be provided with a signed copy of this authorization.