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Authorization to Permit the Use and Disclosure of Protected Health Information for Research Purposes (example)

Title of Project: Early Childhood Nutrition Project

Project Leader: Toki Eley, Maternal Child Health Director, VNA of Chittenden County, at 110 Prim Road, Colchester VT 05446

Purpose and Scope of Authorization

You have agreed to allow a child for whom you have the authority under applicable law to make health care decisions, to participate in the project identified above, and you have signed a separate consent form that explains the project procedures. The project will be completed by the Visiting Nurses Association of Chittenden County (“VNA”) and the Vermont Agency of Human Services (“AHS”), through the Special Supplemental Nutrition Program for Women, Infants and Children (“WIC”) offered by the Vermont Department of Health. Any reference in this Authorization to “AHS” means the Agency of Human Services, acting through the staff that administers the WIC program.

This Authorization is required by privacy regulations that are a part of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), and other applicable laws. The VNA and AHS are required to abide by the HIPAA Privacy Regulations. This Authorization legally permits the VNA, AHS, and your pediatrician to use and disclose your child’s protected health information for the project, but only in accordance with the restrictions outlined below.

The HIPAA Privacy Regulations use a special term to identify protected health information – they call it “protected health information”, or “PHI”, for short. We refer to “PHI” below to mean your child’s protected health information. This Authorization gives you detailed information about how your child’s PHI will be used, disclosed and protected in the context of this project.

1. What PHI about your child will be used or disclosed by the VNA, AHS, or your pediatrician?

Answer:

Basic personal demographic information, including name, address, social security number, date of birth, family status and similar information.

Pre-existing health information pertaining to your child that is relevant to the study, such as information from your pediatrician regarding your child’s development and general health.

All health information resulting from the treatments and other protocols provided under the project, such as information regarding your child’s height and weight and other general health measures.

2. Who within the VNA, AHS, or your pediatrician’s office may use or disclose your child’s PHI?

Answer : The VNA staff and WIC clinic staff assigned to this project, and your pediatrician, for the purpose of conducting the project. More specifically, the following positions are those who will primarily use and/or disclose your child’s PHI:

For the VNA: The Nutrition Resource Coordinator, nurses, home visitors, and their supervisors for the purpose of developing a nutrition care plan, increasing and coordinating services, and determining if the increase in assistance is resulting in improved health of your child.

For AHS: The WIC nutritionist and her supervisor for the purpose of developing a nutrition care plan, increasing and coordinating services, and determining if the increase in assistance is resulting in improved health of your child. The WIC nutritionist will also determine if nutrition education and increased services results in more food resources and increased knowledge about food and nutrition.

For your pediatrician, the person(s) who respond to information requests, for the purpose of providing information necessary to conduct the project.

3. To whom may the VNA, AHS, or your pediatrician disclose your child’s PHI?

Answer : The VNA staff and WIC clinic staff assigned to this project, for the purpose of conducting the project. More specifically, the following positions are those within the VNA and AHS who will primarily receive your child’s PHI:

For the VNA: The Nutrition Resource Coordinator, nurses, home visitors, and their supervisors for the purpose of developing a nutrition care plan, increasing and coordinating services, and determining if the increase in assistance is resulting in improved health of your child.

For AHS: The WIC nutritionist and her supervisor for the purpose of developing a nutrition care plan, increasing and coordinating services, and determining if the increase in assistance is resulting in improved health of your child. The WIC nutritionist will also determine if nutrition education and increased services results in more food resources and increased knowledge about food and nutrition.

4. How long will the VNA, AHS, or your pediatrician be able to use or disclose your child’s PHI?

Answer : This Authorization is valid until the research study is complete.

5. What happens if you decide not to sign this Authorization?

Answer: You are not obligated to sign this Authorization. However, if you elect not to sign, then your child will not be permitted to participate in the project, which means you will not be entitled to receive the nutritional services provided in this project. A decision to not sign this Authorization will otherwise have no effect on your or your child’s current or future medical or other care from the VNA, AHS, or your pediatrician or payment for any such care, nor will it cause any penalty or loss of benefits to which you or your child are otherwise entitled or eligible.

6. Can you change your mind and revoke this Authorization?

Answer: Yes. You may withdraw your permission for the use and disclosure of your child’s PHI for this research project at any time, but you must do so in writing to the Project Leader at the address set forth above. Even if you withdraw your permission, the Project Leader may still use and disclose your child’s PHI that was collected before you withdrew, to the extent necessary to preserve the integrity of the project.

7. What happens once your PHI has been disclosed by the VNA, AHS, or your pediatrician?

Answer: Once the VNA, AHS, or your pediatrician discloses your child’s PHI, as permitted by this Authorization, a re-disclosure of your PHI by the recipient may not be covered by this Authorization, and may not be subject to the HIPAA Privacy Regulations or other privacy laws. Of course, the VNA and AHS agree to protect your child’s PHI by using and disclosing it only as permitted in this Authorization and as directed by state and federal law.

8. Will the results of the project be presented in publications?

Answer: The results of the research project may be presented in publications, however names and other personally identifying information about your child will not be revealed in such publications.

9. Who should you contact with any questions or concerns regarding your privacy rights?

Answer: If you have any questions or concerns about your child’s privacy rights, you should contact the Project Leader.

All of the above has been explained to me and all of my questions have been answered. I understand that, throughout my child’s participation in the research study, I am encouraged to ask any additional questions I may have about the research use and disclosure of my child’s PHI. Such future questions may be answered by the Project Leader, the VNA or AHS.

I have read this Authorization, and acknowledge that I am authorized to act on behalf of my child. By signing this Authorization, I agree to allow the use and disclosure of my child’s PHI for the purposes described above, and I agree to the other terms identified above. A copy of this Authorization (as signed below) will be given to me.

 

Child’s Name [print]:

Signature of Authorized Adult:

Date:

To provide authorization for additional children, please list their names below:

Please provide a description of your authority to act for each child identified above:

 

Staff Person obtaining authorization [print]:

Signature:

Date: