AUTHORIZATION TO USE & DISCLOSE PROTECTED HEALTH INFORMATION

FOR RESEARCH PURPOSES

IRB#: ____

Project Title: ____

Principal Investigator: ____

The privacy law, Health Insurance Portability & Accountability Act (HIPAA), protects my individually identifiable health information (protected health information[1]). The privacy law requires me to sign an authorization (or agreement) in order for researchers to be able to use or disclose my protected health information (PHI) for research purposes in the above referenced study. I authorize [name of researcher] and his/her research staff to use and disclose my protected health information for the purposes described below.

The following doctors and/or health care providers are authorized to disclose my protected health information for the purposes of this research study:

  • [List different physicians and health care providers from whom the investigator would like to receive PHI. e.g., family physician, pediatrician, obstetrician, psychologist, etc.]

My protected health information that may be used and disclosed includes:

  • [List all of the protected health information to be collected for this protocol/study such as demographic information, results of physical exams, blood tests, X-rays, and other diagnostic and medical procedures as well as medical history]

My protected health information will be used for:

  • [Provide a brief description of each research project or paste information from purpose section in the consent form; indicate that one reason to share the information is to be able to conduct the research, another reason is to ensure that the research meets legal, institutional or accreditation requirements]

The Researchers may use and share my health information with:

  • The Pennsylvania State University’s Institutional Review Board/Office for Research Protections
  • Government representatives, when required by law
  • [List any collaborators, outside laboratories, etc.]
  • [If applicable – list the sponsor’s name]
  • [List any other groups with whom the information may be shared]
  • [If applicable - statement thatprimary physician will be contacted if researcher in the course of the project learns of a medical condition that needs immediate attention]

Your health information may be used or shared with other specific people or groups in connection with this research study. Research records that identify you will be kept confidential as required by law. You will not be identified by name, social security number, address, phone number or any other direct personal identifier in research records given to someone outside of The Pennsylvania State University (PSU), except when required by law. For records shared outside of PSU, you will be assigned a code number. The list that matches your name with the code number will be kept in a locked file in the principal investigator’s office.

The researchers [and list sponsor’s name if applicable] agree to protect my health information by using and disclosing it only as permitted by me in this Authorization and as directed by state and federal law.Should the health information be disclosed by the researcher, to someone outside of this study, it may no longer be covered/protected by the federal regulation HIPAA.

I do not have to sign this Authorization. If I decide not to sign the Authorization:

  • It will not affect my treatment, payment or enrollment in any health plans or affect my eligibility for benefits.
  • I may not be allowed to participate in the research study.
  • If applicable, I will not have access to this research-related therapy/treatment.

After signing the Authorization, I can change my mind and:

  • Not let the researcher disclose or use my protected health information (revoke the Authorization).
  • If I revoke the Authorization, I will send a written letter to: [name and contact information] to inform him/her of my decision.
  • If I revoke this Authorization, researchers may only use and disclose the protected health information already collected for this research study.
  • If I revoke this Authorization my protected health information may still be used and disclosed should I have an adverse event (a bad effect).
  • If I change my mind and withdraw the authorization, I may not be allowed to continue to participate in the study.

Optional item: I understand that I will not be allowed to review the information collected for the research until after the study is completed. When the study is over, I will have the right to access the information again.

This Authorization does not have an expiration date.

If I have any questions or concerns about my privacy rights, I should contact the Office for Research Protections at (814) 865-1775.

I am the participant or am authorized to act on the participant’s behalf. I have read this information, and I will receive a copy of this form after it is signed.

______

Signature of research participant or *researchDate
participant’s legal representative

______

Printed name of research participant orRepresentative’s relationship to

*research participant’s legal representativeresearch participant

*Please explain the Representative’s relationship to the participant. Include a description of the Representative’s authority to act on participant’s behalf:

______

Page 1 of 3 – Version 1.1 – Created 04/01/03; Revised – 05/03/16

This form is available electronically at

[1]Name, Address, Dates Directly Related to an Individual, Telephone/Fax Number, E-mail/Internet Protocol or Web URL Address, Social Security Number, Medical Record or Health Plan Number, Account Number, Certificate of License Number, Photographic Images, Vehicle Identifiers, Devise Identifiers, Biometric Identifiers, Any Other Unique Code