HIPAA Authorization Language
This is the University of Utah's preferred HIPAA Authorization language for human subjects research. The following example combines both confidentiality and an Authorization in an informed consent document.
AUTHORIZATION FOR USE OF YOUR PROTECTED HEALTH INFORMATION
Signing this document means you allow us, the researchers in this study, and others working with us to use some information about your health for this research study.
This is the information we will use and include in our research records:
- Demographic and identifying information like <<name, address telephone number, and email address>>
- <<Social Security Number – Tell participants whether they can withhold their social security number and still participate>>
- Related medical information about you like <<family medical history, allergies, current and past medications or therapies, and information from physical examinations, such as blood pressure reading, heart rate, temperature, and lab results>>
- All tests and procedures that will be done in the study
How we will protect and share your information:
We will do everything we can to keep your information private but we cannot guarantee this. Study information will be kept in a secured manner and electronic records will be password protected. Study information may be stored with other information in your medical record. Other doctors, nurses, and third parties (like insurance companies) may be able to see this information as part of the regular treatment, payment, and health care operations of the hospital. We may also need to disclose information if required by law.
In order to conduct this study and make sure it is conducted as described in this form, the research records may be used and reviewed by others who are working with us on this research:
- Members of the research team and << insert appropriate institution(s) e.g. University of Utah Health Sciences Center, Primary Children’s Hospital, Shriners Hospital >>;
- The University of Utah Institutional Review Board (IRB), which reviews research involving people to make sure the study protects your rights;
- Other local hospital(s) that we are working with: <<list VA Salt Lake City Health Care System or any other local hospitals where information could be shared>;
- Other academic research centers we are working with: <<list all other academic centers including those at the University that may not be within UUHSC, and explain their roles in project>>
- The study sponsor: <<Name of sponsor>>
- A research coordinating office: <<Name of group or company>>
- <<Name of federal oversight agencies, i.e. the Food and Drug Administration, Centers for Disease Control, etc.>>
- <<Name any other groups that will receive data>>
Include this statement if you will share PHI outside of the University of Utah Health Sciences Center, Primary Children’s Hospital, the
VA Salt Lake City Health Care System, and/or Shriners Hospital: If we share your identifying information with groups outside of << insert appropriate institution(s) e.g. University of Utah Health Sciences Center,
Primary Children’s Hospital, Shriners Hospital >>, they may not be required to follow the same federal privacy laws that we follow.
They may also share your information again with others not described in this form.
OR
Include this statement if you will not share PHI outside of the University of Utah Health Sciences Center, Primary Children’s Hospital, the VA Salt Lake City Health Care System, and/or Shriners Hospital: If we share your information with groups outside of << insert appropriate institution(s) e.g. University of Utah Health Sciences Center, Primary Children’s Hospital, Shriners Hospital >>, we will not share your name or identifying information. We will label your information with a code number, so they will not know your identity.
If you do not want us to use information about your health, you should not be part of this research. If you choose not to participate, you can still receive health care services at << insert appropriate institution(s) e.g. University of Utah Health Sciences Center, Primary Children’s Hospital, Shriners Hospital >>.
What if I decide to Not Participate after I sign the Consent and Authorization Form?
You can tell us anytime that you do not want to be in this study and do not want us to use your health information. You can also tell us in writing. If you change your mind, we will not be able to collect new information about you, and you will be withdrawn from the research study. However, we can continue to use information we have already started to use in our research, as needed to maintain the integrity of the research.
This authorization does not have an expiration date.
CONSENT
I confirm that I have read this consent and authorization document and have had the
opportunity to ask questions. I will be given a signed copy of the consent and authorization
form to keep.
I agree to take part in this research study and authorize you to use and disclose
health information about me for this study, as you have explained in this document.
Additional Language that may be required
-
Certificate of Confidentiality: If applicable, please provide a description of the Certificate of Confidentiality and any voluntary disclosure plans by the Investigator(s). For more information regarding Certificates of Confidentiality, please refer to the IRB guidance on this topic.
-
ClinicalTrials.gov: If this research represents a clinical trial that must be registered on ClinicalTrials.gov, you must include the following statement verbatim: A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.
-
Reportable Diseases: If testing is performed as a result of study participation for any communicable or infectious diseases reportable by Utah State law, the following must be addressed in this section (refer to http://health.utah.gov/epi/report.html for a current list of Utah’s reportable diseases):
-
Tell the participant about the state reporting.
-
Describe how results will be given to the participant to comply with state reporting requirements.
-
Describe the methods or opportunities participants will be given for appropriate counseling and medical care.
-
-
Include the following paragraph if participants will not have access to their information during the study:
You have a right to information used to make decisions about your health care. However, your information from this study will not be available during the study; it will be available after the study is finished.