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A selection of our local requirements for language that must be included in informed consent documents used at our site can be found here.
Consent documents must be reviewed by the University of Utah IRB/HRPP prior to use at our site. Our full consent guidance is available at: https://irb.utah.edu/informed-consent/index.php.

Research Related Injury Language
 
HIPAA Language
 
Person to Contact Language
 
Data or Biospecimen Banking Language
 
Incidental Genetics Findings Language
 
Short Form Consent and Non-English Speaking Participants
 
Legally Authorized Representative (LAR) Signature Block
 
ClinicalTrials.gov
 
Certificates of Confidentiality (CoC)
 
Reportable Diseases
 

Research-Related Injury Language



If the study is conducted at the University of Utah, include the following statements verbatim: 

If you are hurt from being in this study, you can choose to get medical care at the University of Utah. The University of Utah has not set aside any money to pay the costs of this medical care. The University will work with you to try to address any medical costs.

Costs will be charged to you or your insurance company (if you have insurance). If the study has a sponsor, the costs may be charged to them. Costs can also be charged to others who may have responsibility for paying for your medical care.

Since this is a research study, some health insurance plans may not pay for the costs. By signing this consent form you are not giving up your right to pursue legal action against any parties involved with this research.

The University of Utah is a part of the government. If you are hurt in this study and want to sue the University and its employees and students, special laws may apply.

The Governmental Immunity Act of Utah is a law that controls when a person needs to bring a claim against the government and limits the amount of money a person may recover. You can review sections 63G -7-101 to -904 of the Utah Code.

Please Note: 

  • If you have a sponsor or other party who is assuming responsibility for research-related injury, please include the language here. 
  • If your study takes place at Shriners or Primary Children’s Hospital, please contact us for additional requirements.  

HIPAA Language



This is the University of Utah's preferred HIPAA Authorization language for human subjects research. The following example combines both confidentiality and Authorization into one section intended to be included in a compound consent document. Please replace information included in brackets (“<<**>>”) with specific information for your study.

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 secure 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. 

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>> 

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. 

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 >>. 

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. 

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.

Person to Contact Language



Please replace information included in brackets (“<<**>>”) with specific information for your study.

If you have questions, complaints, or concerns about this study, you can contact <<insert name>> at <<insert phone number>>. If you think you may have been injured from being in this study, please call <<insert name>> at <<insert phone number>><<Insert name>> can be reached at this number during <<specify hours or state it is a number available 24-hours a day>>." 

Contact the Institutional Review Board (IRB) if you have questions regarding your rights as a research participant. Also, contact the IRB if you have questions, complaints, or concerns which you do not feel you can discuss with the investigator. The University of Utah IRB may be reached by phone at (801) 581-3655 or by e-mail at irb@hsc.utah.edu 

Research Participant Advocate:  You may also contact the Research Participant Advocate (RPA) by phone at (801) 581-3803 or by email at participant.advocate@hsc.utah.edu. 

Data or Biospecimen Banking Language



The University of Utah requires that several components describing data or biospecimen banking be included when a study proposes saving tissue for potential future research.

For more information, please go to: https://irb.utah.edu/guidelines/repository/index.php.

Incidental Genetics Findings Language



The University of Utah requires language addressing the potential for identification and disclosure of incidental genetic findings.
Include the following verbatim statement if incidental genetic findings may be disclosed to participants:

“In this research, we are only looking for changes in your genes that are related to <<condition under study>>. But it is possible that we may come across changes in your genes that are related to other health conditions.  These other findings may be important to your health care or the health care of your family members.  

If this happens, we may contact you to give you a choice about learning about these findings.  We will also refer you to a genetic counselor who can help you decide and talk to you about how you might use the results in your health care. 

Although it is possible, we may find gene changes related to other health conditions, it is important to emphasize that we are focused on gene changes associated with <<condition under study>>.  This means that you might have changes in your genes related to other health conditions that we will not identify in this study.

In most cases we may need to retest your original blood sample or obtain a new sample for clinical testing.  We may refer you to clinical specialists where retesting could be done to verify results.  If you choose to receive results, the cost of clinical retesting may be billed to your insurance or you.” 

For more information, please go to: https://irb.utah.edu/guidelines/investigator.php and review our guidance titled, “Genetic Research”.

Short Form Consent and Non-English Speaking Participants


 

Our site allows a short form consent process for individuals with limited English proficiency.

Local policy requires all prospective research with participant interaction conducted by University of Utah researchers within the state of Utah, to have provisions for including people who speak Spanish. Learn more at: https://irb.utah.edu/blog/posts/2023/march/spanish.php.

Studies may utilize either a full Spanish translation of the consent document or the Spanish Short Form consent process, depending on what is most reasonable for the study. Provisions must include the following:  

  • Recruitment methods for people who speak Spanish, including translated recruitment materials and interpretation services if individuals would like to discuss the study.  
  • Consent processes for people who speak Spanish, including translated consent documents and interpretation services during the consent process and discussion.  

Methods for ongoing communication with and data collection from participants who speak Spanish, including translated study materials and interpretation services for ongoing communication. 

Legally Authorized Representative (LAR) Signature Block


 

Utah laws specify who may provide consent when an LAR is utilized. To address these laws, the University of Utah requires that the following LAR designations be included with the LAR signature block:

  • Individual authorized with legal authority to provide consent on behalf of the participant (e.g., an individual named in an Advance Health Care Directive or in a Medical Power of Attorney)
  • Spouse
  • Adult child (18 years of age or over) for his or her parent
  • Parent for an adult child
  • An adult sibling
  • A grandparent for an adult grandchild
  • An adult grandchild (18 years of age or older) for a grandparent

Samples of our Signature Blocks can be found on our Forms Index.

ClinicalTrials.gov



If the 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.

Certificates of Confidentiality (CoC)


The University of Utah prefers that the consent document remain silent on the Certificate protections, but if language must be included, please consult the University of Utah IRB/HRPP for preferred language.

Additional guidance at: https://irb.utah.edu/_resources/documents/pdf/00igs-bmgs/igs-certificates_of_confidentiality_051619.pdf

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.

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