University of Utah Consent Document Language

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.

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.

For studies where the University of Utah is the SIRB:

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.

For studies where the University of Utah is relying on an external SIRB:

You can also contact the Institutional Review Board (IRB) at the University of Utah if you have questions regarding your rights as a research participant, or 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. You may also contact the University of Utah's Research Participant Advocate (RPA) by phone at (801) 581-3803 or by email at participant.advocate@hsc.utah.edu.

For more information, please go to: https://irb.utah.edu/guidelines/consent-document-checklist/#futureuse.

As part of this study, we would like to keep biospecimens and information about you so that researchers may use it in the future in other research projects. When we use the term “biospecimen bank”, it refers to the storage of the samples and information that is collected.

What will be kept? We would like to keep a sample of your <<insert specific biospecimen, e.g., blood, urine, tissue, etc.>>.
What will my sample and information be used for?
Option for specific disease/condition: Your sample and information may be used in future research about <<insert specific disease or condition>> to help us learn more.
Option for no specific disease/condition: We don’t know what kind of future research will be done but we hope to learn more about diseases and how to treat them.
Who will keep my sample and information?
Option for University of Utah-managed biospecimen bank: Your sample will be kept by Dr. [insert name] who manages the biospecimen bank at the University of Utah.
Option for a sponsor-managed biospecimen bank: Your sample will be kept by the study sponsor, [insert sponsor name], who manages the biospecimen bank.
Do I have to allow my sample and information to be saved for future research?
Option for mandatory biospecimen banking (e.g., sole purpose of research study is to save samples for future research): If you do not want your samples and information to be saved for future research, you should not participate in this study. No matter what you decide to do, your decision will not affect your medical care.
Option when choice given to bank biospecimens (note: participation in a biospecimen bank must be optional for treatment/intervention trials): You do not have to participate in the biospecimen bank to be in the main part of this study. No matter what you decide to do, your decision will not affect your medical care. You can tell us your choice by initialing one of the choices below:

___ YES,

(initial)

my sample(s) may be saved for future [specify a specific condition/disease] research.

___ NO,

(initial)

my sample(s) must be destroyed at the end of this research project.

Will personally identifiable information be collected with my biospecimens?
Option for de-identified samples: Your sample will not have your name or other personal information linked to it. No one will be able to tell that you gave us the sample. Your sample may be shared with researchers at the University of Utah and at other institutions without additional informed consent from you or your legally authorized representative. The only information we will keep with the sample is information like your age and what disease you have.
Option for coded samples: Your sample will be coded so that your name is not on the sample. Dr. [insert name] and the University of Utah will keep your name in a separate place so that we can link your sample back to you later if we need to. Your sample may be shared with researchers at the University of Utah and at other institutions without additional informed consent from you or your legally authorized representative. Dr. [insert name] will not give your name to other researchers who want to use your sample and will only give them information like your age and what disease you have.
Option when choice offered regarding removal of identifiers: We would like to code your sample so that your name is not on it. Dr. [insert name] and the University of Utah will keep your name in a separate place so that we can link your sample back to you later if we need to. But if you do not want us to keep your name or any other identifying information with the sample, you can choose to have your sample remain anonymous. You can tell us your choice by initialing one of the choices below:

___ YES,

(initial)

my personal identifiers can be kept with my sample(s). All information will be kept secure and confidential.

___ NO,

(initial)

my name and identifiers must be removed from my sample(s). My sample(s) cannot be linked back to me.

Your sample may be shared with researchers at the University of Utah and at other institutions without additional informed consent from you or your legally authorized representative.

What if I want to withdraw my samples from the biospecimen bank?
Option for de-identified samples: Because we will not keep your name or other identifying information when we store your sample, you will not be able to have the sample removed from the bank later.
Option for coded samples: You can have your sample removed from this biospecimen bank later. You will need to contact [insert name] at [insert contact information].
Option when choice offered regarding removal of identifiers: You can have your sample removed from this biospecimen bank later. You will need to contact [insert name] at [insert contact information]. If you decide to have your identifiers removed from your sample, you will not be able to withdraw your sample later because it cannot be linked back to you.
Will my biospecimens be used for commercial profit? The use of your data and biospecimens may lead to new tests, drugs, devices, or other products or services with commercial value. These products or services could be patented and licensed. There are no plans to provide any payment to you should this occur.
Will future results or findings be given to me?
Option for not disclosing future results: Because the results from future research will not directly affect your health care, we will not share the results from future studies with you or your doctors.
Option for not disclosing future results because of de-identification: Because your sample cannot be linked back to you, we will not share the results from future studies with you or your doctors.

“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.”

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.

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 https://epi.utah.gov/rules-regulations/ 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.

Single IRB Institutional Review Board