(Include PI S Name, Title of Study and Page Numbering Format on Each Page (I

[PI Name] Page 1 of 10 [Title of Study] [If applicable, add investigator version date]

Consent and Authorization Document for Minimal Risk Research

Note to the Investigator: Informed consent is a process, not just a form. Information must be presented to enable persons to voluntarily decide whether or not to participate as a research participant. It is a fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act. The procedures used in obtaining informed consent should be designed to educate the participant population in terms that they can understand. Therefore, informed consent language and its documentation (especially explanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits) must be written in "lay language", (i.e. understandable to the people being asked to participate). The written presentation of information is used to document the basis for consent and for the participants' future reference. The consent document should be revised when deficiencies are noted or when additional information will improve the consent process.

DIRECTIONS FOR USE OF THIS TEMPLATE:  Do not adjust the bottom margin or use the footer. Do not delete the watermark fields in the footer.  Replace bracketed items in the header, such as “[Title of Study]” with the requested information.  Read guidelines for each section, complete as applicable for your project and then delete the template guidelines. Example text may be used if needed but should not be italicized. Instructions in red font should be replaced or deleted.  Example text may be used if needed but should not be italicized. Instructions in red font should be replaced or deleted.  Phrases such as “I understand…” or “You understand…” are not appropriate and should not be included in the document.  For studies involving deception or designed in such a way that providing complete background information will invalidate the study, clearly state this in your application. In addition, attach the debriefing script that will be used to inform participants of the need for deception and the procedures you will follow to address any possible adverse effects of the deception. In the application, you must request a “Waiver or Alteration of Consent” in the electronic application.  The document should be written at an appropriate grade level for the group of participants. Most word processors include the ability to assess the reading level.  NOTE: If your study is determined by the IRB to be more than minimal risk, there are additional elements of informed consent which will be required. If you believe your study is more than minimal risk, you may contact the IRB office for guidance or refer to the HIPAA Consent Template for a description of all the elements of informed consent.

BACKGROUND

FOOTER FOR IRB USE ONLY IRB Template Version: I2815 «Image:Stamp» «Institution» «IRB» «Approved» «ApprovedDate» «Expiration» «ExpirationDate» «Number» [PI Name] Page 2 of 10 [Title of Study] [If applicable, add investigator version date] State that the study involves research and explain the purpose of the research. Briefly tell the participant why this research is being done and how this study will address the problem. Please explain who is conducting the study.

Example: You are being asked to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether you want to volunteer to take part in this study. Example: The purpose of the study is <>.

STUDY PROCEDURE This section should inform the participant about what they will have to do and what they will experience in the study. If any, specify which study procedures are experimental (i.e. untested or non-standard procedures) for this research. Include the length of time that the participants will be involved. Describe all procedures/interventions in lay language. Use simple terms and short sentences.

Example: It will take you approximately 2 hours to complete this study. As part of this study you will be asked to take part in a focus group. Questions will be asked about <>. Example: The following procedures are considered experimental <>.

RISKS Describe any reasonably foreseeable risks or discomforts such as emotional distress/discomfort, psychological trauma from remembering past experiences, invasion of privacy, embarrassment, loss of social status, potential adverse economic or employment consequences, etc. Minor risks such as the possible breach of confidentiality should be listed.

Example: The risks of this study are minimal. You may feel upset thinking about or talking about personal information related to <>. These risks are similar to those you experience when discussing personal information with others. If you feel upset from this experience, you can tell the researcher, and he/she will tell you about resources available to help.

BENEFITS Describe any benefits to the participant or to others that may reasonably be expected from the research. DO NOT include any compensation to be offered to participants in this section. The description of benefits to the participant should be clear and not overstated to avoid coercion. If no direct benefit is anticipated, it should be stated.

Example: We cannot promise any direct benefit for taking part in this study. However, possible benefits include <>.

FOOTER FOR IRB USE ONLY IRB Template Version: I2815 «Image:Stamp» «Institution» «IRB» «Approved» «ApprovedDate» «Expiration» «ExpirationDate» «Number» [PI Name] Page 3 of 10 [Title of Study] [If applicable, add investigator version date] Example: There are no direct benefits for taking part in this study. However, we hope the information we get from this study may help develop a greater understanding of <> in the future.

ALTERNATIVE PROCEDURES List appropriate alternative procedures/interventions, if any, which might be advantageous to the participant. This section may be omitted if there are no alternative procedures or interventions.

Example: If you do not want to take part in the study, you may earn research participation credit by <>.

PERSON TO CONTACT Please include contact information for answers to any questions, complaints or concerns the participant or legal representative may have about the research or related matters. Include the name of the Principal Investigator with a telephone number where a message can be left. Co-investigator contact information may be included. Include specific information as to whom the participant should contact in case of a research-related injury. This should include name(s), telephone number(s), and when the person(s) listed may be contacted. If you believe that there is no chance for a research related injury, you may provide contact information in the event the participant feels they have been harmed by the research (see example).

Example: If you have questions, complaints or concerns about this study, you can contact <> at <>. If you feel you have been harmed as a result of participation, please call <> at <> who may be reached during <>.

Include the following statement verbatim: Institutional Review Board: 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 [email protected].

Include the following statement verbatim: Research Participant Advocate: You may also contact the Research Participant Advocate (RPA) by phone at (801) 581-3803 or by email at [email protected].

VOLUNTARY PARTICIPATION State that participation is voluntary. Indicate that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled. Also indicate that the participant may discontinue participation at any time without any penalty or loss to benefits.

FOOTER FOR IRB USE ONLY IRB Template Version: I2815 «Image:Stamp» «Institution» «IRB» «Approved» «ApprovedDate» «Expiration» «ExpirationDate» «Number» [PI Name] Page 4 of 10 [Title of Study] [If applicable, add investigator version date] Example: Research studies include only people who choose to take part. You can tell us that you don’t want to be in this study. You can start the study and then choose to stop the study later. This will not affect your relationship with the investigator.

COSTS AND COMPENSATION TO PARTICIPANTS Costs related to research procedures should be separated and explained from other regular costs participants might incur. Any additional costs to the participant that may result from the research should also be clearly indicated. If there are no costs and/or compensation, please state that.

Explain whether participants will be compensated for participation. Specify the overall amount, schedule of payment(s) and any plan for prorating payments if participant does not complete the study.

NEW INFORMATION State that new findings developed during the course of the research that may affect to the participant’s willingness to continue participation will be provided to the subject. This section may be omitted if new information could not reasonably used to alter participation (e.g. one-time interventions).

Example: Sometimes during the course of a research project, new information becomes available about the <> that is being studied. If this happens, your research doctor will tell you about it and discuss with you whether you want to continue in the study. Example (additional text if applicable): If you decide to withdraw at that time, your research doctor will make arrangements for your medical care to continue. If you decide to continue in the study, you may be asked to sign an updated consent form. Also, on receiving new information your research doctor might consider it to be in your best interests to withdraw you from the study. He/she will explain the reasons and arrange for your medical care to continue.

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 <>. 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 make a decision and talk to you about how you might use the results in your health care.

In this study about <>, we are not looking for results related to other conditions. This means that you might have changes in your genes related to other health conditions that we will not identify in this study.

FOOTER FOR IRB USE ONLY IRB Template Version: I2815 «Image:Stamp» «Institution» «IRB» «Approved» «ApprovedDate» «Expiration» «ExpirationDate» «Number» [PI Name] Page 5 of 10 [Title of Study] [If applicable, add investigator version date] 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.

AUTHORIZATION FOR USE OF YOUR PROTECTED HEALTH INFORMATION Include the Authorization and Confidentiality information as outlined:

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: Modify the following list as appropriate – delete or add items as necessary. - Demographic and identifying information like <> - <> - Related medical information about you like <> - 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.

 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 website.

 In some cases this section must include a statement about mandatory reporting of confidential information such as when the researcher is legally obligated to reveal instances of child abuse, elder abuse, or abuse of the disabled. If your study involves the possibility of disclosure of abusive situations, the following mandatory language from the Department of Health and Human Services must be inserted: However, if you disclose information that gives study staff a

FOOTER FOR IRB USE ONLY IRB Template Version: I2815 «Image:Stamp» «Institution» «IRB» «Approved» «ApprovedDate» «Expiration» «ExpirationDate» «Number» [PI Name] Page 6 of 10 [Title of Study] [If applicable, add investigator version date] reason to believe that a child or disabled or elderly adult has been subjected to abuse or neglect, study staff will report that information to Child Protective Services, Adult Protective Services, or the nearest law enforcement agency to the extent required by law.

 In some cases reporting of confidential information may not be required by law but other institutional or professional ethics codes will require reporting to the appropriate authorities. For example, if your study involves the possibility participants may disclose information about harming others or themselves (i.e. suicide) include a statement about the potential breach of confidentiality. Example: There are some cases in which a researcher is obligated to report issues, such as serious threats to public health or safety.

 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: o Members of the research team and << insert appropriate institution(s) e.g. University of Utah Health Sciences Center, Primary Children’s Hospital, Shriners Hospital >>; o The University of Utah Institutional Review Board (IRB), who reviews research involving people to make sure the study protects your rights;

Modify the list below as appropriate - delete or add items as necessary. The examples below are suggestions and may be used as applicable.

o Other local hospital(s) that we are working with: <> o Other academic research centers we are working with: <> o The study sponsor: <> o A research coordinating office: <> o <> o <>

 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.

 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 FOOTER FOR IRB USE ONLY IRB Template Version: I2815 «Image:Stamp» «Institution» «IRB» «Approved» «ApprovedDate» «Expiration» «ExpirationDate» «Number» [PI Name] Page 7 of 10 [Title of Study] [If applicable, add investigator version date] 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 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): o Tell the participant about the state reporting. o Describe how results will be given to the participant to comply with state reporting requirements. o Describe the methods or opportunities participants will be given for appropriate counseling and medical care.

 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.

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.

CONSENT: Please include a consent and authorization statement written in first person such as the following:

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.

FOOTER FOR IRB USE ONLY IRB Template Version: I2815 «Image:Stamp» «Institution» «IRB» «Approved» «ApprovedDate» «Expiration» «ExpirationDate» «Number» [PI Name] Page 8 of 10 [Title of Study] [If applicable, add investigator version date] I agree to participate 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.

______Participant’s Name

______Participant’s Signature Date

______Name of Person Obtaining Authorization and Consent

______Signature of Person Obtaining Authorization and Consent Date

FOOTER FOR IRB USE ONLY IRB Template Version: I2815 «Image:Stamp» «Institution» «IRB» «Approved» «ApprovedDate» «Expiration» «ExpirationDate» «Number» [PI Name] Page 9 of 10 [Title of Study] [If applicable, add investigator version date] A witness signature block may be inserted here if required by the sponsor or it appropriate for the participant population. Sample witness signature statements are included below. Delete this section if you do not plan to use a witness to the consent process/signature.

SAMPLE #1:

WITNESS STATEMENT: The participant was unable to read or sign this consent form because of the following reason: The participant is illiterate The participant is visually impaired The participant is physically unable to sign the consent form. Please describe:

______

Other (please specify):

______

I confirm that I was present as a witness for the consent process for this study. I confirm that the participant named above was read the information in the consent document and that the participant has agreed to take part in the research study.

______Name of Witness

______Signature of Witness Date

SAMPLE #2:

WITNESS STATEMENT: (For Non-English Speaking Participants Only) Consent was obtained from the participant using a short form for non-English speakers. The short form is available in the participant’s language and this (long) consent form was read to the participant using an interpreter.

FOOTER FOR IRB USE ONLY IRB Template Version: I2815 «Image:Stamp» «Institution» «IRB» «Approved» «ApprovedDate» «Expiration» «ExpirationDate» «Number» [PI Name] Page 10 of 10 [Title of Study] [If applicable, add investigator version date]

As a witness, I confirm that I was present for the complete consent process for this study. I confirm that the participant named above was read the information in this consent document in a language he/she understands and that the participant has agreed to take part in the research study.

______Name of Witness

______Signature of Witness Date

FOOTER FOR IRB USE ONLY IRB Template Version: I2815 «Image:Stamp» «Institution» «IRB» «Approved» «ApprovedDate» «Expiration» «ExpirationDate» «Number»