university of texas at austin · web view“texas education code, chapter 51, subchapters e-2 and...

Parent Permission for Child Participation in Research

Informed consent is required to provide potential subjects or their legally authorized representatives with the information necessary for them to make a decision about participating in research.

Information in the consent document must be organized to facilitate comprehension. Consent documents should be written in plain language, generally at the 8th grade reading level. The reading level can be higher if the target population tends to have a higher literacy rate than the general population.

We recommend the use of this template to create the informed consent document(s) for your study. Please note:

1. Regulations require that research projects with long informed consent documents begin with a concise and focused presentation of the key information that is most likely to help potential subjects understand why they might or might not want to participate in the study.

Many IRB studies have brief consent documents (2 or 3 pages) that meet this new requirement without the need for a separate key information section. However, if your project is complex, involves numerous research procedures, or the consent document is more than 3 pages in length, this information section is required.

A template for key information sheets may be found on the UT IRB Website Forms Page in the “Standard Consent Language” document.

2. Text in [brackets] represents information about your study that you must add (in plain text).

3. A backslash indicates that you must make a selection depending on the procedures for your study (e.g., “will/will not”).

4. Additional instructions or sample text are provided in blue boxes.

5. Before you upload your consent document to IRBaccess, delete this cover page, brackets, and boxes. The finished document should reflect what you will give to the subject. To delete the boxes, select all text and delete.

6. Use a file name for each consent document such that it clearly identifies type of consent and for which subjects it is intended (e.g. child assent, parental permission, adult consent, etc.).

7. Many studies at conducted at UT Austin involve the use of similar instruments, measures, and devices. The Office of Research Support & Compliance maintains a library of standard consent language for researchers to use. See the Standard Consent Language document located on the Forms Page for sample language and definitions.

For more information on plain language go to http://www.plainlanguage.gov/.

DELETE THIS INSTRUCTION PAGE FROM THE CONSENT FORM PRIOR TO SUBMITTING TO THE IRB

Parental Permission for Child Participation in Research

Basic Study Information

Title of the Project:

Principal Investigator: [Name, credentials, institutional affiliation]

Faculty Advisor: [Name, credentials, institutional affiliation]

Study Sponsor: [If any]

Include Faculty Advisor information if you are a student, resident, or post-doc.

Include the full name of the Study Sponsor. If there is no Sponsor, delete this item.

Invitation to be Part of a Research Study

We would like to invite your child to be part of a research study. This permission form will help you in choosing whether or not to allow your child to participate in the study. Feel free to ask if anything is not clear in this consent document.

Important Information about this Research Study

For research studies that will require more than a 3-page parental permission form, provide a concise and focused presentation of key information that is most likely to help parents of potential subjects understand the full scope of the study to determine whether or not to allow researchers to ask their children to participate. Organize and simplify information to facilitate comprehension.

Delete this section if not necessary for the study.

Things you should know:

· The purpose of the study is to [briefly describe study purpose].

· In order to participate, your child must be [briefly describe eligibility criteria]

· If you choose to allow your child to participate, your child will be asked to [do what, when, where, and how]. This will take [state period of time].

· Risks or discomforts from this research include [briefly describe risk or state that the risks involved in this study are not greater than everyday life].

· The possible benefits of this study include [provide a description of potential benefits to subjects or state that there is no direct benefit for participating in this study].

· Taking part in this research study is voluntary. You or your child may decline to participate or stop participating at any time.

More detailed information may be listed later in this form.

Please take time to read this entire form and ask questions before deciding whether to allow your child to take part in this research study.

What is the study about and why are we doing it?

The purpose of the study is [describe the study purpose].

Even if you have used the “Important Information about this Research Study” section above, provide additional details in this section.

Include in this section a full and complete description of the purpose of the study and any necessary background information regarding why you are conducting the study.

Refrain from using “medicine,” “treatment,” or “therapy” for the investigational drug or device. Instead, use study drug, study procedures, study processes, etc. If you will use an investigational procedure, such as an investigational surgical procedure or innovative diagnostic procedure, clearly identify it as investigational.

Note: If you are using an investigational drug, drug combination, biologic and/or device, include the following definition of “investigational:”

The word “investigational” means the study [drug, drug combination, biologic, device] is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).

What will happen if your child takes part in this study?

If you agree to allow your child to take part in this study, your child will be asked to [provide a detailed description of what the subject will be asked to do in chronological order (what, when, where, how)].

Include in this section a full and complete description of the study procedures explained from the participant’s perspective. After reading this section, the participant should have a good understanding of what they will experience and be asked to do. It is recommend that bullet points are used to facilitate comprehension and clarity.

•[Task One]: [Description of task], [Amount of Time]

•[Task Two]: [Description of task], [Amount of Time]

If study activities occur over many days and would be communicated more clearly chronologically revise the bullet points to describe each day or consider using a table format.

Include only information about the research activities in this study, not activities that would be done for usual care or other purposes (e.g., normal education, standard clinical care, quality improvement) regardless of participation in the study. Explain what aspects of usual care will be altered or omitted because of this study as applicable.

As appropriate, and particularly for complex studies or studies with multiple visits, include study calendars or other tables, figures, or graphics to assist the subject in understanding what will be asked of them.

Use lay language to facilitate the participant’s understanding. DO NOT copy technical language from the IRB application, sponsor protocol or a grant.

If the study involves the collection of sensitive information or the inclusion of questions that might be upsetting, include examples of the type of questions that will be asked or describe the sensitive topic areas.

If the study involves randomization, include the following:

Your child will be randomly assigned (like the flip of a coin) to receive either [include details for arm 1 and arm 2 as applicable]. Your child has a [# in #] chance of receiving the [study drug, treatment, etc.].

If the study involves a placebo, include the following:

Please note: A placebo is an inactive substance given in the same form as the active drug (like a sugar pill).

If the study involves experimental activities, include the following:

Some of what we are doing is experimental and we do not fully know its effects. These activities include:

- [Experimental Activity 1]

- [Experimental Activity 2]

How long will your child be in this study and how many children will be in the study?

Participation in this study will last [describe how long participation will last, (e.g., how many minutes, hours, days, weeks, months) and how many subjects will be enrolled in the study].

Include, if applicable, if you intend to collect follow-up information and how often this will occur. For example, “We will follow up with your child once a month for the next 6 months.”

What risks and discomforts might your child experience from being in this study?

There are some risks your child might experience from being in this study. They are [describe specific risks and indicate what the study team will do to minimize those risks].

The researchers will let you know about any significant new findings (such as additional risks or discomforts) that might make you change your mind about allowing your child to participate in this study.

Include in this section a full and complete description of all reasonably foreseeable risks and discomforts the participants might experience. It is not acceptable to say that there are no risks.

Use lay language (the non-technical meaning), rather than a medical term (ex: use “weakness” instead of “asthenia”).

The information in this section should be a lay description of the risks given in the IRB submission.

Primary risks include physical, psychological, or informational risks. Informational risks could include those involving breach of confidentiality. Psychological risks (e.g., those associated with the completion of a particularly sensitive survey or interview) could be mitigated by providing subjects with contact information for counseling resources.

If there is a risk of loss of confidentiality state so, but do not include information regarding how researchers safeguard against this risk. This will be addressed later.

If there are more than 3-4 side effects in a list, please present in a vertical, bulleted format with the most likely risks first.

Example:

Possible risks associated with the study drug/device/intervention:

Likely (More than a 50% chance that this will happen)

· Likely risk #1

· Likely risk #2

Frequent (Between a 10-50% chance that this will happen)

· Frequent risk #1

· Frequent risk #2

Occasional (Between a 1-10% chance that this will happen)

· Occasional risk #1

· Occasional risk #2

Rare (Less than 1% chance that this will happen)

· Rare risk #1

· Rare risk #2

Many studies at UT Austin involve the use of similar instruments, measures, devices, etc. The Office of Research Support & Compliance maintains a library of standard/sample language that successfully conveys these risks to participants. See the Standard Consent Language document located on the Forms Page for sample language and definitions.

If the study involves an investigational drug or device or involves any research-related interventions for which the risk profile is not well known, the following information is required:

[Insert name of investigational drug/device/treatment/procedure] involves risks that are currently unknown or unforeseeable. [If any of the treatments or procedures have not been well studied in pregnant women, insert:] If your child is or may become pregnant, [insert name of study treatment or procedure] might involve risks to the embryo or fetus that are currently unforeseeable.

How could your child benefit from this study?

Your child might benefit from being in this study because [insert details].

[OR]

Although your child will not directly benefit from being in this study, others might benefit because [insert details].

What should you know about the genetic research?

**This is an optional section that applies only to studies generating, using, or analyzing genetic information**

Delete this section if not applicable to the study.

If the study involves genetic research, explain what genetic information will be used, generated, or obtained.

The samples collected during this research may have genetic information extracted from them. We [do/do not] plan on sequencing your child’s whole genome from this sample.

A Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect your child in the following ways:

· Health insurance companies and group health plans may not request your child’s genetic information that we get from this research

· Health insurance companies and group health plans may not use your child’s genetic information when making decisions regarding their eligibility or premiums.

· Employers with 15 or more employees may not use your child’s genetic information that we get from this research when making a decision to hire, promote, or fire your child or when setting the terms of their employment.

All health insurance companies, group health plans, and all employers with 15 or more employees must follow this law.

Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance, nor does it prohibit discrimination on the basis of a genetic disease or disorder that you already know about.

What will happen to the samples and/or data we collect from your child?

As part of this study we will collect [describe samples or data being collected].

Note: If it is possible that researcher will share samples/data in an identifiable or coded format, this activity would be considered a biobank or repository and will require a separate protocol submission with biobank/repository consent form. Additionally, include the approved biobank/repository consent form with this application.

How will we protect your child’s information?

We will protect your child’s information by [explain]. Your child’s name and any other information that can directly identify your child will be stored separately from the data collected as part of the project. [OR] [Describe limitations to confidentiality, if any.]

Information about you may be given to the following organizations:

· The study sponsor and/or representative of the sponsor [delete if there is no sponsor]

· Representatives of UT Austin and the UT Austin Institutional Review Board

· Other collaborating organizations [list other orgs or delete if not applicable]

· Officials of the Department of Health and Human Services or the Federal Food and Drug Administration [FDA may be deleted if this is not an FDA regulated study]

· [If research is conducted in foreign countries include the following:] This research is also being conducted in foreign countries, so personal information pertaining to you may be shared or copied by authorized agents of governmental agencies in those countries.

Include in this section a description of how the study staff will keep research data secure and identify who may access the data.

Include one of these statements:

Option 1:

We will share your child’s data or samples with other researchers for future research studies that may be similar to this study or may be very different. The data or samples shared with other researchers may include information that can directly identify your child. Researchers will not contact you or your child for additional permission to use this information.

Option 2: We will share your child’s data or samples with other researchers for future research studies that may be similar to this study or may be very different. The data or samples shared with other researchers will not include information that can directly identify your child.

Option 3:The data or samples that we will collect about your child will not be shared with any other researchers.

Option 4 (include only if data will be added to a registry/repository):

If you agree, we plan on sharing your child’s data or samples with other researchers. Those researchers in turn may share your child’s data or samples with additional researchers. Their storage/sharing policies are outlined on a separate form. Future research studies may be similar to this study or may be very different. The data or samples shared with other researchers may include information that can directly identify your child. Researchers will not contact you or your child for additional permission to use this information.

If your project is NIH-funded and collects identifiable, sensitive information, it will be covered by a Certificate of Confidentiality (CoC) –or– if you will apply for a CoC for non-NIH-sponsored research collecting health-related, identifiable, sensitive information, insert the following language:

To help us protect your child’s privacy we have obtained [or insert: will apply for] a Certificate of

Confidentiality from the National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that may identify your child, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the certificate to resist any demands for information that would identify your child, except as explained below. The certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).

A Certificate of Confidentiality does not prevent you, your child, or a member of your family from voluntarily releasing information about your child or your child’s involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information.

All applicable clinical trials must be registered on clinicaltrials.gov. The following language is required for clinical trials:

A description of this study will be available on http://www.ClinicalTrials.gov as required by U.S. law. This web site will not include information that can identify your child. At most, the web site will include a summary of the results. You can search this web site at any time.

Texas law requires anyone to report suspected child abuse or neglect. If the research could uncover child abuse or neglect, the following language is required:

Under certain situations, we may break confidentiality. If during the study we learn about child abuse or neglect, we will report this information to the appropriate authorities including the police and/or the Texas Department of Family and Protective Services.

Title IX requires the following language to be added if it is likely the research may reveal reportable incidents (e.g., sexual assault, sexual harassment, dating violence, and/or stalking):

“Texas Education Code, Chapter 51, Subchapters E-2 and E-3, requires reporting incidents of sexual assault, sexual harassment, dating violence, or stalking committed by or against a person who was a student enrolled at or an employee of UT Austin at the time of the incident. However, the researchers working on this study have been designated as confidential employees. This means that if we learn about any incidents of sexual assault, sexual harassment, dating violence, or stalking, we are only required to report the type of incident reported and the date we learn about the incident. We will not report any information that could identify you.

Include the following if applicable:

We plan to publish the results of this study. To protect your child’s privacy, we will/will not include any information that could directly identify them.

What will happen to the information we collect about your child after the study is over?

We will/will not keep your child’s research data to use for [specify future research or other purpose]. Your child’s name and other information that can directly identify them will be kept secure and stored separately from the research data collected as part of the project. [OR] Your child’s name and other information that can directly identify them will be deleted from the research data collected as part of the project.

What if we learn something about your child’s health that you did not know?

As part of this study, we may learn medically relevant information about your child. If we learn something that you and your child’s doctor did not know, we will [describe process to relay health information].


How will your child’s health information be used and shared during the study?

**This is an optional section that applies only to studies accessing, using, or maintaining PHI AND if the study’s HIPAA pathway is “Signed Authorization Combined with Consent.”


UT researchers can ensure all of the HIPAA authorization requirements are being met by utilizing this template language as directed. This section includes all of the required elements of valid HIPAA Authorization.

Remove this section if a separate HIPAA Authorization form will be used.

Double click on the boxes below to mark the types of information will be used for this research.

As part of this research study, we will ask you to share your child’s identifiable health information with us and/or permit us to access existing information from your child’s healthcare records. New health information may also be created from study-related tests, procedures, visits, and/or questionnaires. This type of information is considered “Protected Health Information” that is protected by federal law.

What type of health information will be used or shared with others during this research?

The following types of information may be used for the conduct of this research:

☐

Complete health record

☐

Information about sexually transmitted diseases

☐

Diagnosis & treatment codes

☐

Discharge summary

☐

History and physical exam

☐

Consultation reports

☐

Progress notes

☐

Laboratory test results

☐

X-ray reports

☐

X-ray films / images

☐

Photographs, videotapes

☐

Complete billing record

☐

Itemized bill

☐

Information about drug or alcohol abuse

☐

Information about Hepatitis B or C tests

☐

Information about mental health

☐

Other physical or mental health information (specify):

Where will you get my child’s records?

For this study, we will obtain records from the following healthcare providers:

· [list covered entities from whom PHI will be requested]

Who will use or share protected health information about my child?

The covered entities listed above are required by law to protect your child’s identifiable health information. By signing this document, you authorize them to use and/or share your child’s health information for this research. The health information listed above may be used by and/or shared with the following people and groups to conduct, monitor, and oversee the research:

· Principal Investigator and Research Staff

· Study Sponsor [delete if none]

· Health Care Providers at UT Health

· Data Coordinators [delete if none]

· Institutional Review Boards

· Research Collaborators [delete if none]

· Government/Health Agencies

· Data Safety Monitoring Boards [delete if none]

· Others as Required by Law

If your child’s health information has been disclosed to anyone outside of this study, the information may no longer be protected under this authorization.

When will this authorization (permission) to use my child’s protected health information expire?

Insert ONE of the following options:

Option 1:

This authorization will expire when the research study is closed, or there is no need to review, analyze and consider the data generated by the research project, whichever is later.

Option 2:

This research study involves the use of a data registry or sample repository and will never expire.

Option 3:

This authorization will expire when [specify other expiration date].

If you later decide that you do not want to share your child’s medical information any longer, please contact the study team in writing to withdrawal your authorization. Contact information for the study team can be found at the end of this form.

How will we compensate your child for being part of the study?

Your child will receive [insert payment, reimbursement, or participation credit]. Payments will occur [explain disbursement/conditions of payment]. [Include circumstances, if any, where partial payment or no payment may occur]. You will be responsible for any taxes assessed on the compensation.

Your child will receive [nature and total amount of incentive/compensation] for your participation in this study. [Describe how compensation will be determined if the subject withdraws from the research before the end of the study.]

[OR]

Your child will not receive any type of payment for their participation.

Who will pay if your child is hurt during the study?

Include this section only if there is a chance for physical injury.


Choose one of the following options:

Option 1 (if there is no research specific medical response):

In the event of a research-related injury, it is important that you notify the Principal Investigator of the research-related injury immediately. You and/or your insurance company or health care plan may be responsible for any charges related to research-related injuries. Compensation for an injury resulting from your participation in this research is not available from The University of Texas at Austin.

Option 2 (if emergency treatment for research-related injuries is arranged by, for example, having a medical doctor available for emergency treatment, it should be clearly stated. However, a statement for extended care should be added):

If your child is injured while participating, we may [describe emergency procedures]. In the event medical or other care is necessary, you and/or your insurance company or health care plan may be responsible for the payment of such charges. Compensation for an injury resulting from your child’s participation in this research is not available from The University of Texas at Austin.

Option 3 (If all participation are students at UT Austin):

If injuries occur as a result of study activity, eligible University students may be treated at the usual level of care with the usual cost for services at the Student Health Center. You and/or your insurance company or health care plan may be responsible for any charges related to research-related injuries. Compensation for an injury resulting from your participation in this research is not available from The University of Texas at Austin.

You are not waiving any of your or your child’s legal rights by allowing your child to participate in this study.

What are the costs to you for your child to be part of the study?

To participate in the research, you will need to pay for [list what costs, if any, subjects will have to pay (such as parking)].


Sample language to use when research will coincide with standard care:

Two types of procedures will be done during this study. Some are part of your standard medical care and others are only for the research study. You or your insurer will be billed for the standard medical care. You will be responsible for your co-pays, deductibles, and any other charges that your insurer will not pay. There is a possibility that your insurer may not cover all standard medical care costs if you are receiving medical services out of network. Any procedures done only for research will not be charged to you or your insurer [OR The following procedures done for research will be charged to you or your insurer – list all procedures the for which the participant will have to pay].

You can ask any questions now about insurance coverage for this study or about the research activities paid for by the sponsor. You can also ask the investigator later, using the contact information on this form.

Who can profit from study results?

Include this section only if a conflict of interest has been identified or if biospecimens are collected


Where a potential Conflict of Interest (COI) for a member of the study team has been identified, subjects must be informed about the nature of the conflict. Examples include:

· Investigators have an ownership, consulting, or similar financial relationship with a sponsor.

· A company or other organization has an ownership or other financial interest in the product or technology under study, and might profit or otherwise benefit from the outcome of the study whose product is being studied, particularly if the company/organization is also the sponsor of the study or has a financial interest with the investigators.

· The University of Texas may be paid licensing fees for the investigational technology, or could be paid in the future. Contact the Office of Technology Commercialization if you are uncertain.

When a conflict may exist, the UT COI review committee may recommend required language to be included in the consent documents.

If an investigator has a financial interest in this research per the UT COI review determination:

One or more individuals involved in this study may benefit financially from this study. The Institutional Review Board (an ethics committee that helps protect people involved in research) has reviewed the possibility of financial benefit. The Board believes that the possible financial benefit is not likely to affect your safety and/or the scientific integrity of the study. If you would like more information, please ask the researchers or study staff.

If collecting/obtaining biospecimens, one of the following must be included:

Option 1:

Your child’s samples may be used for commercial profit and there is no plan to share those profits with you.

Option 2:

Your child’s samples may be used for commercial profit and there are plans to share those profits with you. [Explain profit sharing plan]

What other choices does my child have if you do not take part in this study?

For studies that involve an intervention that might treat or improve a condition or a disease, describe alternatives to participation in the research study. These could include intervention or treatment available outside the research context.


Sample text:

There may be other ways of treating your child’s condition if you do not wish to allow your child to be in this research. Check with your health care provider to discuss other options.

Your Child’s Participation in this Study is Voluntary

It is totally up to you and your child to decide to be in this research study. Participating in this study is voluntary. The decision to participate will not affect your or your child’s relationship with The University of Texas at Austin [add as appropriate: your child’s school, your child’s doctor or healthcare provider, etc.]. You and your child will not lose any benefits or rights you already had it you decide not to participate. Even if you decide to allow your child to be part of this study now, you may change your mind and stop at any time. Your child does not have to answer any questions they do not want to answer.

If you decide to withdraw your child from the study before it is completed, [provide details about disposition of data]

If the study is FDA regulated include the following:

The Food and Drug Administration requires that we keep record of your child’s involvement with the study. Even if your child leaves the study, we must keep the data we have already collected.

If HIPAA authorization was obtained include the following:

You may change your mind and take back the right to use your child’s protected health information at any time. However, even if you take back this permission, the researchers may still use or disclose health information they have already collected about your child for this study. For example, if the law requires it, the sponsor and government agencies may continue to look at your child’s medical records to review the quality or safety of the study. If you take back this permission your child may no longer be allowed to participate in the research study. To take back this permission, you must write to the Principal Investigator.

Is it possible that my child will be asked to leave the study?

Your child may be asked to leave the study if it is determined by [your doctor or] the research team that it is unsafe for them to continue. If any of the following issues come up, we will have to ask your child to stop participating: [list reasons for termination of participation].


Is it safe to start the study and stop before my child is finished?

You and your child are always free to stop participating in the study if you would like. The decision to stop participating will not affect your child’s standard medical care or any other benefit they would receive if they were not in a research study.

Include this section only if there are risks inherent to ceasing participation.


If there are dangers inherent to ceasing participation add the text below:

If you decide to stop your child’s participation in the study, your child may experience some bad reactions:

· [Condition]

If you decide to stop your child’s participation in the study, we will need to do the following to ensure your child’s safety [include dose stepping if required]:

· [Activity][Time]

Contact Information for the Study Team and Questions about the Research

Include the following information:

1. Contact information for UT Principal Investigator and

2. Contact information for an alternate contact if available (e.g., faculty sponsor if student investigator is conducting the study, a medically responsible investigator, or a research coordinator)

3. Contact information for who to contact in case of an injury if applicable and if different from the UT PI. If a clinical study with potential for serious adverse events, this number should be available 24 hours/day.

Provide at least 2 methods of directly contacting the PI (e.g. mail, phone, email, pager).

The PI’s mailing address must be provided if HIPAA Authorization language is included in this consent form.

If you have any questions about this research, you may contact:

[Name of PI]

Phone:

Email:

Or

[Name of secondary contact person(s)]

Phone:

Email:

Contact Information for Questions about Your Rights as a Research Participant

If you have questions about your rights or your child’s rights as a research participant, or wish to obtain information, ask questions, or discuss any concerns about this study with someone other than the researcher(s), please contact the following:

The University of Texas at Austin Institutional Review Board

Phone: 512-232-1543

Email: [email protected]

Please reference the protocol number found at the top of this document.

Your Permission

Required for projects obtaining a signature only – delete this paragraph for projects that will request a waiver of documentation.

For projects involving a waiver of documentation, delete the paragraph and signature lines and include the following:

Before agreeing to be part of the research, please be sure that you understand what the study is about. We will give you a copy of this document for your records [or you can print a copy of the document for your records]. If you have any questions about the study later, you can contact the study team using the information provided above.

For projects adhering to GCP requirements, add an additional line for signature of person obtaining informed consent and the date.

______________________________________________________________

Signature of Person Obtaining Consent Date

If a second parental signature is required, add an additional line for signature and date.

______________________________________________________________

Signature of Parent or Legal Guardian Date

By signing this document, you are agreeing to allow your child to be in this study. Make sure you understand what the study is about before you sign. We will give you a copy of this document for your records. We will keep a copy with the study records. If you have any questions about the study after you sign this document, you can contact the study team using the information provided above.

I understand what the study is about and my questions so far have been answered. I agree to allow my child take part in this study.

______________________________________________________________

Printed Subject Name

______________________________________________________________

Signature of Parent or Legal Guardian Date

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