Template Version: March 2, 2017

INSTITUTIONAL REVIEW BOARDSTATEMENT OF VOLUNTEER CONSENT FOR RESEARCH STUDY

INSTRUCTIONS: This template should be used to develop the consent form for a proposed research study.

Federal regulations require a consent form to contain certain information unless waived by the IRB during review. This template is designed to include all of the required information. However, if something does not pertain to your study, you do not need to include it.

Throughout the template there are instructions concerning each section. These instructions are in italicized text. The language that should be included in the consent form is not italicized and in bold font. There may be choices of which text to include.

The language used throughout the consent form should be written at a 6th to 8th grade reading level. Most word processing programs allow you to check the reading level. Lay language should be used throughout the consent form.

Avoid use of medical / technical terms and symbols (such as <). Suggest having a non-medical person read the consent form to ascertain its clarity. Acronyms (i.e. NIH), should be spelled out the first time they're used (i.e. National Institutes

of Health). Use the question and answer format throughout the consent form and be consistent in the use

of the second person. - If your subjects are not old enough to assent, use "your child" throughout the consent form.- If your subjects are of mixed age groups use "you / your child" throughout the consent form.- If your subjects are old enough to give assent, use "you" throughout the consent form.- If your subjects are adults, use "you" throughout the consent form.

Use a standard 12 pitch font, with 1” top and side margins. Use a 1.5” bottom margin so IRB stamp will not interfere with any wording.

Double space and paginate the consent form (starting with page 1) and line number to facilitate editing.

Add page numbers and version numbers. Logos other than CHW and MCW are not to be attached to the consent form. You may add the HIPAA authorization to this consent template (as with the minimal risk

consent form), or you may keep it as a separate document.

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TITLE OF STUDY: ______________________________________________________________________________

______________________________________________________________________________

PRINCIPAL INVESTIGATOR: ______________________________________________________________________________

PHONE NUMBER: ___________________ FULL STREET ADDRESS: __________

______________________________________________________________________________

E-MAIL ADDRESS: __________________ FAX NUMBER: ____________________

CO-INVESTIGATORS: (list the full name and telephone number with area code of each co-investigator)

If appropriate, list name and address of sponsor:SPONSOR: __________________________ FULL STREET ADDRESS: __________

______________________________________________________________________________

Complete or attach patient’s label to top of consent:NAME OF SUBJECT: __________________ MEDICAL RECORD NUMBER: ______

If the research protocol offers the possibility of direct benefit to the subject, use the following opening paragraph.

WE INVITE YOU TO TAKE PART IN THIS RESEARCH STUDY. TAKING PART IN THIS RESEARCH STUDY IS YOUR DECISION. YOU DO NOT HAVE TO PARTICIPATE. YOU MAY STOP OR DECIDE TO LEAVE THE STUDY AT ANY TIME. IF YOU STOP OR LEAVE THE STUDY, YOU WILL NOT BE PENALIZED. YOU WILL STILL RECEIVE ANY TREATMENTS, HELP OR BENEFITS COMING TO YOU. THE INFORMATION IN THIS CONSENT FORM IS SUPPOSE TO HELP YOU UNDERSTAND WHAT THE RESEARCH TEAM THINKS IS HURTING YOUR HEALTH, AND WHAT THEY THINK CAN BE DONE TO TREAT YOUR CONDITION. THIS FORM EXPLAINS WHAT WILL HAPPEN IN THE RESEARCH STUDY. THE RESEARCHERS MAY BE REVIEWING THIS FORM WITH YOU AND CAN ANSWER ANY QUESTIONS YOU MAY HAVE. THIS FORM ALSO TELLS YOU ABOUT THE RISKS, DISCOMFORTS AND OTHER INFORMATION ABOUT THE STUDY. MEDICAL LANGUAGE IS HARD TO UNDERSTAND FOR MOST PEOPLE. IF THERE IS ANYTHING THAT YOU DO NOT UNDERSTAND OR ARE UNSURE ABOUT, PLEASE ASK QUESTIONS. YOU SHOULD ONLY AGREE TO TAKE PART IN THIS RESEARCH STUDY AND SIGN THE CONSENT FORM IF YOU

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UNDERSTAND WHAT WILL HAPPEN TO YOU, WHAT THE RISKS ARE, AND THAT YOUR QUESTIONS HAVE BEEN ANSWERED.

If the research protocol does not offer any possibility of direct benefit to the subject, use the following opening paragraph. Do NOT use both paragraphs.

WE INVITE YOU TO TAKE PART IN THIS RESEARCH STUDY. TAKING PART IN THIS RESEARCH STUDY IS YOUR DECISION. YOU DO NOT HAVE TO PARTICIPATE. YOU MAY STOP OR DECIDE TO LEAVE THE STUDY AT ANY TIME. IF YOU STOP OR LEAVE THE STUDY, YOU WILL NOT BE PENALIZED. YOU WILL STILL RECEIVE ANY TREATMENTS, HELP OR BENEFITS COMING TO YOU. YOU WILL NOT BENEFIT OR BE HELPED FROM BEING IN THIS RESEARCH STUDY. THE INFORMATION IN THIS FORM EXPLAINS WHAT WILL HAPPEN TO YOU IN THE STUDY. THE RESEARCHERS MAY BE REVIEWING THIS FORM WITH YOU AND CAN ANSWER ANY QUESTIONS YOU MAY HAVE. THIS FORM ALSO TELLS YOU ABOUT THE RISKS, DISCOMFORTS AND OTHER INFORMATION ABOUT THE STUDY. MEDICAL LANGUAGE IS HARD TO UNDERSTAND FOR MOST PEOPLE. IF THERE IS ANYTHING THAT YOU DO NOT UNDERSTAND OR ARE UNSURE ABOUT, PLEASE ASK QUESTIONS. YOU SHOULD ONLY AGREE TO TAKE PART IN THIS RESEARCH STUDY AND SIGN THE CONSENT FORM IF YOU UNDERSTAND WHAT WILL HAPPEN TO YOU, WHAT THE RISKS ARE, AND THAT YOUR QUESTIONS HAVE BEEN ANSWERED.

For behavioral health studies in which you might not know what is hurting your patient's health:

WE INVITE YOU TO TAKE PART IN THIS RESEARCH STUDY. TAKING PART IN THIS RESEARCH STUDY IS YOUR DECISION. YOU DO NOT HAVE TO PARTICIPATE. YOU MAY STOP OR DECIDE TO LEAVE THE STUDY AT ANY TIME. IF YOU STOP OR LEAVE THE STUDY, YOU WILL NOT BE PENALIZED. YOU WILL STILL RECEIVE ANY TREATMENTS, HELP OR BENEFITS COMING TO YOU. THE CONSENT FORM WILL EXPLAIN WHAT WILL HAPPEN TO YOU IN THIS RESEARCH STUDY. THE RESEARCHERS MAY BE REVIEWING THIS FORM WITH YOU AND CAN ANSWER ANY QUESTIONS YOU MAY HAVE. THIS FORM ALSO TELLS YOU ABOUT THE RISKS, DISCOMFORTS AND OTHER INFORMATION ABOUT THE STUDY. MEDICAL LANGUAGE IS HARD TO UNDERSTAND FOR MOST PEOPLE. IF THERE IS ANYTHING THAT YOU DO NOT UNDERSTAND OR ARE UNSURE ABOUT, PLEASE ASK QUESTIONS. YOU SHOULD ONLY AGREE TO TAKE PART IN THIS RESEARCH STUDY AND SIGN THE CONSENT FORM IF YOU UNDERSTAND WHAT WILL HAPPEN TO YOU, WHAT THE RISKS ARE, AND THAT YOUR QUESTIONS HAVE BEEN ANSWERED.

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A. WHAT IS THE PROBLEM?Describe the background issues, child’s diagnosis or reason for selection into this protocol.

For example, add(if appropriate): Note that the suggested language uses cancer as an illustration. Please modify the language based on the subject population and condition you are studying.

You are being asked to take part in this study because you have child’s diagnosis or reason for selection into this protocol Reference and attach information about the diagnosis, etc. (and eligibility requirements, if knowing the eligibility requirements will improve the chance of the subject telling the investigator necessary information).

B. WHAT IS THE PURPOSE OF THIS RESEARCH STUDY?What is to be done that requires informed consent? What is the experimental aspect of the research study?

For example, add (if appropriate):The purpose of this study is to ____[add applicable text]______________________________.

Applicable text:

Phase 1 studies: Test the safety of drug/intervention and see what effects (good and bad) it has on you and your _____. or Find the highest dose of a drug that can be given without causing severe side effects.

Phase 2 studies: Find out what effects (good and bad) drug/intervention has on you and your__________ .

Phase 3 studies: Compare the effects (good and bad) of the new drug/intervention with commonly-used drug /intervention on you and your __________ to see which is better.

This research is being done because______________________________________________.Explain in one or two sentences. Examples are: “Currently, there is no effective treatment for this type of __________,” or “We do not know which of these two commonly-used treatments is better." or "We do not know what factors impact quality of life for children and their families."

If a device or drug being used in the research study has not been approved for general use, or has not been approved for the use involved in this study, add:

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ADD: Drug/Intervention has not been approved for general use or is still being investigated or for use in this disease.

Include previous experience with drug/treatment/test in the study of animals, adults or children.

The final paragraph of this section should indicate the number of subjects and age-range of subjects who will be enrolled in the study, if it is a multi-center study and the sponsorship. If it is a multi-center study, the number of subjects that will be from our site also needs to be included. For example…About _____ children, ages _____, will take part in this study. _____ will be from Children's Hospital of Wisconsin.

Add if appropriate:Is there someone sponsoring this study? If so, please include any financial relationship with the sponsor: There is no financial reimbursement from ___(sponsor's full name)___for staff involvement in this study. Or if there is, The staff is being reimbursed for _______ from the sponsor's full name). Indicate whether research staff are being provided incentives to enroll subjects in the study vs paid for study itself.

C. WHAT IS INVOLVED IN THE RESEARCH STUDY? Describe, in appropriate detail, the things to be done because of the protocol (what's

research vs standard of care). Identify the research component(s) clearly. For complicated protocols, you may want to provide a simplified schema and/or

calendar. Commonly used terms such as “blinded, randomization, placebo” should be explained. The amount of blood drawn should be quantified in teaspoons, tablespoons or ounces.

Indicate who will be doing the blood draws. Indicate whether the amount of blood drawn is safe for the subject.

This section should also include the expected duration of the subject’s participation. Add that medications should not be shared with others - family or friends. If photographs are to be used / associated with this research study, this should be noted.

The separate consent for research subjects is no longer required. This section should state that subject's will need to re-consent once they reach the age of

18 (if appropriate to study).

For randomized studies, add:You will be “randomized” into one of the study groups described below. Randomized means that you are put into a group by chance. It is like flipping a coin. Which group you are put into is decided by a computer. Neither you nor the researcher will choose what group you will be in. You will have an equal / one in three / etc. chance of being placed in either group. Using randomization helps to improve the chance of determining which (if either) treatment is better.

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For non-randomized and randomized studies:

If you take part in this study, you will have the following tests and procedures:List and describe tests and procedures and their frequency under the categories below. For randomized studies, list the study groups and under each describe categories of procedures. Include whether a patient will be at home, in the hospital, or in an outpatient setting. If objectives include a comparison of interventions, list all procedures, even those considered standard. Standard tests / procedures that are part of regular care and may be done even if you

do not join the study. Standard tests / procedures being done because you are in this study. Procedures that are being tested in this study.

Give some indication about the duration of the subject's participation. Where appropriate, state that the study will involve long-term follow-up.

We think you will be in the study for months / weeks / until a certain event.

D. WHAT ARE THE RISKS TO YOU IN THIS RESEARCH STUDY?

While on the study, you are at risk for these side effects. You should discuss these with the researcher and/or your regular doctor. There also may be other side effects that we cannot predict. Other drugs will be given to make side effects less serious and uncomfortable. Many side effects go away soon after the intervention / drugs are stopped. But in some cases side effects can be serious or long-lasting or permanent.

Describe the risks in detail. Do not describe risks in a narrative fashion. List by regimen the physical and nonphysical risks of participating in the study in categories of “very likely” and “less likely but serious.” Non-physical risks may include such things as the inability to work. Highlight or otherwise identify side effects that may be irreversible or long-term or life threatening. If not getting an active drug in a trial (getting placebo), this should also be indicated as a risk.

Risks and side effects related to procedure, drug, device we are studying include: List risks related to the investigational aspects of the trial. Specifically identify those that may not be reversible. Also include that: This procedure, drug, device may not work for you.

Add the following information about pregnancy, if appropriate:Pregnant women should not take part in this research study. The effects of procedures, drugs, or devices on an unborn baby are not known (or) are harmful. (Choose one or both phrases, whichever is appropriate) You should not become pregnant while on this study. You should not nurse / breast feed your baby while on this research study. As far as you

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know, you are not pregnant at this time. You need to take extra safety measures to prevent pregnancy (such as not having sexual intercourse, using more than one barrier method, such as a diaphragm or condom, taking birth control pills, an IUD, etc.) while you are receiving this drug or treatment. You should tell ____________________ at once if you think you are pregnant or become pregnant during this research study. Include a statement about possible sterility when appropriate. Attach additional information about contraception, etc., if appropriate. Include information regarding pregnancy testing.

Add the following information about fathering a child, if appropriate:The effects of procedures, drugs, or devices on a man's sperm or an unborn baby are not known (or) are harmful. (Choose one or both phrases, whichever is appropriate) You should not father a baby while on this study. You need to take safety measures to prevent pregnancy (such as not having sexual intercourse; or you should use a condom AND have your sexual partner use birth control (such as a diaphragm or condom, take birth control pills regularly, or use an IUD, etc.) while you are receiving this drug or treatment. Include a statement about possible sterility when appropriate. Attach additional information about contraception, etc., if appropriate.

Add, if appropriate:

For more information about risks and side effects, ask the researcher or contact ____________________.

Reference and attach drug sheets, pharmaceutical information for the public, or other material on risks.

If blood work is drawn as part of the research study, add:

Taking blood may cause some pain, bleeding or bruising at the spot where the needle enters your body. Rarely, taking blood may cause fainting or infection. (Indicate if EMLA cream will be used.)

E. WHAT IF PROBLEMS OCCUR DURING THE STUDY OR WITH TREATMENT?Describe, in detail, actions to be taken in the event of a specific adverse effect, including appropriate referral for any psychological risks, such as anxiety or stress.

Your health is more important than following the research plan. If any changes are needed to protect your health, we will talk with you about them before they are made. We will also tell you if a better treatment is discovered somewhere else. If you want, this treatment will be given to you in place of or in addition to the current plan. We will also tell you about any new information that may change your willingness to stay in this study.

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Add, when a Data Safety and Monitoring Board exists, replace the last sentence above with:A Data Safety and Monitoring Board (from where), an independent group of experts, will be reviewing the data from this research throughout the study and reporting back to the research team. We will tell you about the new information from this or other studies that may affect your health, welfare, or willingness to stay in this study.

If you are injured as a result of the experimental parts of this research study, you should immediately contact the researcher name(s) at telephone number . Name(s) or one of his/her colleagues on this study will be available 24-hours a day, 7 days a week at phone number or pager. (PLEASE NOTE: THIS HAS TO BE ONE OF THE INVESTIGATORS ON THE STUDY - NO RESIDENTS / FELLOWS. ALSO, IF USING A PAGER NUMBER, THIS SHOULD BE STATED SO FAMILIES KNOW WHAT TO EXPECT WHEN CALLING.). You may also call the Chairperson of the hospital's committee that reviewed this research study at 414-266-2986.

The sponsor's responsibility should be indicated - is or is not available

If the research involves the potential for injury, one of the following statements regarding appropriate compensation for injury should be included.

(Option 1) - In the event that this research activity results in an injury, care for such injuries will be billed in the ordinary manner to you or your insurance company. Insurance companies may refuse to pay for injuries sustained while participating in a research study or while receiving a treatment that is considered experimental. If you think that you have suffered a research-related injury, let the study physician(s) know right away.

(Option 2) - In the event that this research activity results in an injury, care for such injuries will be billed in the ordinary manner, to you or your insurance company. Insurance companies may refuse to pay for injuries sustained while participating in a research study or while receiving a treatment that is considered experimental. The sponsor of the study has some funds available to pay for care for injuries resulting directly from being in this study. If you think that you have suffered a research-related injury and that you may e eligible for reimbursement of some medical care costs, let the study physicians know right away.

(Option 3 - if the preferred injury compensation language is unacceptable to the study sponsor and they state their objection in writing, the following alternative language may be used) - Under some circumstances, the sponsor of the study will pay for injuries resulting directly from being in the study. If you want information about those circumstances or if you think you have suffered a research-related injury, let the study physician(s) know right away.

You do not waive any legal rights by participating in this study or by signing this form.

The researcher may decide to take you off this study if ______________________________.

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List circumstances, such as in the participant’s medical best interest, funding is stopped, drug supply is insufficient, patient’s condition worsens, new information becomes available.

F. WHAT ARE THE POSSIBLE BENEFITS TO YOU IN THIS RESEARCH STUDY?

The information which is obtained may be useful scientifically and possibly helpful to others. The benefits to you which may be expected from participating in this study are (….state potential benefits….), but this is not guaranteed. (This last phrase must be included in the Consent Form.)

If there is no benefit for participating in the study, this should be stated.

Add, if appropriate:If you agree to take part in this study, there may or may not be direct medical benefit to you. We hope the information learned from this study will benefit other patients with __________ in the future.

For Phase 3 studies, when appropriate:The possible benefits of taking part in the study are the same as receiving standard drug / intervention without being in the study.

G. WHAT ARE THE FINANCIAL RISKS TO YOU IN THIS RESEARCH STUDY ?

Clearly delineate what is paid for and what is not. Should make clear distinction between routine clinic and study charges.

Add if appropriate:If you take part in this study, there may be added costs to you or your insurance company. Some third party payers (insurance companies, HMO’s, etc.) may not pay for hospitalization, treatments or procedures which are determined to be experimental or research-related. All costs not paid by your insurance will be your financial responsibility. Please ask about any expected added costs or insurance problems. Financial Counselors are available to discuss insurance, costs and other issues.

Add if appropriate:A commercial product may be developed from this research. You WILL NOT be paid or financially compensated if a commercial product is developed.

Add if appropriate:Is there someone sponsoring this study? If so, please indicate and add the following regarding payment: Such payment by _(sponsor)_ will be limited to medical bills not covered by your health care program or insurance policy. (Sponsor) has no program for providing other payment.

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H. WILL YOU BE PAID FOR TAKING PART IN THE RESEARCH STUDY?

Add, if appropriate:You will receive no payment for taking part in this study.

If compensation exceeds $50.00 total compensation - provide a letter of explanation.

Add, if appropriate:You will receive a total of $__________ for completion of this study. A portion of this payment ($__________) is to reimburse you for costs incurred by your participation in this study, such as parking, meals and transportation. The remaining $__________ is to provide for the time and inconvenience of participating in this study. If you are under 18, the additional $__________ will be given to you in the form of (add non-cash instrument of PI’s choice made out to child subject. This sentence is optional). If you discontinue the study before its completion, a share of the stipend will be paid depending on the extent of participation.

I. DO YOU HAVE TO PARTICIPATE IN THIS RESEARCH STUDY?

You do not have to participate in this study. You are free to withdraw at any time. Your decision to withdraw will not change the quality of care that you receive from the Medical Staff. However, if you decide to stop participating in the study, we encourage you to talk to the researcher and your regular doctor first.

Add, if appropriate:If you choose to withdraw from this study, early withdrawal may pose _________________ risks. Describe any serious consequences of sudden withdrawal from the study.

If you do not wish to participate in this study, you have these options: List alternatives including commonly-used therapy and " Please talk to your regular doctor about these and other options." If appropriate, reference and attach information about alternatives.

Add, if appropriate (for non-investigational treatments):You may get study treatments / drugs at this center and other centers even if you do not take part in the study.

Add, if appropriate (if the subject can participate in some but not all of the research study):You wish to limit your participation in the study as follows (if none, compared to description of participation, write “NONE”):

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J. WHAT IF YOU HAVE MORE QUESTIONS?

For questions about the study or a research-related injury, contact the researcher name(s) at telephone number . Name(s) or one of his/her colleagues on this study will be available 24-hours a day, 7 days a week at phone number or pager. (PLEASE NOTE: THIS HAS TO BE ONE OF THE INVESTIGATORS ON THE STUDY - NO RESIDENTS / FELLOWS. ALSO, IF USING A PAGER NUMBER, THIS SHOULD BE STATED SO FAMILIES KNOW WHAT TO EXPECT WHEN CALLING. IF THE STUDY IS MINIMAL RISK, I.E. A SURVEY OR REGISTRY, YOU DO NOT NEED TO BE AVAILABLE 24/7.) (Add the next sentence, if appropriate) If additional questions arise, you can ask your doctor. Also, the research study has been reviewed and approved by the Institutional Review Board, whose purpose is to see that the rights and welfare of research participants are adequately protected, and that risks are balanced by potential benefits. A member of this committee is available to speak to you if you have any questions or complaints at 414-266-2986. And, if available, list patient representative (or other individual who is not on the research team or Institutional Review Board).

You will get a copy of this form.

K. RESEARCH DATA IN MEDICAL RECORD

A copy of the signed consent, assent (if applicable) and HIPAA Authorization will be kept in your medical record.

All information regarding the storage of data, including the exact date that will be placed in the patient's medical record must be document in the research protocol, consent form and HIPAA Authorization.

Items to Include in Medical Record Informed consent / assent (if applicable) HIPAA authorization Test results and treatment / procedures that are relevant to the care of the patient, even if the

items were part of the research protocol and paid by the sponsor or grant. Clearly defined information in the patient locator or other prominent portion of the record

that the patient is enrolled in a clinical trial, the PI's contact information to notify in case of an emergency or question concerning care.

Processes to ensure confidentiality (especially if a Certificate of Confidentiality has been granted).

L. WILL INFORMATION BE CONFIDENTIAL?

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This section needs to include information about any person or organization that will have access to the data, including the sponsor. Information on how the data will be protected should also be included.

Children's Hospital of Wisconsin / Children's Health System, its researchers and their designees will maintain the privacy and confidentiality of your personal and health information to the extent permitted by law. Efforts will be made to keep your personal information confidential. We cannot guarantee absolute confidentiality. Your personal information may be disclosed if required by law. Also, scientific data from this study, without identifiable information, may be presented at meetings and published so that it may be useful to others, as long as it is not identifiable with you. Some organizations that may inspect and/or copy your research records for purposes of quality assurance and data analysis include groups such as: List relevant agencies like the National Cancer Institute, Food and Drug Administration (if this is a FDA protocol, they must be listed), study sponsor, etc

If the research study has the potential to uncover physical or sexual abuse, add:The researcher is required by law to report child abuse or neglect (or suspicion of abuse or neglect) if you mention it to the researcher or if it is suspected.

Wisconsin state law mandates that patients with positive results of Hepatitis C, HIV, Syphilis,Hepatitis B surface antigen, and certain STDs be reported to the State Lab of Hygiene. The lab conducting the test or the health care provider typically does this. Research subjects must be informed of any positive results that are diagnosed as a result of their study participation and that these results must be reported as per state law.

The following wording should be used if your protocol includes collection of DNA samples.

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 you in the following ways: Health insurance companies and group health plans may not request your genetic information

that we get from this research. Health insurance companies and group health plans may not use your genetic information

when making decisions regarding your eligibility or premiums. Employers with 15 or more employees may not use your genetic information that we get

from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.

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Be aware that this Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.

If this study is an actual clinical trial, the following statement must be included (do not modify this text):A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

M. PERMISSION TO PROCEED

The signing of this consent does not release your doctors from their responsibility for your proper medical care at all times.

The proposed research study and consent has been explained to you by:

___________________________________ ____________________________________Name Of Principal Investigator or Designee Signature Of Principal or Designee

Date: _________________________________ Time: _____________________________

PLEASE NOTE: If the research presents more than minimal risk and offers no prospect of direct benefit to

child participants (i.e., the research is categorized as 45 CFR §46.406/407 or 21 CFR §50.53/54), the IRB requires the permission of BOTH parents, unless one parent is deceased, unknown, incompetent, or not reasonably available, or unless only one parent has legal responsibility for the care and custody of the child.

If the second parent signature is NOT obtained, the PI must document in research records, the reason and/or all attempts made before concluding the second parent was not ‘reasonably available.”

If the child to be involved in the research study is a FOSTER CHILD or a WARD OF THE STATE, the researcher or their staff who is obtaining the consent should be notified.

Parents need to sign a separate consent for each child participating in the study. If parents are also participating, separate consent forms need to be complete for each

participant. On an emergency basis, if the consent form has not been translated into the subject's native

language, the signature and date of the translator also needs to be added. The consent for non-English speaking subjects also needs to be completed. If this happens more than once, you should have the consent form translated and an amendment filed.

When you sign this form, you agree that you have read the above description of this research. You also agree that you have had a chance to discuss the research study with a

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member of the research team; that your questions have been answered, and that you want to take part in this research.

Option 1 – Parent / Legal /Guardian Permission

__________________________________ ______________________________Signature#1 of Subject, Parent or Legal Date / TimeGuardian

__________________________________ ______________________________Signature #2 (if required) of Subject, Parent Date / Timeor Legal Guardian

Option 2 – The PI must document in research records, the reason and/or all attempts made before concluding the second parent was not ‘reasonably available.”

__________________________________ ______________________________Signature #1 of Subject or Subject’s Date / TimeLegal Representative

__________________________________ ______________________________Signature #2 (if required) of Subject or Subject’s Date / TimeLegal Representative

Permission of the second parent not obtained because (select all that apply):_____ Not required by the IRB (Risk Level 46.404 or 46.405) _____ Other parent is deceased _____ Other parent is unknown _____ Other parent is not reasonably available _____ Only one parent has legal responsibility for the care and custody of subject.

If appropriate add:Concerning the results of this study, you consent to the following (please initial one):Should include information about why it's important to discuss the results with their primary doctor.

_____ The results may be shared with your primary care doctor.

_____ The results may not be shared with your primary care doctor.

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OR:

Concerning your participation in this study, you consent to the following (please initial one):

_____ Your participation in this study may be shared with your primary care doctor.

_____ Your participation in this study may not be shared with your primary care doctor.

ASSENT OF MINOR:

The above has been explained to me and I agree to participate.

___________________________________ ____________________________________Signature of Minor Date / Time

If child’s assent is not obtained above, please indicate reason below (check one): Assent is documented on a separate IRB-approved assent form Child is under the required age range for assent The IRB granted a waiver of assent, please specify:

__________________________________

__________________________________ ____________________________________Signature of Principal Investigator Dateor Research Team Designee

__________________________________Time

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