Consent Form Instructions

Many sections on the Consent Form template include brief instructions to provide the user with a general overview of information required in the section. The instructions are shaded so that you can tell the difference between the instructions and required information. Some fill in areas are in red text. All red text must be deleted before submission to the IRB. The template language in black text may not be changed, or deleted, unless approved by the IRB staff. Any changes you make must be tracked or highlighted. Please delete all shaded instruction boxes before submitting to the IRB. To delete, select (click in) a shaded box and hit the "delete" key.

Introduction:The consent to be a research participant should be prepared according to the guidelines below. Although the consent for certain very simple studies can be modified, the majority of consent forms must contain the elements listed below, in the order listed and phrased in the suggested language. Any other language specifically required by the sponsor can be added, provided it is written (or re-written) in simple, 6th to 8th grade language. Investigators should not deviate from these guidelines without prior consultation with the Chair of the IRB or the IRB Manager. Once a consent form has been approved by the IRB, it must not be revised in any way without written permission from the IRB. Investigators must keep a complete paper trail of all communication with the IRB regarding their consent forms, including copies of all versions of the consent.

Format:There are specific requirements for how the consent form must be written. The consent form must be written in the second or third person (you will be, your child will be). The consent form must be written clearly and simply, in language that the average layperson can understand, usually in the sixth grade reading level. Passive voice phrasing should be avoided. Do not use terms like “he/she”; gender free references such as “your child” are preferred.

Please leave adequate top and bottom margins for the IRB stamps. The IRB staff will add the approval and expiration stamp, to the final version of the form(s). PDF documents with IRB stamps and unstamped Word documents will be e-mailed to the PI. All consent forms must include the date of the latest revision in the lower left corner of the footer. At continuing review, even if there are no changes, the form date should be updated (the version date can remain if required).

All consent forms must be identified in the top left corner of the first page, e.g., "Adult" if the form is only for age 18 or older; "Parent" if the form is for parental permission; "You/Your Child" if combined consent is used. When the IRB staff receives the electronic copy, the IRB number will be put in the header.

For any study that involves a medical/clinical intervention, the first page of the consent form must be the "List of Rights of a Participant in a Medical Experiment." The subject must sign and date this page before proceeding to the consent form. If the study does not involve a "medical experiment" as defined below, do not include this.“A medical experiment” is defined under section 24174 of the CA Health and Safety Codes as follows: (a) The severance or penetration or damaging of tissues of a human subject or the use of a drug or device, as defined in Section 109920 or 109925, electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject; (b) The investigational use of a drug or device as provided in Sections 111590 and 111595; (c) Withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject.

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LIST OF RIGHTS OF A PARTICIPANT IN AMEDICAL EXPERIMENT

Under California law, a person participating in a medical research study must be told:

The purpose of the study, The procedures which will be followed in the study, and the drugs or

devices, if any, which will be used, If there are any other possible treatments, procedures, drugs or devices

which can be given (instead of those offered in the study), and the risks or benefits of those other possibilities,

If there are any discomforts or risks that may reasonably be expected from taking part in the study,

What medical treatment, if any, will be available if complications happen during or after the study,

If there are any benefits that can be expected from taking part in the study, and if so, what the benefits might be,

That any questions about the study can be asked, both before agreeing to be involved and during the study, and that answers must be given,

That consent to participate in the study may be withdrawn at any time, without affecting the right to care and quality of care that would be received outside of the study,

That the choice to take part in the study or not should be given freely, without pressure, deceit or other excessive influence on the decision made,

That a copy of the written signed and dated consent form will be given to the participant to keep.

Signature of Participant or Legal Representative Date

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747 Fifty Second Street ● Oakland, CA 94609-1809510-428-3000

www.childrenshospitaloakland.org

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CONSENT TO PARTICIPATE IN A RESEARCH STUDY – ADULT

CONSENT TO PARTICIPATE IN A RESEARCH STUDY – PARENT

FORMTEXT choose one of the above – delete the otherChoose the paragraphs that are customized to apply either to "your child" or "you."

OR

You may combine adult and child consent by using the "you" formatted paragraphs and the following box [delete if not used.]

If you are a parent, as you read the information in the Consent Form, you should put yourself in your child’s place to decide whether to allow your child to take part in this study. Therefore, for the rest of the form, the word “you” refers to your child.

If you are an adult reading this form, and deciding whether to take part in the study, the word “you” refers to you.

NAME OF THE STUDY:

WHAT IS THIS STUDY ABOUT?

FORMTEXT Describe the rationale for doing the study in simple terms. Be sure to state that this is a research study. Include reasons for doing the study, such as safety and/or efficacy, etc.

Explain the medical and practical reasons the subject was selected as a potential participant [why the subject may qualify to be in the study].

WHO IS PAYING FOR THIS STUDY?

FORMTEXT FORMTEXT All consent forms should disclose which agencies or institutions (e.g., National Institutes of Health, Center for Disease Control, State agencies), cooperative groups (COG, ACTG), foundations or industry sponsors are funding the research or providing study drugs or equipment for the study, and state what the sponsor is paying for. FORMTEXT If the study is not being funded by an external agency, then the internal funding source, i.e., Department funds, investigator personal funds, should be identified.

This study is paid for by xxxxx. The medicine being studied, xxxxx, will be provided at no cost to you or your insurance company by [name of sponsor], a pharmaceutical company.

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510-428-3000www.childrenshospitaloakland.org

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HOW MANY PEOPLE WILL BE IN THIS STUDY?

About state total accrual goal for CHO people, age state the age range of the participants will be in this study at UCSF Benioff Children's Hospital Oakland. For multi-center studies, give figures both for the whole study and for local enrollment at CHO.

IS THERE ANY CONFLICT OF INTEREST?

FORMTEXT This section is not required if the sponsor is non-industry (e.g. a governmental agency such as NIH, COG, a non-profit foundation), or there is no external sponsor (study is funded by CHO, CHORI or is non-funded). Delete heading and all paragraphs below.

FORMTEXT If there is a perceived or actual conflict of interests, this information will be released to the IRB and will be addressed in the consent form under this section. Financial ties to the sponsoring company will not necessarily prevent the investigator from performing or participating in research involving that company.

Examples:

Dr. _____________ has stock in a company that is doing research in the same area as this study.

Dr. ___________________ has received an honoraria [or travel reimbursement] during the past 12 months from the study sponsor.

You may also add, This disclosure is [these disclosures are] made so that you can decide if this relationship will affect your willingness to participate in this study.

For Industry-Sponsored Studies, if there is no conflict of interestWhen a person or an organization has a financial or other conflicting interest large enough to give the impression that it could affect their judgment, we call this a conflict of interest. Dr.  name is responsible for doing the study at UCSF Benioff Children’s Hospital Oakland.  Neither Dr.  name nor Children's Hospital Oakland have any significant financial ties or interactions with the sponsor of this study that would influence the conduct of the study or the reporting of results.

WHAT WILL HAPPEN IN THE STUDY?

FORMTEXT Explain the study procedure in simple terms. If appropriate, include a description of randomization. List and explain each part of the study. Be sure to distinguish between standard practice and what is done for the research study. Clearly outline what is experimental.

If you agree to be in this study, the following will happen:

Before you begin the main part of the study...You will need to have the following “screening” exams or tests to find out if you can be in the main part of the study.

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FORMTEXT List tests and procedures as appropriate. Use bulleted format.For example:

Physical exam: You will have a physical exam, like those done for regular medical care.

Medical record review: The study doctors will look at your medical record.

Urine sample: You will be asked to give a urine sample for lab tests.

Blood drawing (venipuncture): You will be asked to give a blood sample for lab tests. [name the types of tests/reasons for tests] This will be done by putting a needle into a vein in your arm.

When describing procedures, use lay terms. For example, if blood is to be drawn, estimate the amount in teaspoons, tablespoons or cups.

During the main part of the study...If the screening exams, tests or procedures show that you can continue to be in the study, and you choose to take part, then the following will be done:

FORMTEXT List tests and procedures as appropriate. Use bulleted format. Estimate the amount of time required for participation in the study.

If a placebo is to be used, indicate that the subject may receive a placebo, with an explanation that a placebo is an inactive substance which looks like an active drug [a "sugar pill"]

For randomized studies:You will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the groups. Neither you nor your doctor can choose the group you will be in. You will have an equal/one in three/etc. chance of being placed in any group.

FORMTEXT If you are in group 1 (often called "Arm A")... [Explain what will happen for this group with clear indication of which interventions depart from routine care.]

If you are in group 2 (often called "Arm B")... [Explain what will happen for this group with clear indication of which interventions depart from routine care.]

For studies with more than two groups, an explanatory paragraph containing the same type of information should be included for each group.

Examples:CT scan: You will have a computed tomography (CT) [/computerized axial tomography (CAT)] scan of your [XXX], done [XXX], to check . . . A CT scan uses special x-ray equipment to make detailed pictures of body tissues and organs. For the CT scan, you will need to lie still on a table with your [XXX] inside a large doughnut-shaped machine. [Explain what will happen during the procedure, what the patient will experience, how long it will take, etc. If a contrast material will be used, explain what this is and how it will be given.] [This makes tissue and organs more visible in the pictures.]

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MRI: You will have a Magnetic Resonance Imaging (MRI) exam. For the MRI exam, you will lie down on a narrow bed [explain what the MRI is like, the need to lie quietly, how long it will take, whether general anesthesia will e used, etc.]

WHAT ARE THE RISKS OR POSSIBLE SIDE EFFECTS OF THIS STUDY?

FORMTEXT Be sure to distinguish between the risks of standard treatment (if applicable) and the risks of the research study. Include the following paragraph, if applicable:

You may have side effects while on the study. Everyone in the study will be watched carefully for any side effects. Side effects may be mild or very serious. Your health care team may give you medicines to help lessen side effects. Many side effects go away soon after you stop taking [drugs/interventions].

FORMTEXT This sentence should be included if appropriate: There is also a risk of death.

Risks and side effects for the [procedures, drugs, interventions, devices] include those that are:

Likely

Less Likely

Rare but serious

FORMTEXT Describe each risk, discomfort, or inconvenience (e.g., having to make extra visits to the hospital or doctor’s office, blood drawing, experimental medicines). Include an explanation of the clinical significance of the risk (what will actually happen to the participant, how the participant will feel) and a statement about the likelihood of occurrence of side effects.

Example: The risks of drawing blood include temporary discomfort from the needle stick and bruising.

[If appropriate to the study, include the following risk statement(s):]

Randomization risks: You will be assigned to a treatment program by chance, and the treatment you get may prove to be less effective or to have more side effects than the other study treatment(s) or other available treatments.

Placebo risks: If you are in the group that gets the placebo, your condition will go without the active (study) treatment for [XX weeks].

HOW LONG WILL I [MY CHILD] BE IN THE STUDY?

FORMTEXT State expected time on the study, including any follow-up time.

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ARE THERE RISKS TO AN UNBORN BABY?

FORMTEXT The consent form must specifically address any treatment or procedure which might involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant), which are currently foreseeable. Include only if this is an exclusion criterion in the protocol. – Delete if not applicable, heading included. Delete sentence about males if not applicable.

Adults onlyThere may be a risk to an unborn baby. Females cannot be in the study if pregnant. They should not breastfeed a baby while on this study. Females able to become pregnant will be asked for a urine sample before starting the study to make sure they are not pregnant. One or more pregnancy tests are absolutely required to be in the study. Males should not father a baby while on this study.

Combined Adult/ChildThere may be a risk to an unborn baby. Females cannot be in the study if pregnant. They should not breastfeed a baby while on this study. Females 12 years or older, or who have had their first menstrual period, will be asked for a urine sample before starting the study to make sure they are not pregnant. One or more pregnancy tests are absolutely required to be in the study. Only the participant (person who is enrolled in the study) will be told the results of the pregnancy test, except as required by law. Males should not father a baby while on this study.

Child only – signed by parent/guardianThere may be a risk to an unborn baby. Females cannot be in the study if pregnant. They should not breastfeed a baby while on this study. Females 12 years or older, or who have had their first menstrual period, will be asked for a urine sample before starting the study to make sure they are not pregnant. One or more pregnancy tests are absolutely required to be in the study. Only your child will be told the results of the pregnancy test, except as required by law. Males should not father a baby while on this study.

FORMTEXT Add sponsor-specific language, including contraception, if required.

ARE THERE BENEFITS TO BEING IN THE STUDY?

FORMTEXT The potential benefits of participating in the study, if any, should be described in simple terms. If there are no benefits, that should be stated. Clearly state whether there is an expected direct benefit or an indirect benefit.

Example: The information we get from this study may help future patients if… or It is possible that the experimental treatment will work better than the treatment usually given or There will be no benefit to you from being in the study.

WHAT OTHER CHOICES DO I HAVE?

FORMTEXT Describe appropriate alternatives, including their relative risks and benefits. If the treatment, device or an FDA-approved drug can be prescribed/obtained outside of the study this must be stated.

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Example: If you choose not to [have your child] be in this study, your child [you] will be treated with standard therapy including [briefly state what is standard therapy] Include no treatment or palliative care if appropriate.

FORMTEXT PRIVACY SECTION BELOW: For most studies, the following statement [either the paragraph for adult or child] should be used. If there is other information specific to the protocol, include the specifics within the CHO language below. For example, identifying data may be collected or be sent to someone outside of CHO, so the statement "for records shared outside of Children's Hospital Oakland" would not apply.

Adult and Combined Adult/ChildHOW WILL MY PRIVACY BE PROTECTED?

Study records that identify you will be kept confidential as required by law. Federal Privacy Regulations protect your privacy, restrict who is allowed to look at your records, and require security to protect your records. The Federal Food and Drug Administration (FDA) may inspect your research records. Except when required by law, you will not be identified by name, social security number, address, telephone number, or any other direct personal identifier in study records shared outside of UCSF Benioff Children’s Hospital Oakland. For records shared outside of Children’s Hospital Oakland, you will be given a code number. The list that can match you to the code number will be kept in a locked file in the Principal Investigator's office. The people whose job is to make sure the study is being done properly will come to the hospital and look at our records that can identify you. Any data released for monitoring the study will not use your name or any identifying information.

FORMTEXT If this is a qualifying clinical trial (see page 2 of the Application for Study Review for definition) the following paragraph must be included in the consent form.

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.

Child onlyHOW WILL MY CHILD'S PRIVACY BE PROTECTED?

Study records that identify your child will be kept confidential as required by law. Federal Privacy Regulations protect your child's privacy, restrict who is allowed to look at your child's records, and require security to protect your child's records. The Federal Food and Drug Administration (FDA) may inspect your child’s research records. Except when required by law, your child will not be identified by name, social security number, address, telephone number, or any other direct personal identifier in study records shared outside of UCSF Benioff Children’s Hospital Oakland. For records shared outside of Children’s Hospital Oakland, your child will be given a code number. The list that can match your child to the code number will be kept in a locked file in the Principal Investigator's office. The people whose job is to make sure the study is being done properly will come to the hospital and look at our records that can identify your child. Any data released for monitoring the study will not use your child's name or any identifying information.

FORMTEXT If this is a qualifying clinical trial (see page 2 of the Application for Study Review for definition) the following paragraph must be included in the consent form.

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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.

DO I HAVE TO PAY TO BE IN THE STUDY?

FORMTEXT For an industry-sponsored study, the sponsor is required to pay for the study drugs or device (if applicable) and all tests done only for research purposes. What will be paid should be specified. If there are any additional costs to the participant that may result from involvement with the research, state each expected cost. If there are no costs involved, the following statement [either the paragraph for adult or child] should be included:

Adult and Combined Adult/ChildNo, there will be no cost to you to be in this research study. Care that would be given to you if you were not in this research study will be charged under your usual payment method. There will be no charge to you or your insurance company for any of the costs directly related to this study.

Child onlyNo, there will be no cost to you for your child to be in this research study. Care that would be given if your child were not in this research study will be charged under your usual payment method. There will be no charge to you or your insurance company for any of the costs directly related to this study.

WILL I BE PAID FOR BEING IN THE STUDY?

FORMTEXT If any reimbursement is to be provided (e.g. to offset travel expenses) that should be clearly stated. The amount of reimbursement must not be large enough that it would, by itself, influence parents to include their child in the study.

Example: In return for [your] you and your child’s time and travel expenses, you will be reimbursed…. State the pro-rated amount to be paid if not all visits are completed. If there is no reimbursement state:

You [or your child] will not be paid to be in this study.

FORMTEXT INJURY SECTION BELOW: Industry sponsors need to be contractually required to pay for treatment for injury caused by the study. This is usually clearly stated in the language in the contract between the hospital and the sponsor of the study. State what the sponsor will pay for in event of injury, as stated in the contract or protoco l. However, if you are not doing an industry-funded study you should use the following paragraph to complete this section, only if the study is greater than minimal risk. If the study is minimal risk, or no risk, the injury section should be omitted.

choose either the paragraph for adult ("I") or child ("MY CHILD") – delete other

Adult and Combined Adult/ChildWHAT DO I DO IF I AM INJURED?

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If you are injured because of something done in this study, Dr. name should be told immediately. If this happens at Children's Hospital or an associated location, we will notify your doctors. If this happens somewhere else, please call the study doctor at (510) phone number. You will be treated at Children's Hospital Oakland or an appropriate facility. However, neither CHO nor the study sponsor have set aside funds for compensation and treatment will not be free of charge. If you want more information about this, please speak with Dr. name at (510) phone number. In the case of injury from this study, you do not lose any legal rights to seek payment by signing this form.

Child onlyWHAT DO I DO IF MY CHILD IS INJURED?

If your child is injured because of something done in this study, Dr. name should be told immediately. If this happens at Children's Hospital or an associated location, we will notify your child's doctors. If this happens somewhere else, please call the study doctor at (510) phone number. Your child will be treated at Children's Hospital Oakland or an appropriate facility. However, neither CHO nor the study sponsor have set aside funds for compensation and treatment will not be free of charge. If you want more information about this, please speak with Dr. name at (510) phone number. In the case of injury from this study, you do not lose any legal rights to seek payment by signing this form.

FORMTEXT Optional paragraph below – When there is the possibility of mental discomfort from participation in the study, the following heading and paragraph should be used. Be sure to contact the mental health professional before offering this service. The cost of the counseling will need to be covered by CHO, your grant or industry contract:

choose either the paragraph for adult ("I") or child ("MY CHILD") – delete other

Adult and Combined Adult/ChildWHAT DO I DO IF I AM UPSET BY BEING IN THE STUDY?

If being in this study causes you distress, or makes you uncomfortable or upset, and you would like to meet with a mental health professional, please call name at (510) phone number. One hour of professional counseling and consultation will be offered without charge.

Child onlyWHAT DO I DO IF MY CHILD IS UPSET BY BEING IN THE STUDY?

If being in this study causes your child distress, or makes your child uncomfortable or upset, and you would like to meet with a mental health professional, please call name at (510) phone number. One hour of professional counseling and consultation will be offered without charge.

WHAT IF I HAVE QUESTIONS OR PROBLEMS?

FORMTEXT This section should include a phone number so participants or parents/guardians can contact one of the CHO investigators at any time. This should be phrased as follows:

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If you have any questions about the research, either before deciding whether to participate or during this study, please call Dr. name at (510) phone number. If you wish to speak to someone not associated with this study about complaints or your rights as a research participant, you may contact the Institutional Review Board (that reviews the research to protect your rights) at:

UCSF Benioff Children's Hospital OaklandIRB Office747 52nd StreetOakland, CA 94609(510) 428-3754

WHAT ARE MY RIGHTS? DO I HAVE TO AGREE TO THIS STUDY?

FORMTEXT The following paragraph [either the paragraph for adult or child – delete the other] must be included in the consent form:

Adult and Combined Adult/ChildYou do not have to be in this research study. It is your choice. If you agree to be in this study and later change your mind, you may stop at any time. No matter what your decision is, including if you withdraw, there will be no penalty. You will not lose any of your medical benefits and the quality of your medical care at Children's Hospital will not be affected. If you wish to be in the study, please sign this form.

Child onlyYour child does not have to be in this research study. You have the right to refuse to have your child take part at all. You may withdraw your child at any time. No matter what your decision is, including if you withdraw your child, there will be no penalty. Your child will not lose any medical benefits and the quality of your child’s medical care at Children’s Hospital will not be affected. If you want your child to be in the study, please sign this form.

WILL I BE TOLD ABOUT NEW INFORMATION?

FORMTEXT Unless the subject's participation in the study will be so brief that no new findings can be expected, the following paragraph [either the paragraph for adult or child – delete the other] must also be included – otherwise delete this section. Do not use this section if the subject will have a one-time intervention, or the study is very short duration.

Adult and Combined Adult/ChildYes, we will tell you as soon as possible about any new information learned in the study, both good and bad, which might affect your wanting to stay in this study.

Child onlyYes, we will tell you as soon as possible about any new information learned in the study, both good and bad, which might affect you wanting your child to stay in this study.

CONSENT TO BE A RESEARCH PARTICIPANT:

FORMTEXT Although the majority of studies require the signature of only one parent, both parents’ signatures may be required if the IRB specifies this. The following statement must be used in this section (choose one paragraph only – delete all the others)

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Adult onlyYour signature below indicates that you agree to be in this study. You will be given a signed copy of this form to keep, which includes the "List of Rights of a Participant in a Medical Experiment".

Combined Adult/ChildYour signature below indicates that you agree, or give permission for your child to be, in this study. You will be given a signed copy of this form to keep, which includes the "List of Rights of a Participant in a Medical Experiment".

Child onlyYour signature below indicates that you give permission for your child to be in this study. You will be given a signed copy of this form to keep, which includes the "List of Rights of a Participant in a Medical Experiment".

If the study is not a "medical experiment" the List of Rights is not required. The following statement [either the paragraph for adult or child – delete the others] must be used:

Adult onlyYour signature below indicates that you agree to be in this study. You will be given a signed copy of this form to keep.

Combined Adult/ChildYour signature below indicates that you agree, or give permission for your child to be, in this study. You will be given a signed copy of this form to keep.

Child onlyYour signature below indicates that you give permission for your child to be in this study. You will be given a signed copy of this form to keep.

FORMTEXT If the form is for parental permission only, include the following signature block (delete the other signature block below this one).

Parent or Legal Guardian:

Date: Time: Signature:

(hh:mm)Name (PRINT):

Child's Name (PRINT):

FORMTEXT If the form is for an adult or the combined adult/child, include the following signature blocks (delete the other signature block above):

Subject:

Date: Time: Signature:

(hh:mm)Name (PRINT):

Subject’s Legally Authorized Representative, if applicable:

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Date: Time: Signature:

(hh:mm)Name (PRINT):

Subject's Name (PRINT):

FORMTEXT Signing the consent form should take place only after the consenting parties have read the “List of Rights” (if applicable). The List of Rights should be on a separate page, incorporated as the first page of the consent form.

The IRB will determine if assent is required, how assent should be documented, and the age range of the assenting children. Generally, children age 7 or older should be asked for assent (agreement to participate), and a separate written Assent Form should be provided, with only the child's signature and date. [see Assent Form template] The IRB can approve a waiver of child assent, or allow oral assent in certain circumstances.

FORMTEXT If the study is not complicated and can be understood by an adolescent, you may add a signature block to the parental consent, instead of asking the adolescent to sign a separate assent form.

ASSENT OF ADOLESCENT AGE 13-17 TO BE A RESEARCH PARTICIPANT:

Your parent or legal guardian has given permission for you to be in this study. You do not have to be in this study. If you do not understand something, please ask the researcher to explain it to you again. You can say yes now and change your mind later. It is up to you. Signing your name below means that you want to be in the study.

Signature Date

STATEMENT OF INVESTIGATOR (or person obtaining consent):

FORMTEXT This section must contain the following paragraph, as well as lines for signature and date. [either the paragraph for Adult only, Combined Adult/Child or Child – delete the others]

Adult onlyI have carefully explained to the participant all of the information in the consent form.

Combined Adult/ChildI have carefully explained to the participant, or the parents/guardians of the participant, and the minor participant if assent is appropriate, all of the information in the consent form.

Child onlyI have carefully explained to the parents/guardians of the participant, and the minor participant if assent is appropriate, all of the information in the consent form.

The person who is giving consent to be in this study:

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• Understands the language that is used, reads well enough to understand this form, or is able to hear and understand when the form is read.

• Was encouraged to ask questions and that all questions were answered.

• Does not have any medical problems and/or is not taking prescribed medications that could make it hard to understand what it means to be in this study.

To the best of my knowledge, when this person signs this form, it is understood:

• What the study is about.

• What needs to be done.

• What the potential benefits might be.

• What the known risks are.

• That taking part in the study is voluntary.

Date: Time: Signature:

(hh:mm)Name (PRINT):

FORMTEXT The IRB determination of the assent requirement for a study must be complied with or a minor subject cannot be enrolled without first obtaining an assent waiver for a specific subject from the IRB. The following checkbox must be completed by the person obtaining child assent.

Assent was obtained for a minor subject, age ____________ as follows:

Assent Form signed and placed in study file. Date:

Assent obtained orally and discussion documented in study file. Date:

Assent is not required. Subject is an adult or under the age of .Specify the minimum age of assent you believe is appropriate.

FORMTEXT This section is for use only if consent will be obtained from parents and/or participants who are not fluent in English or participants who cannot read English. The oral presentation (interpretation) and the short form written addendum should be in a language understandable to the subject. The Spanish short form addendum is on the IRB website. Contact the IRB if you would like this other specific languages for your patient population.At the time of consent the following must be done:1. The short form document should be signed and dated by the subject (or the subject's legally

authorized representative) and by the witness.2. The IRB-approved English language informed consent document should be signed and

dated by the person obtaining consent as authorized under the protocol (e.g., the principal investigator) and by the witness.

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The witness should be fluent in both English and the language of the subject. When a qualified/certified interpreter assists the person obtaining consent, the interpreter may serve as the witness.

If the participant understands English but does not read or write, the participant can make a mark [ X ] if capable.

STATEMENT OF INTERPRETER/WITNESS:

Interpreter’s Name and/or ID#: (PRINT)

The oral discussion and review of this document between the Principal Investigator (or authorized person obtaining consent) and the participant was interpreted by a person fluent in English and _______________ (state language), the participant’s or legal representative’s primary language.

See the attached short form addendum for documentation.

In the presence of the Principal Investigator (or authorized person obtaining consent), I have witnessed the discussion and oral presentation of this document to the participant, who understands English but does not read or write.

To the best of my knowledge, the discussion and oral presentation were accurate and understood. The participant or legal representative signed this document in my presence.

Date: Time: Signature:

(hh:mm)Name (PRINT):

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