consent template: combined hipaa... the word “we” means the study doctor and other ......

Informed Consent Form

Study Title: Insert Full Title of the Protocol

Version Date: Month, Day, 20XX

Consent Name: OPTIONAL Consent Identifier if there is more than one consent for the study (e.g. Control Consent)

Principal Investigator: Investigator Name Telephone: (xxx) xxx-xxxx

Department/DivisionEmergency Contact: Name Telephone: (xxx) xxx-xxxxOmit if minimal risk

Almost all consent forms submitted to the IRB require extensive revision and delay the approval. Don’t just cut and paste. Avoid delays by following this template and by reviewing the Guidance: Writing Readable Consent Forms (on IRB website) before preparing the consent document. This will minimize the need for revision. Consent forms that are not written at grade appropriate level will be returned with a request for revisions. A few key items from the Guidance are listed below.

NOTE: This consent template uses MS Word Style sheets. When cutting and pasting you must use the “Paste Special” function and paste as unformatted text in order to preserve the formatting of this template. DO NOT MODIFY THE FOOTER OF THE DOCUMENT.

Formatting:

1) The entire consent form should be written in the second person, using “you” throughout. If you are only going to enroll children who are unable to assent (e.g. because they are too young, have cognitive deficits, will be sedated, etc.), you may use "you" throughout the consent form to refer to the parent or guardian and "your child" to refer to the child participant.

2) Do not use the word “patient”; use “subject” or “participant”.

3) Modify the words treatment, therapy or device to “investigational treatment/therapy/device” or “research treatment/therapy/device.” This avoids therapeutic misconception.

You, or your child, may be eligible to take part in a research study. This form gives you important information about the study. It describes the purpose of this research study, and the risks and possible benefits of participating.

If there is anything in this form you do not understand, please ask questions. Please take your time. You do not have to take part in this study if you do not want to. If you take part, you can leave the study at any time.

CHOP IRB#: «ID»Effective Date: «ApprovalDate»Expiration Date: «ExpirationDate» of 14

In the sections that follow, the word “we” means the study doctor and other research staff. If you are a parent or legal guardian who is giving permission for a child, please note that the word “you” refers to your child.

If the study only involves adults, the last sentence can be deleted.

Why are you being asked to take part in this study?You are being asked to take part in this research study because you have _____. Briefly include the major reasons why the subject is being approached to participate. For example, “…you have been diagnosed with sickle cell disease and are scheduled to have an MRI.”

What is the purpose of this research study? The purpose of this research study is to ________________ [insert applicable statement(s)]

Example: The purpose of the research is to see if XXXX improves the health of children with sickle cell disease.

Describe the purpose of the research in lay language. Provide the information that a reasonable and responsible parent would want to know before allowing their child to enroll in the study (i.e. focus on the major concepts rather than including detailed explanations of the science behind the research).

Don’t include every single detail about the study. The consent form should include an explanation that is sufficient for most and offer the opportunity for the parent/subject to discuss any aspect of the study in more detail with the investigator.

If the study involves an experimental intervention, agent, device or diagnostic, provide a concise description that includes whether or not it is approved by the FDA. If it is approved, discuss whether it is approved for use for children.

How many people will take part?

Single center: About ____ individuals/people/children etc. will take part in this study.

Multicenter: About ____ people will take part in the study, including approximately ____ participants from CHOP.

What is involved in the study?Provide a brief overview of the study. Keep this as simple as possible and at an 8th grade level. Also include the probability of random assignment to each study group (if applicable).

How long will you be in this study?

If you agree to take part, your participation will last for ________and will involve ________ study visits.

Examples:

If you agree to take part, your participation will last for 1 hour.


If you agree to take part, your participation will last for 18 months and will involve 6 study visits and 3 telephone calls.

What are the study procedures?

The study involves the following tests and procedures.

Explain which procedures would be part of usual medical care (would occur even if the subject did not participate in the study) and which will take place only because of research participation.

List research procedures just one time and then include a table. Do NOT repeatedly list the procedures if it can be avoided. See the examples listed below.

Interviews: A team member will take your medical history, along with a listing of any medications you are taking. Throughout the study you will be asked to report if you think that anything bad has happened as a result of the study.

Physical Examination: Exams will be conducted before and during the study including measurements of weight, height, blood pressure, heart rate and respiratory rate, etc.

Pregnancy Test: If you are eleven years old or older or have already started having periods, you will be asked to take a pregnancy test before starting this study. The results will be shared with you and not with your parent(s). We strongly encourage you to share the results with your parents. If you are found to be pregnant, you will not be able to continue participation in the study. About _____ teaspoons of blood (or urine if urine test) will be needed. Use this language if applicable. The risks of pregnancy, if any, for the study must appear in the Risk section.

Blood Test: Brief description

Urine Test: Brief description

Test: Brief description

Study Medication/Intervention: You will need to take study medication by mouth twice a day for __________ weeks.

(Include if applicable) Some of the procedures in this study will be repeated several times. Tests that are part of your regular, routine medical care will continue to be performed. Additional tests may be performed if any of your initial test results are not normal.

Visit Schedule

For studies with several visits, a table can be helpful. The table below provides a brief description of the purpose and duration of each study visit.

This table is an example. Create a table that makes sense for your study. Very briefly list the visits and most important procedures. Do not simply list every procedure. Keep it as simple as possible.

The subjects/parents are not study coordinators; they just need a basic overview, not the detailed plan. Do not simply attach or paste the study table from the protocol as it is often


too detailed for subjects. For example, don’t list all the blood tests, just “blood tests”, don’t list each individual questionnaire, just “questionnaires”. The table doesn’t have to be complete; it should give an idea of the purpose of the visit and any painful or stressful procedures.

Visit Purpose Main Procedures Duration

Visit 1 Screening visit Blood tests, MRI scan 2 hours

Visit 2, Day 0 Start study drug Distribute medication 30 minutes

Visit 3, Day 28 Routine Visit Lab tests, distribute medication 1 hour

Visit 4, Day 56 End of Study Return unused drug and Quality-of-Life Survey

1 hour

What are the risks of this study?For each study procedure, there should be a corresponding risk description. See the IRB website for standard risk language: https://intranet.research.chop.edu/display/cmtirb/ICF+Standard+Language

Taking part in a research study involves inconveniences and risks. If you have any questions about any of the possible risks listed below, you should talk to your study doctor or your regular doctor.

While in this study, you are at risk for the following side effects:

Risks associated with study medication, device or other intervention (_________):

The main risks of the XYZ are A, B, and C. Use bullet lists as appropriate.

Most severe risks

Less severe risks

Etc.

(Include only if applicable) Because this drug/device/intervention is experimental there may be other side effects we do not know about yet. We can give you other medicines to make any side effects less serious or to make you feel better.

Risks associated with procedure 1:


Most severe risks

Less severe risks

Etc.

Risks associated with procedure 2:


Most severe risks

Less severe risks


Etc.

Reproductive Risks (include only if applicable and include as a part of the procedure that engenders risk to pregnancy)

For female subjects:

If you are pregnant or nursing, you will not be allowed to participate in this study. You will need to take safety measures to prevent pregnancy (such as not having sexual intercourse, or using a medically accepted form of contraception) for a minimum of ____(time period before, during and after the study). If you have questions about how to avoid pregnancy, talk to your doctor or the researcher and they will provide you with information on contraceptive choices. You should contact Dr. XXXXX at once if you become pregnant during this research study.

For male subjects:

You should not father a baby for a minimum of _____ after administration of ___________. You need to take safety measures to prevent pregnancy (such as not having sexual intercourse or using contraception) for a minimum of ____ after administration of ____. If you have questions about how to prevent pregnancy, talk to your doctor or the researcher and they will provide you with information on contraceptive choices.

Are there any benefits to taking part in this study?In this section summarize the potential direct benefits (to the person as a result of participation) and indirect benefits (new knowledge, improved care for future patients with the same condition, etc.). You should never promise or guarantee benefit. Two examples are included below. Use or alter one of these statements to meet the requirements of your study.

Study with prospect of direct benefit

You might benefit by (list the ways in subjects may benefit directly from this research). However, we cannot guarantee or promise that you will receive any direct benefit by participating in this study. The knowledge gained from this research may help doctors determine _______ (whatever it is you hope to learn).

OR study without any prospect of direct benefit use this statement.

There will be no direct benefit to you from taking part in this study. The knowledge gained from this study may help doctors determine _______

Do you need to give your consent in order to participate? If you decide to participate in this study, you must sign this form. A copy will be given to you to keep as a record. Please consider the study time commitments and responsibilities as a research subject when making your decision about participating in this study. (if applicable add) You will need to follow the study doctor’s instructions, keep all study appointments and take the study drug as directed (include “study drug” or add other intervention only if applicable).


What happens if you decide not to take part in this study?

Participation in this study is voluntary. You do not have to take part in order to receive care at CHOP.

If you decide not to take part or if you change your mind later there will be no penalties or loss of any benefits to which you are otherwise entitled.

Can you stop your participation in the study early?

You can stop being in the study at any time. You do not have to give a reason.

If there are consequences of early withdrawal describe them here.

Can the study doctor take you out of the study early?

The study doctor may take you off of the study if: (ONLY include those items that apply. If the study is brief and/or is minimal risk, this section may not be applicable. This section only applies for studies with multiple visits. )

Your condition worsens.

The study is stopped.

The study drug is no longer available.

You cannot meet all the requirements of the study.

New information suggests taking part in the study may not be in your best interests.

What choices do you have other than this study?

ONLY use if this is an intervention study. Do not include for observational study designs. If alternative modes of care exist include this statement and list the options as bullet points – always include at least one option for care outside this study (not participating).

There are options for you other than this study including:

Participation in another study (be specific).

Receiving ______ care outside this study.

Alternative therapy ________.

Not participation in this study.

You may discuss other options available to you with your doctor.

What about privacy and confidentiality? We will do our best to keep your personal information private and confidential. However, we cannot guarantee absolute confidentiality. Your personal information may be disclosed if required by law. People from oversight agencies and organizations such as the Department of Health and Human Services, Office for Human Research Protections and the Food and Drug Administration (FDA) (if applicable) may also look at your study records.


The results of this study may be shown at meetings or published in journals to inform other doctors and health professionals. We will keep your identity private in any publication or presentation about the study.

By law, CHOP is required to protect your private information. The investigator and staff involved with the study will keep your private information collected for the study strictly confidential. Please refer to the separate document "Authorization to Use or Disclose Health Information for a Research Study" that explains more specifically how your personal information will be protected.

Additional Information (optional, include only if relevant)

A Data Safety and Monitoring Board, an independent group of experts, will be reviewing the data from this research throughout the study.

Include the following statement if the study involves an intervention or will take place over a period of time and include the DSMB statement first if it applies. Do not include this statement if it is not relevant to the study.

You will be informed if changes to the study are needed to protect your health. You will be told about any new information that could affect your willingness to stay in the study, such as new risks, benefits or alternative treatments.

For clinical trials where access to the medical records could bias the study, you may add a statement that access to patient records will be restricted during the conduct of the study to maintain the fidelity of the trial.

Financial Information While you are in this study, the cost of your usual medical care – procedures, medications and doctor visits – will continue to be billed to you or your insurance.

Will there be any additional costs?

This information should match the costs and responsible parties outlined in the billing plan.

Study sponsor or CHOP (whichever is appropriate) is providing financial support and material for this study and the following research procedures, medications and study visits:

Cost of travel, parking and meals;

Cost of study medication, etc.

MRI of the knee

Blood tests for X, Y and Z

Etc.

(Include only if applicable) The following research procedures will be billed to you or your insurance:

Any additional costs to subject as a result of study participation.


Will you be paid for taking part in this study? Include one of the following statements

You will not receive any payments for taking part in this study.

or

If there will be payments and/or reimbursement, the consent form should specify how much will be paid for reimbursement of expenses (not taxable) and the form (cash, check, gift card) and the timing of payment. Also specify how much is going to the parent and how much is going to the subject. See the IRB website and IRB SOP 704 for instructions regarding listing payments to subjects and parents and for prorating payments.

Parents/participants will be reimbursed $XXX for travel, meals and parking.

Parents will be paid $XXX for their time and effort.

Children/participants will be paid $XXX for their time and effort.

If you receive payment using a bankcard, the bank will have access to your name, address and phone number.

If payment to an individual could exceed $600 (not including reimbursement for parking, meals, etc.) in a calendar year, then include the following the wording:

In order to receive payment for this study, you will need to complete a W-9 form. The W-9 form includes your name, address, and social security number.

The W-9 form will be kept in The Childrens’ Hospital of Philadelphia Research Finance Office; the research study team will not keep a copy.

If you are paid $600 or more in compensation in one calendar year, then The Childrens’ Hospital of Philadelphia will send you a 1099-MISC form for miscellaneous income. You will need to claim these payments as income on your tax return.

Reimbursements for expenses as part of this study will not count as income for tax purposes.

Who is funding this research study?

Use one of the 4 statements below depending on which is most applicable.

If there is no external funding source: The Division of XXXX at The Children’s Hospital of Philadelphia is funding this research.

or

The National Institutes of Health is providing funding for this study.

or

For industry sponsored studies:

This study is supported by the SPONSOR. SPONSOR is a drug company that makes the medication being studied in this research project. SPONSOR is giving money to Children's Hospital for some of the costs of the study. The results of the study will be reported to SPONSOR. If the study shows that the STUDY DRUG/DEVICE/INTERVENTION may be useful for a new purpose, this could benefit SPONSOR financially.


Please ask Dr . ________ if you have any questions about how this study is funded.

or

For industry-sponsored studies where Investigator has received consulting money below COI limit:

This study is supported by SPONSOR. SPONSOR is a drug company that makes the medication being studied in this research project. SPONSOR is giving money to Children's Hospital for some of the costs of the study. The results of the study will be reported to SPONSOR. If the study shows that the STUDY DRUG/DEVICE/INTERVENTION may be useful for a new purpose, this could benefit SPONSOR financially.

Dr. __________ has received payment to consult with drug companies about medicines to treat <name of disease>.

What if you have questions about the study?If you have questions about the study, call the study doctor, Dr. XXXXX at XXX-XXX-XXXX. You may also talk to your own doctor if you have questions or concerns.

The Institutional Review Board (IRB) at The Children’s Hospital of Philadelphia has reviewed and approved this study. The IRB looks at research studies like these and makes sure research subjects’ rights and welfare are protected. If you have questions about your rights or if you have a complaint, you can call the IRB Office at 215-590-2830.

For studies regulated by the FDA and required to register with clinicaltrials.gov (Phase II, III and IV studies) must include the following statement. This statement may not be edited or modified in any way. If you are unsure if your study must be registered with clinicaltrials.gov, contact Marsha Wallace in the Office of Research Compliance and Regulatory Affairs.

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.

What happens if you are injured during the study? (Not required for minimal risk research studies.)

Example wording for non-industry-funded studies

If you are hurt or get sick from something that was done as part of this study, doctors at the clinic or hospital can arrange for emergency medical care. The Hospital does not offer financial compensation or payment for injuries due to participation in this research.

You and your insurance company will be billed for the costs of any care or injuries.

If you think you have been injured from taking part in this study, call Dr. ________ at (XXX)____________. He/she can go over things with you, let you know of resources that may be available and give you information on what you need to do.


In case of injury resulting from this study, you will not lose any legal rights by signing this form.

Example wording for industry-funded studies

This statement is an example. The language in the ICF must conform to the contract language negotiated between CHOP and the study Sponsor.

If you are hurt or get sick from something that was done as part of this study, doctors at the clinic or hospital can arrange for emergency care. Treatment may be billed to you or your insurer. If your injury is caused by a research procedure or the experimental drug/device/intervention, SPONSOR may pay for treating the injury. This does not mean that a mistake happened.

The Hospital does not offer financial compensation or payment if you are injured as a result of participating in this research.

If you think you have been injured from taking part in this study, call Dr. ________ at (XXX)____________. He/she can go over things with you, let you know of resources that may be available and give you information on what you need to do.

In case of injury resulting from this study, you will not lose any legal rights by signing this form.

Consent for Use of Data or Specimens for Future Research (This section is OPTIONAL. If used, only include the parts that are applicable)

Edit this statement so that it applies to the research activity. If there is even a possibility that you will want to use the data/specimens in the future, it is best to use this statement. Modify the statement to accurately describe what it is you want to use again in the future, e.g., data, biospecimens, etc. This statement is NOT needed when all specimens will be disposed at the end of the study or when there is no plan to ever use the data again in the future or if the purpose of the research as described in prior sections is to establish a registry or repository.

NOTE: only list the data, images, and tissue samples that will be used for future research.

As part of the study, we will collect ______ (List whatever it is that you want to use in the future, such as data, blood, tissue, etc.). We may wish to use this information or samples in a future study about (list the types of research for which you are seeking approval. HIPAA requires that the consent be specific about the nature of the future use). The information and samples will be given a unique code and will not include information that can identify you. (If a Master List will be kept that links the data or specimens to the subject, include the location lab, special room, repository, registry, or computer database in the next sentence.) Information that can identify you or your blood or urine samples may be kept permanently in a ____________ (examples include: lab, repository, registry, or computer database) at CHOP or at (outside lab). Only the study doctors and those working with them on this study will be able to see information that can identify you.

If you leave the study, you can ask to have the data collected about you removed or your samples destroyed. You can also ask us to remove information that identifies you from the data or samples.


If the specimens and data will be de-identified (no link to identifiable information) use the following statements instead. Your data and specimens will be stored with a code number that cannot be linked back to you. If you leave the study, we will not be able to re-identify which specimens are yours. Your data and specimens will remain part of the research.

Please indicate whether you will allow your data or samples to be used for future research by putting your initials next to one of the following choices:

_____ (initials) My ________ (data or specimens) may be used for this study only.

_____ (initials) My _________ (data or specimens) may be used for other future research studies. If the data or specimens are shared outside of CHOP, no identifiable information will be included.

These statements may require modification depending on the requirements of the study.


OPTIONAL (include other optional components after the signature page)

Optional components of the research, such as additional specimens for PK studies or genetic studies should be inserted here. Examples are included in the Guidance. Since these are not required as part of the research, separate signature for each optional study is required.

_____ (initials) I agree to have extra blood taken for the XXXXX study.

_____ (initials) I do not wish to take part in this optional part of the research.

DIRECTION for SIGNATURE PAGE:

• If only adults are participating, delete parent signature lines.

• If only children are participating, delete the signature of subject line.

• If the study is approved under §46.406 then both parents/guardians need to sign the consent document. If approved under §46.404 or 405, the signature line for the second parent/guardian can be deleted.

• If the study only includes adults, edit the paragraph starting with “By signing this form…” to remove references to the parent; it should only refer to the subject.

• If the study involves both the parent and the child, edit the paragraph to make clear that the parent is consenting for both their participation as well as the participation of their child.


Consent to Take Part in this Research Study The research study and consent form have been explained to you by:

Person Obtaining Consent Signature of Person Obtaining Consent

Date

By signing this form, you are indicating that you have had your questions answered, you agree to take part in this research study and you are legally authorized to consent to your child’s participation. NOTE: A foster parent is not legally authorized to consent for a foster child’s participation.

Name of Subject

Signature of Subject (18 years or older) Date

Name of Authorized Representative (if different than subject)

Relation to subject: Parent

Signature of Authorized Representative Date

Only include a Second Parent Signature for studies approved under §46.406.

Name of Authorized Representative (if different than subject)

Relation to subject: Parent

Signature of Authorized Representative Date


Child Assent to Take Part in this Research StudyFor children capable of providing assent:

I have explained this study and the procedures involved to __________________ in terms he/she could understand and that he/she freely assented to take part in this study.

Person Obtaining Assent

Signature of Person Obtaining Assent Date

This study has been explained to me and I agree to take part.

Signature of Subject (optional) Date

For children unable to assent:

I certify that __________________ was not capable of understanding the procedures involved in the study sufficiently to assent to study participation.

Person Responsible for Obtaining Assent

Signature of Person Responsible Date

COMMENTS

1) Delete assent lines if none of the children will be old enough to assent (e.g., neonates) or if the study only involves subjects capable of consenting for themselves.

2) If some may be old enough and some not, include both statements so that the investigator can document on the Assent page, why a particular subject was unable to assent.


consent template: combined hipaa... the word “we” means the study doctor and other ......

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