Seattle Children’s
and
University of Washington(if applicable)
and
(List names of other organizations and agencies if applicable. Include the names of divisions and departments as appropriate.)
Seattle, Washington
Consent Form
(Developed for phase III randomized study)
Title of the Study
(Include the formal title of the study here.)
Researchers:
(List Principal Investigator first. List Co-Investigators and other research team members. All research team members involved in obtaining consent from participants and families must be listed on the consent form. Provide names, degrees, academic or hospital position, department, telephone number, and email address, if appropriate. This information is used for families to contact researchers. If all researchers are from the same department or clinic and have the same phone number, you may list the researchers and include contact information after the list of research team members. Be sure to include information for families to contact researchers after hours and on weekends.)
24-Hour Emergency Contacts and Phone Numbers
(Include a 24-hour emergency number if participants may experience adverse events as a result of the research activities. Indicate who families should contact, e.g., principal investigator, on call specialist. If researchers are named as first contact, include back up for when researchers cannot be reached right away.)
Instructions: Model text for writing a Phase III consent form is presented in boldface type. Revise and add to the model text as needed, based on the specific elements of the study in question. Examples of study-specific information for a real Phase III study are presented in regular typeface.
Use simple language. Avoid medical terms and jargon when possible. When medical terms are used, include a simple definition or explanation in lay language. Keep in mind that consent forms should be written for people who read at lower than the eighth grade level. Word processing software has a spelling and grammar feature that can provide a general reading level of the material you write.
Researchers’ Statement
Introduction
You are being asked to give permission for your child to take part in a research study. Taking part in research is voluntary. Please take time to make your decision, and discuss it with family and friends.
This form provides a summary of the information the researchers will discuss with you. If your child takes part in this research study, you will keep a copy of this form. Be sure to ask any questions you have about the research study.
Your child is being asked to take part in this research because your child has XX.
Why is this research study being done?
This study is being done to compare an experimental treatment with standard treatment for children with XX. (Provide background information about why the study is being done. If you are testing experimental drugs, devices or techniques, provide a brief summary of previous testing of the drug, device or technique in humans. Include information on previous testing in children.)
(If you are using an investigational new drug (IND) or device (IDE), add: “Name of IND or IDE is an investigational new drug or device.) This means that the U.S. Food and Drug Administration allows the drug or device) to be used only in research.” For investigational studies, it is important to make clear to families the purpose of the study. Phase I studies are testing for safety and how much drug can be tolerated. Phase II studies are learning more about safety of the drug/device/technique and beginning to learn about effectiveness. Phase III studies are looking at effectiveness compared to standard care.)
(Phase III): We hope that the new treatment will be as effective or more effective than current, standard treatment. The only way to find out if one treatment is better than the other is to compare them. This will be done by giving some children one treatment and some children the other. Your child will be assigned to one of two groups by chance, like flipping a coin. We make sure that the children in each group are similar to each other so we can compare results between the two groups.
Are there benefits to taking part in the study?
If you agree to let your child take part in this study, there may or may not be direct medical benefit to your child. Half of the children will receive the regular drug treatment, and half of the children will receive the experimental drug treatment. We do not know which will be more effective. That is why we are doing the study.
The possible advantages of the experimental treatment include (Explain the possible benefits based on clinical studies to date, e.g., less frequent dosing, shorter treatment, fewer side effects.) We hope the information learned from this study will benefit other children with XX in the future.
How many people will take part in the study?
About ___ children will take part in this study (if a multicenter study add: “in hospitals and clinics across the country.”) We expect that between _____ and _____ children will take part here at Children’s.
What is involved in the study?
- Briefly describe procedures to be done for research study and their frequency. Parents should understand what is going to happen to their child while in the study, and should be able to distinguish standard care from research. It is usually best to describe procedures in chronological order, e.g., screening, treatment, follow-up.
- State where the care will be given, e.g., in the hospital or the outpatient clinic.
- Include information about the length of time visits and procedures will take.
Tests To See If Your Child Is Eligible To Take Part
If your child takes part in this research some tests must be done to be sure it is safe for your child to take part. These tests will be done (if applicable):
- An exam by the doctor
- Blood tests to check (Describe in simple lay language. Indicate amount of blood to be taken. 5 cc = 1 tsp; 15 cc = 1 tbsp.)
- Urine tests to check (describe in simple lay language.)
- Pregnancy test for girls 12 years old and older
Your child may or may not be eligible to take part in the study based on the test results.
Treatment
Your child will be assigned to one of two groups. This will be done by chance, like flipping a coin. Children in group A will get their regular treatment with XX. Children in group B will get the experimental treatment with XX. Neither you nor the study doctors will know to which group your child is assigned. Your child’s group assignment can be found out quickly, if this information is needed during the study.
Group A
If your child is in Group A your child will receive the regular treatment. (Explain this treatment. Indicate the name of the drug(s), doses, frequency of dosing and how the drug is given. For example, “XX will be taken as one capsule, two times a day by mouth. XX should be taken with meals. The dose given is a standard dose of XX.”) Treatment will last XX. (Indicate how long treatment will last.)
Group B
If your child is in Group B your child will receive the experimental treatment. (Explain this treatment. Indicate the name of the drug(s), doses, frequency of dosing and how the drug is given. For example, “XX will be taken as one capsule, two times a day by mouth. XX should be taken with meals. The dose given is XX.”) Treatment will last XX. (Indicate how long treatment will last.)
Check-up Testing During the Research Study
As long as your child is taking part in the study tests and exams will need to be done. They will help the doctor find out if there are effects that are important to know about. The tests will help check on the safety of the treatment your child receives. Your child will be seen every XX. (Describe scheduling of study visits.) The visits will last XX.(Describe how the monitoring visits compare to standard of care so families understand what is extra for the research study.)
The tests to be done include:
(Describe the tests that will be done to monitor children taking part in the study. Be sure that families understand how the testing to be done compares to standard of care. If the tests are done more often than standard of care, explain this. Any experimental procedures need to be described in detail.)
- An exam by the doctor (How often)
- Blood tests (How often and how much blood each time, e.g., 1 teaspoon of blood at each study visit)
- Urine tests (How often)
(If pregnancy testing will be done, describe how often. If any of the tests will be done at off-site locations, indicate where the tests will be done.)
(Explain if the child’s medical records will be used in this research. For example, if the results of tests done for standard of care will be used. Explain if the results of tests and procedures done in this study will be included in the child’s medical records.)
How long will my child be in the study?
Your child will be in the study for ______.
The research doctor may decide to take your child off this study. If so, the reasons would be explained to you. For example, the doctors may decide it is in your child’s best interest to stop being in the study. Or it may be that your child is not able to make all the study visits.
You can decide that your child should stop taking part in this study at any time. If you decide to stop, talk with the research doctor so your child is taken out of the study in a way that will be safe.
What are the risks of taking part in this research study?
(When describing the risks of the treatments given in this research study, it is most useful for families to understand the likelihood of the risks and how severe they can be. It is recommended that you describe the likely and serous risks first. Then describe the likely but less serious risks. After the likely risks are described, describe the less likely risks and their severity. For all the risks described, explain if these are temporary or if they can be permanent. Families need to understand if the side effects stop once treatment is stopped. Be sure that the implications of the risks are explained. For example, if the treatment lowers blood counts, would the child require transfusions. As appropriate, describe the steps taken to minimize the risks described. As appropriate, describe how the risks will be managed, e.g., the dose will be reduced, the child will be taken off the treatment drugs.)
Risks from Treatment A
(Describe the risks for the children assigned to Group A.) As with any drug or treatment, there may be unanticipated side effects.
Risks from Treatment B
(Describe the risks for the children assigned to Group B.) As with any experimental drug or treatment, there may be unanticipated side effects.
(If appropriate, include:) “Treatment with the study drugs can harm an unborn baby. Because of this, your child should not become pregnant (if appropriate include “or father a baby”) while taking part in this study. Females 12 years old and older will have pregnancy tests before specified procedures.
During the research, if your child has a positive pregnancy test, she will be notified about the test results. By law, she must give her permission in order for the hospital to share the positive results with a parent or guardian. If your child has a positive pregnancy test, we must withdraw her from the study (if applicable; revise as appropriate).”
(Describe the risks of other procedures and tests to be done during the study solely for the purposes of the study. You do not need to describe the risks of procedures that would be done as part of standard of care that would be done whether or not the child takes part in the research.)
Taking blood will cause brief pain for most children. Your child may get a bruise where the needle enters the vein. We can use a cream to numb your child’s skin before the needle poke. It takes about an hour for the cream to numb the skin.
Be sure to ask the research doctors any questions you have about the possible side effects and risks to your child from taking part in this research.
What other options are there?
(If the research involves patient care (diagnosis, treatment) describe the alternatives available, including no further treatment, if appropriate.)
Your child’s alternative(s) to taking part in this study, include (describe briefly). The researchers will discuss with you your child’s alternatives.
What about confidentiality?
We will make every effort to keep your child’s and your family’s personal information confidential. Personal information would be disclosed only if required by law.
Study information (which does not identify your child by name or medical record number) will be given to agencies that sponsor and supervise the research. These agencies are: (List those that are relevant to this study.)
Staff from these agencies have the right to review your child’s medical records only as needed to review the results of this study. Some of these records contain identifying information. These staff are required to keep this information confidential.
If results of this research are published, information that identifies your child will not be used.
(Explain if information obtained in this research will become a part of the child’s medical record. If the research is providing patient care, research results usually go in the permanent medical record. If the research results could place families or children at risk – stigmatization, loss of insurance, they should not be placed in the permanent medical record.)
What are the costs of the research study?
(Note to Investigators: For all research studies, you must describe any additional costs to the subject or their insurance that may result from participation in the study. To accomplish this, recommended options are listed below).
1. Study (except clinical trial as defined below) in which there areno costs to the patient that mayresult from participation
There will be no cost to you or your insurance company as a result of participation in this study.
2. Study (except clinical trial as defined below) in which there are costs to the patients that may result from participation
You or your insurance company will [may] be charged for the following as a result of participation in this study: [Describe the costs to the subject or their insurance carrier that may result from participation in the study.]
3. Clinical Trial (defined here as a study involving both research and usual medical care)
Clinical services provided during a clinical trial are either research-related or related to usual medical care.
Research-related services are those that are done solely to complete the research. The research-related services for this study include the following: [Clearly identify the research-related services for the studyby referencing when they take place (e.g., Day 14 Visit, 4th Visit, etc.)]. [Neither you nor your insurance company will be charged for thecosts of these services.] [You or your insurance company will [may] be charged for thecosts of these services.][State explicitly who is financially responsible for the experimental components (drug, administration of drug, device, implantation of device).]
The usual medical care services that occur during this study include any and all services that are considered routine for your diagnosis/care. You or your insurance will be charged for the costs of this usual medical care, which may include deductibles and co-payments. This care will be subject to all the requirements and restrictions of your insurance. [When applicable, include a statement about pre-certification from insurance (likely for inpatient stays, surgery, devices, and any other high-cost items).]
4. All studies involving more than minimal risk need to include a form of the following language*
If your child is injured as the direct result of taking part in this research study, we (Seattle Children's Hospital) will treat your child. If appropriate, we will refer your child for treatment. [You or your insurance company will be responsible for the cost of this treatment.] [Neither you nor your insurance company will be responsible for the cost of this treatment.] [Thisisthe only injury compensationoffered.] Please call [NAME OF PI] at [TELEPHONE NUMBER] if you believe your child has been injured as a result of this study.
[*See IRB Information Sheet “Who Pays for Research Related Injuries” for more specific guidance re what language to include.]
Will my child or I be paid to take part in the study?
[Your child will not be paid to take part in this study. However, the study will pay for out of pocket costs to you. This would include transportation costs to the hospital or clinic for study tests and visits. This would include the cost for meals or child care that are needed for you and your child to make the study visits. ]