SAMPLE CF #2



SAMPLE BENIOFF CHILDREN’S HOSPITAL CONSENT FORM – BIOMEDICAL & CANCER STUDIES (May 2020)

PLEASE NOTE:

1) Statements in brackets and italics are instructions or examples, and should not be included in the actual consent form.

2) Required wording (in regular font, not italics) should be used as is (if appropriate).

3) Suggested wording (in italics) can be revised as needed to provide the simplest and clearest description of the study.

4) Statements in grey highlight are REQUIRED for New Federally-funded and Federally-conducted studies as of January 2019. The IRB encourages all studies to adopt this new template.

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

CONSENT TO PARTICIPATE IN A RESEARCH STUDY

Study Title: [Insert study title here]

|Research Project Director: |Holly Smith, M.D., Associate Professor of Psychiatry. |

| |UCSF, Room 809, 505 Parnassus Ave, San Francisco, CA. Phone: 415.246.xxxx; e-mail: hollyx@ucsf.edu|

|Study Coordinator: |Joan Buttenfield, Phone: 415.246.xxxx |

| |buttenx@ucsf.edu |

This is a clinical research study. Your study doctor(s), …,[M.D.,] and …, [Ph.D.,] from the [UCSF Department of …], will explain the study to you.

[Important! Remove all highlighting from actual consent form]

STUDY SUMMARY

**THIS SUMMARY IS ONLY REQUIRED IF YOUR COMPLETED CONSENT FORM IS LONGER THAN 6 PAGES**

Introduction: We are asking you to consider taking part in a research study being done by name the study doctor/researcher at UCSF.

The first part of this consent form gives you a summary of this study. We will give you more details about the study later in this form. The study team will also explain the study to you and answer any questions you have.

Research studies include only people who choose to take part. It is your choice whether or not you want to take part in this study. Please take your time to make a decision about participating. You can discuss your decision with your family, friends and health care team.

Purpose of the study: [Limit explanation to why study is being done, explaining in lay language in 1-3 sentences. Some examples provided directly below:]

[Example: Phase I study]

The researchers want to find a long acting drug to better control [medical condition] and reduce the number of pills you take. This study will test the safety of [study drug/intervention] at different dose levels. We want to find out what effects, good and/or bad, it has on you and your [specify type/stage/presentation of diagnosis].

[If this is a first-in-human study, add:] This is called a “first in human” study because it is the first time this drug/intervention will be given to humans. This means that the safety and risk information we have is based on how animals have reacted to the drug/intervention.

[Example: Phase II study]

The researchers want to find a long acting drug to better control medical condition and reduce the number of pills you take. This study will find out what effects, good and/or bad, study drug/intervention has on you and your specify type/stage/presentation of diagnosis.

[Example: Phase III study]

The researchers want to find a long acting drug to better control medical condition and reduce the number of pills you take. This study will compare the effects, good and/or bad, of study drug/intervention with commonly used drug/ intervention/placebo on you and your specify type/stage/presentation of diagnosis to find out which is better. In this study, you will get either the study drug/intervention or the commonly used drug/ intervention/placebo. You will not get both.

Study Procedures: If you choose to be in this study, …[Limit description to 2-3 sentences. Some examples provided directly below:]

[Example: Experimental drug study]

… you will be asked to take the study drug or a placebo (a pill that looks like the study drug but has no drug in it) twice a day for 3 months. In addition, the main study procedures include…

[Example: Experimental drug study]

… you will be asked to come to the clinic every six weeks to receive study drug for as long as your rheumatism responds to the treatment. In addition, the main study procedures include…

[Example: Experimental device study]

…we will give you the heart monitor in the clinic and tell you how to use it. You will wear the monitor while you sleep for two weeks. In addition, the main study procedures include...

You will be in this study about insert number of days, weeks, months or years and visit the research site approximately insert number times.

Possible Risks: There are risks to taking part in a research study. Some of the most likely risks of participation in this study include: [List ~5 most common risks in bullet points.]

•

•

•

•

•

There are also rare but serious risks of participation, like: [List 1-3 rare but serious risks in bullet points.]

•

•

We’ll tell you about the other risks later in this consent form.

Possible Benefits: [Use one of the two examples directly below.]

[Example: If there is a potential for benefit]

You may benefit from participating in the study, but this cannot be guaranteed.

[Example: If no direct benefit to the subject is anticipated]

There will be no direct benefit to you from participating in this study.

Your Other Options: You do not have to participate in this study. Your other choices may include:

• Getting treatment or care for your condition without being in a study.

• Taking part in another study.

• Getting no treatment or receiving comfort care to relieve your symptoms and discomfort. [If comfort care is not an option, delete “or receiving comfort care to relieve your symptoms and discomfort.”

• If there are specific alternative treatments or procedures, add them to this list.]

Please talk to your doctor about your choices before agreeing to participate in this study.

Following is a more complete description of this study. Please read this description carefully. You can ask any questions you want to help you decide whether to join the study. If you join this study, we will give you a signed copy of this form to keep for future reference.

DETAILED STUDY INFORMATION

This part of the consent form gives you more detailed information about what the study involves.

Research studies include only people who choose to take part. Please take your time to make your decision about participating. You may discuss your decision with your family and friends and with your health care team. If you have any questions, you may ask your study doctor.

You are being asked to take part in this study because you have [type/stage/presentation of cancer being studied is briefly described here. For example: “colon cancer that has spread and has not responded to one treatment.”]

Why is this study being done?

The purpose of this study is to…[Limit explanation to why study is being done, explaining in one or two sentences. See examples directly below.

Example: Phase I study

…test the safety of [study drug/intervention] at different dose levels. We want to find out what effects, good and/or bad, it has on you and your [specify type/stage/presentation of] cancer.

Example: Phase II study

…find out what effects, good and/or bad, [study drug/intervention] has on you and your [specify type/stage/presentation of] cancer.

Example: Phase III study

…compare the effects, good and/or bad, of [study drug/intervention] with [commonly used drug/ intervention] on you and your [specify type/stage/presentation of] cancer to find out which is better. In this study, you will get either the [study drug/intervention] or the [commonly used drug/ intervention]. You will not get both.]

[Address sponsorship and financial interests here:

• The IRB requires that all consent forms disclose which agencies or institutions (e.g., National Institutes of Health, Department of Defense, Center for Disease Control, State agencies), cooperative groups (CALGB, COG, ACTG), foundations or industry sponsors are funding the research or providing study drugs or equipment for the study. If the study is not being funded by an external agency, then the internal funding source, i.e., Department funds, personal funds, should be identified. This information should be included either in the section headed Why is this study being done? (Purpose and Background) or in a section headed Who pays for this study?

• Investigators must also disclose the nature of any financial or proprietary interests, though this disclosure can be in general terms. For suggested wording, see Conflicts of Interest in Research.

[Any investigational drug(s) or device(s) to be used in the study should be noted and named. The name by which the drug or device is referred to in this section should be used consistently throughout the form.]

How many people will take part in this study?

About [state total accrual goal here] people will take part in this study. [If appropriate, give a short description about cohorts here. For example: “At the beginning of the study, [state number of first cohort] patients will be treated with a low dose of the drug. If this dose does not cause bad side effects, it will slowly be made higher as new patients take part in the study. You can ask your study doctor what dose you will receive. A total of [state maximum number] of patients is the most that would be able to enter the study.” For multi-center studies, it is good to give figures both for the whole study and for local enrollment at UCSF.]

What will happen if I take part in this research study?

[List tests and procedures and their frequency under the categories below. Indicate whether the subject will be at home, in the hospital, in an outpatient or other setting. See examples below.]

Before you begin the main part of the study...

You will need to have the following exams, tests or procedures to find out if you can be in the main part of the study. These exams, tests or procedures are part of regular cancer care and may be done even if you do not join the study. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor.

• [List tests and procedures as appropriate. Use bulleted format.]

During the main part of the study...

If the exams, tests and procedures show that you can be in the main part of the study, and you choose to take part, then you will need the following tests and procedures. They are part of regular cancer care.

← [List tests and procedures as appropriate. Use bulleted format.]

You will also need the following tests and procedures that are part of regular cancer care, but they will be done more often because you are in this study.

← [List tests and procedures as appropriate. Use bulleted format. Omit this section if no tests or procedures are being done more often than usual.]

You will also need the following tests and procedures done that are either being tested in this study or being done to see how the study is affecting your body.

← [List tests and procedures as appropriate. Use bulleted format. Omit this section if no tests or procedures are being tested in this study or required for safety monitoring.]

← [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.

o If you are in group 1 … [Explain what will happen for this group with clear indication of which interventions depart from routine care.]

o If you are in group 2 … [Explain what will happen for this group with clear indication of which interventions depart from routine care.]

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

When you are finished receiving [drugs or interventions]...

[Explain the follow-up tests, procedures, exams, etc. required, including the timing of each and how they relate to standard care (e.g., they are different from standard care; or they are part of standard care but are being performed more often than usual or being tested for the study. Define the length of follow-up.]

← Study location: All study procedures will be done at . . .[If different procedures will take place at different locations, specify accordingly].

[If appropriate to the study, include the following additional procedure statement(s) using IRB wording:]

• Placebo: Define as "an inactive substance."

• Blood drawing (venipuncture): [Once a week,] a blood sample will be drawn by inserting a needle into a vein in your arm. Each sample will be approximately [XX] teaspoons; a total of about [XX] tablespoons will be drawn for the whole study.

• X-ray: You will have an x-ray of your [lungs, done once at the beginning of the study, and again at the end of the study,] in order to check . . . Each x-ray will take about [XX hour(s)].

• CT scan: You will have a computed tomography (CT) [/computerized axial tomography (CAT)] scan of your [XXX], done[XXX], in order 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. The table will move and the machine will make clicking and whirring noises as the pictures are taken. [If appropriate: An iodine dye (contrast material) will first be [injected into a vein/given to you orally/rectally]. The dye makes tissue and organs more visible in the pictures.] Each CT scan will take about 15 minutes to a half hour.

• MRI: [Once every two weeks,] you will have a Magnetic Resonance Imaging (MRI) exam. For the MRI exam, you will lie down on a narrow bed that will then be placed in a tunnel that is 6 feet long by 22 inches wide and open at each end. You will need to lie there quietly for about one hour, during which time there will be a loud banging noise. You may feel warm during this procedure. [If appropriate: Gadolinium (contrast material) will first be [injected into a vein in your arm]. The dye makes tissue and organs more visible in the MRI.]

• Pregnancy testing (statement 1): [If this form is being used to consent subjects under the age of 18, include the following statement after describing the pregnancy testing procedure. This statement is specific to California law, so please adapt it if the study is conducted elsewhere. Include the bolded italic sentence only if pregnancy is an exclusion criterion.] In California, information about pregnancy test results, engagement in sexual activity, and use of birth control may not be shared with parents without your permission.  We will not inform your parents of the pregnancy test result.  If the pregnancy test is positive, however, your parents may guess you are pregnant because you must be excluded from the study.  If you think you may be pregnant, and you do not want your parents to know, you may not want to participate in this study. If you are pregnant, you will be told about your condition and the study team will ensure you have medical follow up for the pregnancy.

• Pregnancy testing (statement 2): [If this form is being used to get parental permission for a subject under the age of 18, include this statement after describing the pregnancy test procedure. This statement is specific to California law, so please adapt it if the study is conducted elsewhere.] In California, information about pregnancy test results, engagement in sexual activity, and use of birth control may not be shared with parents without your child’s permission. Unless your child gives us permission, we will not inform you of the pregnancy test result. If your child is pregnant, the study team will ensure that your child has medical follow up for the pregnancy.

[Optional Feature: In addition to the mandatory narrative explanation of study procedures as above, a simplified calendar (study chart) or schema (study plan) may be inserted here. The schema from the protocol is too complex, but use of a simplified version of the schema is encouraged. Instructions for reading the calendar or schema should be included. See examples.]

Study Chart [Example]

|You will receive [drugs or interventions] every [insert appropriate number of days or weeks] in this study. This [insert number of days or |

|weeks] period of time is called a cycle. The cycle will be repeated [insert number] times. Each cycle is numbered in order. The chart below |

|shows what will happen to you during Cycle 1 and future treatment cycles. The left-hand column shows the day in the cycle and the right-hand|

|column tells you what to do on that day. |

Cycle 1

|Day |What you do |

|Two days before starting study |Get routine blood tests. |

|treatment | |

|Day before starting study |Check-in to _____________ the evening before starting study. |

|treatment | |

|Day 1 of treatment |Begin taking _____________once a day. Keep taking ____________ until the end of study, unless told to stop|

| |by your health care team. |

|Day 2 |Leave _______________ and go to where you are staying. |

|Day 8 |Get routine blood tests. |

|Day 15 |Get routine blood tests. |

|Day 22 |Get routine blood tests. |

|Day 28 |Get routine blood tests and exams. |

| |Get 2nd chest x-ray for research purposes. |

|Day 29 |Return to your doctor's office at _______ [insert appointment time] for your next exam and to begin the |

| |next cycle. |

Future cycles

|Day |What you do |

|Days 1-28 |Keep taking _____ once a day if you have no bad side effects and [condition] is not getting worse. Call the doctor at |

| |_____________ [insert phone number] if you do not know what to do. |

| |Get routine blood tests each week (more if your doctor tells you to). |

| |Get routine blood tests and exams every cycle (more if your doctor tells you to). |

| |Get routine X-rays, CT scans, or MRIs every other cycle (more if your doctor tells you to). |

|Day 29 |Return to your doctor's office at _______ [insert appointment time] for your next exam and to begin the next cycle. |

Study Plan [Example]

Another way to find out what will happen to you during the study is to read the chart below. Start reading at the top and read down the list, following the lines and arrows.

|Start Here |

[pic]

|Breast Cancer Surgery |

[pic]

|Medicines Used in This Study |

|Doxorubicin + Cyclophosphamide given by vein once every 21 days and repeated 4 times |

[pic]

|Randomize |

|(You will be in Group 1 or Group 2) |

[pic]

|Group 1 |      |Group 2 |

|Paclitaxel by vein | |No Paclitaxel |

|Every 21 days for 4 visits | |                                |

| | | |

How long will I be in the study?

You will be asked to take [drugs or interventions] for [months, weeks/until a certain event]. After you are finished taking [drugs or interventions], the study doctor will ask you to visit the office for follow-up exams for at least [indicate time frames and requirements of follow-up. When appropriate, state that the study will involve long-term follow-up and specify time frames and requirements of long-term follow-up. For example, "We would like to keep track of your medical condition for the rest of your life. We would like to do this by calling you on the telephone once a year to see how you are doing. Keeping in touch with you and checking on your condition every year helps us look at the long-term effects of the study."]

Can I stop being in the study?

Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop your participation safely.

It is important to tell the study doctor if you are thinking about stopping so any risks from the [drugs or interventions] can be evaluated by your doctor. Another reason to tell your doctor that you are thinking about stopping is to discuss what follow-up care and testing could be most helpful for you.

The study doctor may stop you from taking part in this study at any time if he/she believes it is in your best interest, if you do not follow the study rules, or if the study is stopped.

What side effects or risks can I expect from being in the study?

You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. However, doctors don't know all the side effects that may happen. 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 the [drugs or interventions]. In some cases, side effects can be serious, long lasting, or may never go away. [The next sentence should be included if appropriate: There also is a risk of death.]

You should talk to your study doctor about any side effects you experience while taking part in the study.

Risks and side effects related to the [procedures, drugs, interventions, devices] include those which are:

Likely

•

•

•

Less Likely

•

•

•

Rare but serious

•

•

•

[Notes for consent form authors regarding the presentation of risks and side effects:

• Using a bulleted format, list risks and side effects related to the investigational aspects of the trial. Do not list side effects of supportive medications unless the medications are specifically mandated by the study.

• List by regimen the physical and nonphysical risks and side effects of participating in the study in three categories: 1. "likely"; 2. "less likely"; 3. "rare but serious."

• There is no standard definition of "likely" and "less likely." As a guideline, "likely" can be viewed as occurring in greater than 20% of patients and "less likely" in less than or equal to 20% of patients. However, this categorization should be adapted to specific study agents by the principal investigator.

• In the "likely" and "less likely" categories, identify those side effects that may be "serious." "Serious" is defined as side effects that may require hospitalization or may be irreversible, long-term, life threatening or fatal.

• Side effects that occur in less than 2-3% of patients do not have to be listed unless they are serious, and should then appear in the "rare but serious” category.

• Physical and non-physical risks and side effects should include such things as the inability to work. Whenever possible, describe side effects by how they make a patient feel, for example, "Loss of red blood cells, also called anemia, can cause tiredness, weakness and shortness of breath.”

• For some investigational drugs/ interventions/ devices there may be side effects that have been noted during treatment, but not enough data is available to determine if the side effect is related to the drug/ intervention/ device. Inclusion of this information in the informed consent document is not mandatory, but it may be prudent to mention the most serious effects. If included, these side effects should be listed under a separate category titled "Side effects reported by patients, but not proven to be caused by [drug/ intervention/ device]." Side effects in this category do not have to be labeled as "likely," "less likely," or "rare but serious" and should not be repeated here if they appear in a previous category. Similar to the other categories, these side effects should be listed in a bulleted format.]

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

• Randomization risks: You will be assigned to a treatment program by chance, and the treatment you receive 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 receives placebo, your condition will go without the active (study) treatment for [XX weeks].

• Blood drawing (venipuncture) risks: Drawing blood may cause temporary discomfort from the needle stick, bruising, infection, and fainting.

Radiation risks: The language used will depend on the total effective dose from treatments determined to be additional radiation exposure beyond what is required for routine clinical care. IN NO INSTANCE SHOULD A PATIENT RECEIVE MORE RADIATION THAN THE MAXIMUM STATED ON THE CONSENT FORM.

Effective Dose of 50 mSv (>5 mSv for Pediatric)

Radiation risks: This research study involves exposure to a significant amount of radiation. Not all this radiation exposure is necessary for your medical care and is for research purposes only. Typically, persons in the U.S. receive an annual background dose of radiation of about 3 mSv (a mSv, or millisievert, is a measurement of radiation) from the environment. The additional amount of radiation that you will receive as a result of participating in this study will be a maximum of _____ mSv, or approximately ______ times the yearly natural background. This amount of radiation may result in a very small increased risk of future cancer. If you have had a lot of x-rays or other procedures involving radiation, you should discuss this with the principal investigator for this study or your regular doctor and consider whether as a result of total radiation exposure, participation in this study is appropriate for you. The UCSF Radiation Safety Committee has reviewed the use of radiation in this research study and has designated this use as acceptable to obtain the objectives of the study. If you are pregnant or breast feeding, you SHOULD NOT participate in this study. If you have any questions regarding the use of radiation or the risks involved, please consult the physician conducting the study.

Cancer Center Special Criteria for median survival ................
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