IRB#

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.

IRB#

LIST OF RIGHTS OF A PARTICIPANT IN A

MEDICAL 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 bereceived outside ofthe study,
  • That the choice to take part in the studyor 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


CONSENT TO PARTICIPATE IN A RESEARCH STUDY – ADULT

CONSENT TO PARTICIPATE IN A RESEARCH STUDY – PARENT

choose one of the above – delete the other

Choose 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?

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?

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. 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.

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?

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.

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?

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.

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:

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.

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.]

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?

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].

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

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?

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

ARE THERE RISKS TO AN UNBORN BABY?

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.

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

ARE THERE BENEFITS TO BEING IN THE STUDY?

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.