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 simplified, 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.

Banking of excess biological specimens is not a medical experiment, as defined below. Do not include the "List of Rights of a Participant in a Medical Experiment."

“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#

Delete language concerning creation of research database only if such a database will not be created for the research or you do not have the intention of using the database for research.

CONSENT FOR SPECIMEN BANKING FOR FUTURE RESEARCH – ADULT

CONSENT FOR SPECIMEN BANKING FOR FUTURE RESEARCH – 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?

You are being asked to allow excess specimens (blood, tissue, or other biological material) removed from you to be added to a bank of specimens for use in future research. These specimens are taken during your regular medical care, for example, surgery, biopsies, blood or urine tests.

Many advances in medicine have come from research involving the collection and analysis of discarded specimens of patients with a certain disease or condition. Because you are being seen by the UCSF Benioff Children's Hospital Oakland specify department, clinic we are asking your permission to allow us to store your excess specimens in a bank. These specimens will be [labeled only with a code number] OR [labeled with XXXXX information but not your name or address]. Researchers will study specimens in the bank to increase knowledge about XXX disease.


Researchers may also need health information about the patients who provide specimens, so we are also asking for your consent to place information from your medical record in a database to be used for research. Your name and address will not be placed in the database. Dr. [Name of Principal Investigator] will maintain the database and will allow it to be used for research only as permitted by BCHO policies and federal regulations.

WHO IS SPONSORING 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. 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.

HOW MANY PEOPLE WILL BE IN THIS STUDY?

If the number is unlimited include the following sentence, otherwise state numbers and delete this sentence.

There is no limit to the number of people who can allow us to bank their specimens.

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

WHAT WILL HAPPEN IN THE STUDY?

After surgery, the tissue specimens that are removed are brought to a Pathologist who examines them. The pathologist usually uses only a small piece of the specimen to make a diagnosis.

Other specimens, such as blood and urine, are used for diagnosis and other lab tests necessary for medical care.

Any blood or tissue that has already been removed, but is not needed to make the diagnosis, and/or when the tests are finished, is usually thrown away. If you agree, it is these unused specimens that will be kept for use in research studies. No procedures will be done that are not part of treatment. There will be no changes in the treatment because of the collection of these specimens.

The specimens will be stored at a central specimen bank at state where stored. The stored specimens and health information include a summary of the information to be collected from your [your child’s] medical records that has been placed in the research database will be made available to researchers. We will not give the samples to anyone with any information that could identify you [your child]. Specimens will be identified only by a code number. Name and address will not be placed on specimen labels or in the research database and will not be shared with researchers. Only state who, e.g., project director, investigator will have access to the code. We may use the samples for other research related to your [your child’s] disease. Because the tests we do are research tests, we won’t know for a long time whether they are meaningful to patient care. Therefore, the results will not be given back to you.

WHAT ARE THE RISKS OF THIS STUDY?

Adult and Combined Adult/ChildThere will be no risks to your health, or possibility of physical discomfort involved in allowing your specimens to be stored in a bank, because your excess specimens would already have been taken as part of your medical care and will otherwise be thrown away.

Although health information that is collected from your medical record will be kept in a secure database, there is always the risk that it may be accessed by individuals not associated with this study. Efforts will be made to protect your confidentiality as described in this form.

Child only – signed by parent/guardianThere will be no risks to your child’s health, or possibility of physical discomfort involved in allowing your child’s specimens to be stored in a bank, because the excess specimens would already have been taken as part of your child’s medical care and will otherwise be thrown away.

Although health information that is collected from your child’s medical record will be kept in a secure database, there is always the risk that it may be accessed by individuals not associated with this study. Efforts will be made to protect your child’s confidentiality as described in this form.

ARE THERE BENEFITS TO BEING IN THE STUDY?

Adult and Combined Adult/ChildThere is no direct benefit to you from the research use of your specimens and health information. It is hoped the knowledge gained will be of benefit to others in the future.

Child only – signed by parent/guardianThere is no direct benefit to your child from the research use of your child’s specimens and health information. It is hoped the knowledge gained will be of benefit to others in the future.

WHAT OTHER CHOICES DO I HAVE?

If you choose not to [have your child] participate in banking specimens for future research, your [your child’s] usual medical care will not be changed.

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 BCHO language below. For example, identifying data may be collected or be sent to someone outside of BCHO, so the statement "for records shared outside of BCHO" 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. 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 BCHO. Researchers at this or other institutions may wish to use specimens and associated health information from the specimen bank in future research. Before your excess specimens and health information may be used or disclosed for a research project, all direct identifiers will be removed. For records shared outside of BCHO, 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.

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. 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 BCHO. Researchers at this or other institutions may wish to use specimens and associated health information from the specimen bank in future research. Before your child's excess specimens and health information may be used or disclosed for a research project, all direct identifiers will be removed. For records shared outside of BCHO, 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.