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Institutional Review Board (IRB)
You/Your Child Consent

Download: You/Your Child Sample Consent Template [Microsoft Word format]
If you have problems using the Word document listed above, provide us with the information below:

PARENTAL SAMPLE CONSENT

INVESTIGATOR GUIDELINES

Model text suggested for use in the informed consent form is in bold. It is recommended that the bold text be retained when adapting the template to a specific protocol.

Instructions and guidance for informed consent authors are in [italics].

A blank line indicates that the investigator should provide the appropriate information before the document is reviewed with the prospective research participant.

The goal of the informed consent process is to provide potential participants with sufficient information for making informed choices. The consent form provides a summary of the clinical study and the individual's rights as a research participant. It serves as a starting point for the necessary exchange of information between the investigator and potential research participant. This template for the informed consent form is only one part of the larger process of informed consent.

Use “you or/and your child” (whichever is applicable) consistently throughout.

HIPAA Form: This is the standard template required for “Patient Authorization for the Use and Disclosure of Protected Health Information”. DO NOT ALTER THE TEXT THAT IS EMBEDDED IN THIS DOCUMENT; simply insert at the designated spaces the responses to the information on the template. The investigator must keep the authorization until the end of the study for tracking purposes. Complete only the section applicable to your study. All California authorizations for the use and disclosure of medical records must be printed in 14pt font.

EXPERIMENTAL SUBJECT'S BILL OF RIGHTS

The Institutional Review Board at California Pacific Medical Center wishes you to know: Any person who is requested to consent to participate as a subject in a research study involving a medical experiment, or who is requested to consent on behalf of another, has the right to:

Be informed of the nature and purpose of the experiment.

Be given an explanation of both the procedures to be followed in the medical experiment, as well as any drug to be used in the experiment.

Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment.

Be given an explanation of any benefits to the subject reasonably to be expected from the experiment.

Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits.

Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise.

Be given an opportunity to ask any questions concerning the experiment or the procedures involved.

Be instructed that consent to participate in the medical experiment may be withdrawn at any time, and the subject may discontinue participation in the medical experiment without prejudice.

Be given a copy of the signed and dated written consent form when one is required.

Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject's decision.

If you have questions regarding a research study, the researcher or his/her assistant will be glad to answer them. You may seek information from the Institutional Review Board--established for the protection of volunteers in research projects--by calling (415) 600-3688 Monday through Friday, between 9:00 a.m. and 4:00 p.m.

Signature of Parent should be provided

The Principal Investigator is: and the (optional if you include them or not) sub-investigators are:

This study was explained to you and/or your child by:

WHAT IS THE PURPOSE OF THIS STUDY?

drug/device has/ha

Guidelines:
Complete the above sentence by describing why the person reading the consent is a possible subject for your project.

Use simple language.

Be concise.

Provide general description of the project -what is being investigated, what is the hypothesis, what knowledge or information is being sought and why.

If the investigational drug/device is being compared to placebo, that should be mentioned in this introductory section.

HOW MANY PEOPLE WILL PARTICIPATE?

[state total accrual goal here]

HOW LONG WILL MY CHILD BE IN THIS STUDY?

Guidelines:
Discuss length of time for study participation. If more than one visit or contact is involved in the study, give the total number of visits, approximate length of time for each visit, and length of time in between each visit.

If the study involves long-term follow-up, remember to include how long the subject will be followed, even if follow-up is based solely on clinical chart information with no direct subject contact.

WHAT HAPPENS TO MY CHILD DURING THIS STUDY?

Guidelines:
Include a description of the types of drugs and other therapies to be used, the duration of the therapy and the methods of drug administration.

If the protocol involves randomization or the use of a placebo, this must be explained in detail but also in easy-to-understand (no more than 7th grade level) language. If an investigational drug will be used, indicate the drug schedule: e.g.,

(Indicate in what form the drug/placebo will be given.)

-Or-

[equal/one in three/etc.]

Describe, step by step, in sequential order from the subject's point of view, what is going to happen to the subject and what you are going to ask the subject to do if he/she participates.

Define and explain medical and scientific terms in ordinary language (for example, describing the amount of blood to be drawn in terms of teaspoons or tablespoons).

Describe where the procedures will take place (e.g. outpatient clinic, inpatient unit, subject's home).

Describe any procedures, drugs, or devices that are experimental.

For complex protocols, consider including a chart or table showing which procedures/tests are performed at each visit. [Optional Feature: In addition to the mandatory narrative explanation found in the preceding text, a simplified calendar (study chart) or schema (study plan) may be inserted here. The schema from the protocol should not be used as it is too complex; however a simplified version of the schema is encouraged.]

WHAT ARE THE RISKS OF THIS STUDY?

Guidelines:
In simple language, describe any reasonably foreseeable risks or discomforts to the participant - physical, pain, drug toxicity, psychological, emotional, legal, privacy issues, etc. and information about their likelihood and seriousness.

Depending on the type of study, some risks may be better described as things that could make the subject "uncomfortable" -such as fatigue or embarrassment. There is no such thing as a "risk-free" study!

Using a hierarchical format (most common/serious to least common/less serious), describe the known side effects, discomforts and risks of all drugs and/or concomitant therapy required by the protocol. A bullet or table format is preferred to list this information.

If appropriate, add a statement that the particular treatment or procedure may involve risks to the embryo or fetus, which may be currently unforeseeable.

Discuss the procedures for protecting against or minimizing any potential risks to the participant. Provide a plan for emergency care, if appropriate.

[include if appropriate]

If a placebo is involved, include the following statement:

[procedures, drugs, interventions, devices]

WHAT ARE THE POTENTIAL BENEFITS TO MY CHILD AND OTHERS?

(If there is no direct benefit, include the following statement):

Guidelines:
Note that compensation is NOT a benefit.

WHAT OTHER ALTERNATIVES OR TREATMENT OPTIONS ARE AVAILABLE TO MY CHILD?

Guidelines:

List the alternative treatments or procedures. If the participant can receive the same study treatment or therapy without being in the research, that must be disclosed.

WHAT HAPPENS IF MY CHILD IS INJURED OR HARMED IN SOME WAY BY THE STUDY?

(This is a legal clause for research involving more than minimal risk and must be included verbatim. Choose appropriate paragraph - 1 or 2)

IF SPONSOR DOES NOT PAY FOR COST OF INJURY:

IF SPONSOR DOES PAY FOR COST OF INJURY:

HOW CONFIDENTIAL ARE MY CHILD’S RECORDS?

Guidelines:

Indicate whether or not research records will be anonymous. If not, there should be discussion of how records will be coded, and where and how they will be stored.

It should also note where and how signed consent forms would be maintained.

Describe other methods that will be used to ensure confidentiality, e.g., coded names or identification numbers; secure storage area, password-protected computer files, etc.

[For drug/device studies, add: the U.S. Food and Drug Administration and the sponsor, (give company name)]

The State of California mandates that investigators and their staff report a reasonable suspicion or known abuse or neglect of a child (CA Penal Code Section 11160-11163.5). When research is likely to reveal possible child abuse, such as interviews about personal behavior, practices, discipline, relationships, etc. or when research is conducted in the subject’s home, medical facility, or a doctor’s office, the consent should clearly indicate that the investigator is required to report a reasonable suspicion or known abuse or neglect of a child. The following sample is meant to guide the investigator:

CPMC IRB acknowledges the sensitivity of the wording and will consider alternative wording suggested by the investigator as long as the limits on maintaining the child’s confidentiality are made clear.

IS BEING IN THIS STUDY VOLUNTARY?

Guidelines:
For studies involving clinical or physical interventions, or if appropriate to your study, consider adding these sub-sections.

Guidelines:
Describe procedures for withdrawing, such as a coming to a close out visit, and what that visit involves. Describe any other consequences of the subject's withdrawal.

Guidelines:
Describe why the study might be ended without the subject's consent, e.g., because in our judgment it would not be safe for you to continue, because your condition has become worse, because you are or became pregnant, because funding for the research study has ended, etc.

WILL MY CHILD BE PAID FOR PARTICIPATING?

[will/will not]

Guidelines:
Clearly describe the monetary compensation (total amount, average total amount, amount per visit, amount per hour, etc.). If subjects must provide SSN and address to receive check for payment, that should be indicated.
If compensation is pro-rated when a subject withdraws prior to completing the study, explain how it is pro-rated.

If there is non-monetary compensation (e.g. small gift, gift certificate), describe that separately from the monetary compensation statement.

WHO IS FUNDING THIS STUDY?

Guidelines:
Choose only one of the following two statements, whichever correctly describes your study.

[Name of agency/organization/company

[name]

Conflict of interest language, include if appropriate:

WILL IT COST ME and/or MY CHILD ANYTHING TO BE IN THIS STUDY?

Guidelines:
This section should provide information about any costs that subjects and their third party insurance carriers may be expected to assume as a result of participation in the study. It should be made clear if there is a possibility that the subject’s insurer will not cover these costs.

In studies involving patients where costs of clinical diagnosis and care may be difficult to distinguish from costs of procedures done solely for research purposes, clear information regarding this aspect of the study should be presented.

[will/will not]

If the sponsor is not paying for research tests or study treatments, consider adding a sentence instructing subjects to check with their insurance carrier prior to deciding whether to participate.

For studies involving a clinical or therapeutic intervention, consider adding:

WILL I and/or MY CHILD RECEIVE NEW INFORMATION ABOUT THE STUDY WHILE PARTICIPATING?

EXPERIMENTAL SUBJECT'S BILL OF RIGHTS

WHAT IF I OR MY CHILD HAVE QUESTIONS?

[name(s), phone number(s)]

[If study involves significant risks, include 24/7 phone number, instructions about who to ask for (e.g., research fellow on call, resident on call, etc.).

Should you and/or your child have any questions about your rights as a research participant, you may call the Institutional Review Board which is concerned with protection of volunteers in research projects, between 9 a.m. and 4 p.m., Monday through Friday, at (415) 600-3688 or by writing: California Pacific Medical Center Research Institute (CPMCRI) Institutional Review Board Office, 2200 Webster Street 5th floor, SF CA 94115.

PARENT’S STATEMENT

My signature below means that I have read the above information and have had a chance to ask questions to help me understand what my child will do in this study. I have been given a copy of this consent form; the Subject’s Experimental Bill of Rights; and a copy of the Authorization for the Use and Disclosure of Protected Health Information for Research form. If I sign this form, I am not giving up any of my or my child’s legal rights.

BY SIGNING THIS FORM, I WILLINGLY AGREE TO HAVE MY CHILD PARTICIPATE IN THE RESEARCH IT DESCRIBES.

Child’s Name/Age should be provided

Name and Signature of Parent or Guardian/Date should be provided

Name and Signature of Person Conducting Consent Discussion/Date should be provided

PATIENT AUTHORIZATION FOR THE USE AND DISCLOSURE
OF PROTECTED HEALTH INFORMATION FOR RESEARCH

Part I. Patient Authorization for the Use and Disclosure of Protected Health Information (PHI) for Research Purposes

Principal Investigator:

Phone:

Address of Principal Investigator:

Authorization Expiration Date:

Protected Health Information (PHI) is any health information including medical records, mental health records, billing records, survey data, and demographic data that is identified to you. By signing below, you are authorizing the Principal Investigator and the research team to collect, store, use and disclose the PHI described below. You are also authorizing the Principal Investigator and research team to request copies of your medical and/or billing records from the providers listed.

Your authorization is required for participation in the research study.

You may revoke your authorization at any time by sending a written notification to your study doctor at the address above. We will discontinue collecting, using or disclosing your information except as required to maintain the integrity of the research study or as required by law. However, a revocation will not be effective for information that the study doctor has already used or disclosed while the authorization was in effect. For example, we may need to use your information to document why you have withdrawn from the study, for compliance reporting purposes, or to report adverse events.

During the research study, your research team will look at the following information:

Billing records for healthcare services

Medical records

Lab, pathology and/or radiology results

Mental Health records

Previous Research records

Questionnaires and interviews

Other (specify):

During the research study, your research team may disclose your PHI to the following individuals or organizations:

California Pacific Medical Center Institutional Review Board for oversight purposes

Study sponsor:

Contract research organization (CRO):

Office for Human Research Protections (OHRP); Food and Drug Administration (FDA); or National Institutes of Health (NIH) for safety, efficacy, and compliance reports. Also included are other federal or state agencies that have authority over the research project or other governmental offices as required by law.

Statistician for data analysis

Outside lab for specimen processing

A data safety monitoring board, if applicable

Others (list all that apply):

During the research study, we may request copies of your PHI from the following sources (list all that apply):

Name:

Address:

Name:

Address:

California Pacific Medical Center is required by State and Federal laws to protect your information. California law prohibits the recipient from making further disclosure of your health information unless the recipient obtains another authorization from you or unless the disclosure is required or permitted by law. This protection does not extend to recipients outside the state of California. There is always the possibility that your information could be disclosed to a party that is not required to protect its confidentiality. Your identity will not be revealed in any publication that may result from this study.

RESEARCH SUBJECT’S STATEMENT (PARENT):

I hereby authorize the Principal Investigator listed above and the research team to use and disclose my child's protected health information as described above for research purposes.

Signature/Date should be provided

If conservator or individual authorized to make health decisions on behalf of the Research Subject, state relationship to Research Subject:

If this box is checked and initialed, I authorize the Principal Investigator named above to obtain copies of any of my medical records needed for purposes of the research while I am enrolled in this study.
(blank space) (Research subject’s initials)

If this box is checked and initialed, I acknowledge that my right to access my health information pertaining to the research study will be suspended until the study is concluded.
(blank space) (Research subject’s initials)

Institutional Review Board (IRB)You/Your Child Consent

Institutional Review Board (IRB)
You/Your Child Consent