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    Behavioral Consent Template

    Printer-friendly version: Behavioral Consent Template [MS Word 103KB]
    If you have problems using the Word document, provide the IRB with the information below and submit to:
    IRB Office
    2200 Webster Street, 5th Floor, P-Campus,
    San Francisco, CA 94115

    For questions and help, please call:
    Leigh Pruneau, PhD, RN, CIP., Human Research Protection Program Administrator at (415) 600-3688.


    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.

    • 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 the pronoun “you” consistently throughout.

    • HIPAA Form: This is the standard template required for “Patient Authorization for the Use and Disclosure of Protected Health Information”. 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 14 point 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:

    1. Be informed of the nature and purpose of the experiment.
    2. 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.
    3. Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment.
    4. Be given an explanation of any benefits to the subject reasonably to be expected from the experiment.
    5. 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.
    6. Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise.
    7. Be given an opportunity to ask any questions concerning the experiment or the procedures involved.
    8. 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.
    9. Be given a copy of the signed and dated written consent form when one is required.
    10. 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.

    Participant’s Name should be provided
    Participant’s Signature/date should be provided or legal representative if appropriate


    Consent To Act As A Research Participant

    Please provide the names of the Principal Investigator and Sub-investigators names (if any).
    This study was explained to you by (provide name).

    A. WHAT IS THE PURPOSE OF THIS STUDY?

    Explain simply why the prospective subject is eligible to participate in this research study.

    State the purpose of this study.

    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.

    B. HOW MANY PEOPLE WILL PARTICIPATE?


    • About [state total accrual goal here] participants will take part in this study.

    • Approximately (provide number) participants will take part in this study at California Pacific Medical Center.

    C. HOW LONG WILL I BE IN THIS STUDY?


    If you agree to take part in this study, your involvement will last for (provide time-line):

    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.

    D. WHAT WILL HAPPEN TO ME DURING THIS STUDY?

    Guidelines:
    • Describe the procedures chronologically using simple language, short sentences and short paragraphs. The use of subheadings helps to organize this section and increases readability. Medical and scientific terms should be defined and explained. Identify any procedures which are experimental.

    • Specify the subject's assignment to study groups, length of time for participation in each procedure, frequency of procedures, location of the procedures to be done, etc.

    • Optional Feature: In addition to the narrative explanation, a simplified calendar (study chart) or schema (study plan) may be used. Graphs may also be useful.
    If you volunteer to participate in this study, we would ask you to do the following:
    • You will be asked to respond to questionnaires about (provide title of questionnaire) .
    • If you agree, audiotapes will be made of these conversations.

    E. WHAT ARE THE RISKS OF THIS STUDY?

    Some of the questions may make you uncomfortable or upset, but you are free to decline to answer any questions you do not wish to, or to stop the interview at anytime.

    Guidelines:
    • Describe any reasonable foreseeable risks, discomforts, inconveniences, and how these will be managed.

    • If there are significant physical or psychological risks to participation, please discuss.

    • 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!

    F. WHAT ARE THE POTENTIAL BENEFITS TO ME AND OTHERS?

    Directly to you: Participation in this study offers certain benefits. State those benefits.

    If there is no direct benefit, include the following statement:
    "There will be no direct benefit to you from participation in this study. However, it is hoped that the information gained from the study will help in the treatment of future patients with conditions like yours."

    Guidelines: Note that compensation is NOT a benefit.


    G. WHAT OTHER ALTERNATIVES OR TREATMENT OPTIONS ARE AVAILABLE TO ME?


    Before you decide whether or not to be in this study, your doctor will discuss the other options that are available to you. Instead of being in this study, you could (state options):

    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.


    H. WHAT HAPPENS IF I AM 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)

    1. IF SPONSOR DOES NOT PAY FOR COST OF INJURY:

      You have been advised that California Pacific Medical Center and the Investigators have no special program to provide compensation if injury occurs during biomedical research. If you are injured or made ill as a result of participation in this study, treatment will be made available. Because insurance companies may not pay for research-related costs, they may not pay for an injury resulting from your participation in this study. Any costs not paid by your insurance company will be your responsibility.

    2. IF STUDY SPONSOR DOES PAY FOR COST OF INJURY:

      You have been advised that California Pacific Medical Center and the Investigators have no special program to provide compensation if injury occurs during biomedical research. If you are injured or made ill as a result of participation in this study, treatment will be made available.

      Under certain circumstances, (Study Sponsor) will pay for the cost of medical care for any injury you might suffer as a result of this research. If you request it, the Investigator will provide you with the details of the program. (Details would include whether sponsor pays all costs or only those not covered by the participant’s insurance; or that payment is conditional on following protocol, etc.)

    Include the following sentence for either paragraph 1 or 2 above:
    In the event of a research-related injury, you should contact the Principal Investigator at (Provide Investigator’s telephone number, include area code). This is a 24-hour number.

    I. HOW CONFIDENTIAL ARE MY 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.

    • If activities are to be audio- or videotaped, describe the subject's right to review/edit the tapes, who will have access, if they will be used for educational purpose, and when they will be erased.

    We will keep your participation in this research study confidential to the extent permitted by law. Federal government regulatory agencies, [For drug/device studies, add: the U.S. Food and Drug Administration and the sponsor, (give company name)] and the California Pacific Medical Center Institutional Review Board (a committee that reviews and approves research studies) may inspect and copy records pertaining to this research. Some of these records could contain information that personally identifies you. If we write a report or article about this study, we will describe the study results in a summarized manner so that you cannot be identified. However, it is possible that other people may become aware of your participation in this study.

    An authorization describing how health information about you may be used and to whom it will be disclosed by the principal investigator and the research team will be provided to you. Federal and state law requires that patients must give authorization for use of their protected health information in order to participate in this research study. Please refer to the “Patient Authorization for the Use and Disclosure of Protected Health Information for Research” form that is given to you when you sign the consent form.


    J. IS BEING IN THIS STUDY VOLUNTARY?

    Taking part in this research study is completely voluntary. You may choose not to take part at all. If you decide to be in this study, you may stop participating at any time. You may also refuse to answer any questions you don’t want to answer and still remain in the study. If you decide not to be in this study, or if you stop participating at any time, you won't be penalized or lose any benefits for which you otherwise qualify.


    K. WILL I BE PAID FOR PARTICIPATING?


    You [will/will not] be paid for being in this research study.

    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.

    L. WHO IS FUNDING THIS STUDY?


    Guidelines:
    Choose only one of the following two statements, whichever correctly describes your study.
    • California Pacific Medical Center and the research team are receiving no payments from other agencies, organizations, or companies to conduct this research study.

      • -Or
    • [Name of agency/organization/company] is funding this research study. This means that California Pacific Medical Center is receiving payments from [name] to support the activities that are required to conduct the study. No one on the research team will receive a direct payment or an increase in salary from [name] for conducting this study.
    Conflict of interest language, include if appropriate:
    In addition, your physician may also be an investigator of this research protocol, and, as an investigator, is interested not only in your clinical well-being, but the results of this study. It is possible that occasionally these two goals may be in conflict. At any time during this study, you may ask for a second opinion from another doctor who is in no way associated with this study at your own expense.


    M. WILL IT COST ME 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.
    You [will/will not] have any costs for being in this research study.

    • 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.


    N. WILL I RECEIVE NEW INFORMATION ABOUT THE STUDY WHILE PARTICIPATING?

    During the course of the study, you will be informed of any significant new findings (either good or bad), such as changes in the risks or benefits resulting from participation in the research or new alternatives to participation that might cause you to change your mind about continuing in the study. If new information about the risks or benefits of this study is provided to you, your consent will be re-obtained.


    O. EXPERIMENTAL SUBJECT'S BILL OF RIGHTS

    A copy of the Experimental Subject's Bill of Rights and a copy of this consent form will be given to you for your own use.


    P. WHAT IF I HAVE QUESTIONS?

    We encourage you to ask questions. If you have any questions about the research study itself, please contact: [provide study personnel's 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 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.

    Signature and Statement Of Research Subject Or Legal Representative

    I have read (or someone has read to me) the information provided above. I have been given an opportunity to ask questions and all of my questions have been answered to my satisfaction. 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.

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

    Participant's Name printed/date should be provided

    Participant's Signature/date should be provided

    Name and Signature of Legally Authorized Representative/date should be provided (if appropriate)

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

    Patient Authorization For The Use And Disclosure of Protected Health Information (PHI) for Research Purposes

    • Principal Investigator's name:
    • Principal Investigator's Phone Number:
    • 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:

    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 and Signature

    I hereby authorize the Principal Investigator listed above and the research team to use and disclose my 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. Please choose one of the following options and initial the option you chose.

    1. 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.
    2. I acknowledge that my right to access my health information pertaining to the research study will be suspended until the study is concluded.