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Biomedical Consent Template

Printer-friendly version: Biomedical Consent Template [MSWord 128KB]

If you have problems using the Word document listed above, 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 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.

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?

This is a clinical trial, a type of research study. Clinical trials include only people who choose to take part. Please take your time to make your decision about taking part. You may discuss your decision with your friends and family. You can also discuss it with your health care team. If you have any questions, you can ask your study doctor for more explanation.
You have been asked to participate in a research study because you have been diagnosed with [state condition].
State the purpose of this study.
State the approval status by the U.S. Food and Drug Administration (FDA)of this drug/device.

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.

B. HOW MANY PEOPLE WILL PARTICIPATE?

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

Approximately (provide number) of 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 timeline):

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:

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.,
- Group A will receive the investigational drug, (provde schedule) times a week for (provide number of weeks) weeks. Group B will receive a placebo (an inactive substance), according to the same schedule. This process is called randomization and means you have a 50/50 chance of being in either group. (Indicate in what form the drug/placebo will be given.)
  -Or-
- 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 study 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.
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.]

E. 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 ubject "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.

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 [drug(s) or intervention]. In some cases, side effects can be serious, long lasting, or may never go away.

There also is a risk of death. [include if appropriate]

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

If a placebo is involved, include the following statement: If you are in the group that receives a placebo, your condition may go without treatment for (provide number of weeks) weeks.

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

Likely

Less Likely

Rare but serious

Are there any Unforeseen Risks? In addition to the risks described above, there may be unknown risks, or risks that we did not anticipate, associated with being in this study.

Reproductive risks. You should not be or become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use one or more acceptable methods of birth control while on this study. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study.

Include a statement about possible sterility when appropriate. For example: Some of the drugs used in the study may make you unable to have children in the future.

If appropriate include a statement that pregnancy testing may be required.

HIV Testing: Your blood will also be tested for HIV; a test used in the screening for the virus that causes AIDS. This will be conducted in a confidential manner. You will be informed that pre and post counseling will be provided regarding HIV testing. If you have any questions regarding the nature of the HIV blood test, its expected benefits, its risks, and alternate tests, you may ask questions before you decide to consent to the HIV blood test.

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)

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.

IF 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 Principal Investiagtor at the phone number proved. 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.

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 will be given to you when you sign your 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. 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.

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

What if I Decide to Drop Out of the Study?
If you decide to leave the study early, we will ask you to provide the reasons.
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.

Can Someone Else End My Participation in this Study?
Under certain circumstances, the researchers or the study sponsor might decide to end your participation in this research study earlier than planned. This might happen because [state possible reasons].
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.

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

You and/or your medical/hospital insurance carrier will remain responsible for your regular medical care expenses.

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: [Prove the 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:
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.

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