UNIVERSITY OF CALIFORNIA IRVINE



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|UCLA BIOMEDICAL CONSENT FORM TEMPLATE |

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|Template Instructions: |

|This template is designed for greater than minimal risk medical studies. |

|Review the UCLA Consent Form Standards on the OHRPP website before using this template. |

|Delete this boxed information, all instructional text in blue and red, and any sections of the consent template that are not applicable to |

|your study. The font color of the finished consent document should be black. |

|All sections of this template are required unless they are labeled in red as an optional section. See the UCLA Consent Form Standards for |

|more details. |

UNIVERSITY OF CALIFORNIA LOS ANGELES

CONSENT TO PARTICIPATE IN RESEARCH

[Insert title of the study]

[Insert a lay or working title of the study – for study participants]

INTRODUCTION

[Insert name and degrees of the Principal Investigator], and associates from the [insert department affiliation] at the University of California, Los Angeles are conducting a research study. This study is being funded by [insert funding agency or sponsor name.]

KEY INFORMATION (required section):

The following is a short summary of this study to help you decide whether or not to be a part of this study. More detailed information is listed later on in this form.

WHY AM I BEING INVITED TO TAKE PART IN A RESEARCH STUDY?

We invite you to take part in a research study because _____________. [Fill in the circumstance or condition that makes participants eligible for the research.]

WHAT SHOULD I KNOW ABOUT A RESEARCH STUDY?

Someone will explain this research study to you.

Whether or not you take part is up to you.

You can choose not to take part.

You can agree to take part and later change your mind.

Your decision will not be held against you.

You can ask all the questions you want before you decide.

You can discuss this study with friends and family.

You can also discuss it with your health care doctor or request a second opinion.

WHY IS THIS RESEARCH BEING DONE?

[Tell the participant the purpose of the research. Explain the background of the research problem. Explain any potential benefits to others.]

How long will the research last and what will I need to do?

We expect that you will be in this research study for ________ [hours/days/months/weeks/years, until a certain event].

You will be asked to _________ [include a high level summary of the procedures that will be done.  For example: You will be given an investigational drug and asked to be asked to come for 3 study visits.  You will give a total of 3 blood samples and fill out questionnaires asking about how you feel.] More detailed information about the study procedures can be found under “WHAT WILL HAPPEN IF I TAKE PART IN THIS STUDY?”

WHAT KINDS OF RISKS OR DISCOMFORTS COULD I EXPECT?

[This beginning section of the consent form should identify the most important risks, e.g., emotional distress resulting from a series of questions in a social-behavioral research project or similar to the information that a physician might deliver in the clinical context in telling a patient how sick, e.g., the chemotherapy drugs will make them, but with a particular emphasis on how those risks are changed by participating in the study]

More detailed information about the risks of this study can be found under “WHAT KINDS OF RISKS OR DISCOMFORTS COULD I EXPECT? (Detailed Description)”

ARE THERE ANY BENEFITS IF I PARTICIPATE?

[This beginning section of the consent form should identify one or more likely benefits resulting from participation in the study; in doing so, you should not overemphasize the benefits. If you need to discuss benefits in additional detail, add an additional section later in the consent document]

[Include if there are benefits to participation. Otherwise delete.] We cannot promise any benefits to you or others from your taking part in this research. However, possible benefits include __________________. [First describe any direct benefits to the participant, then any benefits to others. If benefits from participation may not continue after the research has ended, describe them here. Monetary reimbursement for participation is not a benefit.]

[Include for a study with no benefits to participation. Otherwise delete.] There are no benefits to you from your taking part in this research. We cannot promise any benefits to others from your taking part in this research. However, possible benefits to others include __________________. [Note: Do not use statements indicating no direct benefit if participants will be billed for research-related procedures.]

[Describe any benefits to society or others.

Monetary reimbursement for participation is not a benefit.]

WHAT OTHER CHOICES DO I HAVE IF I DON’T WANT TO PARTICIPATE?

Participation in research is completely voluntary. You can decide to participate or not to participate.

[Include if there are alternatives other than participating.] Instead of being in this research study, your choices may include: [List alternatives procedures. For clinical trials describe the options that you would normally offer patient. If applicable, include supportive care as an option.]

[Include if there are no alternatives other than participating.] Your alternative to participating in this research study is to not participate.

Disclosure Statement (optional section)

Your health care provider may be an investigator of this research protocol, and as an investigator, is interested in both your clinical welfare and in the conduct of this study. You are not under any obligation to participate in any research project offered by your clinician.

HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY? (optional section)

XX people will take part in this study at UCLA. About XX people will participate in this study nationwide.

WHAT WILL HAPPEN IF I TAKE PART IN THIS STUDY?

Before you begin the study:

Before you begin the study, you will need to [Explain any exams, tests, procedures, etc. that are required for screening or determining eligibility.]

The following definitions may help you understand how this research study is designed: [define all study design elements, such as randomized and double-blind that apply to this study.]

During the study:

If you take part in this study, the researcher(s) will ask you to [Explain the procedures involved in the study, and provide an explanation of which procedures are considered investigational and why.

Explain how participation in the study differs from standard treatment (if applicable).

List procedures in the order they will occur using simple language and short paragraphs.

Use bullets and numbering where appropriate.

You may provide a visit schedule, a study chart, simple diagram, schedules or other visual aids to assist the participant with comprehension and decision-making.

Provide information whether clinically relevant results will be returned to participants or not – use language in the Consent Form Standards, as applicable to the research.]

WHAT KINDS OF RISKS OR DISCOMFORTS COULD I EXPECT? (Detailed Description)

Known risks and discomforts:

The possible risks and/or discomforts associated with the procedures described in this consent form include: [Categorize the risks by severity and the likelihood of the risk occurring. A bulleted list should be used. Be sure to consider all types of risks – psychological, social, economic, legal and physical - see sample risk language in the consent template instructions.]

Unknown risks and discomforts:

The experimental treatments may have side effects that no one knows about yet. The researchers will let you know if they learn anything that might make you change your mind about participating in the study.

CAN THE RESEARCHERS REMOVE ME FROM THIS STUDY? (optional section)

The researchers may end your participation in this study for a number of reasons, such as if your safety and welfare are at risk, if you do not follow instructions or if you miss scheduled visits. The researchers or the study sponsor might also decide to stop the study at any time.

If you decide to stop being in the study, or are removed from the study, or the study is stopped the researcher will ask you to [complete this sentence. For example, return for a final close-out visit or evaluation, return unused study medication, completes an exit telephone interview.]

HOW WILL INFORMATION ABOUT ME AND MY PARTICIPATION BE KEPT CONFIDENTIAL?

The researchers will do their best to make sure that your private information is kept confidential. Information about you will be handled as confidentially as possible, but participating in research may involve a loss of privacy and the potential for a breach in confidentiality. Study data will be physically and electronically secured. As with any use of electronic means to store data, there is a risk of breach of data security.

Use of personal information that can identify you:

[Explain how participant identifiers will be linked to the research data/records/specimens.]

How information about you will be stored:

[Describe how the data/records/specimens will be maintained.]

People and agencies that will have access to your information:

[Explain who will have access to the research data/records/specimens and how they will be shared.]

[UCLA standard language for routine access to data and records]

The research team, authorized UCLA personnel, the study sponsor (remove if not applicable), and regulatory agencies such as the Food and Drug Administration (FDA), may have access to study data and records to monitor the study. Research records provided to authorized, non-UCLA personnel will not contain identifiable information about you. Publications and/or presentations that result from this study will not identify you by name.

Employees of the University may have access to identifiable information as part of routine processing of your information, such as lab work or processing payment. However, University employees are bound by strict rules of confidentiality.

[If consent forms will be included in medical records] (optional section)

Because this study involves the treatment of a medical condition and/or medical procedures, a copy of this consent form will be placed in your medical record.  This will allow the doctors that are caring for you to obtain information about what medications and/or procedures you are receiving in the study and treat you appropriately.

How long information from the study will be kept:

[Explain how long the research data/records/specimens will be maintained.]

USE OF DATA AND SPECIMENS FOR FUTURE RESEARCH (required section)

[Please select one of the statements in the Consent Form Standards. The following statement is suggested for most studies]

My data and/or specimens, including de-identified data and/or specimens may be kept for use in future research.

ARE THERE ANY COSTS FOR TAKING PART IN THIS STUDY? (optional section)

[UCLA standard costs language - use one of the three statements in the Consent Form Standards, as applicable to the research.]

WILL I BE PAID FOR MY PARTICIPATION? (optional section)

[If participants will not be paid or reimbursed for out of pocket expenses, insert:] You will not be paid for your participation in this research study.]

You will be reimbursed for the following out of pocket expenses that you might have [complete this sentence, for example parking or transportation fees.] [If no reimbursement will be provided, delete the above statement and insert – You will not be reimbursed for any out of pocket expenses, such as parking or transportation fees.]

WHAT OTHER THINGS SHOULD I CONSIDER BEFORE PARTICIPATION?

(optional section unless specimens are collected and/or there are researcher financial interests)

Use of My Specimens:

[If the study involves collection of specimens, use of the statements in the Consent Form Standards document is required.]

Researcher or Institutional Financial Interests in this Study

[If a member of the study team has a personal financial interest in the outside entity funding the study or other personal financial interests in entities that might reasonably be affected by the research, a financial interests statement is required. Please see the Consent Form Standards Document or the following OHRPP guidance for suggested statements ]

Whole Genome Sequencing (optional)

[Please refer to language in the Consent Form Standards Document]

WHO CAN I CONTACT IF I HAVE QUESTIONS ABOUT THIS STUDY?

The Research Team:

You may contact [insert name(s)] at [insert phone number(s)] with any questions or concerns about the research or your participation in this study. You can also call the UCLA Page Operator at (310) 825-6301 to reach [insert name(s)] 24 hours a day, 7 days week.

UCLA Office of the Human Research Protection Program (OHRPP):

If you have questions about your rights while taking part in this study, or you have concerns or suggestions and you want to talk to someone other than the researchers about the study, you may contact the UCLA OHRPP by phone: (310) 206-2040; by email: participants@research.ucla.edu or U.S. mail: UCLA OHRPP, Box 951406, Los Angeles, CA 90095-1406.

[Required statement for “Applicable Clinical Trials” – see consent form standards for details]

Public Information about this Study:

is a website that provides information about federally and privately supported clinical trials. A description of this clinical trial will be available on , as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.

WHAT HAPPENS IF I BELIEVE I AM INJURED BECAUSE I TOOK PART IN THIS STUDY?

It is important that you promptly tell the researchers if you believe that you have been injured because of taking part in this study. You can tell the researcher in person or call him/her at the number(s) listed above.

If you are injured as a result of being in this study, UCLA will provide necessary medical treatment. The costs of the treatment may be covered by the University of California or the study sponsor [sponsor name], or billed to you or your insurer just like other medical costs, depending on a number of factors. The University and the study sponsor do not normally provide any other form of compensation for injury.  For more information about this, you may call the UCLA Office of the Human Research Protection Program at (310) 206-2040 or send an email to participants@research.ucla.edu.

WHAT ARE MY RIGHTS IF I TAKE PART IN THIS STUDY?

Taking part in this study is your choice. You can choose whether or not you want to participate. Whatever decision you make, there will be no penalty to you and you will not lose any of your regular benefits.

• You have a right to have all of your questions answered before deciding whether to take part.

• Your decision will not affect the medical care you receive from UCLA.

• If you decide to take part, you can leave the study at any time.

• If you decide to stop being in this study you should notify the research team right away. The researchers may ask you to complete some procedures in order to protect your safety.

• If you decide not to take part, you can still get medical care from UCLA.

HOW DO I INDICATE MY AGREEMENT TO PARTICIPATE?

If you want to participate in this study you should sign and date below. You have been given a copy of this consent form and the Research Participant’s Bill of Rights to keep. [If Protected Health Information as defined by HIPAA will be accessed, used, created, or disclosed, add the following statement: You will be asked to sign a separate form authorizing access, use, creation, or disclosure of health information about you.]

SIGNATURE OF THE PARTICIPANT

[Note: Additional signature lines may be required. See Consent Form Standards for details.]

______________________________________

Name of Participant

______________________________________ ______________________

Signature of Participant Date

SIGNATURE OF PERSON OBTAINING CONSENT

______________________________________ ______________________

Name of Person Obtaining Consent Contact Number

______________________________________ ______________________

Signature of Person Obtaining Consent Date

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