Minimal Risk Consent Form - Research Administration



Delete 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. See the UCLA Consent Form Standards for more details

University of California, Los Angeles

CONSENT TO PARTICIPATE IN RESEARCH

[Insert title of the study.]

INTRODUCTION

[Insert name and degrees of the Principal Investigator and Faculty Sponsor as appropriate], 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.] You were selected as a possible participant in this study because [explain why the potential participant is eligible to participate]. Your participation in this research study is voluntary.

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.

WHY IS THIS RESEARCH BEING DONE?

[Describe in a few sentences what the study is designed to assess or establish. Use language that will be easily understood by participants. Avoid jargon/technical terms.]

HOW LONG WILL THE RESEARCH LAST AND WHAT WILL I NEED TO DO?

Participation will take a total of about [specify time and duration]. [When appropriate, state that the study will involve long-term follow-up/specify time frames.]

If you volunteer to participate in this study, the researcher will ask you to do the following:

• [List and describe the procedures/tests/activities and their frequency chronologically using simple language, short sentences and short paragraphs.]

• [Use bullets or number the paragraphs as appropriate.]

• [Describe types of questions in questionnaires/surveys or interviews.]

• [Specify the location of study activities.]

• [If the study will include experimental or non-experimental procedures, please specify which procedures are experimental.]

ARE THERE ANY RISKS IF I PARTICIPATE?

• [List and describe any reasonable foreseeable risks, discomforts, inconveniences, and how these will be managed.]

• [If there are significant psychological risks that might cause the researcher to end the participant’s participation in the study, please describe them.]

• [If there are no anticipated risks or discomforts, please state, “There are no anticipated risks or discomforts.”]

ARE THERE ANY BENEFITS IF I PARTICIPATE?

You may benefit from the study …[Describe benefits to participants expected from the research. If the participants will not directly benefit from participation, please state, "You will not directly benefit from your participation in the research."]

The results of the research may …[Describe the potential benefits to science or society expected from the research.]

What other choices do I have if I choose not to participate?

IMPORTANT NOTE: This section is required ONLY for research that:

• includes treatment (e.g., behavioral therapy) and/or

• recruits participants from student subject pools.

IF RESEARCH INCLUDES TREATMENT: Please describe any appropriate alternative therapeutic, diagnostic, or preventive procedures that should be considered before the subjects decide whether or not to participate in the study. If applicable, explain why these procedures are being withheld. If there are no efficacious alternatives, state that an alternative is not to participate in the study.

IF RESEARCH RECRUITS PARTICIPANTS FROM STUDENT SUBJECT POOLS: Describe the alternatives to participating in the research study (e.g., to write a paper or participate in another research study to receive course credit). This section should reflect the alternatives that were approved by the UCLA IRB as part of the IRB protocol for the subject pool(s). Please contact the persons responsible for administration of the subject pool(s) if you have any questions about the approved alternatives.

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

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 subject 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, and the study sponsor (remove if not applicable), 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.

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 following statements]

Your data and/or specimens, including de-identified data and/or specimens may be kept for use in future research.(Preferred for most research studies)

No data and/or specimens collected during this study, including de-identified data and/or specimens will be shared for future research. (This should be used in rare circumstances)

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

[If participants will not be paid, insert:] You will not be paid for your participation in this research study.

[If participants will be paid or reimbursed for out of pocket expenses, insert:] You will receive … [describe amount of payment and how and when payment will be received. If research recruits participants from student subject pools, specify the course credit.]

WHAT OTHER THINGS SHOULD I CONSIDER BEFORE PARTICIPATION?

(optional section unless specimens collected are and/or there are researcher financial interests – refer to Consent Form Standards document for language.]

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

The research team:

If you have any questions, comments or concerns about the research, you can talk to the one of the researchers. Please contact: [add the name of the PI and faculty sponsor as appropriate] at [phone number(s)—add postal and/or email address if appropriate].

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

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

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

• You can choose whether or not you want to be in this study, and you may withdraw your consent and discontinue participation at any time.

• Whatever decision you make, there will be no penalty to you, and no loss of benefits to which you were otherwise entitled.

• You may refuse to answer any questions that you do not want to answer and still remain in the study.

You will be given a copy of this information to keep for your records.

HOW DO I INDICATE MY AGREEMENT TO PARTICIPATE?

If you want to participate in this study you should sign and date below.

SIGNATURE OF THE PARTICIPANT

______________________________________

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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