UNIVERSITY OF CALIFORNIA IRVINE



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INFORMED CONSENT

Title of Study--required

Headings with (*) are required for all studies

Participation in this research study is completely voluntary. Please read the information below and ask questions about anything that you do not understand before deciding if you want to participate. A researcher listed below will be available to answer your questions.

RESEARCH TEAM AND SPONSORS*

Name and title of Lead Researcher:      

Department/Room Number:

Telephone Number:

Email:

Other Researchers:

(Only list those researchers qualified to be involved in the informed consent process)

Name and Title of Researcher:      

Department/Room Number:      

Telephone Number:

Email:

Study Location(s):      

PURPOSE OF STUDY*

The purpose of this research study is to…(complete this sentence) Example: “to explore attitudes of first-generation Americans regarding education.”

SUBJECTS*

Inclusion Requirements

You are eligible to participate in this study if you…(complete this sentence or use a bulleted list of inclusion criteria) Examples include, “are at least 18 years of age or older,” “have been clinically diagnosed with depression.”

Exclusion Requirements

You are not eligible to participate in this study if you...(complete this sentence or use a bulleted list of exclusion criteria) Examples include, “are at least 18 years of age or older,” “are taking high blood pressure medications”

Number of Participants

This study will include approximately       subjects and will involve approximately       of your time over the next       days/weeks/months.

PROCEDURES*

The following procedures will occur: (Explain the research procedures in chronological order; include the expected duration of each procedure(s) to be completed at the visit. You may provide a visit schedule to assist the participant.)

Total Time Commitment

You will be involved in this study...(complete this sentence)

RISKS AND DISCOMFORTS*

The possible risks and/or discomforts associated with the procedures described in this study include: (Complete this sentence. Categorize the risks by severity and include the probability of the risk occurring. A bulleted list may be used. Make sure to consider all risks – psychological, social, economic, legal and physical.) Examples of risks include: embarrassment, social stigma (shame or disgrace), psychological distress, loss of employment, invasion of privacy and breaches of confidentiality).

BENEFITS*

Benefits to the Participant

The possible benefits you may experience from the procedures described in this study include…(Complete this sentence) Example: a better attention span.

[If no direct benefit to the subject is anticipated, delete the above statement and insert – You will not directly benefit from participation in this study.]

Benefits to Others or Society

[Insert a statement about possible benefits to science or society here. Example: a decrease in the number of children injured in car accidents.]

ALTERNATIVES TO PARTICIPATION*

If you decide not to participate, or if you withdraw from this study before it is completed, the following alternative procedures…………

[If there are no alternative procedures, delete the above statement and insert - The alternative to the procedures in this study is not participate in this study.]

COMPENSATION, COSTS AND REIMBURSEMENT*

Compensation for Participation

You will be paid $ [enter type of payment and amount of compensation] after each study visit. There are [enter # of study visits if applicable] visits. Total payment for participation in this study is $[enter total compensation for completion of the study]. If you decide to withdraw from the study or are withdrawn by the research team, you will receive compensation for the visits that you have completed.

[If subjects will not be compensated, please insert - You will not be paid for your participation in this research study.]

OR

You will receive course credit for an eligible course through ………

WITHDRAWAL OR TERMINATION FROM THE STUDY AND CONSEQUENCES*

[Required if subjects may be terminated by researcher and/or if there are adverse consequences (physical, social, psychological, economic, or legal) of the subject’s withdrawal from the study]

You are free to withdraw from this study at any time. If you decide to withdraw from this study you should notify the research team immediately. The research team may end your participation in this study if you do not follow instructions, miss scheduled visits, your safety and welfare are at risk, or the study sponsor decides to stop the study.

CONFIDENTIALITY*

Data Storage

Your research records will be stored in the following manner: (Complete this sentence. Also, specify the level of privacy afforded to subject data. Examples include:

• All identifiable information about you will be removed, with only a code to identify you. The code that links your name to the data will be kept separate from the study data.

• Data will be recorded anonymously, which means no one, including the research team, can identify you from the study data.

• Identifiable information about you will be kept with the study data.

This information will be protected and kept confidential in the following manner: (Complete this sentence.) Examples include:

• All study data will be kept under lock and key and only authorized research team members will have access to it.

• All data stored electronically will be stored on a secure network server, or on portable devices, such as a laptop with encryption (special software) and password protection.

Other privacy options:

• The [audio/video recordings] will be transcribed and maintained for ____ and then erased.

• The [audio/video recordings] will be transcribed and the tapes will be erased at the end of the study.

• The research data will be maintained by a repository indefinitely. Other researchers will have access to the data for future research.

The researchers plan to maintain your identifiable research data (Complete this sentence.) Examples include: until all data has been collected, until the research is published, indefinitely, for approximately __ years.

NEW FINDINGS

If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the researcher team listed at the top of the form.

IF YOU HAVE QUESTIONS*

If you have any comments, concerns, or questions regarding the conduct of this research, please contact the research team listed at the top of this form.

If you are unable to reach a member of the research team listed at the top of the form and have general questions, or you have concerns or complaints about the research study, research team, or questions about your rights as a research subject, please contact The Research Foundation of SUNY/Office of Sponsored Programs by phone, (716) 878-6700 or by e-mail at gameg@rf.buffalostate.edu or in person at Bishop Hall, Room 17, 1300 Elmwood Avenue, Buffalo, NY 14222.

VOLUNTARY PARTICIPATION STATEMENT*

Participation in this study is voluntary. You may refuse to answer any question or discontinue your involvement at any time without penalty or loss of benefits to which you might otherwise be entitled. Your decision will not affect your future relationship with Buffalo State. Your signature below indicates that you have read the information in this consent form and have had a chance to ask any questions that you have about the study.

SIGNATURE LINES*

___________________________________________________ __________________

Subject Signature* Date

___________________________________________________ __________________

Legally Authorized Representative/Guardian Date

___________________________________________________ __________________

Legally Authorized Representative/Guardian Date

___________________________________________________ __________________

Researcher Signature* Date

___________________________________________________ __________________

Witness Signature Date

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