SAMPLE CONSENT FORM – ONE-TIME SURVEY

PLEASE NOTE: This form is a sample and requires editing for each specific study, particularly the statements in italics and the statements in brackets.

Some survey research qualifies for exempt certification. There are separate consent templates for exempt studies that you may choose to use.

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

CONSENT TO BE IN RESEARCH

Study Title: [Insert study title here]

This is a research study, and you do not have to take part. The researcher, … Ph.D., or … from the Department of … will explain this study to you. If you have any questions, you may ask the researcher.

You are being asked to take part in this study because you have [medical condition, or other reason, e.g., “…because you are a healthy volunteer”].

In this study, the researchers are doing a survey to learn more about … [Try to limit explanation to one or two sentences.] [Sponsor] is paying for this research. About [total accrual goal] people will participate in this study.

What will happen if I take part in this study?

If you agree to be in this study, you will complete a survey at [location]. The survey asks about … [list main topics]. It will take you about [length of time] to complete the survey.

Are there any risks to me or my privacy?

Some of the survey questions may make you feel uncomfortable or raise unpleasant memories. You are free to skip any question.

We will do our best to protect the information we collect from you. Information that identifies you will be kept secure. The survey itself will not include details that directly identify you, such as your name or address. Please do not put this information on your survey. The completed surveys will be kept secure and separate from information that identifies you. Only a small number of researchers will have direct access to completed surveys. If this study is published or presented at scientific meetings, names and other information that might identify you will not be used.

Authorized representatives from the following organizations may review your research data for the purpose of monitoring or managing the conduct of this study:

  Representatives of the Sponsor [list Sponsor name(s), as applicable]

  Representatives of the National Institutes of Health [remove if this is not an NIH-funded study]

  Representatives of the University of California

  Representatives of the Food and Drug Administration (FDA) [remove if this is not an FDA-regulated study]

  [List any other agencies – in or outside the U.S. – that might inspect research records]

Are there benefits?

There is no benefit to you. The survey results will be used for research.

Can I say “No”?

Yes, you do not have to complete a survey. If you choose not to be in this study you will not lose any of your regular benefits, and you can still receive medical care from UCSF.

Are there any payments or costs?

You will not be paid for completing the survey. There are no costs to you.

[If subjects will be paid, see the IRB website for more info on subject payment and sample consent form language.]

Who can answer my questions about the study?

You can talk with the study researcher about any questions, concerns, or complaints you have about this study. Contact the study researcher(s) ______[name(s)] at ______[telephone number(s)].

If you wish to ask questions about the study or your rights as a research participant to someone other than the researchers or if you wish to voice any problems or concerns you may have about the study, please call the office of the Institutional Review Board at 415-476-1814. [If there are additional informational sources related to the study (e.g., patient representatives or individuals at other study sites as appropriate), list here with contact information.]

CONSENT

PARTICIPATION IN RESEARCH IS VOLUNTARY.

You have been given copies of this consent form to keep.

[If Protected Health Information is involved] You will be asked to sign a separate form authorizing access, use, creation, or disclosure of health information about you.

If you wish to be in this study, please sign below.

Date Participant's Signature for Consent

Date Person Obtaining Consent

[Sample One-time Survey Consent] [May 2018] Page 3 of 3