Example Consent Language (Integrated into a Questionnaire)

Form Approved

OMB No. 0920-0910

Exp. Date 03/31/2018

National Tobacco Education Campaign

Pre-Focus Group Questionnaire and Informed Consent for
Creative Concept Testing

Public reporting burden of this collection of information is estimated to average 5 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-0910).

Consent to Participate in The Plowshare Group Research

Purpose

The Plowshare Group, on behalf of the Centers for Disease Control and Prevention (CDC), invites you to participate in an in-person focus group. The purpose of the study is to help CDC get reactions to creative concepts about health consequences related to cigarette smoking. These concepts will be used to develop future advertisements that raise awareness about the dangers of smoking and motivate smokers to quit. You will be asked to give your opinions on how information is presented. CDC has approved the information in this consent document and has given approval for the study investigator to do the study.

Procedures

If you agree to participate, you will take two short surveys, view potential creative concepts, and answer questions about the concepts in a group setting. The discussion will be audio-taped and we will use the tapes to prepare a report; however, your name will not be used in the reports about this study. Other people from CDC or The Plowshare Group will be observing the session, either in-person or via a secure, password protected site on the internet.

Study Duration

The total time spent in the focus group and filling out the surveys will be approximately 1 hour and 40 minutes.

Possible Risks or Discomforts

There are minimal psychological, social, or legal risks to participating in this study. You will be asked to share your thoughts and opinions in a focus group setting; however, the topic for discussion is not sensitive in nature. Your participation is voluntary, and you can choose not to answer any of the questions.

Benefits

There are no direct benefits to you for participating in this study. Your opinions will help CDC develop advertisements to raise awareness about the dangers of cigarette smoking and motivate smokers to quit.

Payment for Participation

You will receive $75 in cash for your participation in this study.

Confidentiality

Your name will not be connected to any of the answers you provide; therefore, no information that you provide during the study can be used to identify you. All notes and materials will be kept in a secure, locked location. No one outside of this project will have access to notes and materials created for this study. Anything discussed during the focus group will be private. The Plowshare Group and CDC will treat data in a secure manner and will not disclose unless otherwise compelled by law.

Future Contacts

We will not contact you in the future.

Your rights

Your participation is voluntary. Refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled. You can leave the discussion at any time, for any reason, without penalty or loss of benefits. You should notify or tell the study investigator if you want to stop being in the study. You will still receive $75 in cash for participating in the discussion.

Your questions

Please ask the research team to explain anything you do not understand. They will answer all the questions you have. You can ask questions about the study at any time. If you have additional questions about this study or wish to report a complaint about this study, please call Carol Haney, the principal investigator, at 802.258.0518 or by email [email protected].

Your signature below indicates that you have read the information provided above and agree to participate in this discussion. By agreeing to participate in this study, you are not giving up any of your legal rights. You will receive a copy of this consent form for your records.

Participant Name Date

Participant Signature Witness

Thank you for your participation.

Pre-Focus Group Questionnaire

On behalf of the Centers for Disease Control and Prevention (CDC), we're conducting a study about different health and smoking-related advertising and messages that you might see in the media, such as on TV or the internet. Your opinions are very important to us! Please fill out the following questions carefully and completely. Do not write your name on this survey.

Background Questions

DAGE1: What is your current age, in years?

___________________________ age in years

DEMO1. What is your gender?

1. Male

2. Female

3. Prefer not to answer

DEMO3. Ethnicity (SELECT ONE)

Please indicate your race or ethnic background. Are you….?

1. Hispanic or Latino

2. Not Hispanic or Latino

DEMO4. Race (SELECT ONE OR MORE)

1. White

1. Black or African American

2. American Indian or Alaska Native

3. Native Hawaiian or Other Pacific Islander

4. Asian

S1. What is the highest level of education you have completed or the highest degree you have received? If you received your education in another country, please indicate the equivalent level below.

1. Less than high school

2. Completed high school

3. Completed General Education Diploma (GED)

4. Job-specific training program(s) after high school

5. Some college, but no degree

6. Associate Degree

7. College (such as B.A., B.S.)

8. Some graduate school, but no degree

9. Graduate degree (such as MBA, MS, M.D., Ph.D.)

10. Prefer not to answer

S2. Which of the following income categories best describes your total 2015 household income before taxes?

1. Less than $15,000

2. $15,000 to $19,999

3. $20,000 to $24,999

4. $25,000 to $29,999

5. $30,000 to $34,999

6. $35,000 to $49,999

7. $50,000 to $74,999

8. $75,000 to $99,999

9. $100,000 or more

10. Prefer not to answer

S3. Which statement best describes your current employment status?

01 Working – as a paid employee

02 Working – self-employed

03 Not working – on temporary layoff from a job

04 Not working – looking for work

05 Not working – retired

06 Not working – disabled

07 Not working – other

08 Prefer not to answer

Cigarette Questions

The next questions are about traditional cigarettes, which are any form of tobacco wrapped in paper. Traditional cigarettes typically come in packs of 20 and some brand examples include Marlboro, Newport, Camel, Lucky Strike and Pall Mall.

TS1. Have you smoked at least 100 traditional cigarettes in your entire life?

1. Yes

2. No

3. Don’t know/not sure

4. Prefer not to answer

TS2. Do you now smoke traditional cigarettes every day, some days, or not at all?

1. I smoke every day

2. I smoke on some days

3. I do not smoke at all

TS3: On how many of the past 30 days did you smoke traditional cigarettes?

Enter number: _______

Don’t know/Not Sure

Prefer not to answer

E-Cigarette Questions

The next questions are about electronic vapor products. These are devices that usually contain a nicotine-based liquid that produces an aerosol that is inhaled. You may also know them as e-cigarettes, vape-pens, hookah-pens, electronic hookahs (e-hookahs), electronic cigars (e-cigars), electronic pipes (e-pipes), e-vaporizers, or tank systems. Some brand examples are Blu, NJOY, Vuse, MarkTen, and Starbuzz. For the rest of this survey we will call all of the products in this category e-cigarettes.

E1. Have you ever used an e-cigarette, even one time?

1. Yes

2. No

E2. Do you now use e-cigarettes…?

1. Every day

2. Some days

3. Not at all

E3. On how many of the past 30 days did you use an e-cigarette?

Enter number: _______

Don’t Know/Not Sure

Prefer not to answer

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