OMB Justification Memo

FDA DOCUMENTATION FOR THE GENERAL CLEARANCE

OF PRETESTING COMMUNICATIONS ON TOBACCO PRODUCTS

(0910-0674)

TITLE OF INFORMATION COLLECTION: Focus Group Study of Youth Reactions to Creative Advertising Concepts Designed to Reduce Tobacco Use among General Market Youth; OMB Control Number 0910-0674.

DESCRIPTION OF THIS SPECIFIC COLLECTION

1. Statement of need:

The Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) is seeking OMB approval under generic clearance OMB No. 0910-0674 to conduct focus groups with youth aged 12–17 who have experimented with cigarettes (i.e., have reported smoking fewer than 100 cigarettes in lifetime) and youth aged 12-17 who are at risk of initiating (e.g., would smoke if a friend offered them a cigarette). The purpose of these focus groups is to assess participants’ perceptions about advertising concepts designed to reduce youth tobacco use.

2. Intended use of information:

The study is designed to evaluate emotional and cognitive reactions to creative advertising concepts or strategic concepts designed to reduce tobacco use. Information obtained during focus group discussions will be used to inform the development of FDA’s second round of advertisements for its General Market At-Risk Youth Tobacco Prevention Campaign (“The Real Cost”) intended to reduce cigarette smoking among youth aged 12–17, with a focus on those who have experimented with cigarettes or are at risk of initiating. Specifically, the results will help identify the most promising creative and strategic concepts as well as indicate areas for further refinement to guide creation of effective advertisements.

3. Description of respondents:

The study will consist of twenty-four (24) focus groups, each with approximately six (6) youth aged 12–17 who report having smoked fewer than 100 cigarettes in their lifetime (“experimenters”) or indicate they have never smoked but are open to trying cigarettes in the future (“at-risk non-trier”). Groups will be segmented by age, gender, and self-reported tobacco use. This information will be gathered during the screening process. Groups will be otherwise diverse by race/ethnicity. Approximately twelve (12) groups will include experimenters and twelve (12) groups will include at-risk non-triers. For each group, eight (8) youth will be recruited in order to obtain the desired number of participants.

4. Date(s) to be conducted:

The focus groups are projected to begin on April 3, 2014 and be completed by the week of April 24, 2014.¹ The focus groups will be conducted in facilities located in geographically diverse markets where there are above average youth tobacco use rates.

5. How the information is being collected:

The information will be collected through twenty four (24) in-person focus groups led by a professional moderator with experience leading focus groups with youth. The moderator will expose each group to up to six (6) creative concepts or six (6) strategic concepts and ask a series of questions using a semi-structured discussion guide to encourage participants’ feedback around understanding, relevance, impact and motivation of the shared concepts and strategic concepts. The moderator will encourage participants to respond openly and spontaneously, and will audiotape participants’ answers and reactions to questions if all participants provide consent before discussions begin. The focus groups will also be observed by FDA and campaign contractor staff.

6. Confidentiality of respondents:

All data will be collected with an assurance that the respondents’ responses will remain private to the extent allowable by law.

Before each group begins, the moderator will obtain verbal consent from the participants to audiotape the session. In the event consent is not given, the contractor will refrain from audiotaping the session.

The contractor will also produce transcriptions of the tapes to assist in report writing and to provide the FDA with a written record of the sessions. One paper and one electronic copy of the transcripts will be supplied. The audiotape and transcript for a given group will be available to the FDA within two weeks of the completion of that data collection. To ensure participant privacy, the contractor will redact the recordings and transcripts.

All data will be collected with an assurance that the respondents’ discussions will remain private to the extent provided by law. The moderator’s guide and consent form will contain a statement that no one will be able to link a respondent’s identity to his/her responses. Identifying information will not be included in the data files delivered by contractors to the agency.

Neither independent contractors nor focus group agencies will share personal information regarding participants with any third party without the participant’s permission unless it is required by law to protect their rights or to comply with judicial proceedings, a court order, or other legal process. Identifying information will not be included in the transcripts and digital recordings delivered to the agency. Upon final delivery to the FDA, transcripts and digital recordings will be destroyed. All data received by the FDA will remain in a secured area. No data will contain identifying information.

7. Amount and justification for any proposed incentive:

The amount of the incentive as a token of appreciation is a $50 gift card.

As participants often have competing demands for their time, incentives are used to encourage participation in research. The use of incentives treats participants justly and with respect by recognizing, and acknowledging the effort they expend to participate. In this particular research we are asking respondents to provide thought-intensive open-ended feedback on concepts that require a high level of participation. When applied in a reasonable manner, incentives are not an unjust inducement and are an approach that acknowledges respondents for their participation.²

Incentives must be high enough to equalize the burden placed on respondents with respect to their time and cost of participation,³ as well as provide enough motivation for them to participate in the study rather than another activity. If the incentive is not adequate, participants may agree to participate and then not show up or drop out early. Low participation may result in inadequate data collection or, in the worst cases, loss of government funds associated with facility rental and moderator and observer time.⁴

Additionally, this can cause a difficult and lengthy recruitment process that, in turn, can cause delays in launching the research both of which lead to increased costs. Incentives are also necessary to ensure adequate representation among harder-to-recruit populations such as youth, low socio-economic groups and high-risk populations (current or former tobacco users and those susceptible to tobacco use).⁵

In the context of this study, the target population is considered a harder-to-recruit population on multiple accounts (youth aged 12–17 who are also at-risk of or currently experimenting with tobacco use). The study also requires respondents to comment on an activity that is a sensitive subject matter and could cause them to be reluctant to participate. Thus, it is critical to provide adequate incentives to encourage and retain participation among the limited number of potential youth respondents.

8. Questions of a sensitive nature:

Some studies require the inclusion of people who match selected characteristics of the target audience that the FDA is trying to reach. This may require asking questions about race/ethnicity, income, education, health behaviors and/or health status on the initial screening questionnaire used for recruiting. Potential participants are informed that this is being done to make sure that the FDA speaks with the kinds of people for whom its messages are intended. Respondents are assured that the information is voluntary and will be treated as private to the extent allowable by law. All information on race/ethnicity will fully comply with the standards of OMB Statistical Policy Directive No. 15, October 1997 (http://www.whitehouse.gov/omb/fedreg/1997standards.html).

FDA tobacco use communications may be concerned with the prevention of premature mortality from heart disease and oral and respiratory cancers, and some projects may involve asking questions about (or discussing) how one perceives his/her own personal risk for serious illness. This information is needed to gain a better understanding of the target audience so that the messages, strategies and materials designed will be appropriate and sensitive. Questions of this nature, while not as personal as those about sexual behavior or religious beliefs, for instance, still require some sensitivity in how they are worded and approached. In face-to-face data collections, questions of this kind are generally asked later in the interview or group discussion, when respondents are more comfortable with the interview situation and are more at ease with the interviewer/moderator. Participants are informed prior to actual participation about the nature of the activity and the voluntary nature of their participation. The interviewer/moderator makes it clear that they do not have to respond to any question that makes them uncomfortable.

FDA tobacco communications may also be concerned with discouraging tobacco use by youth before they start. The FDA acknowledges the sensitivity of questions about the purchase and use of tobacco, which is illegal for minors in most states. Because questions are being asked of youth aged 12–17, interviews will be conducted by moderators specifically trained for interactions with youth.

Raw data from data collections that include sensitive information (e.g., screening questionnaires and audiotapes) are not retained once the data have been extracted and aggregated. The information never becomes part of a system of records containing permanent identifiers that can be used for retrieval.

9. Description of statistical methods:

This research relies on qualitative methods and is not intended to yield results that are statistically projectable. Participants will be identified using standard telephone recruitment procedures that employ screening questions about age; current, past and intended tobacco use; race and ethnicity; and gender. Recruitment will continue until a representative sample of the required number of participants for each group is obtained.

BURDEN HOUR COMPUTATION Number of respondents (X) estimated response or participation time in minutes (/60) = annual burden hours:

Type/Category of Respondent	No. of Respondents	Participation Time for Screening (5 minutes) and Focus Group (90 minutes)	Burden (hours)
(Aged: 12–14) Experimenter	4 groups of 6 = 24	95	38
(Aged: 15–17) Experimenter	8 groups of 6 = 48	95	76
(Aged: 12–14) At-Risk Non-Trier	8 groups of 6 = 48	95	76
(Aged: 15–17) At-Risk Non-Trier	4 groups of 6 = 24	95	38
Total	144	95	228

REQUESTED APPROVAL DATE: Thursday, April 10, 2014

NAME OF PRA ANALYST & PROGRAM CONTACT:

PRA Analyst Jonna Capezzuto

301-796-3794

Jonnalynn.Capezzuto@fda.hhs.gov

Program Contact Tesfa Alexander

301-796-9335

Tesfa.Alexander@fda.hhs.gov

FDA CENTER: Center for Tobacco Products (FDA/CTP)

1 Pending approval dates and recruitment time.

2 Halpern, SD., Karlawish, JH., Casarett, D., Berlin, JA., Asch, DA. Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials. Archives of Internal Medicine. 2004; 164(7), 80l-803.

3 Russell, ML., Moralejo, DG., Burgess, ED. Paying research subjects: Participants’ perspectives. Journal of Medical Ethics. 2000;26(2), 126-130.

4 Morgan, DL, Scannell, AU..Planning Focus Groups. Thousand Oaks, CA: Sage, 1998.

5 Groth, SW. Honorarium or coercion: use of incentives for participants in clinical research. Journal of the New York State Nurses Association. 2010.

4