Fast Track Submission Form

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB#: 0925-0648 Exp Date: 3/31/2018)

T ITLE OF INFORMATION COLLECTION:

Educational Game Focus Group

PURPOSE:

Obtain feedback from children in grades 4–6, parents, teachers, and pediatric clinical trials professionals about the general concept and proposed format of an educational game designed to increase awareness of, knowledge about, empathy for, and acceptance of pediatric clinical research among elementary-school-age children.

DESCRIPTION OF RESPONDENTS:

We are targeting four audiences:

1. Children in grades 4–6

2. Parents of children in grades 4–6

3. Elementary school teachers

4. Professionals involved in pediatric clinical trials.

TYPE OF COLLECTION: (Check one)

[ ] Customer Comment Card/Complaint Form [ ] Customer Satisfaction Survey

[ ] Usability Testing (e.g., Website or Software [ ] Small Discussion Group

[X] Focus Group [ ] Other: ______________________

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

4. The results are not intended to be disseminated to the public.

5. Information gathered will not be used for the purpose of substantially informing influential policy decisions.

6. The collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the future.

Name:________________________________________________

To assist review, please provide answers to the following question:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [X] Yes [ ] No

2. If Yes, is the information that will be collected included in records that are subject to the Privacy Act of 1974? [X] Yes [ ] No

3. If Applicable, has a System or Records Notice been published? [ ] Yes [X] No

Contact information for each focus group participant will be collected for scheduling purposes only. All contact data will be destroyed at the conclusion of the study.

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [X] Yes [ ] No

1. Each parent/child pair will receive a $25 gift card for their time and effort.

2. Each teacher will receive a $25 gift card for their time and effort.

3. Each professional involved in pediatric clinical trials will receive a $50 gift card.

Use of a $25 incentive is recommended for the parent-child pairs and teacher focus groups. Most potential respondents are likely to have minimal awareness of the topic, so the incentive is necessary to arouse interest and attention. Furthermore, because teachers and parents have numerous demands on their time, taking time out of their schedule for a focus group is likely to be a low priority unless there is some incentive involved. Of particular concern is that without an incentive, respondents with less interest in science and computer games will not take the time to participate. Yet, the opinions of these individuals are important to ensuring that that Edugame is developed with children with varied interests in mind. The $25 will partially offset the cost of participation for parents picking up their children after school and for teachers who may normally use the time to grade class assignments and prepare for classroom activities. An incentive level of $25 has been shown to be effective in increasing response rates.¹

The $50 incentive for CT professionals is necessary due to the fact that medical researchers and professionals are extremely busy and notoriously hard to recruit. NOVA has conducted several online usability tests (with similar time requirements and process as these focus groups) with health professionals and scientists and used a similar incentive to obtain sufficient numbers of participants. [OMB Control Number: 0925-0642-18, Expiration Date 9/30/2014; Cancer Imaging Program (CIP) Web Site Usability Testing] The study would likely have taken much longer or not enrolled sufficient participants had we not used incentives. Participation of CT professionals in this study is critical. Given we are asking them for up to one hour of their time, we believe the $50 incentive is necessary to facilitate recruitment. While the subject of clinical trials is one that they are very familiar with, the online focus group is likely to be held during non-business hours and thus the $50 will offset costs for participation in a group that is typically well-compensated and would likely not participate for just $25.

ESTIMATED BURDEN HOURS and COSTS

	No. of Respondents
Category of Respondent	Who Participate	Who do not Participate	No. of Responses per Respondent	Time per Response (in hours)	Total Burden Hours
Potential Respondents: CT Professionals / Teachers / Parents (screen)	24	24	1	5/60	4
CT Professionals / Teachers / Parents (focus group/consent)			1	55/60	22
Children (focus group/assent)	8		1	35/60	5
Totals	32	24			32

Category of Respondent	Total Burden Hours	Wage Rate*	Total Burden Cost
2CT Professionals	9	$46.98	$383.31
3Teachers	9	$28.89	$260.01
4Parents	9	$34.19	$307.71
Children	5	$ 0.00	$ 0.00
Totals	32		$951.12

FEDERAL COST: The estimated annual cost to the Federal government is $9,520.

Staff	Grade/Step	Salary	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Ellen Rosenberg	14/5	$119,238	1		$1,192
Tara Knox	12/5	$82,359	1		$823
Contractor Cost
Staff Avg.		$150,092*	5	Included	$7,505
Travel
Other Cost

*Loaded salary (including fringe)

² Median hourly wage for Medical and Health Services Managers in Maryland is $46.98. http://www.onetonline.org/link/details/11-9111.00

³ Median annual wage for Elementary School teachers in Maryland is $60,100. http://www.onetonline.org/link/summary/25-2021.00

⁴ Maryland average income per capita is $71,122 or $34.19/hour. http://msa.maryland.gov/msa/mdmanual/01glance/economy/html/income.html

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents

1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe? [ ] Yes [X] No

If the answer is yes, please provide a description of both below (or attach the sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

• We will approach local elementary schools to recruit children in grades 4–6 and their parents for the focus groups. We will screen to identify diversity with respect to the child’s gender, race/ethnicity, and grade in school.

• We will approach local elementary schools to recruit teachers for the focus group. We will screen on the basis of relevant experience with children in grades 4–6.

• Purposive sampling will be employed to identify specific pediatric clinical trial professionals who will be invited to participate in a webinar focus group. These are professionals who have experience working with children in grades 4–6, and their opinions and feedback are relevant to the game's purpose.

Administration of the Instrument

1. How will you collect the information? (Check all that apply)

[X] Web-based or other forms of Social Media

[ ] Telephone

[X] In-person

[ ] Mail

[ ] Other, Explain

2. Will interviewers or facilitators be used? [X] Yes [ ] No

1 Goritz, AS. Incentives in web surveys: Methodological issues and a review. International Journal of Internet Science, 2006, 1(1), 58-70.

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