Focus Group Invitation Letter

OMB No.: 0925-0642

Expiration Date: 9/30/2014

ATTACHMENT 2: Educational Game Focus Group Recruitment Letters

Letter 1: Parents of Children in Grades 4–6 to recruit children and parents (via hard copy letter)

SUBJECT LINE: PARENTS AND CHILDREN NEEDED FOR FOCUS GROUPS TO DISCUSS A NEW EDUCATIONAL GAME, INCENTIVE PROVIDED

Dear Parent:

NOVA Research Company, under funding provided by the National Heart, Lung, and Blood Institute, is developing an educational game designed to teach elementary-school-aged children about pediatric clinical research. We are inviting children in grades 4–6 and a parent or guardian to review an educational game designed to increase awareness of, knowledge about, empathy for, and acceptance of pediatric clinical research among elementary-school-age children. We would like to ask you to participate in a focus group to talk about the game and help ensure that it achieves these objectives.

During the focus group session, we will describe the game and focus group participants will look at paper mockups of the game and give us feedback. Parents will observe the children’s focus group, which is expected to take approximately 20–30 minutes. After the children’s focus group ends, parents will be asked to discuss what they observed and provide feedback. This parent-only portion of the focus group is expected to take approximately 10–15 minutes to complete, during which time the children will be provided with some learning activities and/or materials.

The focus group will take place at [your child’s school] between [X and Y p.m.] during the week of [date].

Should you choose to participate and are selected, you will receive a $25 gift card as a token of our appreciation for your participation time.

Your participation is voluntary. We will not share information about you with anyone outside of this study.

If you are interested in participating, please let us know as soon as possible by contacting Kathy Sedgwick at 240-752-7265. We are limiting participation to 6–8 parent/child pairs. When you contact us, we will confirm space availability in the focus group; provide details about the focus group location, date, and time; and answer your questions.

Thank you for your time, and again, we would appreciate hearing from you as soon as possible.

Sincerely,

[Contact name/Project Officer/Lead investigator]

[Contact signature/contact info]

Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of study participants are protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing from the study at any time. Refusal to participate will not affect your benefits in any way. The information collected in this study will be kept private under the Privacy Act. Names and other identifiers will not appear in any report of the study. Information provided will be combined for all study participants and reported as summaries. You are being contacted by telephone to complete this instrument so that we can determine whether you qualify to participate in a website usability study.

Public reporting burden for this collection of information is estimated to average 45 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: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0642). Do not return the completed form to this address.

Letter 2: Targeting Elementary School Teachers (via hard copy letter)

SUBJECT: ELEMENTARY SCHOOL TEACHERS NEEDED FOR Focus Groups to Discuss a New EDUCATIONAL Game, INCENTIVE PROVIDED

Dear Teacher:

NOVA Research Company, under funding provided by the National Heart, Lung, and Blood Institute, is developing an educational game designed to teach elementary-school-aged children about pediatric clinical research. We are inviting children in grades 4–6, parents, and teachers to review an educational game designed to increase awareness of, knowledge about, empathy for, and acceptance of pediatric clinical research among elementary-school-age children. We would like to ask you to participate in a focus group to talk about the game and help ensure that it achieves these objectives.

During the focus group session, we will describe the game and focus group participants will look at paper mockups of the game and give us feedback. Parents and teachers will observe the children’s focus group, which is expected to take approximately 20–30 minutes. After the children’s focus group ends, parents and teachers will break into two groups to discuss what they observed and provide feedback. This teacher-only portion of the focus group is expected to take 1approximately 0–15 minutes to complete.

The focus group will take place at [your school] between [X and Y p.m.] during the week of [date].

Should you choose to participate and are selected, you will receive a $25 gift card as a token of our appreciation for your participation time.

Your participation is voluntary. We will not share information about you with anyone outside of this study.

If you are interested in participating, please let us know as soon as possible by contacting Kathy Sedgwick at 240-752-7265. We are limiting participation to 6–8 elementary school teachers. When you contact us, we will confirm space availability in the focus group; provide details about the focus group location, date, and time; and answer your questions.

Thank you for your time, and again, we would appreciate hearing from you as soon as possible.

Sincerely,

[Contact name/Project Officer/Lead investigator]

[Contact signature/contact info]

Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of study participants are protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing from the study at any time. Refusal to participate will not affect your benefits in any way. The information collected in this study will be kept private under the Privacy Act. Names and other identifiers will not appear in any report of the study. Information provided will be combined for all study participants and reported as summaries. You are being contacted by telephone to complete this instrument so that we can determine whether you qualify to participate in a website usability study.

Public reporting burden for this collection of information is estimated to average 45 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: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0642). Do not return the completed form to this address.

Letter 3: Targeting Pediatric Clinical Trial PIs and Staff (via email)

SUBJECT LINE: PEDIATRIC CLINICAL TRIALS PROFESSIONALS NEEDED FOR FOCUS GROUP TO DISCUSS A NEW EDUCATIONAL GAME, INCENTIVE PROVIDED

Good Morning/Afternoon, [Contact name/title]:

NOVA Research Company is conducting a research study for the National Heart, Lung, and Blood Institute (NHLBI). We are inviting clinical trials professionals to review an educational game designed to increase awareness of, knowledge about, empathy for, and acceptance of pediatric clinical research among elementary-school-age children. We would like to ask you to participate in a focus group to talk about the game and help ensure that it achieves these objectives.

If you agree, you will view paper mockups of the game and give us feedback. This focus group session is expected to take approximately 30–45 minutes to complete.

The focus group will take place via a live webinar from [X to Y p.m.] on [date].

Should you choose to participate and are selected, you will receive a $50 gift card as a token of our appreciation for your participation time.

Your participation is voluntary. We will not share information about you with anyone outside of this study.

Please let us know if you would be interested in participating by contacting Kathy Sedgwick at 240-752-7265. We are limiting participation to 6–8 pediatric clinical trials professionals. When you contact us, we will confirm space availability in the focus group; provide details about accessing the focus group webinar; and answer your questions.

Thank you for your time, and we would appreciate hearing from you as soon as possible.

Sincerely,

[Contact name/Project Officer/Lead investigator]

[Contact signature/contact info]

Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of study participants are protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing from the study at any time. Refusal to participate will not affect your benefits in any way. The information collected in this study will be kept private under the Privacy Act. Names and other identifiers will not appear in any report of the study. Information provided will be combined for all study participants and reported as summaries. You are being contacted by telephone to complete this instrument so that we can determine whether you qualify to participate in a website usability study.

Public reporting burden for this collection of information is estimated to average 45 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: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0642). Do not return the completed form to this address.

NOVA Research Company, January 27, 2015 Page 3 of 3