Virtual Focus Groups with Primary Care Physicians and OBGYNs

Request for Approval

OMB No. 0920-0840

Expiration Date: 10/31/2021

Virtual Focus Groups with Primary Care Physicians and OBGYNs:

Attitudes about Proposed Hepatitis C Screening Guidelines

DVH 2019

Attachment #4

Confidential Consent for Participation in a Focus Group

Public reporting burden of this collection of information is estimated to average 3 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 Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; Attn: OMB-PRA (0920-0840)

Consent Form for Participation in a Physician Focus Group

You have been asked to take part in a small group discussion, called a focus group, that is being conducted by KRC Research for the Centers for Disease Control and Prevention (CDC). Your participation in this research is voluntary. If you agree to participate, we ask you to read and sign this consent form. You may withdraw your consent to participate, for any reason, at any time.

Details about this study are discussed in the following sections. It is important that you make an informed choice about participating. You should ask the researchers named below any questions you have at any time.

Key Information

• Your consent is being sought to participate in a research study.

• Participation is voluntary.

• The research is to learn about physician practices and thinking about patient screening guidelines and recommendations for certain diseases.

• You will participate in a phone/web focus group that will last about 75 minutes, the session will be video and audio recorded.

• If any questions make you feel uncomfortable, you may choose not to answer.

• There is no direct benefit to you for participating in this research study.

• The results may help CDC learn more about the practices of physicians related to patient screening guidelines and recommendations and to help inform CDC’s educational and outreach efforts.

• The alternative to participating in this study is to not participate.

Purpose

These virtual focus groups are being conducted by KRC Research on behalf of the CDC to learn about physician practices and thinking about patient screening guidelines and recommendations for certain diseases. You will be asked about your screening opinions and practices. You do not need to disclose any information that you do not want to share. Qualifying physicians are being asked to participate in these focus groups because their feedback about patient screening guidelines and recommendations will help inform the CDC’s educational and outreach efforts.

Procedures

The focus group will take place virtually, over the phone and with a web component that allows for viewing other participants and documents. This focus group will meet only once and will last about 75 minutes. Around six to eight physicians from across the United States will participate virtually in this focus group. The discussion will be conducted in English. During the session we will address you with a first name that you provide to the moderator. We will not use your full name. At any time, you can choose to not answer a question.

The session will be video and audio recorded. Only project staff from KRC Research and CDC will have access to these recordings. They will be used to create a written transcript of the focus group. There will be no information in the transcript to identify you personally. The transcript will only be used for writing an accurate report about the focus group discussion. You must consent to the video and audio recordings, transcript, and note taking to participate.

Project staff from KRC Research and CDC may listen in on the focus group and take notes. They will not be joining the discussion, and they will not identify you by name in their notes. There will be no casual observers or persons unrelated to the project listening to the focus group.

Anticipated Benefits and Potential Risks

There are no foreseeable risks to participating in this study. However, if any questions make you uncomfortable, you may choose not to provide an answer. As with all research, there is a chance that confidentiality of the information you share could be breached, but we will take steps to minimize this risk, as discussed below.

There is no direct benefit to you for participating. However, the research is expected to help CDC learn more about the practices and preferences of physicians related to patient screening guidelines and recommendations and to help inform CDC’s educational and outreach efforts.

Costs and Payment for Participation

There is no cost to you to participate in this study except for the time you spend participating in the focus groups. You will be paid a $100 by check or gift card as a token of appreciation for your participation in the focus group.

Privacy and Confidentiality

The video and audio recordings and any written notes made by the focus group moderator or project staff will be used for analysis and reporting only. The recordings and transcript will be stored securely at KRC Research and made accessible only to authorized staff at KRC Research, the managerial staff of the CDC Division of Viral Hepatitis, and transcribers. The recordings and transcript will not be made public or used for any advertising or commercial purposes. Identities of individual focus group participants will not be included in the transcript.

KRC Research will report summarized results from the whole group with excerpts (quotes) from individuals not identified by name, so your identity will not be known to report readers. We will not disclose any information that can be used to identify you, or connect your name to information presented in reports or papers. The audio and video recordings will be destroyed after the transcript has been completed and the project report approved by the CDC.

In most cases, only the CDC and research staff involved in this opinion research project will have access to the research records, the focus group video and audio recordings, and the transcript with what participants in the group said. Although rare, regulatory authorities and the Institutional Review Board have authority to view research records if necessary.

Participation and Withdrawal

You are free to withdraw from or leave the study at any time, for any reason. If you decide not to take part, there will be no penalty or loss of benefits to which you are otherwise entitled. If you do not take part in the focus group, you will not receive the $100 token of appreciation.

Identification of Investigators

If you have any questions or concerns about this research, feel you may have been harmed by participating, or would like to offer input, you may call the KRC Research Principal Investigator Mark Richards, PhD at (202) 230-8767 or send a message to mrichards@krcresearch.com.

If you would like to speak to someone other than the study staff about your rights as a research participant, you can contact the IRB Ethical & Independent Review Services (E&I) at subject@eandireview.com. Reference E&I study 19123.

________________________________________________________________

I have read all of the information about my involvement in the study and agree to participate in this focus group which will be audio/video recorded.

________________________________________

Print Name

________________________________________ _____________________________

Signature Date

Please email [email address] or fax [fax number] your signed consent form to [name], the Reckner study coordinator. If you need assistance, please call [phone number and extension]. Please keep a copy of this form for your records.

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