0920-0572 HMTS Evaluation Consent Form

Form Approved
OMB Control Number: 0920-0572
Expiration Date: 08/31/2021

[Programmer: Link ‘click here’ to the email address pi@forsmarshgroup.com]

[Programmer: Link ‘print a copy now’ to the browser’s printer options]

Thank you for completing the screening questionnaire. Your opinions are very important to us. Please read this information carefully. If there is anything you do not understand, please click here to email us. The project team will be happy to answer your questions. If you have any questions or complaints as a participant in this project, please contact the project team (please see below for contact information).

INFORMED CONSENT FORM

TITLE OF INFORMATION COLLECTION: Evaluation of Emergency Use Fact Sheets Regarding Medical Countermeasures – Comprehension Evaluation/Message Testing.

Sponsor: The Centers for Disease Control and Prevention (CDC)

Principal Investigator: Yon Yu, PharmD

Project Team Contact: Ronne Ostby, MA

Telephone: 571-858–3757

Address: Fors Marsh Group, LLC

1010 N. Glebe Road

Suite 510

Arlington, VA 22201

You are being asked to participate in an in-depth interview to help evaluate readability and understanding of fact sheets about medicines that would be used during emergencies. After reading this form, which explains the project, you may decide if you would like to participate in the in-depth interview or not. Your participation is completely voluntary. If you decide to participate and then change your mind, you can withdraw from this project at any time before or during the interview.

You may ask the project team questions about the project at any time. They will explain anything you do not understand.

You must complete and submit this form before you can take part in the project. If you would like a copy for your records, you can print a copy now, or you may request a copy from the project team, and they will provide you with a copy.

About this Project:

Fors Marsh Group is a company partnering with the Centers for Disease Control and Prevention (CDC) to assess individual’s knowledge, comprehension, and attitudes regarding fact sheets about medicines that would be used during public health emergencies to help people know why and how to take medicines. We plan to conduct remote in-depth interviews via computer with individuals across the country.

During the remote interview, which will last about 60 minutes, you will be asked to share your thoughts with the moderator about the fact sheets presented to you. You will need access to your computer during the interview, and you will be provided a link to access and view materials. We will be audio recording the interview. We will also be recording the screen; however, you will not need a webcam and the recording will only capture the screen from which you are working. There are no costs associated with your participation in this project. You may skip any questions you do not want to answer.

People from the project team will be observing the session via live streaming; however, you only will be interacting with the moderator.

Project Benefits:

There is no direct benefit to you. Your feedback will help us to decide how information regarding medicines that will be provided during a public health emergency can be improved.

Incentive:

You will receive an incentive of $40 as appreciation for your participation. FieldGoals will mail a check to you upon completion of the interview. You will receive the incentive for your time even if you choose not to answer some questions during the discussion.

Anticipated Risks:

We will take all the necessary precautions to let only members of the project team see your information. There is a small risk however that others might find out what you say, despite all of our best efforts. In the case of a breach of confidentiality, appropriate steps will be taken to notify participants. Remember that you can stop participating in this interview at any time.

Privacy:

Everything you say during the interview can be heard by the project team.

The interview will be audio recorded and transcribed for note-taking purposes. It also will be livestreamed so that other project team members can observe. By signing this form, you consent to being audio recorded and screen capture recorded as well as the session being live streamed during the interview.

Your identity will not be linked to your responses. This means that only the recruiting team who scheduled you will have access to your contact information. The interview team will not have information that can link what you said back to you. We will not share anything you provide with anyone outside the project unless it is required to protect you or if required by law. However, if you show a direct threat of harm to yourself or others, we have the right to take action out of concern for you and concern for others.

All information we collect, including anything you say in the interview, information collected during screening, audio files, and transcripts will be stored on a password-protected computer and/or in locked cabinets that only the project team can access. We will collect some personal information from you, such as your age, gender, and race/ethnicity, but it will only be used for eligibility and scheduling purposes. After three years, all collected data will be destroyed by securely shredding documents or permanently deleting electronic information.

Results from this project may potentially appear in professional journals or at scientific conferences. No individual participants will be identified or linked to the results. We will not disclose your identity in any report or presentation. Results also may potentially be used to improve how information is communicated in the future about medicines used during a public health emergency. . Your name or any identifying information will not be shared.

Participation and Withdrawal:

Participation in this project is completely voluntary. You may withdraw at any time by contacting Ronne Ostby of Fors Marsh Group at pi@forsmarshgroup.com or 571-858–3757.

You do not have to answer any questions that you do not want to. You will receive the incentive for your time in the interview even if you choose not to answer some questions.

We advise you to keep a copy of this consent form for future reference. If you would like to do so, print a copy now.

Please read the statement below. Then, using the mouse, please click on the statement that indicates you would like to participate in this project. After checking the box that best represents your willingness to participate, please type your name and the date click “Finish.”

By checking “yes” below, you are agreeing to participate in this project. If you check “no” below, you are not agreeing to participate.

Consent. I have read and understand the information provided above, and the project’s purpose and procedures are clear to me.

[SINGLE PUNCH]

Yes, I agree to participate in this project. 01

No, I do not wish to participate in this project. 02

Please type your name and date below and click “Finish.”

Name: [OPEN END]

Date: [OPEN END]

[FINISH BUTTON]

Public reporting burden of this collection of information is estimated to average 65 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 (0920-0572).