Attachment C - Consent Language for Provider + Consumer IC

OMB No. 0920-0572

Expiration Date 3/31/2018

Consent Language and Scripts for use with Information Collection with Provider and Consumer Audiences

1. Consent to Participate in Provider Screening Instrument and Provider Survey Online

Online survey administrators may have additional procedures in addition to the consent language provided below. At least one of the expected survey administrators works with physician members who are part of a panel and have already consented to receive a survey on a routine basis. If a survey matches the physician member’s profile, they will receive an invitation to participate in the survey.

1. Provider Survey Screening Instrument: Consent to be screened

Hello, my name is _______________ and I’m contacting you on behalf of Abt Associates, a private research organization, and the Centers for Disease Control and Prevention (CDC). 

We are not selling or promoting any product.  We are contacting health care providers to take part in a health education initiative. 

The purpose of the initiative is to learn health care providers’ thoughts on [INSERT TOPIC HERE] being developed for [INSERT TARGET AUDIENCE] and involves participating in a survey. 

If you are eligible and choose to participate in the survey, you will receive $75 as a token of our appreciation for participating in the survey. We estimate the survey will take about 30 minutes to complete.

To see if you are eligible to participate in the survey, we need to ask you some questions.  It is your choice to answer these questions. Your answers will be kept private.  You can refuse to answer a question or stop at any time. 

All of your responses will be kept private.  If you are not eligible and/or choose not to be part of the survey, all responses you give me today will be destroyed and you will not be contacted again. 

My questions will only take a few minutes. May I proceed?

Yes____ [CONTINUE] 

No____ [THANK/END]

2. Provider Survey Screening Instrument: Consent to participate for eligible individuals

Now that [you/we] are ready to begin, I am required to share the following information with you: There are no costs to you for being in this study and your participation is completely voluntary. This interview will take about [30] minutes to complete. The study is funded by the Center for Disease Control and Prevention. You may refuse to answer any questions and may choose to quit the study at any time. The risks to you for participating in this study are minimal. You may experience some discomfort when answering some of the more personal questions.

We can assure you that procedures to protect the confidentiality of your data will be strictly followed, with your answers kept in a secure database only accessible to the researchers working on this study.

Would you like to continue with the [survey]?

Yes____ [CONTINUE] 

No____ [THANK/END]

3. Provider Survey: Consent to participate in survey [If not linked to survey after the screening consent to participate]

We are interested in your opinions about Zika virus. We would also like to get some additional information about you, your practice and patients. If you’re not sure, choose an answer that comes closest to what you think might be true for each question.

Now that [you/we] are ready to begin, I want to remind you of the following information: There are no costs to you for being in this initiative and your participation is completely voluntary. This survey will take about [30] minutes to complete. The initiative is funded by the Center for Disease Control and Prevention. You may refuse to answer any questions and may choose to stop the survey at any time. The risks to you for participating in this initiative are minimal. You may experience some discomfort when answering some of the more personal questions.

We can assure you that procedures to protect the confidentiality of your data will be strictly followed, with your answers kept in a secure database only accessible to the researchers working on this study.

Would you like to continue with the [survey]?

Yes____ [CONTINUE]

No____ [THANK/END]

2. Consent to Participate in Consumer Individual Interview Screening Instrument and Interview Online with Moderation

Online interview moderators may have additional procedures in addition to the consent language provided below. The consent script may be provided in writing or read aloud.

1. Consumer Individual Interview Screening Instrument: Consent to be screened

Hello, my name is _______________ and I’m contacting you/calling on behalf of Abt Associates, a private research organization, and the Centers for Disease Control and Prevention.

We are not selling any product. We are contacting [INSERT TARGET POPULATION] in your area to join in [GROUP OR INDIVIDUAL] interviews. The purpose of the interview is to get your honest opinions and feedback on a health education initiative. No preparation is needed for this interview.

If you are eligible and choose to participate in the interview, you will receive [REMUNERATION VALUE] as a token of our appreciation for participating in this [GROUP OR INDIVIDUAL] interview.

To see if you are eligible to participate in the interview, we need to ask you some personal questions. It is your choice to answer these questions.

I am required to share the following information with you: There are no costs to you for being in this initiative and your participation is completely voluntary. These questions will take about 10 minutes to complete. The initiative is funded by the Centers for Disease Control and Prevention. You may refuse to answer any questions and may choose to quit at any time. The risks to you for participating in this initiative are minimal. You may experience some discomfort when answering some of the more personal questions.

We can assure you that procedures to protect the confidentiality of your data will be strictly followed, with your answers kept in a secure database only accessible to the researchers working on this study. If you are not eligible and/or choose not to be part of the interview, all responses you give me today will be destroyed and you will not be contacted again.

These screening questions will only take a few minutes. May I ask you the questions now?

₁ Yes

₀ No [END SCREENING QUESTIONS]

2. Consumer Individual Interview Screening Instrument: Invitation to participate in the interview

Based on your answers, you are eligible to participate in the interview. As I mentioned earlier, we are talking to men/women about a health condition and we would like to include your opinions. We would like to invite you to take part in [AN INTERVIEW] that will last about [INSERT 60 MINUTES FOR INTERVIEWS/]. You will not be asked to buy anything. The risks to you for participating in this initiative are minimal. You may experience some discomfort when answering some of the more personal questions. You will be contacted one day before your interview to remind you of your appointment. We can assure you that procedures to protect the confidentiality of your data will be strictly followed, with your answers kept in a secure database only accessible to the researchers working on this study. Any information that you provide to us will be kept private We're simply interested in your opinions. There is no preparation needed for this [GROUP/INDIVIDUAL] interview.

We will be recording the interview and some project staff from Abt and CDC may be observing the interview. We may also use a live video or audio stream so project staff from Abt and CDC can observe from a computer or telephone in another location. In order to participate in the interview, you must agree to being recorded and allowing staff from the Abt and CDC to observe. As I said, if you choose to attend, whatever you say will be kept private. We will never link your name with any comment you make in the interview in any report that we write.

20. For participating in the [INTERVIEW], you will receive [REMUNERATION VALUE] as a token of our appreciation. Will you be able to join us for an [INTERVIEW]?

₁ Yes [SKIP TO TEXT BELOW]

₀ No (Refuse to participate) [THANK AND END]

[IF “YES” TO INVITATION, READ THE FOLLOWING STATEMENTS…]

If you need to wear glasses either for reading or watching TV, please bring them with you to the interview.

Also, we need to let you know that there will not be any childcare provided at the facility, so please make the appropriate childcare arrangements if you have children.

In order for us to send you a reminder email with directions to the interview and to call to remind you of your appointment time, I need to ask for your contact information. We will destroy this information after the interview is over.

3. Consumer Individual In-Depth Interview Guide: Welcome and consent to participate in interview

Welcome

Welcome and thank you very much for agreeing to participate in this interview. Your participation is very important. I’m __________ [INSERT NAME] and I work for Abt Associates, a private research organization. The Centers for Disease Control and Prevention (CDC) is sponsoring this health education initiative.

The purpose of this interview is to hear your views and opinions on important health topics concerning Zika virus. I’m not an expert in the topic we’ll be discussing, so I have no particular agenda or point of view. We will have about 60 minutes for our discussion.

The purpose of this discussion is to get your opinions on [INSERT MATERIAL TYPE] for a Zika Prevention Initiative in [INSERT LOCATION] for [INSERT TARGET POPULATION].  What we learn will help us raise awareness about the actions people can take to protect themselves and their babies from the Zika virus.

Before we get started, I’d like to point a few things out:

I will be asking for your opinions only; not for personal information. There are no costs to you for being in this initiative and your participation is completely voluntary. This interview will take about one hour to complete. The initiative is funded by the Center for Disease Control and Prevention. Also, please remember, choose not to answer a question at any time and may choose to quit the interview at any time. You may refuse to answer any questions. The risks to you for participating in this initiative are minimal. You may experience some discomfort when answering some of the more personal questions.

We can assure you that procedures to protect the confidentiality of your data will be strictly followed, with your answers kept in a secure database only accessible to the researchers working on this initiative. Everything you have to say is confidential and any identifying information will be removed from reports and other data. 

You have probably noticed the recorder [INSERT DEVICE TYPE] in the room. It is here because we are recording the interview. I want to give you my full attention and not have to take a lot of notes. At the end of our discussion, I have to write a report and may refer to the recording when writing the report. As a reminder, some of the project staff from Abt and CDC are observing or listening. [At the end, there will be a few minutes to address questions you may have about Zika with the people observing this interview.]

Would you like to continue with the interview?

Yes [CONTINUE]

No [THANK/END]

Do you have any questions before we begin?

7

Public reporting burden of this collection of information is estimated to average 10 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 (0920-0572)