PRAMS Field Testing Questionnaire Informed Consent (English)

Attachment 15c – PRAMS Field Testing Questionnaire Informed Consent - English

Informed Consent Form for One-on-one Interviews for Field Testing

You are being asked to take part in a research study sponsored by the Centers for Disease Control and Prevention. This consent form tells you about the study and what you will be asked to do. You can choose to take part in the study or not. If you choose to take part, you will need to read this entire form.

Purpose of the Research

• Surveys are used to collect information on the health and wellbeing of Americans. The surveys help to develop programs to improve the health and health care of people living in the United States.

• Before health surveys are conducted, the questions are tested with people of different backgrounds. It is important that the questions make sense, are easy to answer, and that everyone understands the questions the same way.

• If you agree to take part in this test, we will ask you to answer the survey questions. Then, you will be asked to provide feedback on the quality of the survey questions.

• The questions that we are working on today are about your experiences shortly before, during, and shortly after your recent pregnancy.

• Your interview will show us how to improve the questions for this survey. This type of study will teach us about the different kinds of problems people have answering survey questions. The study will help us write better questions in the future.

Procedures

• This interview will be conducted in-person <or virtually through video conferencing software>.

• The interview will last no more than 40 minutes, and we will mail you <reward>. You will also be asked demographic questions from a personal information sheet.

• During the interview, you will be asked some survey questions. Then, the interviewer will ask you some questions about the quality of the survey questions.

• You may find that some of the questions we are testing are sensitive. You may choose not to answer any question for any reason. If you do not want to answer a question, say so, and we will move on to the next one. You may also stop the interview at any time.

Recordings

• We would like to audio <or video> record your interview. The recording allows us to study and improve the questions more carefully. If you agree, you may still ask to stop the recording at any time, and we will stop recording. If you decide to stop recording, we will ask your consent to retain the portion already recorded.

• You may decide at any time after the interview that you don’t want us to keep a recording of the interview. In this case, you may contact <Project Investigator contact information>.

Privacy

• Recordings are stored in a locked room or secured by a password. All recordings are labeled by a code number, date, time, and project title. The recording is never labeled with your name or other personal facts.

• Your name or other personal facts that would identify you will not be used when we discuss or write about this study. People working on this project those viewing the audiovisual recording or audio recording, however, may recognize you or your voice.

Benefit and Risks

• There are no direct benefits to you from taking part in this study. Participation in this study will not affect the care that you and/or your baby receive.

• The possible risks of taking part in this study are minimal. We will take all possible steps to protect your privacy. Information collected from this interview, including survey responses, will be strictly confidential.

• As a thank you for your participation in this study, you will receive a <reward>.

• You do not have to give us any information that you do not want to, and you can choose not to answer any question in the interview. You may also stop at any time and still receive the full <reward>.

• If you have any questions about this study, please call < IRB contact >.

Consent

• I have read this information and agree to participate in the research project under the conditions presented.