Informed Consent Form

Formative Research and Tool Development

Att 6 Informed Consent Forms

Formative Research to Develop Social Marketing Campaigns: Prevention Is Care (PIC)

OMB: 0920-0840

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Form Approved

OMB No. 0920-0840

Expiration Date 02/29/2016





Attachment 6
Informed Consent Forms



Formative Research to Develop Social Marketing Campaigns: Prevention Is Care (PIC)



















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PIC Consent Form for Infectious Disease Specialists

One-on-One Interviews

Formative Research to Develop Social Marketing Campaigns: Prevention Is Care (PIC)



Introduction and Purpose:

You have been asked to take part in a research study. The purpose of the research is to conduct one on one interviews to learn about your views related to a communications campaign. What we learn from this study will be used to develop materials for health care providers who deliver care to people with HIV. RTI International, a non-profit company in North Carolina, is conducting the interview. The interview is sponsored by the Centers for Disease Control and Prevention (CDC).


Procedures:

During the interview, we will ask you about the discussions you have with HIV positive patients. The interview will take about an hour. We will be doing interviews with physicians in 4 cities. About 80 physicians will take part in the interviews.

CDC staff working on this project may observe the interview through a one-way mirror or a live video-stream. There is also a note-taker taking notes behind a one-way mirror.


Before the interview, you will be asked to fill out a paper and pencil survey. Your name will not go on this survey. The survey will contain some general questions about your practice and your patient population.


Benefits:

There is no direct benefit to you for being in this interview. However, you will be exposed to educational materials that are designed to serve as resources to share with patients and for the provider to use in their day to day practice. You may find the discussion interesting and informative. What we learn from the interview will help us to improve the materials being developed.


Risks:

The questions we ask are not meant to be sensitive. Still, there is a chance that you may feel discomfort about some of the questions we ask. During both the interview and paper and pencil survey, you may choose not to answer any question you wish or end your participation at any time. We do not know of any other risks related to taking part in this study.


Privacy:

We will be audio recording the interview. Digital files from audio recordings will be kept on a password-protected computer, accessible only by authorized staff. Notes will be made of the audio recordings. We will only refer to people by their first name in the notes. Because we are not transcribing the audio recordings, we will keep the records for reference if needed to confirm the notes. All audio files will be destroyed three years after completion of the project. Your comments will be kept private to the extent allowable by law. The notes will also be kept on a password-protected computer. Only authorized project staff will be able to see them. Any forms related to the project that have your name or information that could identify you will be kept in a locked file cabinet. These forms will be destroyed after the interview ends. However, there is still a small risk that your privacy could be broken.


Also, any information that this local facility already has about you -- because you have been in other projects -- will still be kept there. You may be contacted by them to be in other projects in the future. If you have not been contacted by this facility before this project, they will not keep any of your contact information.


Reimbursement:

We will give you [INSERT AMOUNT] as a token of appreciation for your involvement.


Right to Refuse or Withdraw:

It is your choice to take part in this interview. You can choose not to talk about any topic. You can end the interview at any time. You can withdraw from the study for any reason at any time.


Persons to Contact:

If you have questions about the interview, you can call Dr. Julia Kish Doto at 1-800-334-8571 extension 8280. She can be reached between 9 AM and 5 PM Eastern Standard Time Monday - Friday. If you have questions about your rights as a participant, you can call RTI’s Office of Research Protection toll-free at 1-866-214-2043.


Your Consent:

I have read this consent form. I had a chance to ask questions and my questions were answered. I was given a copy of this consent form. I agree to be in the interview.




Signature


Date


Facilitator Signature



PIC Consent Form for Primary Care Physicians

One-on-One Interviews

Formative Research to Develop Social Marketing Campaigns: Prevention Is Care (PIC)



Introduction and Purpose:

You have been asked to take part in a research study. The purpose of the research is to conduct one on one interviews to learn about your views related to a communications campaign. What we learn from this study will be used to develop materials for health care providers who deliver care to people with HIV. RTI International, a non-profit company in North Carolina, is conducting the interview. The interview is sponsored by the Centers for Disease Control and Prevention (CDC).


Procedures:

During the interview, we will ask you about the discussions you have with HIV positive patients. The interview will take about an hour. We will be doing interviews with physicians in 4 cities. About 80 physicians will take part in the interviews.

CDC staff working on this project may observe the interview through a one-way mirror or a live video-stream. There is also a note-taker taking notes behind a one-way mirror.


Before the interview, you will be asked to fill out a paper and pencil survey. Your name will not go on this survey. The survey will contain some general questions about your practice and your patient population.


Benefits:

There is no direct benefit to you for being in this interview. However, you will be exposed to educational materials that are designed to serve as resources to share with patients and for the provider to use in their day to day practice. You may find the discussion interesting and informative. What we learn from the interview will help us to improve the materials being developed.


Risks:

The questions we ask are not meant to be sensitive. Still, there is a chance that you may feel discomfort about some of the questions we ask. During both the interview and paper and pencil survey, you may choose not to answer any question you wish or end your participation at any time. We do not know of any other risks related to taking part in this study.


Privacy:

We will be audio recording the interview. Digital files from audio recordings will be kept on a password-protected computer, accessible only by authorized staff. Notes will be made of the audio recordings. We will only refer to people by their first name in the notes. Because we are not transcribing the audio recordings, we will keep the records for reference if needed to confirm the notes. All audio files will be destroyed three years after completion of the project. Your comments will be kept private to the extent allowable by law. The notes will also be kept on a password-protected computer. Only authorized project staff will be able to see them. Any forms related to the project that have your name or information that could identify you will be kept in a locked file cabinet. These forms will be destroyed after the interview ends. However, there is still a small risk that your privacy could be broken.

Also, any information that this local facility already has about you -- because you have been in other projects -- will still be kept there. You may be contacted by them to be in other projects in the future. If you have not been contacted by this facility before this project, they will not keep any of your contact information.


Reimbursement:

We will give you [INSERT AMOUNT] as a token of appreciation for your involvement.


Right to Refuse or Withdraw:

It is your choice to take part in this interview. You can choose not to talk about any topic. You can end the interview at any time. You can withdraw from the study for any reason at any time.


Persons to Contact:

If you have questions about the interview, you can call Dr. Julia Kish Doto at 1-800-334-8571 extension 8280. She can be reached between 9 AM and 5 PM Eastern Standard Time Monday - Friday. If you have questions about your rights as a participant, you can call RTI’s Office of Research Protection toll-free at 1-866-214-2043.


Your Consent:

I have read this consent form. I had a chance to ask questions and my questions were answered. I was given a copy of this consent form. I agree to be in the interview.




Signature


Date


Facilitator Signature


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitlePIC
Authorjkdoto
File Modified0000-00-00
File Created2021-01-30

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