Educating Groups Influencing Generic Drug Use

Data to Support Drug Product Communications

Appendix B - Verbal Consents for Interviews

Educating Groups Influencing Generic Drug Use

OMB: 0910-0695

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D E P A R T M EN T O F
Health Outcomes Research
and Policy

Informed Consent: Formulary Managers

(NOTE: DO NOT AGREE TO PARTICIPATE UNLESS AN IRB APPROVAL STAMP WITH CURRENT DATES HAS
BEEN APPLIED TO THIS DOCUMENT.)
Informed Consent for a research study entitled: “Educating Groups Influencing Generic Drug Use”
You are invited to participate in a research study to better educate groups influencing generic drug use, based
on their unique educational needs, sponsored by the US Food and Drug Administration (FDA). The study is
being conducted by Dr. Jingjing Qian, Assistant Professor in the Auburn University Department of Health
Outcomes Research and Policy and Dr. Ilene Harris, Principal Research Scientist at IMPAQ International. You
were selected as a possible participant because you were identified as having a role in the prescription drug
formulary process within the previous six months and are age 19 or older.
As part of your participation in this research study, you will speak to one of our team’s researchers via
telephone regarding your review of the developed educational materials. Your total time commitment will be
approximately 45 minutes.
The risks associated with participating in this study are minimal. Your protected health information will not
be used or disclosed to a third party. If you participate in this study, what the research team learns from your
interview may better inform whether the developed educational materials are successful in educating
various groups on generic drugs. You will receive $75 as a token of our appreciation for your participation
after completion of the interview.
If you change your mind about participating, you can withdraw at any time during the study. Your
participation is completely voluntary. If you choose to withdraw, your data can be withdrawn as long as it is
identifiable. Your decision about whether or not to participate or to stop participating will not jeopardize
your future relations with Auburn University, the Department of Health Outcomes Research and Policy, or
IMPAQ International.
If you agree, interviews will be audio recorded. However, any data obtained in connection with this study will
be made anonymous as soon as possible. We will protect your privacy and the data you provide by deidentifying the data, including assigning pseudonyms and removing any identifiable information from
transcripts of the audio file. Notes and transcripts from the study will be saved in password protected folders
on a password and firewall protected server at IMPAQ International. Audio recordings will be destroyed
immediately upon completion of the transcriptions.
Information collected through your participation may be published in governmental reports, professional
journals, and/or presented at a professional meeting. As described above, notes and transcriptions from the
audio recordings will have no identifying information attached to them, and if information learned from this
study is published, you will not be identified by name or other personal information. Also, transcriptions and
written notes will be used for analytical purposes only.
If required, personal information collected in connection to your honorarium (i.e. W-9 form) will be saved in
password protected folders on a password and firewall protected server at IMPAQ International. This

Page 1 of 2

information is being collected in order to withhold necessary tax payments on your behalf and will
remain private to the extent permitted by law.
If you have questions about this study, please ask them now or contact Jingjing Qian at (334) 844-5818 or
[email protected] or Ilene Harris at (443) 259-5250 or [email protected].
If you have questions about your rights as a research participant, you may contact the Auburn University
Office of Research Compliance or the Institutional Review Board by phone at (334) 844-5966 or e-mail at
[email protected] or [email protected].
HAVING READ THE INFORMATION PROVIDED, YOU MUST DECIDE WHETHER OR NOT YOU WISH TO PARTICIPATE IN
THIS RESEARCH STUDY. IF YOU DECIDE TO PARTICIPATE, THE DATA YOU PROVIDE WILL SERVE AS YOUR AGREEMENT
TO DO SO. YOU MAY REQUEST A COPY OF THIS LETTER FROM YOUR INTERVIEWER.

______________________________ ______
Investigator’s Signature
Date
____________________________________
Printed Name
____________________________________
Co-Investigator’s Signature
Date
____________________________________
Printed Name

020 James E. Foy Hall, Auburn, AL 36849-5501; Telephone: 334-844-5152
www.auburn.edu

Page 2 of 2

D E P A R T M EN T O F
Health Outcomes Research
and Policy

Informed Consent: Large purchasers

(NOTE: DO NOT AGREE TO PARTICIPATE UNLESS AN IRB APPROVAL STAMP WITH CURRENT DATES HAS
BEEN APPLIED TO THIS DOCUMENT.)
Informed Consent for a research study entitled: “Educating Groups Influencing Generic Drug Use”
You are invited to participate in a research study to better educate groups influencing generic drug use, based
on their unique educational needs, sponsored by the US Food and Drug Administration (FDA). The study is
being conducted by Dr. Jingjing Qian, Assistant Professor in the Auburn University Department of Health
Outcomes Research and Policy and Dr. Ilene Harris, Principal Research Scientist at IMPAQ International. You
were selected as a possible participant because you have been identified as someone involved in prescription
drug purchasing decisions for a commercial entity within the previous six months and are age 19 or older.
As part of your participation in this research study, you will speak to one of our team’s researchers via
telephone regarding your review of the developed educational materials. Your total time commitment will be
approximately 45 minutes.
The risks associated with participating in this study are minimal. Your protected health information will not
be used or disclosed to a third party. If you participate in this study, what the research team learns from your
interview may better inform whether the developed educational materials are successful in educating
various groups on generic drugs. You will receive $75 as a token of our appreciation for your participation
after completion of the interview.
If you change your mind about participating, you can withdraw at any time during the study. Your
participation is completely voluntary. If you choose to withdraw, your data can be withdrawn as long as it is
identifiable. Your decision about whether or not to participate or to stop participating will not jeopardize
your future relations with Auburn University, the Department of Health Outcomes Research and Policy, or
IMPAQ International.
If you agree, interviews will be audio recorded. However, any data obtained in connection with this study will
be made anonymous as soon as possible. We will protect your privacy and the data you provide by deidentifying the data, including assigning pseudonyms and removing any identifiable information from
transcripts of the audio file. Notes and transcripts from the study will be saved in password protected folders
on a password and firewall protected server at IMPAQ International. Audio recordings will be destroyed
immediately upon completion of the transcriptions.
Information collected through your participation may be published in governmental reports, professional
journals, and/or presented at a professional meeting. As described above, notes and transcriptions from the
audio recordings will have no identifying information attached to them, and if information learned from this
study is published, you will not be identified by name or other personal information. Also, transcriptions and
written notes will be used for analytical purposes only.

Page 1 of 2

If required, personal information collected in connection to your honorarium (i.e. W-9 form) will be saved in
password protected folders on a password and firewall protected server at IMPAQ International. This
information is being collected in order to withhold necessary tax payments on your behalf and will remain
private to the extent permitted by law.
If you have questions about this study, please ask them now or contact Jingjing Qian at (334) 844-5818 or
[email protected] or Ilene Harris at (443) 259-5250 or [email protected].
If you have questions about your rights as a research participant, you may contact the Auburn University
Office of Research Compliance or the Institutional Review Board by phone at (334) 844-5966 or e-mail at
[email protected] or [email protected].
HAVING READ THE INFORMATION PROVIDED, YOU MUST DECIDE WHETHER OR NOT YOU WISH TO PARTICIPATE IN
THIS RESEARCH STUDY. IF YOU DECIDE TO PARTICIPATE, THE DATA YOU PROVIDE WILL SERVE AS YOUR AGREEMENT
TO DO SO. YOU MAY REQUEST A COPY OF THIS LETTER FROM YOUR INTERVIEWER.

______________________________ ______
Investigator’s Signature
Date
____________________________________
Printed Name
____________________________________
Co-Investigator’s Signature
Date
____________________________________
Printed Name

020 James E. Foy Hall, Auburn, AL 36849-5501; Telephone: 334-844-5152
www.auburn.edu

Page 2 of 2

D E P A R T M EN T O F
Health Outcomes Research
and Policy

Informed Consent: Policymakers

(NOTE: DO NOT AGREE TO PARTICIPATE UNLESS AN IRB APPROVAL STAMP WITH CURRENT DATES HAS
BEEN APPLIED TO THIS DOCUMENT.)
Informed Consent for a research study entitled: “Educating Groups Influencing Generic Drug Use”
You are invited to participate in a research study to better educate groups influencing generic drug use, based
on their unique educational needs, sponsored by the US Food and Drug Administration (FDA). The study is
being conducted by Dr. Jingjing Qian, Assistant Professor in the Auburn University Department of Health
Outcomes Research and Policy and Dr. Ilene Harris, Principal Research Scientist at IMPAQ International. You
were selected as a possible participant because you were identified as having a role in the policymaking
process for prescription drugs within the previous six months and are age 19 or older.
As part of your participation in this research study, you will speak to one of our team’s researchers via
telephone regarding your review of the developed educational materials. Your total time commitment will be
approximately 45 minutes.
The risks associated with participating in this study are minimal. Your protected health information will not
be used or disclosed to a third party. If you participate in this study, what the research team learns from your
interview may better inform whether the developed educational materials are successful in educating
various groups on generic drugs. You will receive $75 as a token of our appreciation for your participation
after completion of the interview.
If you change your mind about participating, you can withdraw at any time during the study. Your
participation is completely voluntary. If you choose to withdraw, your data can be withdrawn as long as it is
identifiable. Your decision about whether or not to participate or to stop participating will not jeopardize
your future relations with Auburn University, the Department of Health Outcomes Research and Policy, or
IMPAQ International.
If you agree, interviews will be audio recorded. However, any data obtained in connection with this study will
be made anonymous as soon as possible. We will protect your privacy and the data you provide by deidentifying the data, including assigning pseudonyms and removing any identifiable information from
transcripts of the audio file. Notes and transcripts from the study will be saved in password protected folders
on a password and firewall protected server at IMPAQ International. Audio recordings will be destroyed
immediately upon completion of the transcriptions.
Information collected through your participation may be published in governmental reports, professional
journals, and/or presented at a professional meeting. As described above, notes and transcriptions from the
audio recordings will have no identifying information attached to them, and if information learned from this
study is published, you will not be identified by name or other personal information. Also, transcriptions and
written notes will be used for analytical purposes only.

Page 1 of 2

If required, personal information collected in connection to your honorarium (i.e. W-9 form) will be saved in
password protected folders on a password and firewall protected server at IMPAQ International. This
information is being collected in order to withhold necessary tax payments on your behalf and will remain
private to the extent permitted by law.
If you have questions about this study, please ask them now or contact Jingjing Qian at (334) 844-5818 or
[email protected] or Ilene Harris at (443) 259-5250 or [email protected].
If you have questions about your rights as a research participant, you may contact the Auburn University
Office of Research Compliance or the Institutional Review Board by phone at (334) 844-5966 or e-mail at
[email protected] or [email protected].
HAVING READ THE INFORMATION PROVIDED, YOU MUST DECIDE WHETHER OR NOT YOU WISH TO PARTICIPATE IN
THIS RESEARCH STUDY. IF YOU DECIDE TO PARTICIPATE, THE DATA YOU PROVIDE WILL SERVE AS YOUR AGREEMENT
TO DO SO. YOU MAY REQUEST A COPY OF THIS LETTER FROM YOUR INTERVIEWER.

______________________________ ____
Investigator’s Signature
Date
__________________________________
Printed Name
____________________________________
Co-Investigator’s Signature
Date
____________________________________
Printed Name

020 James E. Foy Hall, Auburn, AL 36849-5501; Telephone: 334-844-5152
www.auburn.edu

Page 2 of 2


File Typeapplication/pdf
AuthorJennifer Howard
File Modified2018-02-21
File Created2017-11-20

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