Educating Groups Influencing Generic Drug Use

Data to Support Drug Product Communications as Used by the FDA

Informational Letters

Educating Groups Influencing Generic Drug Use

OMB: 0910-0695

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Auburn Letterhead
(NOTE: DO NOT SIGN THIS DOCUMENT 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, Principle Research Scientist at IMPAQ International. You were selected as a possible
participant because you or a loved one are currently taking or have taken a prescribed
medication within the last month and are age 19 or older.
If you decide to participate in this research study, you will be asked to be interviewed by one of
the team’s researchers. Your total time commitment will be approximately 60 minutes or one
hour.
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 study may better inform how information is provided
related to generic medications. To thank you for your time, by participating in this study, you
will be offered an honorarium of a $50 gift card after the 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withdrawn as long as it is identifiable.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 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 de-identifying 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 journal 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
Page 1 of 2

other personal information. Also, transcriptions and written notes will have no identifying
information attached to them, and will be used for analytical purposes only.
If you have questions about this study, please ask them now or contact Jingjing Qian at (334)
844-5818 or jzq004@auburn.edu or Ilene Harris at (443) 259-5250 or iharris@impaqint.com.
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 (334)-8445966 or e-mail at IRBadmin@auburn.edu or IRBChair@auburn.edu.
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. THIS LETTER IS YOURS TO KEEP. YOU CAN PRINT IT BY
YOURSELF OR REQUEST A COPY FROM THE INTERVIEWER.

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

Page 2 of 2

Auburn Letterhead
(NOTE: DO NOT SIGN THIS DOCUMENT 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, Principle Research Scientist at IMPAQ International. You were selected as a possible
participant because you have prescribed a medication within the last two weeks and are age 19
or older.
If you decide to participate in this research study, you will be asked to be interviewed by one of
the team’s researchers. Your total time commitment will be approximately 60 minutes or one
hour.
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 study may better inform how information is provided
related to generic medications. To thank you for your time, by participating in this study, you
will be offered an honorarium of $ a xx check after the 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 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 de-identifying 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 journal 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
Page 1 of 2

Comment [j1]: The amount of incentive will be a
fixed amount based on specialty of physicians ($175
for primary care providers, $250 for specialist, and
$375 for oncologists and surgeons).

Page 2 of 2

Auburn Letterhead
(NOTE: DO NOT SIGN THIS DOCUMENT 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, Principle Research Scientist at IMPAQ International. You were selected as a possible
participant because you have dispensed a medication within the last two weeks and are age 19
or older.
If you decide to participate in this research study, you will be asked to be interviewed by one of
the team’s researchers. Your total time commitment will be approximately 60 minutes or one
hour.
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 study may better inform how information is provided
related to generic medications. To thank you for your time, by participating in this study, you
will be offered an honorarium of $a xxx check after the 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 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 de-identifying 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 journal 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
Page 1 of 2

Comment [j1]: The amount of incentive will be a
fixed amount based on the setting of pharmacists
they work on ($150 for retail pharmacists and $200
for hospital-based pharmacists).

Page 2 of 2

Auburn Letterhead
(NOTE: DO NOT SIGN THIS DOCUMENT 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, Principle 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.
If you decide to participate in this research study, you will be asked to be interviewed by one of
the team’s researchers. Your total time commitment will be approximately 60 minutes or one
hour.
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 study may better inform how information is provided
related to generic medications. To thank you for your time, by participating in this study, you
will be offered an honorarium of a $150 check after the 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 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 de-identifying 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 journal 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
Page 1 of 2

Page 2 of 2

Auburn Letterhead
(NOTE: DO NOT SIGN THIS DOCUMENT 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, Principle 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.
If you decide to participate in this research study, you will be asked to be interviewed by one of
the team’s researchers. Your total time commitment will be approximately 60 minutes or one
hour.
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 study may better inform how information is provided
related to generic medications. Your participation will greatly contribute to our research which
will support the promotion of generic drug utilization.
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 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 de-identifying 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 journal 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
Page 1 of 2

Page 2 of 2

Auburn Letterhead
(NOTE: DO NOT SIGN THIS DOCUMENT 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, Principle 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.
If you decide to participate in this research study, you will be asked to be interviewed by one of
the team’s researchers. Your total time commitment will be approximately 60 minutes or one
hour.
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 study may better inform how information is provided
related to generic medications. To thank you for your time, by participating in this study, you
will be offered an honorarium of a $150 check after the 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 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 de-identifying 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 journal 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,
Page 1 of 2

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 have no identifying
information attached to them, and will be used for analytical purposes only.
If you have questions about this study, please ask them now or contact Jingjing Qian at (334)
844-5818 or jzq004@auburn.edu or Ilene Harris at (443) 259-5250 or iharris@impaqint.com.
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 (334)-8445966 or e-mail at IRBadmin@auburn.edu or IRBChair@auburn.edu.
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. THIS LETTER IS YOURS TO KEEP. YOU CAN PRINT IT BY
YOURSELF OR REQUEST A COPY FROM THE INTERVIEWER.

Page 2 of 2

File Type	application/pdf
Author	Jennifer Howard
File Modified	2016-03-11
File Created	2016-03-11