Educating Groups Influencing Generic Drug Use

HARRISON SCHOOL

OF

PHARMACY

DEPARTMENT OF HEALTH OUTCOMES RESEARCH AND POLICY

(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 that aims to better educate groups
influencing generic drug use, based on their unique educational needs. 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. This study is funded by the U.S. Food
and Drug Administration (FDA). You were selected as a possible participant because
you are age 19 or older and a formulary manager, large purchaser of prescription
drugs, or policymaker.
As part of your participation in this research study, you will be asked to attend a focus
group (with up to 5 other participants in your group and up to 3 Auburn University
researchers on the research team) at Auburn University main campus (Auburn, AL,
36849). During the focus group you will be asked to provide your thoughts on the
content, format, channel, and satisfaction of one example of an educational material
developed for your stakeholder group. Your total time commitment will be
approximately 60 minutes.
The risks associated with participating in this study are minimal. Any information
collected as part of the focus group will remain confidential and will not be shared
with anyone outside of the research team. If you participate in this study, what the
research team learns from you may better inform the development of educational
materials regarding generic drugs. To thank you for your time spent participating in
this study, you will be offered an honorarium of a $25 check after completion of the
focus group.
020 JAMES E. FOY HALL
282 WEST THACH CONCOURSE
AUBURN, AL 36849

If you change your mind about participating, you can withdraw at any time during
the study. Your participation is completely voluntary. 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,
IMPAQ International, or the FDA.

TELEPHONE:
334-844-5152

FAX:

Participant’s initials ______

334-844-8307

Page 1 of 3

PHARMACY.AUBURN.EDU

If you agree, the group discussion will be audio recorded. However, any information
you share with the research team will be made anonymous as soon as possible. We
will protect your privacy and the data you provide by assigning a false name and
removing any recognizable information from records of the audio file. Notes and
records from the study will be saved in password-protected folders on a passwordand firewall-protected server at Auburn University. Audio recordings will be
destroyed immediately upon completion of the study. Even though we will emphasize
to all participants that comments made during the focus group session should be kept
confidential, it is possible that participants may repeat comments outside of the group
at some time in the future. Therefore, we encourage you to be as honest and open as
you can during the discussion, but remain aware of our limits in protecting
confidentiality.
Information collected through your participation may be published in governmental
reports, professional scientific journals, and/or presented at a professional meeting.
As described above, notes and records 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.
Personal information collected in connection to your honorarium will be saved in
password protected folders on a password and firewall protected server at Auburn
University. This information is being collected in order to withhold necessary tax
payments on your behalf and will remain private.
If you have questions about this study, please ask them now or contact Dr. Jingjing
Qian at (334) 844-5818 or jzq004@auburn.edu.
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)-844-5966 or email 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. YOUR SIGNATURE INDICATES YOUR WILLINGNESS TO
PARTICIPATE.
__________________________________
Participant’s Signature
Date

__________________________________
Printed Name
Page 2 of 3

__________________________________
Investigator’s Signature
Date
__________________________________
Printed Name

____________________________________
Co-Investigator’s Signature
Date
____________________________________
Printed Name

Page 3 of 3

HARRISON SCHOOL

OF

PHARMACY

DEPARTMENT OF HEALTH OUTCOMES RESEARCH AND POLICY

(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 that aims to better educate groups
influencing generic drug use, based on their unique educational needs. 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. This study is funded by the U.S. Food
and Drug Administration (FDA). You were selected as a possible participant because
you are age 19 or older and a patient or caregiver.
As part of your participation in this research study, you will be asked to attend a focus
group (with up to 5 other participants in your group and up to 3 Auburn University
researchers on the research team) at Auburn University main campus (Auburn, AL,
36849). During the focus group you will be asked to provide your thoughts on the
content, format, channel, and satisfaction of one example of an educational material
developed for your stakeholder group. Your total time commitment will be
approximately 60 minutes.
The risks associated with participating in this study are minimal. Any information
collected as part of the focus group will remain confidential and will not be shared
with anyone outside of the research team. If you participate in this study, what the
research team learns from you may better inform the development of educational
materials regarding generic drugs. To thank you for your time spent participating in
this study, you will be offered an honorarium of a $25 check after completion of the
focus group.
020 JAMES E. FOY HALL
282 WEST THACH CONCOURSE
AUBURN, AL 36849

If you change your mind about participating, you can withdraw at any time during
the study. Your participation is completely voluntary. 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,
IMPAQ International, or the FDA.

TELEPHONE:
334-844-5152

Participant’s initials ______
FAX:
334-844-8307

Page 1 of 3

PHARMACY.AUBURN.EDU

If you agree, the group discussion will be audio recorded. However, any information
you share with the research team will be made anonymous as soon as possible. We
will protect your privacy and the data you provide by assigning a false name and
removing any recognizable information from records of the audio file. Notes and
records from the study will be saved in password-protected folders on a passwordand firewall-protected server at Auburn University. Audio recordings will be
destroyed immediately upon completion of the study. Even though we will emphasize
to all participants that comments made during the focus group session should be kept
confidential, it is possible that participants may repeat comments outside of the group
at some time in the future. Therefore, we encourage you to be as honest and open as
you can during the discussion, but remain aware of our limits in protecting
confidentiality.
Information collected through your participation may be published in governmental
reports, professional scientific journals, and/or presented at a professional meeting.
As described above, notes and records 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.
Personal information collected in connection to your honorarium will be saved in
password protected folders on a password and firewall protected server at Auburn
University. This information is being collected in order to withhold necessary tax
payments on your behalf and will remain private.
If you have questions about this study, please ask them now or contact Dr. Jingjing
Qian at (334) 844-5818 or jzq004@auburn.edu.
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)-844-5966 or email 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. YOUR SIGNATURE INDICATES YOUR WILLINGNESS TO
PARTICIPATE.
__________________________________
Participant’s Signature
Date
__________________________________
Printed Name
Page 2 of 3

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

Page 3 of 3

pharmacy.auburn.edu

HARRISON SCHOOL

OF

PHARMACY

DEPARTMENT OF HEALTH OUTCOMES RESEARCH AND POLICY

(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 that aims to better educate groups
influencing generic drug use, based on their unique educational needs. 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. This study is funded by the U.S. Food
and Drug Administration (FDA). You were selected as a possible participant because
you are age 19 or older and a healthcare provider.
As part of your participation in this research study, you will be asked to attend a focus
group (with up to 5 other participants in your group and up to 3 Auburn University
researchers on the research team) at Auburn University main campus (Auburn, AL,
36849). During the focus group you will be asked to provide your thoughts on the
content, format, channel, and satisfaction of one example of an educational material
developed for your stakeholder group. Your total time commitment will be
approximately 60 minutes.
The risks associated with participating in this study are minimal. Any information
collected as part of the focus group will remain confidential and will not be shared
with anyone outside of the research team. If you participate in this study, what the
research team learns from you may better inform the development of educational
materials regarding generic drugs. To thank you for your time spent participating in
this study, you will be offered an honorarium of a $25 check after completion of the
focus group.
020 JAMES E. FOY HALL
282 WEST THACH CONCOURSE
AUBURN, AL 36849

If you change your mind about participating, you can withdraw at any time during
the study. Your participation is completely voluntary. 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,
IMPAQ International, or the FDA.

TELEPHONE:
334-844-5152

Participant’s initials ______
FAX:
334-844-8307

Page 1 of 3

PHARMACY.AUBURN.EDU

If you agree, the group discussion will be audio recorded. However, any information
you share with the research team will be made anonymous as soon as possible. We
will protect your privacy and the data you provide by assigning a false name and
removing any recognizable information from records of the audio file. Notes and
records from the study will be saved in password-protected folders on a passwordand firewall-protected server at Auburn University. Audio recordings will be
destroyed immediately upon completion of the study. Even though we will emphasize
to all participants that comments made during the focus group session should be kept
confidential, it is possible that participants may repeat comments outside of the group
at some time in the future. Therefore, we encourage you to be as honest and open as
you can during the discussion, but remain aware of our limits in protecting
confidentiality.
Information collected through your participation may be published in governmental
reports, professional scientific journals, and/or presented at a professional meeting.
As described above, notes and records 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.
Personal information collected in connection to your honorarium will be saved in
password protected folders on a password and firewall protected server at Auburn
University. This information is being collected in order to withhold necessary tax
payments on your behalf and will remain private.
If you have questions about this study, please ask them now or contact Dr. Jingjing
Qian at (334) 844-5818 or jzq004@auburn.edu.
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)-844-5966 or email 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. YOUR SIGNATURE INDICATES YOUR WILLINGNESS TO
PARTICIPATE.

__________________________________
Participant’s Signature
Date
__________________________________
Printed Name
Page 2 of 3

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

Page 3 of 3