Generic Drug Substitution in Special Populations

1

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: “Generic Drug Substitution in
Special Populations”
You are invited to participate in a Food Drug Administration (FDA) funded
research study to gain insight into the alignment of clinical practice and generic
drug labels, including, but not limited to the communication taking place between
patients and their physicians and pharmacists about drug administration, risks, and
instructions that are unique to special populations. 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 prescribed or dispensed a generic medication to one or more of
the target special populations [pregnant women, a parent or guardian of a child, a
racial or ethnic minority group, etc.], within the last month and are age 19 or older.
As part of your participation in this research study, you will attend a focus group
with up to 8 other prescribers and dispensers. One or more of our team’s
researchers will lead a discussion regarding your current prescribing and dispensing
patterns for generic drugs, your communication about generic drugs with patients,
and your desired methods of receiving information related to drug risks and
instructions for special populations. Your total time commitment will be
approximately 60 minutes.

020 JAMES E. FOY HALL
282 WEST THACH CONCOURSE
AUBURN, AL 36849

TELEPHONE:
334-844-5152

The risks associated with participating in this study are minimal. Any information
collected including, but not limited to, name, address, email, personal information,
and responses will not be used by or disclosed to a third party. Your participation in
this study will allow the study team to examine the communication taking place
between patients and their physicians and pharmacists about drug risks and
instructions based on the unique needs of their population group identified. To
thank you for your time, by participating in this study, you will be offered an
honorarium of a $275 check after the completion of the focus group.

FAX:
334-844-8307

Participant’s initials ______

The Auburn University Institutional
Review Board has approved this
Document for use from
05/02/2018
05/03/2017
_______________to_______________
17-140 EP 1705
Protocol # ______________________

2

The Auburn University Institutional
Review Board has approved this
Document for use from
05/02/2018
05/03/2017
_______________to_______________
17-140 EP 1705
Protocol # ______________________

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, IMPAQ International, or the FDA. However, your decision to
participate or withdraw may impact your receipt of the honorarium. Honorariums
will only be distributed upon completion of the focus group.
If you agree, the group discussion 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 your 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. 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, but remain
aware of our limits in protecting confidentiality.
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 transcripts 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 have no identifying information attached to
them, and will be used for analytical purposes only.
Personal information collected in connection to your honorarium 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 confidential.
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 (334)-844 5966 or e-mail at [email protected] or
[email protected].

3

__________________________________
Participant’s Signature
Date

__________________________________
Printed Name

__________________________________
Investigator’s Signature
Date

__________________________________
Printed Name

____________________________________
Co-Investigator’s Signature
Date

____________________________________
Printed Name

The Auburn University Institutional
Review Board has approved this
Document for use from
05/02/2018
05/03/2017
_______________to_______________
17-140 EP 1705
Protocol # ______________________

4

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: “Generic Drug Substitution in
Special Populations”

You are invited to participate in a Food Drug Administration (FDA) funded
research study to gain insight into the alignment of clinical practice and generic
drug labels, including, but not limited to the communication between patients and
their doctors and pharmacists about drug guidance, risks, and instructions that are
unique to special populations. The study is being led 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 are 65 years or older of age
and are currently taking or have taken a prescribed generic medication with the last
month OR you are a parent or guardian of a child 18 years of age or younger who is
currently taking or has taken a prescribed generic medication within the last month
and are age 19 or older.
Should you choose to participate in this research study, you will take part in a focus
group with up to 8 other older adult patients where one or more of our team’s
researchers will lead a discussion regarding your current medications, the
communication you have had with your doctor about generic drugs, and ways you
would prefer receiving information about drug risks and instructions based on the
unique needs of a parent or guardian of a child 18 years of age or younger. Your
total time commitment will be approximately 60 minutes.
020 JAMES E. FOY HALL
282 WEST THACH CONCOURSE
AUBURN, AL 36849

TELEPHONE:
334-844-5152

There are few risks associated with this study. Any information you provide will
remain protected and will not be used by or given to a third party. Your
participation in this study will allow the study team to better understand how
patients talk to their doctors and pharmacists about the drug risks and instructions.
To thank you for participating in this study, you will be offered an honorarium of a
$75 check after the completion of the focus group.

FAX:
334-844-8307

Participant’s initials ______

The Auburn University Institutional
Review Board has approved this
Document for use from
05/02/2018
05/03/2017
_______________to_______________
17-140 EP 1705
Protocol # ______________________

5

The Auburn University Institutional
Review Board has approved this
Document for use from
05/02/2018
05/03/2017
_______________to_______________
17-140 EP 1705
Protocol # ______________________

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, IMPAQ International, or the FDA. However, your decision to
participate or withdraw may impact your receipt of the honorarium. Honorariums
will only be distributed upon completion of the focus group discussion.
If you agree, the group discussion will be 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 password
and firewall protected server at IMPAQ International. Audio recordings will be
destroyed immediately upon completion of the records. 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, but remain aware of our limits in protecting confidentiality.
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 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. Also,
records and written notes will have no identifying information attached to them, and
will only be used for analysis.
Personal information collected in connection to your honorarium 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.
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 (334)-844 5966 or e-mail at [email protected] or
[email protected].

6

__________________________________
Participant’s Signature
Date

__________________________________
Printed Name

__________________________________
Investigator’s Signature
Date

__________________________________
Printed Name

____________________________________
Co-Investigator’s Signature
Date

____________________________________
Printed Name

The Auburn University Institutional
Review Board has approved this
Document for use from
05/02/2018
05/03/2017
_______________to_______________
17-140 EP 1705
Protocol # ______________________

7

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: “Generic Drug Substitution in
Special Populations”

You are invited to participate in a Food Drug Administration (FDA) funded
research study to gain insight into the alignment of clinical practice and generic
drug labels, including, but not limited to the communication between patients and
their doctors and pharmacists about drug guidance, risks, and instructions that are
unique to special populations. The study is being led 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 are 65 years or older of age
and are currently taking or have taken a prescribed generic medication with the last
month OR you are a parent or guardian of a child 18 years of age or younger who is
currently taking or has taken a prescribed generic medication within the last month
and are age 19 or older.
Should you choose to participate in this research study, you will take part in a focus
group with up to 8 other older adult patients where one or more of our team’s
researchers will lead a discussion regarding your current medications, the
communication you have had with your doctor about generic drugs, and ways you
would prefer receiving information about drug risks and instructions based on the
unique needs of individuals who are 65 years or older. Your total time commitment
will be approximately 60 minutes.
020 JAMES E. FOY HALL
282 WEST THACH CONCOURSE
AUBURN, AL 36849

TELEPHONE:
334-844-5152

There are few risks associated with this study. Any information you provide will
remain protected and will not be used by or given to a third party. Your
participation in this study will allow the study team to better understand how
patients talk to their doctors and pharmacists about the drug risks and instructions.
To thank you for participating in this study, you will be offered an honorarium of a
$75 check after the completion of the focus group.

FAX:
334-844-8307

Participant’s initials ______

The Auburn University Institutional
Review Board has approved this
Document for use from
05/02/2018
05/03/2017
_______________to_______________
17-140
EP 1705
Protocol # ______________________

8

The Auburn University Institutional
Review Board has approved this
Document for use from
05/02/2018
05/03/2017
_______________to_______________
17-140
EP 1705
Protocol # ______________________

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, IMPAQ International, or the FDA. However, your decision to
participate or withdraw may impact your receipt of the honorarium. Honorariums
will only be distributed upon completion of the focus group discussion.
If you agree, the group discussion will be 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 password
and firewall protected server at IMPAQ International. Audio recordings will be
destroyed immediately upon completion of the records. 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, but remain aware of our limits in protecting confidentiality.
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 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. Also,
records and written notes will have no identifying information attached to them, and
will only be used for analysis.
Personal information collected in connection to your honorarium 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.
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 (334)-844 5966 or e-mail at [email protected] or
[email protected].

9

__________________________________
Participant’s Signature
Date

__________________________________
Printed Name

__________________________________
Investigator’s Signature
Date

__________________________________
Printed Name

____________________________________
Co-Investigator’s Signature
Date

____________________________________
Printed Name

The Auburn University Institutional
Review Board has approved this
Document for use from
05/02/2018
05/03/2017
_______________to_______________
17-140 EP 1705
Protocol # ______________________