Generic Drug Substitution in Special Populations

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 # ______________________

To  compensate  participant's  time,  we  will  offer  one  time  compensation  of  $25‐$100  to 
participants  who  participant  in  a  key  informant  interview  and  $75‐$275  to  participants  who 
participate in a focus group.  

The proposed compensation or “incentive” is not a reward or salary. Rather, it is a stimulus to 
participate in the interview. Proposed incentive rates are in accordance with standard practice 
and  based  on  several  factors  including  education  and  training,  level  of  expertise,  access  to 
participants,  and  willingness  to  participate.  More  specifically,  incentives  for  subspecialties  of 
physicians  and  pharmacists  are  based  on  these  factors  as  well  as  the  necessity  to  include 
representation from these subspecialties for their unique role in generic drug utilization among 
patients representing a special population. It is well documents in the research that money spent 
on the promotion of prescription drugs varies significantly between primary care providers and 
specialist,  ultimately  influencing  their  prescribing  patterns.[19]  Oncologists  and  surgeons  are 
more  likely  to  prescribe  high  cost  drugs.[20]  Likewise,  differences  in  dispending  policies  and 
incentives may uniquely influence retail‐based pharmacists and hospital‐based pharmacists.[21] 
Therefore, to ensure that we capture a complete picture of the beliefs, informational needs, etc. 
of generic drugs among primary care providers, specialists and high cost drug prescribers, such 
as  specialists,  it  is  key  to  the  success  of  this  study  that  the  research  team  is  able  to  recruit 
participants from each of these subspecialties. However, all physicians and pharmacists will be 
provided an incentive at the specialist or hospital pharmacist rate because one focus group will 
consist of all four groups (physician, primary care providers and specialists; pharmacist, retail and 
hospital).  

Incentives are based on Baltimore Research’s experience. Offering an incentive below these rates 
may result in increased costs exceeding the amount saved with a lower incentive. Consequences 
of insufficient incentives include increased time and cost of recruitment, increased “no‐show” 
rates, and increased probability of cancelled or postponed interviews and focus groups.  

Table: Respondent Compensation Rate 
Incentive Amount-FG
Group
Incentive AmountKII1
Physicians 
275
 Primary Care Providers 75

Pharmacists


Specialist

100

275

Retail

75

275

1

Incentives are based on physician specialty, level of expertise, years in school and average salaries. The more
schooling and training, the higher the incentive. Incentives are also based on willingness to participate. For
example, dermatologists are very difficult to recruit because their rate is high enough that it is more beneficial to see
patients than to participate in research. The $75 incentive is for retail pharmacists. The incentive for hospital
pharmacists is $100. These incentives are based on the pharmacist, availability, specialty and willingness to
participate. More specifically, retail pharmacists are more prevalent than hospital-based pharmacists, making
hospital pharmacists more difficult to recruit.

 Hospital
Patient/Caregiver

100
25

275
75

Incentives will be distributed upon completion of the interviews. All incentives will be 
distributed in a check paid by IMPAQ International. No taxes will be withheld. The name and 
address of the recipient and date mailed will be the only information noted. All financial 
records will be kept confidential and stored on a secure server. Information will not be shared 
with anyone outside of the IMPAQ financial staff. Upon completion of this project all 
confidential participant information not pertinent to financial record keeping will be destroyed.    

DEPARTMENT
OF HEALTH OUTCOMES
RESEARCH AND POLICY

AUBURN UNIVERSITY
HARRISON SCHOOL
OF PHARMACY

5/1/2017

Office of Research Compliance
Auburn University

Dear IRB review committee,
This memo is to support revisions of IRB protocol application #17-140, which has been submitted
for Aim 2 of a U.S. FDA funded project “Generic Drug Substitution in Special Populations” (grant #
1U01 FD005875-01). The purpose of this project is to identify research needs, monitor, and
improve generic drug substitution in special populations.
After the submission of the revision on 4/13/2017, we received the following feedback from Auburn
IRB committee:
“Waiver of signed consent for phone interviews granted (use term "Information Letter at top - not
informed consent).
Put all consent documents (focus group and phone interviews on letterhead)”
We thanks Auburn IRB committee’s approval of waiver of signed consent for phone interviews.
We’ve made the following changes to respond to committee’s comments:
1. We corrected the “informed consent” on the top of interview information letters as
“information letter”;
2. We put all consent documents for both focus groups and interviews on letterhead.
Please contact me if you have any questions.

Sincerely,

Jingjing Qian, PhD
Assistant Professor
Department of Health Outcomes Research and Policy
Auburn University Harrison School of Pharmacy
Auburn, AL 36849-5506
Phone: 334-844-5818
Email: [email protected]

022 Foy Hall, Auburn, AL 36849-5506; Telephone: 334-844-5152; Fax: 334-844-8307

w w w . a u b u r n . e d u

First revision memo sent on 4/13/2017

DEPARTMENT
OF HEALTH OUTCOMES
RESEARCH AND POLICY

AUBURN UNIVERSITY
HARRISON SCHOOL
OF PHARMACY

4/13/2017

Office of Research Compliance
Auburn University

Dear IRB review committee,
This memo is to support a revision of IRB protocol application #17-140, which has been submitted
for Aim 2 of a U.S. FDA funded project “Generic Drug Substitution in Special Populations” (grant #
1U01 FD005875-01). The purpose of this project is to identify research needs, monitor, and
improve generic drug substitution in special populations.
After the submission, we received the following feedback from Auburn IRB committee:

“10 - Identify who will recruit and consent
12b/13a We prefer signed consent for research which will be audio-recorded and in the case of
patients could contain information on medications they are taking whether you asked it or not.
Waiver for signed consent not granted.
15 No need to repeat first part of Internet section - can divide info between sections with the internet
part starting with "Recordings will be saved..."
Used signed consent language at end (your heading already was for signed consent)
Please add focus group confidentiality language to consent. IT can read something like the
following.
"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.”
Therefore, we’ve made the following changes to respond to committee’s comments:
1. We identified and added the personnel who will recruit and consent for this aim in the IRB
application form item 10;
2. We will use signed consent for focus groups and verbal consent (information letters) for key
informant interviews, which has been revised in the IRB application form item 12b/13a as
well as the supporting materials (signed consent documents for focus groups with the
suggested language, and focus group protocols). We hope the committee could consider to
allow us to waive for signed consent for key informant interviews because obtaining signed
consent from phone interviewees will be difficult and slow down the procedure;
3. We modified language in the IRB application form item 15 as suggested.

022 Foy Hall, Auburn, AL 36849-5506; Telephone: 334-844-5152; Fax: 334-844-8307

w w w . a u b u r n . e d u

We hope that we have addressed the committee’s comments. Please contact me if you have any
questions.

Sincerely,

Jingjing Qian, PhD
Assistant Professor
Department of Health Outcomes Research and Policy
Auburn University Harrison School of Pharmacy
Auburn, AL 36849-5506
Phone: 334-844-5818
Email: [email protected]

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