IRB Approval Study #1

Institutional Review Board
Registration Number 00000900

8 May 2015
James Bethea, Principal Investigator
Danya International, Inc.
#9 Corporate Blvd., Suite 1100,
Atlanta, GA 30329
RE: “Review of Existing CDC Materials” – Study #1
Contract No. 200-2009-TO-31372-TO-0058
Division of Community STD Prevention (DCSTDP),
Centers for Disease Control & Prevention (CDC)
Dear Mr. Bethea:
This will confirm that the Danya International, Inc. Institutional Review Board (IRB) met in
expedited session (Chairman plus one other reviewer) on 13 March 2015 to review the abovecaptioned research project’s Initial Review Memo, Proposal Statement of Work, research
protocol, draft survey instruments, focus group questions, consent forms, facilitator guides, and
other data collection instruments. (In all, there were 16 attachments (forms, etc.) submitted to
the IRB; each was viewed separately.) This was an Expedited Review and an Initial Review for
this project. The project was conditionally approved, with numerous changes required. What
follows summarizes your project’s approach and then details the IRB’s conclusions.
Overview of the Research Project
Danya has received funding from CDC's Division of STD Prevention (DSTDP) to address the
immediate need for useful communication resources to reach target populations, and to optimize
the use of available technology to deliver timely, accurate STD-related information to target
audiences, including staff in STD programs; clinicians; and affected populations, such as
adolescents and men who have sex with men (MSM), and the general public. Danya will be
conducting message testing of existing CDC informational materials to gauge the overall
message effectiveness and usability of those materials. To this end, among other activities under
the grant, Danya plans to conduct the following study:


Study 1--Online Surveys: Danya will conduct anonymous online surveys with groups of
adolescents (ages 15 - 24) (n = 75) and men who have sex with men (MSM) (n = 75).
Respondents will answer survey questions about how much they like images and messages found
on existing fact sheets as well as a brief demographics section.

This study will be conducted online using Think Tank for the online focus groups. Project staff
are located in the Atlanta and Silver Spring offices of Danya. In Study #2, Danya researchers
hope to recruit a total of 20 clinicians, 20 adolescents, and 20 MSMs for focus groups.
The researchers will use the feedback garnered from focus groups to modify and update CDC
fact sheets and informational materials to make them more relevant and appropriate for intended
target audiences. Pending completion of the studies with key stakeholders, feedback will be
generalized and prioritized in our report to the client; feedback will be used in developing

8737 COLESVILLE ROAD, SUITE 1200 SILVER SPRING, MARYLAND 20910 TEL: (301) 565-2142
FAX: (301) 565-3710 www.danya.com

recommendations for revisions to materials and suggested next steps. All materials will be
revised, as appropriate, and re-posted on the CDC-INFO website for download.
Online surveys will be completely anonymous, thus there will be no confidentiality issues. All
identifying information for focus group participants will be collected during recruitment. All
focus group participants will be asked to use only their first names when logging into the focus
group and will be encouraged to not share personal or identifying information during the focus
group. An experienced moderator will ensure that personal responses are addressed.


Study 1 – Potential respondents will be e-blasted a link to their respective survey.
Respondents interested in completing the online surveys will follow the link to the
survey. Each survey should take respondents approximately 7-10 minutes to complete.
Survey responses will be anonymous.



For the MSM target group, Danya will utilize the National Prevention Information
Network (NPIN), partners from Community Based Organization (CBO), and any
recommended DSTDP partners. Danya staff will provide key contacts with links to both
the online survey and the focus group screener, with brief descriptions of each study, to
be e-blasted to potential participants. Danya staff will also post the links and brief study
descriptions on its social media channels.



For the adolescent target group, Danya will be working with Advocates for Youth, which
champions youth involvement in sexual and reproductive health advocacy. Similar to
recruitment for the MSM group, Danya will provide our contact at Advocates for Youth
with links to the survey and focus group screener to be e-blasted to their listserv. Danya
staff will also post the links and brief descriptions on its social media channels.



All focus group participants will receive a check for their participation: clinicians will receive
$100, and MSMs and adolescents will receive $50. Because the researchers are relying on
recruitment partners to e-blast the survey links to potential youthful respondents, they will have
very limited control over the diversity of our survey participants. That said, it is anticipated that
the pool of potential focus group participants will be limited based on the recruitment partners’
reach, as well as by the modest incentives being provided focus group participants. In contrast,
the clinician group’s recruitment will come heavily from DSTDP’s health department contacts,
NPIN, Prevention Training Centers (PTCs), and potentially health care provider professional
organizations such as the American College Health Association or the National Medical
Association. Similar to the other groups, links to the survey and focus group screener, as well as
brief descriptions of the studies, will be e-blasted to listservs and posted on Danya's social media
channels.



Focus group participants will be encouraged to not share any personal or identifiable
information. All questions are designed to garner feedback regarding the likability of
informational materials and perceived usefulness or effectiveness of the materials and should not
garner any sensitive information from participants.

IRB Actions
The IRB has determined that this project is minimal risk and without any direct benefits to study
participants. It received a “conditional” approval in March 2015, based on changes required in
ten (10) major areas, as follows:

2

Attachment 1/Planned Enrollment Tables for Study 1a (MSM Online Surveys) Incorrect totals are included under "Racial Category". The totals for "Males" and "Total"
= 70 not 75.
.
2. Attachment 4/DSTDP Survey for MSM - Define STD in introduction. Define CDC at
first use. Each image should include a reference number so that questions pertaining to
that image are more obvious. It is difficult to follow which image some of the questions
are referring to (see pages 3, 4, 5 and 6).
1.

Attachment 5/Adolescent Online Survey - Each image should include a reference number
so that questions pertaining to that image are more obvious. It is difficult to follow which
image some of the questions are referring to (see pages 3, 4, 5 and 7). A high proportion
of adolescents may not understand the words "stereotypical" or "stigmatizing."
.
4. Attachment 6/Clinician Screener. No message to eligible, ineligible respondents.
3.

5.
6.

Attachment 7 /Clinician Focus Group Participant Consent procedures.






At page 1, "Procedures" - Please include the total number of study participants
(20) in addition to the number of participants to be included in a given focus
group (6-8). PLEASE NOTE THAT THIS COMMENT APPLIES TO EACH
CONSENT.
Please briefly descibe how a transcript of the focus group will be "generated
automatically". PLEASE NOTE THAT THIS COMMENT APPLIES TO
EACH CONSENT.
"Privacy", 2nd paragraph - Please expound on where information will be kept
secure. Specifically, expound on "locked place" . PLEASE NOTE THAT
THIS COMMENT APPLIES TO EACH CONSENT. Please indicate whether
email addresses will be kept and for how long (this is relevant to each consent
form).

7.

Attachment 8/Clinician Focus Group Moderator's Guide – At page 8, iii, #6: Does
Question #6 ("…does it address questions or needs you'd have when taking a patient's
sexual history?") apply to the Pocket Guide in question (STD Treatment Guidelines) or
does it apply to "Guide to Taking a Sexual History"?

8.

Attachment 11/ MSM Focus Group Moderator's Guide:
 At page 1, Item B.e. - Revise "…, please also think about consider how…" to
read, "…, please also think about how…".
 At page 1, Item D.c. - Revise "Why do you and go to these sources?" to read
"…Why do you go to these sources?".
 At pages 7-8, questions 2 (Line A), 3 (Line B) and 4 (Line C) - Item "i" for
Lines A, B and C should be revised from "…would not be helpful for gay or
bisexual men.." to read "…would not be helpful to gay, bisexual or other
MSMs…".
 At page 10, Item "f" - Revise "…appropriate and relevant for gay or bisexual
men.." to read "…appropriate and relevant for gay, bisexual or other
MSMs…".

3



9.

At page 10, Item "g" - Revise "…important to a gay man…" to read
"…important to MSMs…"

Attachment 12/Adolescent Focus Group Screener - Please specify when and how the
parent/guardian will be contacted for permission. Revise term "adolescents, ages 15-24,"
to adolescents and young adults, ages 15-24."

10. Attachments13, 14 and 15. Revise "youth, ages 15-24," to "youth and young adults, ages

15-24."
11. Attachment 16/ Adolescent Focus Group Moderator's Guide:







At page 3, Item "d. iii." - This item is blank, please delete.
At page 4, Item "f. iii." - Revise "Is there or images…" to read "Are there
other images…".
At page 12, Item "D. 1" - Revise "…not for gay or bisexual men or other
MSMs, etc." to read "…not for youth, etc."
At page 12, Item "D. 2" - Revise "Is this designed for gay or bisexual men or
other MSMs?" to read "Is this designed for young people?"
At page 12, Item "D. 3" - Revise "…for gay or bisexual men or other MSMs?" to
read "…for young people?".

Conclusion and Approval to Begin Data Collection
The answers to the above questions and all the required changes related to these questions were
reviewed and approved by the IRB Chairman and the IRB Coordinator on 2 April 2015 and
approved. Data collection efforts may now commence. It is your responsibility to notify your
government project officer, your government contract officer that your project has been reviewed
and approved.
Please note that you are required to notify the Danya IRB immediately if you make changes to the data
collection protocol that affect the participants. This initial approval is effective for 12 months from the
date the IRB met and approved the project, after which time your project must again be presented to the
IRB for an annual review.

If questions, please feel free to contact me.

Sincerely yours,

John P. Bellassai

John P. Bellassai, JD
Authorized Institutional Official
Danya International, Inc.
/jpb

4