IRB Approval Letter

KDHRC Institutional Review Board
FWA00011177, IRB 00005850, IORG0004908
Edward Morgan, Chair

PROTOCOL APPROVAL
DATE:

January 16, 2020

TO:

Kristen Holtz, Ph.D.
Principal Investigator
KDH Research & Communication

FROM:

Edward Morgan, IRB Chair

PROTOCOL:

FDA ETC Focus Groups

MEETING DATE:

January 14, 2020

APPROVAL DATE:

January 15, 2020

EXPIRATION DATE:

December 31, 2020

IRB APPROVED DOCUMENTATION:
Materials submitted to the IRB
•
•
•
•
•
•
•
•
•
•
•

Attachment A: Research Protocol
Attachment B: Consent Form – Study 1
Attachment C: Screener – Study 1
Attachment D: Screener Contact Sheet – Study 1
Attachment E: Discussion Guide
Attachment F: Ranking Worksheet – Study 1
Attachment G: Rating Worksheet – Study 1
Attachment H: Stimuli [for reference only]
Attachment I: Screener – Study 2
Attachment J: Recruitment Flyer – Study 2 [for reference only]
Attachment K: Consent Form – Study 2

1

Actions taken
The IRB reviewed the project in accordance with the 45 CFR Part 46, Subpart D Federal Regulations
which provide for additional protections for children as research subjects. The Principal Investigator
asked the IRB to take the following actions:
•
•
•
•
•
•
•
•
•

Review and vote on the research protocol (Attachment A)
Review and vote on the consent form – study 1 (Attachment B)
Review and vote on the screener – study 1 (Attachment C)
Review and vote on the screener contact sheet – study 1 (Attachment D)
Review and vote on the discussion guide (Attachment E)
Review and vote on the ranking worksheet – study 1 (Attachment F)
Review and vote on the rating worksheet – study 1 (Attachment G)
Review and vote on the screener – study 2 (Attachment I)
Review and vote on the consent form – study 2 (Attachment K)

Outcomes
Outcome 1: The IRB determined that the research study meets the criteria found in the risk category
described as follows:
•

45 CFR 46.404: “Research not involving greater than minimal risk.”

Outcome 2: The following documents received full approval
•
•
•
•

Attachment D: Screener Contact Sheet – Study 1
Attachment E: Discussion Guide
Attachment F: Ranking Worksheet – Study 1
Attachment G: Rating Worksheet – Study 1

Outcome 3: The following documents received conditional approval pending chair-only re-review of
requested changes:
Protocol - Attachment A
1. Request for change: make change to ordering of inclusion criteria for study 2. LGBTQ+ should
come first.
• Revisions made: re-ordered inclusion criteria. See highlighted text on page 8 of protocol.
2. Request for change: add “will” under General Methods on page 5
• Revisions made: added “will” to sentence. See highlighted text on page 5.
Consent Form – Study 1: Attachment B
1. Request for change: delete repeated “Certificate of Confidentiality” sentence on page 3.
• Revisions made: deleted repeated sentence. See highlighted text on page 3.
2. Request for change: delete “youth” in last paragraph.
• Revisions made: deleted “youth” and replaced with “consent”. See highlighted text on
page 4.

2

Screener – Study 1: Attachment C
1. Request for change: add name of vendor.
• Revisions made: vendor is yet to be selected. Once the vendor is selected, we will ask
IRB approval via amendment.
Screener – Study 1: Attachment I
1. Request for change: include language that indicates that potential participants should only
mention letter and not option.
• Revisions made: include language that indicates selection of letter. See highlighted text
on pages 2 and 3.
Consent Form – Study 1: Attachment K
1. Request for change: delete repeated “Certificate of Confidentiality” sentence on page 3.
• Revisions made: deleted repeated sentence. See highlighted text on page 3.
2. Request for change: delete “youth” in last paragraph.
• Revisions made: deleted “youth” and replaced with “consent”. See highlighted text on
page 4.
3. Request for change: add “up to nine participants” on page 1.
• Revisions made: added “up to nine participants”. See highlighted text on page 1.
4. Request for change: fix the following typos:
i. Page 2 – add “s” on “other”.
ii. Page 3 – add “article” before incentive.
• Revisions made:
i. Added “s” in sentence. See highlighted text on page 2.
ii. Added “the” in sentence. See highlighted text on page
Outcome 4: Revised materials were submitted to the chair, who reviewed and approved the changes on
January 15, 2020. The following documents received full approval after chair re-review. The IRB issued
final disposition forms showing approval of the documents for use in an external research project.
•
•
•
•
•
•
•
•
•

Attachment A: Research Protocol
Attachment B: Consent Form – Study 1
Attachment C: Screener – Study 1
Attachment D: Screener Contact Sheet – Study 1
Attachment E: Discussion Guide
Attachment F: Ranking Worksheet – Study 1
Attachment G: Rating Worksheet – Study 1
Attachment I: Screener – Study 2
Attachment K: Consent Form – Study 2

3

Conclusion:
If there are any changes to the IRB approved materials and reference only materials, IRB approval will be
needed prior to use.

1-16-20
________________________
IRB Chairperson

__________________
Date

4