IRB Exemption Letter

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service
Centers for Disease Control
and Prevention (CDC)

Memorandum
Date

May 25, 2017

From

Angela M. Morley
Chair, NIOSH Institutional Review Board

Subject

IRB Approval of Amendment for NIOSH Protocol 17-PMRD-02XM, "Mobile Proximity
Initial User Feedback" (Exemption)

To

Jennica Bellanca
Project Officer, NIOSH/PMRD

The NIOSH Human Research Protection Program (HRPP) received your submission for
review of changes to exempt protocol 17-PMRD-02XM, "Mobile Proximity Initial User
Feedback.” I find this research activity remains exempt under 45 CFR 46.101(b)(2). The
following modifications were reviewed and approved.
1. Increase number of participants.
As a reminder, additional changes to this protocol may not be implemented until they are
reviewed and determined to be consistent with the exemption categories. Also, you will
be asked to confirm that no changes have occurred in the protocol or the related science
that would affect the ethical appropriateness of the research or this exemption from the
current expiration date of January 27, 2020.
Please be reminded that the investigators remain responsible for appropriate human
research protections even for research that is exempt from regulations for protecting
human subjects.
If you have any questions, please contact the HRPP at [email protected], or by telephone
at (513) 533-8591.

0.1252X

Centers for Disease Control and Prevention

Date received
5/24/2017 J Bellanca

Request for Review of Changes to
Exempted Protocol
Use this form to seek exemption for changes to a protocol that HRPO has deemed exempt
from human subjects regulations. See HRPO Guide: Exempt Review Cycle for further
details on how to complete this form.

1

Protocol identifiers
CDC protocol ID: 17-PMRD-02XM
Protocol version number 3 version date 5/24/17
Protocol title: MOBILE PROXIMITY INITIAL USER FEEDBACK
Amendment number:
Amendment title or brief descriptor (optional):
No change in keywords. If no change, please skip to section 2.
Suggested keywords (optional). Enter each term in a separate cell:

2

Key CDC personnel
No change in key CDC personnel. Please list all CDC investigators.
User ID

SEV #

CDC NC/division

Jennica Bellanca

wje9

12351

NIOSH/OMSHR/PMRD

Jennica Bellanca

wje9

12351

NIOSH/OMSHR/PMRD

Investigator 2

Justin Helton

ndhi1

4309

NIOSH/OMSHR/PMRD

Investigator 3

Michael McNinch

msv1

17841

NIOSH/OMSHR/PMRD

Investigator 4

Dana Willmer

dpr4

5881

NIOSH/OMSHR/PMRD

Investigator 5

LaTasha Swanson

mre6

11983

NIOSH/OMSHR/PMRD

Name and degrees
(FirstName LastName, Degrees)

Primary contact
(required)

Principal investigator
(required)

SEV # is CDC’s Scientific Ethics Verification Number. CDC NC/division is the national center (or equivalent) and
division (or equivalent), or coordinating center or office if submitted at that level.
List all other CDC investigators, if any. Include name and degrees, user ID, SEV #, CDC NC/division:

3

CDC’s role in project
Check yes or no for each of the following.
y
n CDC employees or agents will obtain data by interacting with participants.
y
n CDC employees or agents will obtain or use identifiable (including coded) private data or biological
specimens.
y
n CDC employees or agents will obtain or use anonymous or unlinked data or biological specimens.
y
n CDC employees will provide substantial technical assistance or oversight.
y
n CDC employees will participate as co-authors in presentation(s) or publication(s).
“Agents” includes on-site contractors, fellows, and others appointed or retained to work at a CDC facility
conducting activities under the auspices of CDC.
CDC Form 0.1252X
Version 1.0 2006-04-13

Page 1 of 4

Request for review of changes to exempted protocol

4

CDC’s research partners
Research partners include all direct and indirect recipients of CDC funding (e.g., grants, cooperative agreements,
contracts, subcontracts, purchase orders) and other CDC support (e.g., identifiable private information, supplies,
products, drugs, or other tangible support) for this research activity, as well as collaborators who do not receive such
support. On review of changes, HRPO needs current information on partners that have been added or dropped since
the last review. See HRPO Guide: CDC’s Research Partners for further details. Check one of the following.
No research partners have been added since the last review.
Research partners have been added and are listed on form 0.1370, which accompanies this form.

5

Study participants—planned demographic frequencies
No change in planned demographic frequencies. If no change, please skip to section 6.
Report estimated counts (rather than percentages). Include participants at domestic and foreign sites. See HRPO
Guide: Exempt Review Cycle for definitions.
Number of participants
250
Location of participants
Participating at domestic sites
Participating at foreign sites

250
0

Sex/Gender of participants
Female
Male
Sex/gender not available

0
0
250

Ethnicity of participants
Hispanic or Latino
Not Hispanic or Latino
Ethnicity not available

0
0
250

Race of participants
American Indian or Alaska Native
Asian
Black or African American
Native Hawaiian or Other Pacific Islander
White
More than one race
Race not available
Comments on demographics

CDC Form 0.1252X
Version 1.0 2006-04-13

0
0
0
0
0
0
250

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Request for review of changes to exempted protocol

6

Regulation and policy

6.1 Exceptions or restrictions on exemptions
Check yes or no for each of the following.
y
n Research poses greater than minimal risk to participants.
CDC does not exempt research that poses greater than minimal risk to subjects.
y
n Research involves prisoners (either intentionally or incidentally).
These exemptions do not apply to research involving prisoners.
y
n Research involves interaction with children or obtaining identifiable private information about children
through surveys or interviews of others.
The exemption at category 2 is restricted when children are research subjects.

6.2 Exemption categories
Check all that apply to the modified protocol. See HRPO Worksheet for Exemption from Human Subjects
Regulations for details.
Educational practices
1
Normal educational practices in commonly accepted educational settings
Educational tests, surveys, interviews, or observation of public behavior
2a Adults only; data are not identifiable
2b Adults only; data may be identifiable but are not potentially damaging
2c Children; limited to use of educational tests or observations of public behavior when the
investigators do not participate in the activities being observed
3a Public officials or candidates
3b Federal statute requires confidentiality during and after research
Existing data, documents, records, pathological specimens, or diagnostic specimens
4a Publicly available sources
4b Information recorded by the investigator such that participants cannot be identified, directly or
through linked identifiers
Research and demonstration projects (subject to the approval of the HHS Secretary)
5a Public benefit or service programs
5b Procedures for obtaining benefits or services under those programs
5c Possible changes in or alternatives to those programs or procedures
5d Possible changes in methods or levels of payment for benefits or services under those programs
Taste and food quality evaluation and consumer acceptance
6a Foods that are wholesome without additives
6b Foods that contain an ingredient, chemical, or contaminant at a level found to be safe

7

Summary of proposed changes
Describe and justify proposed modifications to the protocol, except for modifications justified above. Include page
numbers in reference to clean copy (and marked copy if possible). Continue summary in supplemental document if
necessary.
The participant number is being increased from 175 to 250 (page 2).

CDC Form 0.1252X
Version 1.0 2006-04-13

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Request for review of changes to exempted protocol

8

Material submitted with this form
Check all that apply. Describe additional material in the comments section. Clean and marked copies are required
for modified materials. Entire documents may not be needed if there is enough context to enable a meaningful
review. Optional items may be requested by HRPO.
Clean Marked
Complete protocol
Consent, assent, and permission documents or scripts
Other information for recruits or participants (e.g., ads, brochures, flyers, scripts)
Data collection instruments (e.g., questionnaires, interview scripts, record abstraction
tools)
Certification of IRB approval or exemption for research partners being added

9

Additional comments
All materials are located in one document.

CDC Form 0.1252X
Version 1.0 2006-04-13

Page 4 of 4