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pdfDEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Centers for Disease Control
and Prevention (CDC)
Memorandum
Date
May 18, 2016
From
Angela M. Morley
Chair, NIOSH Institutional Review Board
Subject
IRB Exemption Determination for NIOSH Protocol 16-DART-01XM, "Survey of MSD
Prevention Tools/Methods: 10-year Follow-Up"
To
Brian D. Lowe
Project Officer, [NIOSH/DART]
On behalf of the NIOSH Human Research Protection Program (HRPP), I reviewed the
request to exempt 16-DART-01XM, and find this research activity (administration of the
survey) is exempt under 45 CFR 46.101(b)(2). This determination is valid for a period of
three years through May 17, 2019. However, we strongly encourage investigators to close
out exempt protocols as soon as NIOSH staff are no longer engaged in the research
activity, rather than waiting for a reminder of the three-year expiration date.
Please be aware changes to this protocol may not be implemented until they are reviewed
by the NIOSH HRPP and determined to be consistent with the exemption categories. You
will be reminded in three years (if the study has not been completed and closed) to submit
another request for continuation and to confirm that no changes have been made to the
protocol or the related science that would affect the ethical appropriateness of the
research or this exemption determination.
Please also be advised investigators remain responsible for the ethical conduct of
this study and for ensuring appropriate human research protections even for
research that is exempt from the regulations governing the protection of human
subjects in research.
If you have questions, please contact the HRPP at [email protected], or by telephone at
(513) 533-8591.
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Digitally signed by Angela Morley -S
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC, ou=People, cn=Angela
Morley -S, 0.9.2342.19200300.100.1.1=1000726807
Date: 2016.05.18 11:19:33 -04'00'
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0.1250X
Centers for Disease Control and Prevention
Date received
5/17/2016 e K Ashley
Request for Exemption from
Human Subjects Regulations
e G DeBord
Use this form to submit a protocol for exemption from human subjects regulations. See
HRPO Guide: Exempt Review Cycle for further details on how to complete this form.
1
Protocol identifiers
Leave protocol ID blank if not yet assigned.
CDC protocol ID: 16-DART-01XM
Protocol version number
Protocol title: Survey of MSD Prevention Tools/Methods: 10-year Follow-Up
Suggested keywords (optional). Enter each term in a separate cell:
ergonomics
2
version date
MSDs
Key CDC personnel
Name and degrees
User ID
SEV #
CDC NC/division
Brian Lowe, Ph.D.
bfl4
10556
NIOSH/DART
Brian Lowe, Ph.D.
bfl4
10556
NIOSH/DART
Investigator 2
Patrick Dempsey, Ph.D.
pbd8
9252
NIOSH/OMSHR
Investigator 3
Evan Jones, B.S.
eoj1
6568
NIOSH/DART
(FirstName LastName, Degrees)
Primary contact
(required)
Principal investigator
(required)
Investigator 4
Investigator 5
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 0.1250X
Version 1.0 2006-04-13
Page 1 of 3
Request for exemption from human subjects regulations
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. See HRPO Guide: CDC’s Research Partners for further details. Check one of the following.
No research partners.
Research partners are listed on form 0.1370, which accompanies this form.
5
Study participants—planned demographic frequencies
Report estimated counts (rather than percentages). Include participants at domestic and foreign sites. See HRPO
Guide: Exempt Review Cycle for definitions.
Number of participants
938
Location of participants
Participating at domestic sites
Participating at foreign sites
938
0
Sex/Gender of participants
Female
Male
Sex/gender not available
200
738
0
Ethnicity of participants
Hispanic or Latino
Not Hispanic or Latino
Ethnicity not available
0
0
938
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
6
0
0
0
0
0
0
938
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.
Research
involves interaction with children or obtaining identifiable private information about children
y
n
through surveys or interviews of others.
The exemption at category 2 is restricted when children are research subjects.
CDC Form 0.1250X
Version 1.0 2006-04-13
Page 2 of 3
Request for exemption from human subjects regulations
6.2 Exemption categories
Check all that apply. 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
Material submitted with this form
Check all that apply. Describe additional material in the comments section.
Complete protocol
Documentation in support of exemption 3b, if applicable (e.g., §308(d) Assurance of Confidentiality)
Peer reviewers’ comments or division waiver (NIOSH)
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
8
Additional comments
This data collection consists of a web-based survey that will only be administered to professional ergonomists with a
specific certification through one of the International Ergonomics Association (IEA) endorsed accreditations. This
highly specific group of eligible participants possess education at the level of a 4-year university degree plus postgraduate training in almost all cases. We do not believe that reading level assessements for written materials are
necessary as would be typical for surveys and consent forms for a worker population. An informed consent
statement is attached.
CDC Form 0.1250X
Version 1.0 2006-04-13
Page 3 of 3
16-DART-01XM Recd 5/17/2016 e K Ashley/G Debord
Project Officer: Lowe, Brian D.
Research Protocol FY16 MSD
NIOSH Study Protocol
TITLE OF PROJECT (Limited to 60 characters, including spaces. Please Do Not put the project
title in ALL CAPS.)
Survey of MSD Prevention Tools/Methods: 10-year Follow-Up
PROJ. OFFICER (Last, first middle)
Lowe, Brian D.
POSITION TITLE
Research Industrial Engineer
DIVISION/LABORATORY/OFFICE AND BRANCH
Division of Applied Research and Technology/Organizational Science
and Human Factors Branch
Email Address
[email protected]
TELEPHONE (Area code, number)
(513) 533-8161
HUMAN SUBJECTS:
Will this project utilize human
subjects?
(Yes/No)
Yes
VERTEBRATE ANIMALS:
Will this project utilize
vertebrate animals? (Yes/No)
No
Species of animals to be used:
n/a
Approximate number of animals
to be used:
Radionuclide Use? (Yes/No)
If “Yes,” please Address in the
Health and Safety Plan Section
n/a
No
-1-
Project Officer: Lowe, Brian D.
Research Protocol FY16 MSD
Table of Contents
Key Personnel ........................................................................................................... 3
A.
Background and Significance ................................................................................ 3
B.
Specific Aims ........................................................................................................... 4
C.
Study Design and Methods ..................................................................................... 5
D.
Study Environment ................................................................................................. 9
E.
Protection of Human Subjects ............................................................................. 10
F.
Inclusion of Women, Minorities, and Children ........................................................ 10
G.
Vertebrate Animals ............................................................................................... 10
H.
Staff Health and Safety Plan ................................................................................ 11
I.
References .............................................................................................................. 11
Appendices ....................................................................................................................... 12
-2-
Project Officer: Lowe, Brian D.
Research Protocol FY16 MSD
Key Personnel
A.
NAME
ORGANIZATION
ROLE ON PROJECT
Lowe, Brian
NIOSH/DART
Project Officer
Jones, Evan
NIOSH/DART
Computer/IT support
Statistical Support Team
NIOSH/DART
Statistical Support (ad hoc)
Dempsey, Patrick
NIOSH/OMSHR
Consultant
Background and Significance
The purpose of this project is to administer a large scale survey of ergonomics
professionals as a 10-year follow-up to a survey conducted of U.S. Certified Professional
Ergonomists (CPEs) by Dempsey et al and published in 2005 (see Appendix A). The project
will extend the original survey conducted by Dempsey et al (2005) in two ways: (1) the sample
will be broadened to the international community of ergonomics practitioners, and, (2) the
queried tools and methods will be modernized to reflect new and emerging technologies not
included in the original survey. The purpose of the original survey will be unchanged - to
gather information on the types of basic tools, direct and observational measurement
techniques, and software used in the field by ergonomics practitioners to assess risk factors for
musculoskeletal disorders and to evaluate workplace interventions (Dempsey et al., 2005). The
recent NIOSH intramural funding opportunity for small studies in the area of musculoskeletal
disorders (MSD) prevention offered a timely opportunity to conduct an important follow-up
survey to assess current trends in the field and compare/contrast the practice to the findings
reported in 2005.
The motivation for the original 2005 survey was to better understand the types of tools
and methods practitioners use, their opinions of these tools, and to potentially gain an
understanding of the constraints or preferences that influence this selection. At the time of the
2005 survey there were many tools reported in the literature, but little information on the extent
to which these different tools were used by practitioners. Similarly, there was little published
information on users’ experiences with these different tools. There has been considerable
interest in the findings and the Dempsey et al (2005) publication has been widely cited. We
anticipate that a follow-up effort will result in even greater interest as changes in the practice
of ergonomics and prevention of soft tissue MSDs can be inferred from comparisons between
the two surveys time points.
Since publication of the initial survey findings there has been a proliferation of smart
phone/smart device-embedded gyroscopic and linear acceleration sensors and related “apps”
for human motion and activity logging. Further, the capture of digital still photos and video is
now trivial with small touchscreen mobile pads, tablet and smartphones. In the 2005 survey
summary digital and video cameras were used by 87% and 96%, respectively, of the
respondents. Little is known about the extent to which ergonomics practitioners are using
-3-
Project Officer: Lowe, Brian D.
Research Protocol FY16 MSD
newer technologies towards assessing workplace physical activity (and now, workplace
inactivity and “sedentarism”) and other job demands. Thus, the survey will provide a
contemporary perspective on the scope of use of assessment tools and methods by these
professionals.
MSD Program Strategic Goal 16PPMSDSG2 is to: Reduce the incidence of workrelated MSDs by implementing practical and effective workplace interventions to reduce
exposure to MSD risk factors. This small study does not directly addresses the effectiveness
of various ergonomics and MSD prevention methods for assessing workplace interventions,
however the results will clearly be used to understand the prevalence of use of those methods
by practitioners within the discipline. Results of this study will have implications for
dissemination efforts related to musculoskeletal disorder risk assessment tools and methods
since they will provide insight into the current practices of ergonomics professionals. It is
ineffective to continue dissemination efforts for tools and methods that practitioners do not
have a need for or do not find useful.
The project is innovative in that we are not aware of any international formalized webbased survey of tools and methods used by ergonomics practitioners in the assessment of
workplace risk factors having ever been conducted. The study by Dempsey et al. (2005) is the
most comprehensive data we are aware of on the degree of use of various tools and techniques
for MSD risk factor assessment. With time, the development and acceptance of newer
technologies, and new emerging issues of relevance to the scope of ergonomics practice the
2005 study becomes increasingly dated.
B.
Specific Aims
The proposed project has the following aims:
Aim 1: Extend the original ergonomist survey population to include the international
community of practicing ergonomists. This will serve to better characterize the current scope
of practices of the international community of specialists working in the field of MSD
prevention and to formally determine international use of various tools and techniques.
Specific attention will be given to quantifying international use of the NIOSH Lifting Equation
(NLE) - to determine whether its high use (83%) reported among U.S. ergonomics
practitioners in 2005 is similar internationally, and if this use has increased domestically since
the 2005 survey.
Aim 2: Through modification to the original survey items and queries, determine the use of
contemporary technologies that in the 2005 survey were not yet available, or used by only the
earliest adopters. One specific example is the use of touch screen smartphone or pad/tablet
devices with photo and video capture capabilities, and associated use of mobile applications
(“apps” on Android, Apple iOS, etc., platforms.) A second example includes the class of
physical activity monitoring technologies based on popular consumer-grade
smartphone/smartwatch/app activity monitoring systems (e.g. “FitBit” and “Pebble” devices).
This aim aligns with Total Worker Health™ objectives related to physical activity promotion
as a part of workplace safety and health. Surveying the use of these technologies will assess
-4-
Project Officer: Lowe, Brian D.
Research Protocol FY16 MSD
the degree to which the ergonomics scope of practice may be evolving to include the
assessment of physical activity exposure at both extremes - occupational overuse vs.
occupational sedentarism. This topic has generated significant interest, evidenced by increases
in conference, journal and professional ergonomics publications (i.e. “Combating the
Sedentary Workplace: Is Sitting Too Much Bad for Your Health”, Ergonomics in Design, July
2015, vol 23, issue 3). The current use of these new technologies, as well as their desired use
among practitioners without access to them, will be determined to inform researchers about
dissemination choices that best match the current scope of practice.
C. Study Design and Methods
Phase I: Survey Update and Revision
This phase will consist of identifying tools and methods that should be added to the
existing questionnaire. Existing tools/items from the original survey will be kept unchanged
in their original format for facilitating direct comparison between responses at the two points
in time. Because of the international expansion of the survey we will add the response option
of “regulatory requirement(s)” as a reason for use of analysis methods. While this response is
not relevant to U.S. practitioners it may be so for international respondents.
New survey items to be added to the tools/methods list will be identified and pilot tested
in a manner similar to that described by Dempsey et al. (2005). The categorization of tools
and methods may require some restructuring in light of newer technologies. For instance, in
the 2005 survey the video camera, laptop, and personal digital assistants were individually
classified in the category of “Basic Measurement Tools” (section 6). As of 2015, pad or tablet
devices with an integrated camera (still and video image capture) serve as a hybridized version
of these tools. This will involve restructuring of the form. Another technologic example in
need of consideration is that of consumer gaming consoles that are now capable of lower
resolution markerless motion capture. This technology is moving closer to viability in field
environments for low cost assessment of worker motion in industry. Such technologies may
be worthy of consideration in section 8 – Direct Measurement Techniques. A second newer
technology to consider for inclusion in section 8 are physical activity monitoring devices in the
form of wearable smart devices.
We will further modify the survey to contain questions that cover use of apps from
smart device platforms by Google and Apple. Due to the large potential number of apps
(especially those centered on office ergonomics), the survey will ask about use of apps by
categories (e.g. office ergonomics, materials handling, etc.). Further, we will consult with the
internal NIOSH TWH program, and possibly its extramurally funded Centers, to identify
existing TWH toolkits and/or evaluation approaches (for example, the CDC Worksite Health
ScoreCard).
Because of the expansion of the survey to query ergonomics practitioners
internationally, a modification to response categories will be made to reflect regulatory
directives that exist outside of the U.S. A response option will be added to indicate that a
reason for using a measurement technique, tool, or method might be based on regulatory
compliance.
-5-
Commented [LBD(1]: It was decided that use of “apps” and
TWH methods will be queried as free response questions on the
survey.
Project Officer: Lowe, Brian D.
Research Protocol FY16 MSD
Another planned addition to the survey will be a question about effective modes of
dissemination of information. The purpose of this item will be to identify the types of
information products or sources (e.g. scientific literature, trade journal literature, society
newsletters, technical reports, professional conferences, mobile applications, etc.) that are most
utilized by ergonomics practitioners to keep informed about current and emerging issues,
assessment techniques and methods.
The pilot testing will have three steps:
1.
2.
3.
We will conduct an informal review of practitioner-oriented conference programs of
ergonomics societies (e.g. National Ergonomics Conference & ErgoExpo, Applied
Ergonomics Conference, etc), society newsletters, and possibly keyword search
frequencies in ergonomics databases. This will be for the purpose of identifying
emerging issues that have related methods and/or tools of relevance.
After integrating question items on what we identify as emerging issues, tools, and
methods not represented in the 2005 survey we will seek input on the updated set of
tools/methods and the resulting revision of the original survey questionnaire by the
NIOSH MSD Cross Sector Program.
A small group (less than 10) of certified ergonomics practitioners will be engaged to
participate in a survey pilot and provide feedback on the integration of new items into
the questionnaire and the web interface used to administer (a new aspect of the
survey). We intend to seek input from ergonomists in the U.S., Netherlands, UK,
Sweden, Switzerland, and Canada through participation in a pilot version of the
survey.
Feedback will be obtained through individual level telephone-based
debriefings/consultations. Inclusion of the international pilot group will also address
potential issues of country/cultural bias in the methods and tools included in the
survey. We will consider including faculty of university symposiums and short
courses that provide instruction on using selected tools (e.g. Harvard School of Public
Health, UCLA Ergonomics Symposium, U-Michigan, Center for Ergonomics, Ohio
State University courses, and others).
Commented [LBD(2]: These steps have been completed. We
received input from over 15 professional ergonomists in the U.S.,
Canada, and UK. We met with 10 U.S. ergonomists face to face at
the 2016 Applied Ergonomics Conference.
(Note: The revised questionnaire is shown in Appendix D.)
Federal information collection requests that involve survey administration with more
than 10 respondents require review and clearance by the Office of Management and Budget
(OMB). The timeline for this process is lengthy, and it can be expected to take up to one year
to obtain OMB clearance for this information collection request. After modification and pilot
testing of the questionnaire in October-February of FY16 the OMB clearance process will
commence. We have planned for the possibility of a full 18 months from project start date
(FY16 Q1) until the survey administration can commence in approximately March (Q2) of
FY17.
Phase II: Survey Method
-6-
Commented [LBD(3]: OMB review package will be submitted
in April, 2016.
Project Officer: Lowe, Brian D.
Research Protocol FY16 MSD
A similar approach to the 2005 survey will be followed (Dempsey et al, 2005) with the
exception that the survey will be administered on a web based platform. The project team
has determined that the use of SurveyMonkey® is authorized for CDC research use with
limitations that would not affect this information collection request.
Commented [LBD(4]: Survey Monkey will be used as the web
platform.
Sampling Strategy. In addition to the U.S. Board of Certification of Professional Ergonomists
(www.bcpe.org), from whom the investigators have obtained commitment from the Executive
Director (C. Stuart-Buttle), participation will be sought internationally from other certifying
organizations (see Table 1). These are primarily organizations that have been endorsed by the
International Ergonomics Association (IEA). We also plan to include the Canadian College
for the Certification of Professional Ergonomists whose certification requirements are
consistent with those of the U.S. BCPE. We have identified approximately 1,150 potential
respondents.
Table 1. Certification organizations whose members will be included as eligible participants.
Certification Organization
Country
Board of Certification in Professional
Ergonomics (BCPE)
U.S.
Access to # of
Directory Certificants
yes1
853*
AEP/CPE designation certificants
U.S. Total
European CREE in United Kingdom - Centre
for Registration of European Ergonomists
Australian Register of Certified Professional
Ergonomists
New Zealand BCNZE - Board for Certification
of New Zealand Ergonomists
Canadian College for the Certification of
Professional Ergonomists
International Total
853
European
Countries
Australia
no2
45643
yes1
20
New Zealand
yes1
15
Canada
yes1
241
319
1
Project team has full access to certificant holder contact information through public website or through
BCPE membership
2
Public access to certificant holder names, but not contact information. We will request contact
information from the organization.
We will only administer the survey in English as we do not have sufficient resources
for translation. We do not anticipate English language to be problematic for European,
Australian, New Zealand, or Canadian participants. Additionally, the team may explore the
possibility of involving relevant societies within developing nations. If this is feasible, these
would represent a secondary study population. Because certification processes in these
-7-
Commented [LBD(5]: Only 43 of these are in the United
Kingdom
Project Officer: Lowe, Brian D.
Research Protocol FY16 MSD
countries are likely to be unaccredited, or non-existent, responses from participants in this
secondary population would be analyzed as a separate cohort.
All eligible respondents will be sent an initial e-mail contact with a description of the
survey and its purpose (see Appendix B). This initial e-mail will be signed by the lead project
investigator for the purpose of giving eligible respondents advanced notice of forthcoming email correspondence that will contain a web link for survey completion. The e-mail contact
distribution list of eligible respondents will be obtained from listed directories of certificants
on the organizations’ websites (see Table 1). As a courtesy, we will give prior notification to
all of these organizations of our intent to solicit participation from their members. BCPE has
already endorsed this effort.
Since the survey emphasis is on musculoskeletal disorders prevention, certificants
within BCPE with a Certified Human Factors Professional designation (or equivalent) will not
be contacted as eligible respondents. Individuals with this designation, at least in the U.S., do
not typically engage in physical occupational ergonomics assessment nor musculoskeletal
disorders prevention. We will invite all certificant holder members of the organizations in
Table 1 to participate as eligible respondents. We will have the ability to accurately report
survey response rate as the number of completed surveys divided by a denominator term
comprised of the number of certificant-holders on the e-mail distribution list less any e-mail
addresses that are invalid. (E-mails that are returned due to invalid addresses will not be
counted in the denominator for purposes of participation rate.) Any individual from whom a
survey is not received (assuming a valid e-mail delivery) will be treated as a decline of the
invitation to participate. Recipients also have the option to actively decline participation in the
informed consent statement. (See Appendix C for informed consent statement.) Dempsey et
al (2005) did not discuss participation bias and we have no reason to suspect that nonparticipants would have any systematic differences in their use of tools and methods in practice
than those reported by participators who do complete the survey.
Contacting Eligible Participants. We will engage an outside contractor (TKC Global, SBACertified 8(a) Alaska Native Corporation) to coordinate electronic mailings to the membership
of the ergonomics certification organizations. Dedicated funds have been allocated for such a
contract award. After the initial e-mailing the external contractor will distribute individual emails each with a unique web link URL address (to the same survey). The URL will be
uniquely linked to a respondent’s identity so that the investigators can incentivize survey
participation. However, only survey responses and non-identifying personal information will
be submitted through the web. The survey contains no sensitive data and no personally
identifying information (PII) will be transmitted over the web through SurveyMonkey. The
linkage of names to survey item responses will be through the key to the anonymous unique
URL web addresses. This information will be delivered by courier to the NIOSH Washington,
DC Office by the contractor in northern Virginia. The Project Officer in Cincinnati will obtain
these master linkages from the NIOSH Washington Office over the CDC secured network.
Incentives to Participation. Various approaches to lightly incentivizing participation were
explored for their consistency with NIOSH HSRB policies and past success in recruitment. At
present, we are likely to forego any type of direct monetary incentive or time reimbursement
for the 20-30 minute web-based questionnaire. A limiting factor is that the project funding level
will preclude anything but a trivial monetary incentive for what could exceed 700 questionnaire
respondents (two-thirds participation rate) that we believe reasonable to anticipate. Past
-8-
Commented [LBD(6]: We will NOT do this within the present
IRB clearance request.
Commented [LBD(7]: Further information we have obtained
subsequent to this protocol development indicates that this is not a
feasible approach due to data confidentiality concerns. We will
NOT use an outside contractor.
Commented [LBD(8]: We will NOT use a monetary
reimbursement or any type of incentive.
Project Officer: Lowe, Brian D.
Research Protocol FY16 MSD
experience (Dempsey et al, 2005) indicates that many participants will contribute this time out
of professional interest and good will.
Follow-up. Follow-up reminders (two) will be sent to survey non-responders approximately
four and eight weeks after the first notification is mailed. Six months will be allocated for
survey administration (Q3-Q4 FY17) from the time initial e-mailing is sent to the final
tabulation of data prior to statistical analysis.
Phase III: Data Analysis and Publication
Dempsey et al (2005) reported a response rate of 53% in the original survey, and we
hope to achieve a significantly higher response rate with an easier web-based questionnaire
requiring no physical mailing of paper surveys. Thus, we hope to exceed 700 respondents.
Analysis of the original survey consisted of descriptive statistics, primarily percentages
responding affirmatively for use of each method or tool and frequency of use for each method
or tool. This analysis will be repeated for the present survey administration. For those tools
and methods repeated from the original survey Chi-squared tests on the proportions (proportion
reporting affirmative use) will be conducted to determine if changes in the proportions are
statistically different between the 2005 and present follow-up survey. For the various methods
and tools we will also explore a conversion of the reported frequency of use categories (once per year,
once every 6 months, once every 3 months, once a month, more than once a week) to ordinally scaled
categories suitable for a more powerful non-parametric test, such as Wilcoxon-Mann-Whitney (Siegel
and Castellan, 1988). This analysis would test for changes in frequency of use of the particular
tool or method among the U.S. CPEs from pre-2005 to present. This would be more
informative than simple changes in affirmative use. A priori sample size calculations are
unnecessary as we will be inviting the population of eligible respondents to participate. The
only factor limiting us from reporting population statistics will be the non-participation
proportion. Statistical support for the project is available through the Division of Applied
Research and Technology Statistical Support Team.
An additional 6-12 months after the survey administration phase is completed will be
dedicated to data analysis and preparation of publications and information products. These
publications would be prepared in FY18. Thus, the three-year project timeline was proposed.
We anticipate a publication in a peer reviewed journal (e.g. Applied Ergonomics) and a NIOSH
published information product, in a format to be determined, that describes the state of the art
in Ergonomics and MSD prevention. We will explore other modes of dissemination of the
findings through the certification organizations from which we recruit participants (listed in
Table 1).
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Project Officer: Lowe, Brian D.
D.
Research Protocol FY16 MSD
Study Environment
Facilities:
CDC/NIOSH/DART, Robert A. Taft Laboratory Building, 1090 Tusculum Ave, Cincinnati,
OH 45226 (Rooms 344, 435, etc.): At this site, NIOSH/DART staff (Lowe, Jones) will
monitor the overall project, perform data analysis, and generate publications.
CDC/NIOSH/OMSHR, Pittsburgh, PA: Dr. Dempsey, at the NIOSH Pittsburgh facility will
collaborate with the Cincinnati-based investigators in all aspects of the project.
Major equipment:
The major equipment available for this project include:
DELL Desktop and Laptop Computers
CDC/NIOSH/DART Rooms 417, 435
Software :
• Stata v. 11
• SAS v 9.2
• Web based survey administration platform
(Survey Monkey)
E.
CDC/NIOSH/DART Room 349 Taft Building
CDC/NIOSH/DART Room 435
CDC/NIOSH/DART Room 435
Protection of Human Subjects
This project will involve the collection of non-sensitive data via web-based survey
questionnaire methods. Survey data relate only to respondents’ professional practice within
the OS&H discipline of ergonomics. Nonetheless, safeguards will be taken to insure data
confidentiality and the dissociation of personally identifying information (PII) from individual
questionnaire responses. The survey administration platform allows the investigator to use an
e-mail invitation to send a unique URL survey link to each eligible respondent that ties survey
response to the respondent’s email address. This feature will be used for the purpose of
tracking which individuals responded and for validating that completed surveys originate from
eligible participants.
Participants’ web responses will not contain PII in association with their submitted data, but
the investigators will have a linkage between respondent’s personal identity (name) and the individual
unique URL entry to the survey. Thus, participants’ identity will not be sent over the web through the
survey administration system but the investigators will know the identity of individual respondents.
Informed consent for participation in this study is straightforward. We anticipate approval to use
electronic informed consent in which participants will acknowledge consent by "I agree" or "I
decline" buttons on the website. (See Appendix C.) Basic demographic information collected
over the web, including years’ experience in the field, current occupation, expertise
specialization, highest academic degree attained would not compromise anonymity of the
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Project Officer: Lowe, Brian D.
Research Protocol FY16 MSD
individual identity. We do not believe that any of the demographic information would be
considered sensitive. No experts we discussed this with suggested that the questionnaire content
contained any sensitive information.
F.
Inclusion of Women, Minorities, and Children
The study population of professional ergonomics practitioners does not include children. Inclusion of
women and minorities is automatic because the entire population of eligible respondents will be invited
to participate. We anticipate participation among women and minorities in proportion to their
demographic make-up in the membership of the societies from which we will solicit participation.
Among U.S. ergonomists (BCPE organization) we anticipate a sample that is representative of female
and minority participation in the ergonomics field. The representativeness of the study respondents will
be compared to the known demographic composition of that organization’s membership to the extent
feasible.
G.
Vertebrate Animals
Not applicable.
H.
Staff Health and Safety Plan
There will be no laboratory or field data collection involving interaction with research participants in
this project. Project staff will work in their NIOSH offices. Standard NIOSH facility staff health and
safety plans are applicable to this study. Since there will be no laboratory activity associated with this
research, laboratory health and safety plans are not applicable.
I. References
Dempsey, P.G., McGorry, R.W., and Maynard, W.S. (2005). A survey of tools and methods used by
certified professional ergonomists. Applied Ergonomics, 36, 489-503.
Siegel, S. and Castellan, N.J. (1988). Nonparametric statistics for the behavioral sciences. New
York: McGraw Hill.
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Project Officer: Lowe, Brian D.
Research Protocol FY16 MSD
Appendix A – Dempsey et al (2005) article – “A survey of tools and methods used by certified
professional ergonomists”.
Appendix B – Sample invitation e-mail to all eligible participants
Appendix C – Informed Consent Statement
Appendix D – Revised questionnaire instrument.
- 12 -
Project Officer: Lowe, Brian D.
Research Protocol FY16 MSD
Appendix B – Sample invitation e-mail to all eligible participants
Dear ________:
We are writing to let you know about a survey of certified Ergonomics professionals that will
be conducted by the U.S. National Institute for Occupational Safety and Health in the next few
weeks. The purpose of the survey is to investigate what tools are most commonly used by
practicing Ergonomists, and the frequency of use. Although there are many measurement and
assessment approaches available, little formal feedback to the research community is
available. Such feedback has the potential to inform the development of future tools and
techniques. Practitioners can benefit as well, as the survey results will provide an opportunity
to compare the tools you use to those used by a larger sample of Ergonomists.
A similar survey was conducted among Ergonomists practicing in the U.S. in 2004 by the
Liberty Mutual Insurance Company. The upcoming survey represents a follow-up to that study
and the study group will be broadened to include certified ergonomics professionals
internationally. You are receiving this invitation to participate based on your certified
credentials in the practice of Ergonomics through one of the several accredited organizations
we have identified. You will be receiving information about how to complete the online survey
in the next few weeks, and we hope you will take a few minutes to share your opinions with
your fellow Ergonomists. Participation in this survey is, of course, completely voluntary.
We anticipate publishing the survey results in multiple formats, and we look forward to sharing
these results openly.
Sincerely,
Brian D. Lowe, Ph.D., CPE
Patrick G. Dempsey, Ph.D., CPE
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Project Officer: Lowe, Brian D.
Research Protocol FY16 MSD
Appendix C – Informed Consent Statement
[This statement will appear when the respondent launches the web-site link. The
survey can not be started unless the “Accept” button is clicked.]
Statement of Consent to Participate In Survey
If you agree to participate in this research, you will be asked to complete a survey with
questions about tools and assessment methods used by professional ergonomists like yourself.
The questionnaire should take about 30 minutes to complete. There is no direct benefit to you
from taking part in this study. This research is intended to improve our understanding of the
use of various tools and assessment methods in the field of ergonomics related to the prevention
of musculoskeletal disorders. We plan to report these findings in a peer-reviewed journal.
Your individual data will be handled as confidentially as possible. When results are
reported, personally identifiable information will not be used. No personally identifying
information will be collected through the web-based survey. The linkage of submitted
questionnaire responses to individual identity is only accessible to the project Principal
Investigator to assure the legitimacy of each respondent’s certification. (We have only sent email invitations to participate to ergonomists with professional certification in the United
States, Canada, United Kingdom, Australia, and New Zealand.)
You will not be compensated for taking part in this survey. You are free to decline to
participate and you can decline to answer any question(s) or stop taking part in the survey at
any time. If you have any questions about this research, please feel free to contact Brian Lowe
at the U.S. National Institute for Occupational Safety and Health (NIOSH): [email protected].
If you have questions about your rights or treatment as a participant in this study, please contact
the NIOSH Human Subjects Review Board Office at: [email protected].
By clicking the ACCEPT button below you are consenting to participate in this study.
⃝ ACCEPT
⃝ DECLINE
[Respondent who click this option will continue to the questionnaire as
participants.]
[Respondents who click here will receive the message “Thank you for your
time and consideration given to participating.” There will be no further
action for them.]
- 14 -
| File Type | application/pdf |
| File Title | CDC Memo Template |
| Subject | CDC Memo Template |
| Author | CDC |
| File Modified | 2016-05-18 |
| File Created | 2016-05-18 |