Law Enforcement Officer Recruitment and Informed Consent

Consent to be in a Research Study
Online training for law enforcement to reduce risks associated with
shift work and long work hours

1

Who is
conducting the
study?

NIOSH is a federal agency that studies worker safety and health. We are
part of the Centers for Disease Control and Prevention (CDC). NIOSH has
partnered with Washington State University (WSU) to carry out this pilot
study.

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What is the
purpose?

This pilot study will test a new online training program that NIOSH and
Washington State University developed to educate law enforcement
officers and their managers about strategies to reduce the health and
safety risks that are linked to shift work, long work hours, and not getting
enough sleep. The pilot study will examine participants’ sleep before and
after taking the training and ask their feedback on the training program.

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Criteria for police
officers
participating in
the pilot study

These are the criteria for police officers to participate in the pilot study.
•

Patrol police officer working full time (no alternate assignment
because of injury, illness, or other reasons)

•

Working fixed night shift including hours of midnight to 6 AM (no
rotating work schedules)

•

Not pregnant or planning to become pregnant during the 12 week
study period

•

No travel across three or more time zones in the previous 3 months
or plans for travel across three or more time zones during the 12
week study period

•

New patrol police officers in their first field experience after
graduating from the police academy who have worked less than 1
year as a police officer

•

Experienced patrol officers who have worked 2 to 10 years as a
police officer.

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What will I do?
When, where, for
how long will I be
needed?

1) If you are interested in participating, you will send an email to Dr. Claire
Caruso (policestudy@cdc.gov). After getting your email, she will
schedule a phone call at a convenient time that will take about 30
minutes. During the call, she will ask if you meet the study criteria,
explain the study, and answer your questions. Dr. Caruso will be
available by phone (513-533-8535) or email to answer your questions
during the study.
2) You will read and sign this informed consent and send it to Dr. Caruso in
a postage paid envelop.
3) NIOSH staff will insert your ID number on your survey, diary, and
actigraph files before sending these to you. The study number will
enable NIOSH study staff to connect all your survey and actigraph data
together. This will enable us to compare your responds before and after
taking the training. The study ID number will not be visible on the
actigraph device, diary, or survey.
4) NIOSH study staff will email you links for the surveys and diaries that
you will fill out during the study.
5) During the study, you will have four conference calls with Dr. Claire
Caruso.
6) You will have an initial 30-minute conference call with Dr. Caruso. She
will mail you a wrist actigraph, which you will wear to record your activity
and estimate the times of your sleep. Dr. Caruso will explain the study
including the actigraph, online sleep diary, surveys, and answer any
questions you have. You will fill out an online survey which asks basic
information such as your age, work experience, your sleep, and
worktime sleepiness.
7) For the next 28 days, you will keep an online sleep activity diary and
wear the actigraph. While wearing the actigraph, you will go about your
life as usual. You can remove the actigraph to bathe (although you do
not have to – they are waterproof). Otherwise please keep it
continuously on your wrist during this 28-day period. The online sleep
activity diary takes about 1 minute at the beginning of your day and 1
minute at the end to complete. We are using the sleep diary and
actigraph together so we can obtain a more accurate timing of your sleep
and activity.
8) During week 3 of the study, NIOSH study staff will send you a link for the
online training. This will take about 2 to 3 hours to complete. You can
take the training at any times that are convenient for you. You can take it
all at one time or over a series of several short time periods during week
3.
9) Immediately after taking the training, you will complete an online survey
that will check what you learned and will ask your feedback about the
training, for example what you liked or did not like. This survey will take
about 10 minutes.
10) You will continue to wear the actigraph and keep the online sleep activity
diary until the end of week 4 of the study.
11) At the end of week 4, you will have a 10-minute conference call with Dr.
Caruso to answer any questions. You will mail back to Dr. Caruso the
actigraph in a postage paid envelope.
12) No data collection occurs during the next 6 weeks which are weeks 5 to
10 of the study.
13) At the beginning of week 11 of the study, Dr. Caruso will mail you the
actigraph and you will have a 10-minute conference call with her to begin
wearing the actigraph and keeping the sleep activity diary for the next 14
consecutive days (during weeks 11 and 12 of the study).
14) At the end of week 12, you will have a 15-minute meeting with Dr.

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Caruso to complete a 5 minute online survey. It will ask about your sleep
and any changes you made since taking the training. Dr. Caruso will mail
you a gift card for $20, which will be a small token of our appreciation for
your participation in this pilot test. You will mail back the actigraph in a
postage paid envelope. After this conference call, your participation in
the study ends.

5

Are there any
risks?

We do not foresee problems from filing out the survey and sleep diary,
wearing an actigraph, and taking the online training program. Researchers
have safely used actigraphs for many years in studies. NIOSH study staff
will keep the list matching the study identification number and your name
and contact information on an encrypted folder on the NIOSH computer
network. Only NIOSH staff working on this project will have access to the
matched list. When we complete the study, we will destroy the matched list
with your study identification number and name. When we publish the
study results, we will report grouped data and will not report any
individual’s data. With these procedures, we think the chances are very low
that the confidentiality of your data will be lost.

6

Is my
participation
voluntary?

The study is voluntary. You may choose to be in the study or not. You may
choose to answer any or all questions. You may drop out any time for any
reason and without consequences to you. However, please keep in mind
that pilot testing the new training program is a critical part of developing
effective training. We expect that once we finalize the training and release
it to the public, law enforcement officers and their managers nation-wide
will benefit from it. By completing the pilot study, you will be helping the law
enforcement community across the nation.

7

What if I am injured
or harmed at a
NIOSH research
facility or at
another location
where the NIOSH
research project is
being conducted?

NIOSH will summon emergency medical aid by calling 911. If NIOSH finds
your injury was a direct result of participation in the study and if appropriate
documentation is provided, NIOSH may provide short-term medical
treatment that it deems necessary to treat the immediate medical needs
arising from the injury. In general, no long-term medical care or financial
compensation of research-related injuries will be provided by NIOSH, the
CDC, or the Federal Government. However, if you believe NIOSH has
been negligent in conducting the research study and you believe you have
suffered a harm as a result, you have the right to pursue a legal remedy
under the Federal Tort Claims Act (28 U.S.C. §§ 2671-2680 and 28 U.S.C.
§ 1346(b)). To learn more about how to file a Federal Tort claim, call the
General Law Division of the HHS Office of the General Counsel at (202)
619-2155 or go to https://www.hhs.gov/about/agencies/ogc/key-personnel/
general-law-division/index.html.

8

Will I be
reimbursed or
paid?

We will give you a gift card worth $20 after you complete the four
conference calls with Dr. Caruso. The gift card is a small token of our
appreciation for your participation in this pilot test.

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Are there other
benefits?

10 Will my personal
information be
kept private?

11 Will I or anyone
else receive
study results?

12 Who can I talk to
if I have more
questions?

The new training will give you strategies for coping better with shift work,
long work hours, and will give you strategies to improve your ability to sleep
well and be alert on the job. After you take the training program and use
the strategies in your daily life, you may benefit from improved health,
safety, and sense of well-being. Your relationships with family, friends, and
people at work may also improve because of improving your sleep and
other daily habits. Your long-term health may also improve as you use
these strategies since these reduce the chances for injuries due to fatigue
and the development of a wide range of chronic diseases like high blood
pressure, heart disease, and diabetes.

NIOSH is authorized to collect your personal information and will protect it
to the extent allowed by law. There are conditions under the Privacy Act
where your information may be released to collaborators or contractors,
health departments or disease registries, to the Departments of Justice or
Labor, or to Congressional offices. We will destroy your personal
identifiable information after we complete the data analyses.

The online training program includes a sleepiness scale that you will fill out.
The website points out that if your score is 10 or greater on the sleepiness
scale that raises concern. You may need to get more sleep, improve your
sleep practices, or seek medical attention to determine why you are sleepy.
A score of 13 indicates you should see your healthcare provider. If your
responses on the other sleep questionnaire indicate a high chance for a
sleep disorder, we will inform you by mail. We will not inform anyone
outside of the NIOSH research team about your responses on the surveys
or actigraphs. If you have concerns about your sleep or sleepiness, you
can contact Dr. Claire C. Caruso who can give information about finding an
accredited sleep disorders clinic.

For questions about the research study, contact the principal investigator,
Claire C. Caruso PhD RN, 1090 Tusculum Avenue MS C-24, Cincinnati,
OH 45226; policestudy@cdc.gov or 513-533-8535.
For questions about your rights, your privacy, or harm to you, contact the
Chair of the NIOSH Institutional Review Board (IRB) in the Human
Research Protection Program at 513-533-8591.
You can also contact the Chair of the Washington State University
Institutional Review Board (IRB) in the Human Research Protection
Program at (509) 335-3668.

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13 Your signature

The study was explained to me. My questions were answered. I agree to
be in the study.

__________________________________________________________
Printed name of participant

__________________________________________________________
Participant signature

Date

_________________________________________________________
Address

__________________________________
Phone number

___________________________________
Email address

I have accurately described this study to the participant. [Optional]

________________________________________________________
NIOSH representative signature
Updated March 29, 2016

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Date