COPE Survey Consent

NHRC.2018.0016
Version #6, Date: 05JANUARY2024

Meets 2018 Common Rule Requirements
Naval Health Research Center
CONSENT TO PARTICIPATE IN RESEARCH
Title: Challenges of Operation Environments (COPE) Study
Principal Investigator: Jennifer Belding, PhD
You may be eligible to take part in this research study. This form gives you important
information about the study.
Please take time to carefully review this information. You should talk to the researchers about
the research study and ask them any questions you have. You may also wish to talk to others
(for example, your friends, family, or your personal physician) about your potential participation
in this research study. You do not have to take part in this study. Participation is voluntary.
You may also leave the research study at any time without penalization.
1. KEY INFORMATION: The purpose of this study is to learn more about the stressors
experienced by Sailors while assigned to ships. We are specifically interested in stressors
experienced by shipboard Sailors and are seeking volunteers who are assigned to ships. This
study was funded by the Defense Health Agency because they want to learn about specific
factors that affect the health, performance, and readiness of Sailors assigned to ships. This
study is being conducted by researchers at the Naval Health Research Center in San Diego,
California. Up to 86,000 people will take part in this study across several sites. Up to 6,000
will be asked to participate in discussions with study staff. Participation in this research study
is completely voluntary. If you have any questions, do not hesitate to ask them.
If you agree to participate, you will be asked to spend about 30 minutes completing an
anonymous questionnaire about your health, readiness, and experiences in a shipboard
environment. You will complete this questionnaire in one of three ways: (1) electronically, on
a tablet loaned to you by the study staff; (2) electronically, on a personal computer, using a
weblink provided by study staff, or (3) on a hard copy (paper) survey provided by study staff.
Study staff will announce which of these options is relevant to you during the consent
process. No personally identifying information will be collected on the questionnaire. Sailors
who participate in person while off duty will receive a $15 gift card for completing the
questionnaire to thank them for their participation. After completing the questionnaire, you
will receive the gift card if you can attest that you were off duty while you completed it.
Additionally, you may be asked to talk to one of our staff for 60 to 90 minutes about your
experiences being deployed at sea. This discussion will take place in a group setting with
several other service members who are also participating. In the discussion, a researcher
will ask the group approximately 15 open-ended questions. At the end of the discussion you
will also be asked to spend about 5-10 minutes filling out a questionnaire about your
personal characteristics

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and experiences. No personally identifying information will be collected during the
discussion or on the questionnaire. If you participate in person and while you are off duty,
you will be offered a $40 gift card to thank you for your participation. You can still
participate if you are on duty with appropriate permission from your command, but you will
not be able to receive a monetary incentive. Participants who complete remote data
collection will not be eligible for gift card incentives for survey completion.
There are no direct benefits to you for participating; however, the information learned from
this research study may help researchers improve the training, programs and services
provided to Sailors.
The investigators believe that the risks or discomforts to you from participating in this study
are minimal and include psychological discomfort and accidental disclosure of your
information. The questionnaire includes questions about your health and your experiences on
deployment or during field training operations at sea; if you feel uncomfortable answering
any of the questions you can decline to answer the question or end your participation
completely. If you feel particularly upset by any portion of this study, we encourage you to
call your regular healthcare provider or chaplain.
Several safeguards are in place to minimize the risk of accidental disclosure of your
information. For example, to protect your privacy and information, we will not collect your
name or other identifying information as part of your participation, and we will store all
study data on secure servers at the Naval Health Research Center. We may ask for your first
name and phone number if you choose to volunteer to participate in the telephone interview,
but we will destroy that information once the interview is complete. If you participate in a
discussion with study staff we will ask you, and other participants, to refrain from using any
identifying information such as names during the discussion. A full description of all
safeguards is provided below under “What health information will be collected and will it
be kept confidential?”
There may be other risks, which are unknown at this time.
If you decide to take part in this research study, you will be asked to indicate your consent to
participate by checking a box on this document. Before you check this box, be sure you
understand what the research study is about in all sections of the consent form, including the
risks and possible benefits to you.
Please tell the researchers if you are taking part in another research study.
2. WHAT IS THE PURPOSE AND DURATION OF THIS RESEARCH AND WHO
WILL TAKE PART?
You are being asked to take part in this research study because you are an active-duty Sailor
who has unique knowledge about challenges Sailors experience while assigned to ships that
may affect the health, performance, and readiness of shipboard Sailors. As you can imagine,
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we are more effective as researchers and health care professionals if we learn from you what
you are experiencing. The primary purpose of this study is to learn about how challenges
experienced while underway may affect the health and readiness of sailors. We are
particularly interested in learning about what can cause stress and health problems and
potentially reduce performance in shipboard environments. If you agree to participate, you
will be asked to spend about 30 minutes outside of working hours completing an anonymous
questionnaire either on a tablet, on the internet, or on paper.
You may also be invited to participate in a 60-90-minute conversation in a group setting
about your experiences while underway. During this discussion you will be asked about 15
questions.
There will be up to 86,000 people taking part in the study from multiple ships over the
course of a year. Up to 6,000 people will be asked to participate in focus group.
3. WHAT WILL HAPPEN IF YOU DECIDE TO BE IN THIS RESEARCH?
If you agree to participate, you will be asked to spend about 30 minutes outside of working
hours completing an anonymous questionnaire. No identifying information will be collected
on the questionnaire. You will be offered a $15 gift card to thank you for completing the
questionnaire if you complete it while off duty. You may also be asked to participate in a 6090-minute discussion with one of our research staff in a small group of other Sailors. You
will be offered a $40 gift card for participating in the discussion if you participate while you
are off duty. No identifying information will be collected during this discussion.
4. WHAT ARE THE RISKS OR DISCOMFORTS FROM BEING IN THIS RESEARCH?
The questionnaire and discussion include questions about your health and your experiences on
deployment or during field training operations at sea; if you feel uncomfortable answering any
of the questions you can decline to answer the question or end your participation completely.
If you feel particularly upset by any portion of this study, we encourage you to call your
regular healthcare provider or chaplain.
Although efforts are made to protect your research study records, there is always a risk that
someone could get access to the personal information researchers have stored about you.
Several safeguards are in place to minimize the risk of accidental disclosure of your
information, including labeling all data with a unique numeric code instead of personally
identifiable information, and storing all data on secure servers at the Naval Health Research
Center. We may ask for your first name, phone number, and/or personal email address to send
you a gift card code or if you choose to volunteer to participate in the interview or focus group
discussion, but we will destroy that information once the discussion is complete. If you
participate in a discussion with study staff, we will ask you, and other participants, if
applicable, to refrain from using any identifying information such as names during the

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discussion. A full description of all safeguards is provided below under “What health
information will be collected and will it be kept confidential?”
There may be other risks that we do not yet know about.
5. WHAT ARE THE POSSIBLE BENEFITS FROM THIS RESEARCH?
There are no direct benefits to you for taking part in the study. However, others may benefit
in the future from the information learned during this study. For example, the information
from this research study will help researchers improve training, programs and services
provided to Sailors.
6. WHAT ARE THE ALTERNATIVES TO TAKING PART IN THIS RESEARCH?
Participation in this study is voluntary, you do not have to participate in this research.
7. IS THERE COMPENSATION FOR YOUR PARTICIPATION IN THIS RESEARCH?
Yes, for your participation, you will receive: a $15 gift card for completing the questionnaire.
If you volunteer and are selected to participate in a discussion with study staff, you will
receive an additional $40 gift card. You will only be eligible to receive incentives if you
complete your participation in person and while off duty.
8. ARE THERE COSTS FOR PARTICIPATING IN THIS RESEARCH?
No, there are no costs to you for taking part in this research study.
9. PRINCIPAL INVESTIGATOR (the person(s) responsible for the scientific and
technical direction of the study):
Dr. Jennifer Belding at (619) 553-6889 or [email protected].
10. STUDY SPONSOR (the organizations or persons who oversee the study and are
responsible for analyzing the study data):
This study is being conducted by the Naval Health Research Center.
As the sponsor of this research, the Department of Defense may have access to your research
data in accordance with DoDI 3216.02.

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11. SOURCE OF FUNDING:
This research was funded by a grant awarded by the Defense Health Agency and the Office of
Naval Research.
12. LOCATION OF THE RESEARCH:
This study is being conducted by the Naval Health Research Center in San Diego, California.
13. DISCLOSURE OF FINANCIAL INTERESTS AND OTHER PERSONAL
ARRANGEMENTS:
There are no financial interests or other personal arrangements to disclose.
14. WHO WILL SEE MY INFORMATION (PRIVACY) AND HOW WILL IT BE
PROTECTED (CONFIDENTIALITY)?
Records of your participation in this research study may only be disclosed in accordance with
state and federal law, including the Federal Privacy Act, 5 U.S.C.552a, and its implementing
regulations. DD Form 2005, Privacy Act Statement - Military Health Records, contains the
Privacy Act Statement for the records. A copy of DD Form 2005 can be given to you upon
request, or you can read it online at:
https://www.esd.whs.mil/Portals/54/Documents/DD/forms/dd/dd2005.pdf
Federal regulations give you certain rights related to your personal information. If you
choose to be in this study, the study staff will obtain the following information about you,
including information that will identify you (first name, cell phone number, and personal
email address). Please note that no personal health information will be collected as part of
this study.
The research team will keep your research records. These records may be looked at by staff
from the Naval Health Research Center, the Institutional Review Board (IRB), and the DoD
Higher Level Review as part of their duties. These duties include inspection of your research
records to ensure that the rights and safety of all research participants are protected.
Confidentiality of your records will be protected to the extent possible under existing
regulations and laws but cannot be guaranteed.
Procedures to protect the confidentiality of the data in this study include but are not limited
to: using a study identification number instead of a name or other identifying information on
study data; never linking study data with potentially identifying information; destroying any
potentially identifying information as soon as gift card codes have been delivered; storing all
data on password-protected, secured servers at the Naval Health Research Center.
You will be asked to complete questionnaire that will contain questions about your personal
and professional experiences in the military. You may also be asked to participate in a
discussion. In the discussion, you will be asked not to use your name or other identifying
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information. However, if you do, all identifying information will be redacted from the audio
transcripts; also, all audio files will be permanently deleted as soon as they are transcribed. The
questionnaires will not include identifying information and all of the data we collect from you will be kept
private and confidential so that none of your responses can be linked back to you as an individual.

The Principal Investigator is responsible for storing all information collected about you during
the study. This information will be protected by storing all electronically collected data in
password protected files, on password protected computers, on the secure computer network at
the Naval Health Research Center. All files that may identify you (i.e. contact information such
as phone numbers and email addresses) will be stored separated from your study data so that it
will not be possible to link your study data to your contact information. Your contact
information will be destroyed or deleted within one month after data collection for the study is
completed.
Access to all data will be limited to staff involved in this study and will not be shared with any
other organizations.
Researchers will make every effort to protect your privacy and confidentiality; however,
there are risks of breach of information security and information loss.
If you participate in a focus group discussion we also ask that each of you respect the privacy
of everyone in the group and not share or repeat what is said during the discussion in any
way that could identify anyone here. However, since someone in the group may not obey
instructions to keep all comments confidential, we recommend that you avoid saying
anything that you don’t want to be repeated outside the group. We ask your cooperation in
protecting the privacy of the comments made within this session by not saying anything that
would identify you or other participants.
Information gained from your participation in this research study may be published in literature,
discussed for educational purposes, and used generally to further science. You will not be
personally identified when your information is shared in these ways; all information will deidentified.
15. VOLUNTARY PARTICIPATION
The decision to take part in this research study is completely voluntary on your part which
means you do not have to take part if you do not want to. You may also leave the research
study at any time. If you choose not to take part in this research study or if you leave the
study before it is finished, there will be no penalty or loss of benefits to which you are
otherwise entitled.
You will be informed if significant new findings develop during the course of this research
study that may relate to your decision to continue participation.
16. Long Term Use of Data
The Principal Investigator has requested to save selected data collected from your
participation in this study for use in possible future research. Since all stored data will have
no identifying links, the data is unable to be linked back to a specific participant. By
consenting to take part in this effort, you are also agreeing for the future use of your data as
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outlined in this consent. This future research may be in the same area as the original study or
it may be for a different kind of study.
Any future research using your retained data will require a research protocol for the
proposed study approved by an Institutional Review Board (IRB) (a committee
responsible for protecting research participants) or other authorized official responsible for
protecting human subjects of research. The data protections for privacy and confidentiality
described in this consent form will apply to any future use of your stored data.
17. WHAT HAPPENS IF I WITHDRAW FROM THIS RESEARCH?
Should you choose to withdraw, you must write to the Principal Investigator. If you do not
follow these procedures, you will still be considered an active participant in the study. If you
decide to no longer participate in this research study, no new information about you will be
gathered after that date and you may no longer be allowed to participate in the study.
Information that has already been gathered may still be used and, because all of your data will be
collected anonymously, there is no way to guarantee that it can be removed from the electronic
database for this study.
The principal investigator of this research study may terminate your participation in this
research study at any time if she determines this to be in your best interest, if you are unable
to comply with the procedures required, or if you no longer meet eligibility criteria.
18. CONTACT INFORMATION:
Principal Investigator (PI)
The Principal Investigator or a member of the research staff will be available to answer any
questions throughout this study.
Principal Investigator: Dr. Jennifer Belding
Phone: (619) 553-6889
Mailing Address: 140 Sylvester Rd. San Diego, CA 92106
Institutional Review Board (IRB) Office
If you have any questions about your rights as a research participant or if you have concerns
or complaints about the research study, please contact the IRB Chair by phone
619-553-8424 or email [email protected].
IF THERE IS ANY PORTION OF THIS DOCUMENT THAT YOU DO NOT
UNDERSTAND, ASK THE INVESTIGATOR BEFORE CONSENTING TO PARTICIPATE
IN THIS STUDY. YOU MAY CONSULT WITH YOUR PERSONAL PHYSICIAN OR
LEGAL ADVISOR, IF YOU WISH.
A signed and dated copy of this document will be given to you.

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CONSENT OF PARTICIPANT
By checking the box below, I agree that I have been provided time to read the information
describing the research study in the consent form. The content and meaning of this information
has been explained to me. I have been provided with the opportunity to ask questions. I
voluntarily consent to participate in this study.
By checking the box below, I have not given up any of my legal rights as a research participant.

Mark this box if you agree to participate

Date

SIGNATURE OF INDIVIDUAL ADMINISTERING CONSENT
(Can only be signed by an investigator or staff approved to administer consent)

Printed Name of Administering Individual

Date

Signature of Administering Individual

Date

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IRB NUMBER: NHRC.2018.0016
IRB APPROVAL DATE: 01/11/2024