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Informed Consent Form for Participation in Research
This Informed Consent Form is to be filled out by the members of Neuroscience in
Psychiatry Network 2400 who are willing to participate in the research on the impact of the
initial COVID-19 outbreak on young adults’ mental health. The official title of the study is
“The impact of the initial COVID-19 outbreak on young adults’ mental health: a longitudinal
study of risk and resilience factors.”
Name of Principal Investigator: Polina Len
Name of Organization: University of Cambridge
Name of Sponsor: Wellcome Trust, NIHR Cambridge Bioresource, and NIHR ARC East of
England
Name of Proposal: “The impact of the initial COVID-19 outbreak on young adults’ mental
health: a longitudinal study of risk and resilience factors”
This Informed Consent Form has two parts:
● Information Sheet (to share information about the research with you)
● Certificate of Consent (for signatures if you agree to take part)
You will be given a copy of the full Informed Consent Form
PART I: Information Sheet
Introduction
I am Polina Len, an active researcher from the Department of Psychiatry, University of
Cambridge. My team and I are interested in the effect of the COVID-19 outbreak on the
mental health of young adults, and we would like to invite you to participate in our study.
Please, read carefully the information provided below. You are free to discuss the details with
anyone you deem necessary/appropriate. There is no time constraint, so you can
communicate your decision whenever you feel ready. In case any part/term in this form is not
familiar to you, do not hesitate to ask. My colleagues and I will be glad to clarify every
detail.
Purpose of the research
The recent COVID-19 pandemic has brought the attention of the scientific community to
possible long-term side effects of the disease on the psychiatric conditions of patients. Even
though brain malfunction is not very common for younger generations, other mental health
issues, such as depression and mental distress, might become highly prevalent among young
adults. We have noticed a significant gap in the published materials regarding the long-term
effects of SARS-CoV-2 on this age group. In this research, we are trying to investigate the
relationship between young adults’ mental wellness and the COVID-19 pandemic, as well as
determine possible risk and resilience factors.
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Type of Research Intervention
This study will include several different self-report questionnaires mostly based on the Likert
scale, i.e. asking you to evaluate statements according to their plausibility/likelihood.
Example:
Q: During the past 30 days, about how often did you feel nervous?
All of the time | Most of the time | Some of the time | A little of the time | None of the time
Participant selection
In this study, we want to compare the state of mental health of young adults before and after
the initial COVID-19 outbreak - longitudinal effect. Thus, we are inviting all members of the
Neuroscience in Psychiatry Network 2400 (NPN 2400) cohort, who have successfully
completed all three home questionnaire packs during the 2012-2017 year period, have not
withdrawn consent in previous assessments, and are available online to take part in our
research.
⮚ STOP AND THINK: Did you understand what this study is about, and why were you
asked to participate in it?
Yes
No
Voluntary Participation
Please keep in mind that participation in this study is entirely voluntary. Your decision will
not affect your membership in the NPN 2400 cohort or your ability to receive medical help
from this or any other organization.
⮚ STOP AND THINK: Do you know that you can refuse to participate in the study if
you wish to? Do you understand that your decision does not affect your eligibility for
medical care or NPN 2400 membership?
Procedures
We are kindly asking you to help us investigate the impact of the COVID-19 outbreak on the
mental health of young adults. If you agree to participate in the study, you will be asked to
complete an online survey that consists of the following sections:
1. Four questionnaires about your general state and/or problems you might have
experienced over the last 2-4 weeks; the answers shall be given on a Likert scale, i.e.
ranging from ‘all the time’ to ‘none of the time’ / ‘not at all’.
2. Several surveys exploring your individual characteristics (such as self-esteem and
self-expression) and family/community interactions (such as parenting and
friendship).
Please, be informed we will be also assessing your personal information, such as age, sex,
education level, ethnicity, socio-economic status, etc. Hence, all necessary information will
be collected online (from you directly or from stored records) and kept confidential.
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Duration
All the survey materials are expected to be sent at the beginning of May 2020. We will close
the submission after 3 months in July 2020. You are encouraged to complete the survey
within this period.
If you agreed to participate in the study, we expect you to complete all surveys and answer all
the questions; otherwise, it won’t be possible for us to include the submission for the
evaluation.
⮚ STOP AND THINK: Can you tell me if you remember what kinds of information we
will be collecting? How long will you have to complete the questionnaires?
Risks
We are asking you to share with us some personal and confidential information about your
mental health and well-being, and you may feel uncomfortable talking about some of the
topics. You may skip any questions you don’t want to answer, and you may end the survey at
any time if you wish to do so. You do not have to give us any reason for not responding to
any question, or for refusing to take part in the research.
Benefits
Participating in this study may not benefit you directly, but it will help us learn more about
the influence of the initial outbreak of the COVID-19 pandemic and the first national
lockdown on young adults’ mental health and well-being.
Reimbursements
You will not be provided with any incentive to take part in the research.
⮚ STOP AND THINK: Can you tell me if you have understood correctly the benefits
that you will have if you take part in the study?
Confidentiality
If you participate in this study, all information you share with us will be kept completely
confidential. Each participant’s personal data will be stored with its own numerical
identification code that is unique to this study. The list connecting real names (values) to
these numbers (keys) will be kept in a locked file, available only to the Principal Investigator
and Research group. Study findings will be presented only in summary form, and your name
would not be used in any report.
⮚ STOP AND THINK: Do you understand the procedures that will be used to ensure
that any information you share will remain confidential?
Sharing the Results
The summary of results that we get from analyzing the data will be shared with each
participant individually before it becomes publicly available. Private information that we
collect will be kept confidential, and only non-identifying information will be included upon
publishing.
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Right to Refuse or Withdraw
Participation in this study is voluntary. You are not under any obligation to take part in this
research. If you wish, you can withdraw from the study at any point and without any
consequences. It is your choice and all of your rights will still be respected.
Who to Contact
Principal Investigator Len Polina
polina.len@nu.edu.kz
Research Group
Kushbassova Kamilla
kamilla.kushbassova@nu.edu.kz
Kuzembayeva Aruzhan
aruzhan.kuzembayeva@nu.edu.kz
Mamadil Zere
zere.mamadil@nu.edu.kz
Ethical approval for this study was granted by the Cambridge East Research Ethics
Committee under REC 12/EE/0250 for the first three assessments and REC 16/EE/0260
for the fourth assessment. The research team asserts that all procedures contributing to
this work comply with the ethical standards of the relevant national and institutional
committees on human experimentation and with the Helsinki Declaration of 1975, as
revised in 2008.
➢ STOP AND THINK: Would you like to clarify any details related to the information
above? Was everything clear for you regarding this project? Is there any additional
information you’d like us to provide you with?
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PART II: Certificate of Consent
(This section is mandatory)
I have read the foregoing information, or it has been read to me. I have had the opportunity to
ask questions about it, and any questions that I have asked have been answered to my
satisfaction. I consent voluntarily to participate as a participant in this research.
Print Name of Participant__________________
Signature of Participant ___________________
Date ___________________________
Day/month/year
If illiterate1, the following form is filled by a literate witness suggested by a participant
I have witnessed the accurate reading of the consent form to the potential participant, and the
individual has had the opportunity to ask questions. I confirm that the individual has given
consent freely.
Print name of witness_____________________
AND
Thumbprint of participant
Signature of witness ______________________
Date ________________________
Day/month/year
Statement by the researcher/person taking consent
I have accurately read out the information sheet to the potential participant, and to the best of
my ability made sure that the participant understands that the following will be done:
1. Online questionnaire will be sent to the participant
2. All obtained information will be kept confidential
I confirm that the participant was given an opportunity to ask questions about the study, and
all the questions asked by the participant have been answered correctly and to the best of my
ability. I confirm that the individual has not been coerced into giving consent, and the consent
has been given freely and voluntarily.
A copy of this ICF has been provided to the participant.
Print Name of Researcher/person taking the consent ________________________
Signature of Researcher /person taking the consent ________________________
Date ___________________________
Day/month/year
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