Participation information sheet for development of a training

needs assessment tool consent (adults)

CONFIDENTIAL

Title: Clinical Training Needs Assessment of clinical staff managing snakebite patients in hospitals in
Eswatini and Kenya – to inform future clinical training protocols

Lay Title: A study to identify the priorities for training in snakebite management for healthcare workers in
Eswatini and Kenya.

Principal Investigator: Rob Harrison Study Country: Eswatini and Kenya

Introduction:
This study aims to better understand the priority needs in snakebite management training for healthcare
workers in Eswatini and Kenya. The first part of the study is to develop a tool for assessing snakebite training
needs. In the second part of the study, this tool will be used in surveys of healthcare workers in Eswatini
and Kenya. This information sheet is for the first part of the study only.

Who is carrying out this study?

• This study is being carried out by the Liverpool School of Tropical Medicine Centre for Snakebite
Research and Interventions (LSTM CSRI), in collaboration with the Eswatini-Snakebite Research and
Intervention Centre (E-SRIC) and the Kenya Snakebite Research and Intervention Centre (K-SRIC).
• The LSTM CSRI is a leading UK research institute that is dedicated to improving the treatment of
snakebite envenoming, and it works closely with E-SRIC and K-SRIC to do so.
• The LSTM CSRI, E-SRIC and K-SRIC are all part of the African Snakebite Research Group, which is carrying
out research into snakebite across Africa.

What is this study about?

• In this study, we aim to better understand what healthcare workers think are their most important
training needs in relation to snakebite management. This information will be used to inform design and
delivery of training programmes in snakebite management.
• We are asking experts in snakebite management in lower or middle income countries to take part in
the first part of the study. The first part of the study will involve refining and agreeing adaptations to
the Hennessey-Hicks training needs assessment tool so it can be used in sub-Saharan Africa to
specifically assess training needs in snakebite management.

Training Needs Assessment/Consent Forms/Delphi Panel V1.0 22/04/2021

Participant number: _________________ Delphi Panel Participation Information Sheet

What will it involve for me?

• Taking part in this research is entirely voluntary. If you agree to participate in this research we will ask
you to participate in two stages of questionnaire development by modified Delphi methods.
• Firstly, we will ask you to provide online written feedback on the proposed training needs assessment
tool. We will ask you
o Whether you think each of a list of skills should be included or excluded from the tool
o Whether you would recommend any changes in how each skill is worded
o Whether you think any other skills should be added
We ask you to respond by 16th May 2021.
• The written feedback from all participants will be anonymised and collated. If necessary, a revised skills
lists will sent for a second round of written feedback.
• Secondly, all participants will be invited to an online workshop using Zoom to agree the final wording
of the tool. Audio participation will be required in the workshop. Video participation will be voluntary.
This workshop will be recorded to allow analysis of the transcript. Unless an additional round of written
feedback is required, we anticipate the workshop will take place 2-3 weeks the close of round one. We
have tentatively set a date of Wednesday 2nd June AM.
• If you agree to take part in the study, we ask you to sign a consent form identical to that shown below
via a secure online link to protect your personal details. You can download and save a copy of your
completed consent form for your own records. Completing the consent form will open the written
feedback form, which will have to be completed at the same sitting. Please therefore allow a minimum
of 20-30 minutes to complete the consent form, read the instructions for the written feedback and
complete the feedback form. You can complete the form at any point up the end of 16th May 2021,
when the survey will close.
• All those who consent will be invited to participate in all rounds to maximise the expertise consulted.
The invitation to the second round will be sent to the email address you provide in your consent form.
However, if your choice or diary availability means you cannot or do not wish to participate in all rounds,
you will be able to participate in whichever rounds you can or choose.
• If you have any questions about the study or participating in the study that are not covered in this
information sheet, please contact the researchers via Clare.Baker@lstmed.ac.uk and we will be happy
to answer by email or via an online meeting.

Are there any risks or disadvantages to me in taking part?

• This study involves interaction between participants. The group workshop will allow other participants
to hear and, if you choose to show your video, see you. Therefore, we cannot guarantee confidentiality.
None of your personal details will be shared and all participants will be requested to respect the
confidentiality of other participants by not disclosing any of the details of the study participants or
participant contributions.
• All written feedback will be anonymised before sharing with the expert panel, but it is possible that
participants may be able to identify other participants from their contributions. Again, none of your
personal details will be shared and all participants will be requested to respect the confidentiality of
other participants by not disclosing any of the details of the study participants or participant
contributions.
• We anticipate providing written feedback will take about 30 minutes per round and the online
workshop 2-3 hours.

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Are there any advantages to me of taking part?

There are no individual benefits, including financial compensation, for you in taking part in this study.
However, by participating you will help us refine a tool that will improve our understanding of snakebite
training needs in health care workers. This may help us to design better training programmes to improve
health care worker performance and improve the care of children and adults who have snakebite in the
future.

What happens if I refuse to participate?

Nothing. All participation in research is voluntary. You are free to decide if you want to take part. If you
do agree, you can change your mind at any time and withdraw yourself from the research. If you
withdraw from the study, identifiable information will be destroyed. However, information that has
already been used by researchers cannot be withdrawn from current or completed studies. While you
have been sent this invitation because of your professional expertise, participation is not required
because of your job. Your decision on whether you want to take part will not affect your employment.
Your manager or supervisor will not know whether or not you have taken part.

Who will have access to information about me in this research?

All our research records are stored securely in locked cabinets and on password protected computers. Only
a very small number of responsible people who are closely concerned with the research will be authorised
to view detailed information from participants. Individual and summary information we collect or generate
will be shared with the African Snakebite Research Group team, but only after information that could
identify people (for example, names and where they live) has been replaced with number codes, so that
individual participants’ identities are not revealed. This is known as pseudonymisation. The information
you provide will not be available to your supervisor or manager.
In future, information collected or generated during this study may be used to support new research by
other researchers in Eswatini, Kenya, Africa, UK or elsewhere. In all cases, we will again only share
pseudonymised information with other researchers, so that individual participants’ identities are kept
confidential. Any future research using information from this study must first be approved by a local or
national expert committee to make sure that the interests of participants and their communities are
protected.

Data Protection Notice

LSTM is the Sponsor for this study. We will be using information from you in order to undertake this study
and will act as the data controller for this study. This means that we are responsible for looking after your
information and using it properly. LSTM will keep identifiable information about you for ten years after the
study has finished.
Your rights to access, change or move your information are limited, as we need to manage your information
in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we
will keep the information about you that we have already obtained. To safeguard your rights, we will use
the minimum personally-identifiable information possible.
You can find out more about how we use your information at https://www.lstmed.ac.uk/privacy-statement.
LSTM Data Protection Officer can be contacted if you have any concerns about the collection or storage of
your personal data: dataprotection@lstmed.ac.uk
If you have any complaints about the handling of your personal data, you can contact the UK Information
Commissioners Office: https://ico.org.uk/make-a-complaint/
If you do not have internet access, please ask your research study liaison to assist you in making a complaint.

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Who has allowed this research to take place?

All research carried out by LSTM is approved by research ethics committees. This study has been approved
by the LSTM research committee. Research committees in Eswatini and Kenya are reviewing the relevant
later parts of the study that will be carried out in these countries using the questionnaire developed in this
part of the study. These committees look carefully at planned work and must agree that the research is
important, relevant to Eswatini and Kenya and follows nationally and internationally agreed research
guidelines before it can go ahead. This includes ensuring that all participants’ safety and rights are
respected.

Study Conduct
The Sponsor is ultimately responsible for the safe conduct of the study and the well-being of participants.
Any unforeseen circumstances will be reported to the Sponsor and dealt with appropriately.

Sponsorship and Funding

This research is sponsored by LSTM, and has been reviewed and been approved by LSTM Research Ethics
Committee. Later stages of the study are also being reviewed and approved by the Eswatini Research Ethics
Committee and the Kenya Research Ethics Committee. It is funded by the NIHR and the Wellcome Trust,
UK.

Complaints
If you have a concern about any aspect of this study, you should ask to speak to the researchers who will
do their best to answer your questions (Clare.Baker@lstmed.ac.uk). If you remain unhappy and wish to
complain formally, you can do this by contacting Robert Harrison, the lead researcher for LSTM CSRI. Details
can be obtained from the Brent Thomas, the programme manager for LSTM CSRI (+44-151-705-3180).
As study Sponsor, LSTM has insurance to cover this research study, which includes compensation cover in
the event that any claims arise from participation in the study.

What if I have any questions?

You are free to ask any of our staff any question about this research. If you have any further questions about
the study, you are free to contact:
Dr Jonathan Pons, Good Shepherd Eye Clinic, Good Shepherd Hospital, Siteki-Maphungwane Road, Siteki,
Eswatini. Email: jono@mabuda.com
Dr George Oluoch, Kenya-Snakebite Research & Intervention Centre, IPR, Karen, Nairobi (Email:
ogemosh@gmail.com)
Prof Robert Harrison, Centre for Snakebite Research & Interventions, Liverpool School of Tropical
Medicine, Pembroke Place, Liverpool L3 5Q9, UK (Email: Robert.Harrison@lstmed.ac.uk)
LSTM Research Ethics Committee Secretariat, Research Governance & Ethics Office, Liverpool Life
Sciences Accelerator Building, Room 221, 1 Daulby Street, Liverpool, UK L7 8XZ. Email:
lstmrec@lstmed.ac.uk

Training Needs Assessment/Consent Forms/Delphi Panel V1.0 22/04/2021

 Delphi Panel Consent Participant’s Copy

Participant’s copy

Consent form for: Clinical Training Needs Assessment of clinical staff managing snakebite patients in
hospitals in eSwatini and Kenya – to inform future clinical training protocols: Part 1 – Development of a
training needs assessment tool

Please initial box.

1. I confirm I have read and understood the information sheet dated 22/04/2021
(Version 1.0) for the above study. I have had the opportunity to consider the
information, ask questions and have had these answered satisfactorily.

2. I understand that participation in this study is voluntary and I am free to change

my mind and withdraw consent at any time, without giving a reason, without
any penalties.

3. I understand that data collected during the study may be looked at by individuals
from or delegated by LSTM and from regulatory authorities. I give permission
for these individuals to have access to my data.

4. I hereby declare that I have not been subjected to any form of coercion in giving
this consent.

5. I agree to the data about me collected in this study being stored for further use
in the future.

6. I understand that my personal data will be handled in accordance with European

Union Regulations.

7. I agree for quotes from me to be used anonymously in reports of this study.

8. I agree to participate in this study.

Signing this declaration does not affect your right to decline to take part in any future study.

Name of participant Date Signature

____________________________________ _________________ _________________________

(print name)

Training Needs Assessment/Consent Forms/Delphi Panel V1.0 22/04/2021