Are there any specific traumas generated by sailing on foiling boats? If so, What are they?
Dear participant, you are asked to be involved in this scientific study. Before deciding whether to participate or not, it is important that you are informed about the reasons for which the research is conducted and what the research participation will entail for you. Take all the time you need to carefully read this information and, if you wish, discuss it with your friends and relatives. Do not hesitate to ask questions if something (for example some technical term expression) is not clear to you or if you want more information.
Who is conducting this research and how many people will be involved?
This research will involve the Foiling Week participants who will give their consent, and is led by EXTREMESPORTMED and Foiling Week.
Why were you asked to participate in this study?
You have been asked to participate in this research as participant in the Foiling Week.
Why is this study so important ?
Hydrofoil is a relatively new technology in the sport of sailing.
The 34th edition of the America's Cup (2013; San Francisco, USA) was disputed with boats equipped with hydrofoil and in 2017, World Sailing included the Olympic class Foiling-NACRA 17- as part of the 2020 Olympic Games.
The hydrofoil is a technology that changes the performance requirements of the crews and allows sailing boats to reach speeds never reached so far: well above 40 knots (74 km/h, 46 mph).
The hypothesis of this study is that hydrofoil may change the incidence, the dynamics and the kind of injury events.
To date, no studies in scientific literature exist.
What is the purpose of the research?
This research aims to promote safety in sailing with hydrofoil, in particular 1) directing the research and development of protective equipment for the crew, 2) Obtaining indications for the design of foiling boats that limit the risks of man-boat trauma, 3) Providing guidelines for the safe organization of events involving this type of sail-crafts.
What happens if I agree to be involved in the study?
If you agree to participate in this research, you must sign the Informed Consent form.
At the end of each day of the regatta, you will be asked to answer a mini- questionnaire to classify any health problems or trauma you suffered from during or soon after your sporting activity.
How long is the study?
The study will last for the whole Foiling Week .
Anyway, you are free to stop participating in the research when you consider it appropriate, without having to provide any explanation.
In this case we invite you to promptly inform the research manager.
Are you obliged to be involved in this research?
Your decision to participate in this research is completely free and voluntary.
You are free to decide to withdraw from the research at any time and without giving any explanation, without any penalty or loss of benefits.
What risks are you exposed to by taking part in this research?
Is there a fee for your participation in the study?
There is no reward for your participation in the study. At the same time you will not have to pay anything to take part.
Who can you ask questions?
You have the right to ask questions about the research at any time at: E-mail: firstname.lastname@example.org
How will your privacy be protected?
Your consent to participate in this research means that you authorize the use of personal and sensitive data that will be collected anonymously for exclusive research reasons.
These data may also be compared for statistical purposes with similar ones from other epidemiological or clinical sources. All information (personal, clinical, etc.) collected during this research is confidential and will be treated in compliance with current legislation (Code regarding the protection of personal data).
At the end of the research the results may be published but participants identity will remain anonymous.
We also inform you that the original documentation concerning you can be viewed by the Promoter of the study or by its representatives, by the Ethics Committee or by the Regulatory Authorities, such as the Italian Ministry of Health, the Food and Drug Administration (United States), to verify that the information reported on the study documents is correct and true.
You may decide not to give your consent to the use of your data, but in this case you will NOT be able to participate in the search. You can also decide to withdraw your consent to participate at any time, but the information collected until your withdrawal can still be used as study data.
You have the right to see personal information concerning you, e.g. name, address, and you have the right to correct such data if necessary.
In the event that photos, videos or audio recordings are obtained by third parties, in order to better understand the dynamics of any occurred accidents, the identity of you /your child /of your tutelar will be protected or hidden. If necessary the face or the sail number will be darkened with apposite masks on the video while the audio will be deleted or altered with appropriate programs to camouflage the voice and make it unrecognizable.
In any case, the parents or legal guardians have the right to view the videos, authorize the reproduction, approving who will have access to the material and for how long it will be stored.
What does it mean to give informed consent?
If you consent to participate in the research, you will have to sign the attached consent form. Signing this form will in no way reduce your rights; it is only required to ensure that you have been fully informed about the study, that you understand its purpose and your involvement.
Before signing, please, check if you are all clear about the study and what you should do; if you have any doubts, do not be afraid to request further explanations.
If you have any questions, including those related to this study or concerning your rights, or if you believe you have been damaged in any way by participating in this study, please let the research manager know now or during the study by contacting him at the phone number shown below. The research manager and the staff who assist him in conducting the research will be happy to answer your questions. No pressure will be made on you to participate in this study.
This study was already approved by the Ethics Committee of the Politecnico di Milano, to which the principal investigator refers.
We thank you in advance for your help with this research!