Consent for study participation
Track-and-field master athletic cohort (TaFMAC): an international study of the benefits and risks of maintaining exercise over the lifespan for health
Information to research persons
We want to ask you if you want to participate in a research project. In this document you will get information about the project and what it means to you to participate. If you chose to participate in the research project, you complete and return the consent form.
What is the project and why do we want you to participate?
World Master Athletic Stadia Championship engages many track-and field athletes worldwide who maintain training and competition throughout their life. Maintaining a high level of physical activity is important for body function and health. We are an international group of researchers that investigate the connection between athletic training, body function and health. Our aim is to follow the athletes during 10 years. You are asked to participate in this study as you have registered to participate in the World Masters Athletic Stadia Championship in Gothenburg 13-25 of August 2024. We collaborate with the organizer of the competition World Masters Athletic in order to send an invitation to you. It is possible that you have participated in the project previously.
This study has been approved by the Ethical Commission of North Rhine, Cologne, Germany (ref no 2020401) for the Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany. The responsible organization for the research in Gothenburg is the University of Gothenburg. The measurements in Gothenburg have been approved by the Swedish Ethical Review Authority (diary no xxx).
What happens if you chose to participate in the study?
When you have provided consent for participation in the study, you will take part of several tests. Before the competition you will complete several questionnaires online by logging-in to our digital system. You will answer questions on training level, medical history, wellness, socioeconomics, intake of food and nutrition supplements, menstruation, sleep pattern, falls, injuries and problems with tendons. We will also ask for your competition results.
In connection to the competition in Gothenburg we will do following measurements:
These measurements are performed at the competition stadia and in the labs of the Center for Health and Performance that is located close to the stadia. The total time for the physical tests is 3-4 hours, equally distributed between stadia and labs. Measurements are performed by experienced researchers including medical doctors and trained students. Blood samples are taken by an experienced nurse employed at the health care in Västra Götaland Region, Sweden. All measurements follow routine and security standards.
Resting energy expenditure measurement is performed in lying position with a plastic canopy over the with fresh air passing through to breath normal. The air flow, oxygen and carbon dioxide are analyzed.
Cardiorespiratory fitness is performed on a cycle ergometer where the load is increasing until exhaustion. You breathe through a face mask for analyse of respiratory volume, oxygen and carbon dioxide. An electrocardiography (ECG) is performed simultaneously.
Body composition is determined with DEXA on full body in lying position to assess muscle mass, fat mass and bone density. DEXA use a low level of x-ray harmless for the body. Simultaneously, body composition is determined using bioelectrical impedance analyses (BIA), where a very weak, harmless electrical current goes through your body. Fat leads electrical current slower than muscle tissue, and the method allows the determination of the composition of body fat and muscle tissue.
Possible consequences and risks with participation in the project
You will take part of all your results. None of the methods and measurements performed will add more load, effect on the body or discomfort that is experienced during the competition. The exercise test of cycle ergometer is of short duration and will not contribute to exhaustion interfering with competition performance. The x-ray methods used contain only weak radiation with no risk of negative effect on the body. If any problems will occur, there are medical doctors in the research team that will call for additional medical expertise if required. If we observe any deviant results, we will return with recommendation on additional examinations.
What happens with your information?
The research project collects and registers information about you. Your answers and results will be handled in a way that no unauthorized person has access to them. Name, study participant ID, contact information and questionnaire data will be stored on a protected server the the Institute of Aerospace Medicine, German Aerospace Center, Cologna, Germany, which is the international coordinator for this research project.
Data collected in Gothenburg 2024 will be stored on a protected server at the University of Gothenburg. Only authorized researchers in the project at the University of Gothenburg can login to access the data. Blood samples will be sent to labs of search collaborators outside Sweden for analyses. Name and civic number will be replaced with a study code (pseudonymization) for all data collected in Gothenburg. Data collected in Gothenburg will be shared with research collaborators in the project. Formal agreements will be signed between collaborating research institutes before data sharing to guarantee safety.
All data and results in the research project will be stored on the protected server at the Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany. Data will be shared with all collaborators in the project. Shared data will not contain name, civic numbers or contact information, only study-ID, and therefore not connected to you. The key for translation between study-ID and other data will be stored on the German server only, but separated. Before data is shared, formal agreements will be signed between collaborating research institutes to guarantee safety. Data collected in connection to the competition in Gothenburg will be related to data from previous competitions and forthcoming competitions to answer our research questions
The purpose of handling personal information is for research, where GDPR (EU 2016/679) and the law of public access to information and secrecy (2009:400) is applied. The research project has been approved by the Swedish Ethical Review Authority (diary no xxx). Data collection at previous competition and before the competition in Gothenburg has been approved by the Ethical Commission of North Rhine, Cologne, Germany (ref no 2020401) for the Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.
According to GDPR you have the right, without any fee, to get access to your registered information, required that wrong information is revised or that the information is deleted. You also have the right to restrict the use of your personal information or object to the treatment. The right to delete or restrict the use of the personal information are not applied if the information is essential for the research. If you want to get access to your information, you contact responsible researcher Associate Professor Daniel Arvidsson at the Department of Food and Nutrition, and Sport Science, University of Gothenburg, Skånegatan 14b Gothenburg, phone +46 707 44 41 64. The Data Protection Officer at the University of Gothenburg can be contacted by email dataskyddsombud@gu.se or phone number +46 31 98 90 00. If you are dissatisfied with how your personal information is handled, you have the right to complain to the Swedish Authority for Privacy Protection.
What happens with the blood samples?
Blood samples taken during the competition in Gothenburg will be coded (pseudonymized), which means that they will not be directly linked to you as a person. Blood samples will be stored temporarily in the lab of the Center for Health and Performance, Department of Food and Nutrition, and Sport Science, University of Gothenburg. They will later be sent to respective lab of the collaborating researchers outside Sweden for specific analyses. Blood samples will be destroyed immediately after analysis and not stored in a biobank. The blood samples can only be used in accordance with your consent, i.e. for analyses of DNA, genetical biomarkers and biomarkers for cardiometabolic health (e.g. blood glucose, blood fats).
How will you be informed about the results from the research project?
All participants will be provided their own results. Results from the research project are planned to be presented in the form of scientific publications or at scientific conferences. The scientific publications will preferably be in open-access journals, which are public accessibly. You will be informed about unexpected findings and how you get in contact with relevant medical experts.
Insurance
Participants in the study are protected by an injury insurance from Kammarkollegiet covering injuries occurred during measurements in Gothenburg. Blood sampling is covered by the Swedish Patient Insurance.
Voluntary participation
Your participation in the research project is voluntary and you can at any time cancel it. If you decide to not participate or want to cancel it, you do not need to explain why, and it will not affect any future medical treatment of health care.
If you want to cancel your participation, you contact the researcher responsible for the project (contact information below).
You may have participated in this research project at previous competitions and may be asked for participation in forthcoming competitions. Your participation in 2024 does not mean that you say yes to forthcoming competitions. You will be asked for participation in connection to these competitions.
Responsible for the research project in Gothenburg
Associate Professor Daniel Arvidsson, nutritionist Center for Health and Performance
Department of Food and Nutrition, and Sport Science Skånegatan 14b
Box 300
SE-405 30 Gothenburg
Phone: +46 707 44 41 64
Email: daniel.arvidsson@gu.se