Informed Consent Document

Garmin-RUNSAFE Running Health Study

Dear Runner,

You are invited to join the research study entitled “Garmin-RUNSAFE Running Health Study”, in which the relationship between running activity, personal characteristics and running-related injuries will be investigated. Participation in this study is voluntary. You have the right not to participate at all or to leave the study at any time. Deciding not to participate or choosing to leave the study will not affect you in any way, result in any penalty or loss of benefits to which you are entitled, and it will not harm your relationship with Garmin Ltd. and/or RUNSAFE, Denmark. The decision to join, or not to join, is up to you.


WHAT IS INVOLVED IN THE STUDY?

If you chose to participate in the study, you provide RUNSAFE researchers with valuable data from the time of enrollment to December 31st 2020. Should you decide to leave the study before December 31st 2020, the data flow will terminate on the day of disengagement. During the study period, you:

- Are free to schedule your running activities as you like. There are no requirements regarding when, where and why you run.
- Are not asked to follow any particular running or exercise program, the study is purely observational.
- Must agree to have your Garmin Connect data shared with RUNSAFE researchers (See below for more information on confidentiality and anonymization).
- Will receive baseline-, weekly- and monthly- questionnaires by e-mail, and there may also be additional questionnaires on an ad-hoc basis.
- Are free to leave the study at any time.


BENEFITS OF PARTICIPATING IN THE STUDY?

It is reasonable to expect the following benefits from this research:

(i) You contribute to an improved understanding of the causes of running-related injuries and, ultimately, better prevention strategies through real-time feedback on running activity.

(ii) You will receive a monthly newsletter by e-mail from RUNSAFE regarding study progress and novel scientific findings from RUNSAFE as well as other research groups working with running-related injuries.

(iii) From a public-health perspective, the findings from this study will contribute to reduced socio-economic costs for injury treatment.

However, we can’t guarantee that you will personally experience benefits from participating in this study. Others (runners and coaches in particular) may benefit in the future from the results we publish and disseminate, based on the data collected in this study.


WHO IS RUNSAFE

RUNSAFE is a Danish research group. Our vision is to promote recreational running as an accessible, effective and safe intervention to improve physical and mental health and quality of life in all populations. The mission is to provide scientific evidence for initiatives (e.g. use of digital tools/solutions, virtual arenas and real-time feedback) that ensures adherence to running in different populations by shedding light on barriers for maintained exercise (e.g. lack of motivation, emotional stress) and dangers of excessive exercise (e.g. exercise addiction, eating disorders, musculoskeletal injuries). Our philosophy is: we perform research with runners, for runners. Read more about us here: http://runsafe.au.dk/

The study “Garmin-RUNSAFE Running Health Study” is conducted by- and data is handled by the following researchers at Aarhus University, Denmark:

- Rasmus Oestergaard Nielsen, Post-Doctoral researcher, Ph.D. (responsible for the study)
- Søren Kjærgaard, Associate professor, Ph.D. (Leader of RUNSAFE)
- Erik Parner, Professor in Biostatistics, Ph.D.
- Henrik Sørensen, Associate Professor, Ph.D.

In addition, bachelor-, masters and Ph.D. students enrolled at Aarhus University, as well as other researchers, technical engineers and software-developers employed by Aarhus University handle and analyze data.

All RUNSAFE researchers certify that they have NO affiliations with or involvement in any organization or entity, including Garmin, with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in relation to the “Garmin-RUNSAFE Running Health Study”.


WHAT IS AARHUS UNIVERSITY?

Among over 17,000 universities world-wide, Aarhus University is ranked in the top 100 by several influential rankings. A high ranking is an important competitive advantage for a university which seeks to attract and retain the best students, researchers and partners. Aarhus University has approximately 11,500 employees and 45,000 students (http://www.au.dk/en/). The institution is owned by the Danish Government. Since government-based research in Denmark is obliged to conduct research, the primary focus of the RUNSAFE research group is to publish scientific articles and to disseminate finding to runners, coaches, sports organizations, and the mass media.


WHAT DATA DO YOU SHARE?

If you decide to participate you will be asked to provide researchers at Aarhus University, Denmark with access to your Garmin Connect data through Garmin’s Health API until you decide to leave the study or when the study ends by December 31st 2020. In addition to Garmin Connect data, you will be asked to complete an enrollment- and baseline questionnaire, and respond to scheduled questionnaires once weekly (regarding injury), and once monthly. In addition, other questionnaires may be distributed on an ad-hoc basis. Scheduled questionnaires are distributed to your e-mail address. We anticipate it will take you between 1-5 minutes to respond to each weekly questionnaire and approximately 15 minutes to respond to a monthly- or ad-hoc questionnaire. During a 1-year period, you are asked to respond to 52 weekly questionnaires, and 12 monthly questionnaires.


CONFIDENTIALITY AND ANONYMIZATION

We will take the following steps to keep information about you confidential, and to protect it from unauthorized disclosure, tampering, or damage: Aarhus University, Denmark has obtained approval from the Danish Data Protection Agency (the Danish Data Protection Agency’s journal-number: 2015-57-0002; Aarhus University’s journal-number: 62908, serial number 309) for its own processing and storage of the personal data of participants (first name, last name, e-mail address, and all other “personal data”) collected and processed by Aarhus University. Also, Aarhus University will always observe the obligations imposed by the Danish Act on Processing of Personal Data and the Executive Order (no. 528 of 15 June 2000) on Security Measures for Protection of Personal Data that is Processed for the Public Administration, and all other applicable laws and regulations. In any dissemination of study findings (including scientific articles published based on this study, conference presentations, media releases, etc.), no personally identifiable data will ever be included. No personally identifiable information (first name, last name, email address) will ever be shared outside of Aarhus University.

The RUNSAFE research group consists of researchers from several Danish institutions - including Aarhus University, Aalborg University Hospital (Dr. Sten Rasmussen, Søndre Skovvej 15, room 612, 9000 Aalborg, Denmark), University College of Northern Jutland (Dr. Daniel Ramskov, Selma Lagerløffsvej 2, 9220 Aalborg East) and Aalborg University (Dr. René Korsgaard Brund, Frederik Bajers Vej 5, E2-208, 9220 Aalborg, Denmark). For the research project to be carried out, it is necessary for the entire RUNSAFE group to have access to all raw data. In case of data sharing, no personally identifiable information (first name, last name, e-mail address) will be distributed. Person-specific label numbers will be used to merge Garmin Connect data with injury data from questionnaires. These person-specific label numbers will be used during all sharing and processing of data within the RUNSAFE collaboration.

All data will be stored until December 31st 2025.


INCENTIVES

Participants in the Garmin-RUNSAFE Running Health Study receive no money for their participation. In addition, they receive no economic support to cover expenses related to clinical examinations and/or treatment. Since the project is observational in nature, we are not allowed to provide runners with advice on running programs or treatment of running-related injuries.


FUNDING

The researchers (Senior Researchers, Post Docs, and Ph.D. students) collecting- and analyzing- data and publishing articles from The Garmin-RUNSAFE Running Health Study are financially supported by Aarhus University, Aarhus University Research Fund and Aalborg University.


RISKS AND LIABILITY

There are no direct risks of participating in the “Garmin-RUNSAFE Running Health Study”. Aarhus University cannot be held responsible for any losses or damages, either direct or in-direct, on participants in the “Garmin-RUNSAFE Running Health Study”.

The researchers may stop the study or take you out of the study at any time they judge it is in your best interest. They may also remove you from the study for various other reasons, like no data uploaded to Garmin Connect or no response to questionnaires over a 6-month period. The researchers can remove you from the study without your consent.


PUBLICATIONS

RUNSAFE researchers intend to publish scientific articles in peer reviewed journals based on data from the “Garmin-RUNSAFE Running Health Study”. In newsletters distributed by e-mail, we will notify runners enrolled in the study of newly published findings and research activities.


ETHICS COMMITTEE APPROVAL

The Local Ethics Committee Central Denmark Region has approved the project under Request number: 227/2016 - Journal number: 1-10-72-189-16.


CONTACTS FOR QUESTIONS OR PROBLEMS?

Please contact our support team by e-mail at garmin-runsafe@ph.au.dk if you have questions about the study or think that something unusual or unexpected is happening.

Contact Dr. Rasmus Oestergaard Nielsen, Research Coordinator in RUNSAFE, Dalgas Avenue 4, room 438, Aarhus, DK-8000 at +45 87 16 81 79 or roen@ph.au.dk if you have any questions or concerns about your rights as a research participant.


Consent of Subject (or Legally Authorized Representative)

Please take whatever time you need to discuss the study with your family and friends, or anyone else you wish to.


We hope you are willing to join this world-wide project.