Obtaining informed consent

Available at: http://urn.fi/URN:ISBN:978-952-302-700-8 Based on EHES Manual, Part A. Planning and preparation of the survey, 2nd edition (2016) Available at: http://urn.fi/URN:ISBN:978-952-302-700-8 These slides can be used freely, translated and adapted to national use (e.g. concerning national legislation).

Informed consent Process of providing an individual with sufficient information for making an informed decision to participate in the survey A process of communication, not just signing a form Key to ethically and legally acceptable survey data collection

Aims for obtaining informed consent All invited persons: Understand that participation is valuable and voluntary Are well informed of all key aspects of their participation

Legal and ethical basis The process of obtaining informed consent depends on national legislation, on general survey guidelines and on standards defined by ethics committees. You need to know and understand how these have been applied in this survey. Laws Survey guidelines and standards Protocols for this survey

Information material Make sure that the individual has: received all information read and understood the material

Understanding To ensure that the information material has been understood: Give sufficient time to read all information Point out the key messages Consider the participant’s competence, e.g. decision making capacity Lisättävä kielikysymys

Before signing the informed consent form Make sure that the participant is aware of and understands: The aims and purpose of the survey The importance of the survey for public health Which tests and measurements will be performed Where and how the data will be used Who will have access to the data

Before signing the form Explain: What data protection is How confidentiality and privacy are assured How the participant receives feedback on his/her personal results

Additional issues to be discussed Risks (e.g. the minimal risk of drawing blood samples) Compensation of expenses and incentives, if used Record linkage, if used Sample storage, including Biobank, if needed Additional sub-studies and follow-up, if planned

Voluntariness Use language that is easy to understand Avoid excessively technical or scientific terms Explain that the participant can: Ask questions on the measurements and use of data both during the examination and later Withdraw from the study or refuse any measurement at any time

Communication Make sure that the individual: Has the opportunity to ask questions Receives adequate answers to all questions Does not feel pressured or coerced

Obtaining the consent Make sure that you, as the person who is obtaining the consent: Are adequately informed to answer questions Know whom the participant can consult in case you are not able to give an answer to participant’s questions Ask the participant to sign the consent. Then, sign it yourself.

Importance of obtaining informed consent The process of obtaining consent can affect the individual’s willingness to: Participate in this survey Undergo all tests and measurements Allow his/her data and samples to be used for future studies Participate in future studies It can also affect the individual’s and the public’s attitudes towards surveys (e.g. public image of the institute responsible for the survey)

Frequently asked questions “How do you make sure that the participants’ personality cannot be identified from the data?” “In the survey data, no names and ID-information are used. Your data will be linked to you only for the purpose of sending you feedback on your personal results.”

“Can I withdraw from the study later if I sign the consent form now?” “You can withdraw from the study any time later if you change your mind. In that case, you may contact the person whose contact information is given on the consent form.” Lisätty 27.3. (Laura)

Acknowledgements Slides prepared by: Susanna Conti, Mark Kanieff, Sanna Ahonen, Päivikki Koponen, Laura Paalanen Photographs by: Hanna Tolonen Demonstration by: Shadia Rask and Saara Vallivaara with voluntary participants Experiences and feedback from the EHES network have been utilized in the preparation of these slides Funding: Preparation of the slides is part of the activities of the EHES Coordinating Centre which has received funding from the EC/DG SANTÉ in 2009-2012 through SANCO/2008/C2/02-SI2.538318 EHES and Grand Agreement number 2009-23-01, and in 2015-2017 through Grand Agreement number 664691/BRIDGE Health

Disclaimer The views expressed here are those of the authors and they do not represent the Commission’s official position.