1. Obtaining informed consent

2. 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:
These slides can be used freely, translated and adapted to national use (e.g. concerning national legislation).

3. 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

4. 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

5. 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

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

7. 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

8. 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

9. 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

10. 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

11. 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

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

13. 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.

14. 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)

15. 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.”

16. “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 (Laura)

17. 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 through SANCO/2008/C2/02-SI EHES and Grand Agreement number , and in through Grand Agreement number /BRIDGE Health

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