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Obtaining informed consent. EHES Training material. What is informed consent?. Process of providing an individual with sufficient information for making an informed decision to participate in the survey Needs to be a process of communication, not just signing a form

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obtaining informed consent

Obtaining informed consent

EHES Training material

what is informed consent
What is informed consent?
  • Process of providing an individual with sufficient information for making an informed decision to participate in the survey
    • Needs to be a process of communication, not just signing a form
  • Key to ethically and legally acceptable survey data collection
aims for obtaining informed consent
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
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
information material
Information material

Make sure that the individual:

  • Receives all information
  • Reads and understands the material
understanding
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
before signing the informed consent form
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
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
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
  • Additional studies and follow-up, if planned
voluntariness and communication
Voluntariness and communication
  • 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
voluntariness and communication1
Voluntariness and 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
Obtaining the consent
  • Make sure that you, as the person who is obtaining the consent:
    • Are adequately informed to answer questions
    • Know whom you can consult in case you are not able to give an answer to participant’s questions
importance of obtaining informed consent
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)

acknowledgements
Acknowledgements
  • Slides
    • Päivikki Koponen, Susanna Conti, Mark Kanieff, Sanna Ahonen
  • Photographs
    • Hanna Tolonen