obtaining informed consent
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
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Obtaining informed consent
EHES Training material
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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
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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
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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
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Information material Make sure that the
individual:• Receives all information• Reads and understands
the material
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UnderstandingTo 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
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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
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Before signing the formExplain:• What data
protection is• How confidentiality
and privacy are assured
• How the participant receives feedback on his/her personal results
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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
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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
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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
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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
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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)
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Acknowledgements• Slides
• Päivikki Koponen, Susanna Conti, Mark Kanieff, Sanna Ahonen
• Photographs• Hanna Tolonen