Obtaining informed consent

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Obtaining informed consent EHES Training material

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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 - PowerPoint PPT Presentation

Transcript of Obtaining informed consent

Page 1: Obtaining informed consent

Obtaining informed consent

EHES Training material

Page 2: Obtaining 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

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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