Obtaining informed consent

1
Obtaining informed consent

• Data Management and Sharing workshop
• London, 24 June 2008

2
Foundations for consent

• Historical Nuremberg, Geneva Convention,
  Declaration of Human Rights
• Philosophical
• Consequentialist (e.g., utilitarianism)
• Deontological (e.g., rights or duties)
• Situational (e.g., contextual)
• Need to balance
• Aims of research
• Best interests of participants
• Obligations to wider audiences (publication,
  dissemination, data sharing)

3
Is informed consent possible?

• Active and legitimate debate about this, but
• no is not a viable answer in the current
  research environment

4
What can participants consent to?

• Engagement in the research process
• Use of their data / materials in various outputs,
  presentations, publications
• Who approves research outputs?
• Data sharing and archiving

5
A good consent form

• Meets requirements of DPA
• Informs participant about
• purpose of the research
• what is involved in participation
• benefits and risks
• mechanism of withdrawal
• usage of data for primary research (incl.
  storing, processing, destroying,) and sharing
• strategies to ensure confidentiality of data
  (anonymisation, access restriction,.) where this
  is relevant
• Simple
• Avoids excessive warnings
• Complete for all purposes use, publishing,
  sharing of information obtained

6
Issue 1 When to ask for consent
7
Issue 2 Right to withdraw

• What about already collected data?
• What if project is longitudinal?

8
Issue 3 Format for consent

• Written
• More solid legal ground (participant agreed to
  disclose confidential info international data
  sharing)
• Not possible for some cases infirm, illegal
• Can be perceived to be off-putting
• Can help or even be required for Ethical Review
  (REC)
• May offer more protection for researcher
• Verbal-with or without recording
• Can be difficult to make all issues clear
  verbally
• Possibly greater risks for researcher
• Law is not specific
• Written consent not used for large surveys
• Need to match format of consent with research
  content

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Issue 4 Types of material

• Ranging from less sensitive (survey) to highly
  sensitive (NHS protocols for medical)
• Text and transcripts
• Quantitative data
• Audio recordings
• Still and moving images
• Data more likely to reveal identities
• Data more likely to be rendered useless by
  anonymising (blurring)
• Gaining consent is a better alternative
• and how materials are expected to be used,
  shared, archived

10
Issue 5 Special cases of participation

• Children
• under 16s not presumed competent
• but if they understand, then parental consent
  not necessary
• Employees
• Vulnerable
• balance protection from harm
• with right to participate