Chapter 4
Shouldering responsibility
An autoethnographic perspective on informed consent and exoneration in a
clinical trial
This chapter explores my experience as a participant in the
Covid-19 Oxford vaccine trial and particularly the contrapuntal relationship between
the naïve event diary I kept and my increasingly careful reading of the Participant
Information Sheet (PIS). Adopting an autoethnographic approach, I describe the
gradual process by which I came to realize how naively I had understood my role and
how I then applied a pragmatic framework in re-evaluating the PIS as an exercise in
exoneration and the transfer of responsibility from the investigator to the
participant. While the PIS focuses on enumerating risks without considering the
false negative possibility that the trial might be successful and yet still fail to
identify a serious risk, my event diary shows how a volunteer’s sense of participant
integrity is undermined when this risk that dare not speak its name actually
occurs.
Article outline
- 1.Background
- 1.1Timelines
- 1.2Responsibility
- 2.Method
- 3.Data
- 3.1The participant information sheet
- 3.2The trial participant diary
- 4.Shouldering responsibility: Informed consent and exoneration
- 4.1Accounts and responsibility
- 4.2Self-reflexivity
- 4.3Inclusion
- 4.3.1Lay and professional descriptions: Glossing
- 4.3.2Lay and professional register
- 4.4Controlling inference
- 4.5Authorial voices and metapragmatic awareness
- 5.Conclusion
- 5.1Risk and responsibility
- 5.2The study
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Acknowledgements
-
Notes
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References