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Table 2 Description of foreseeable harms and benefits in approved consent forms*

From: Informed consent for MRI and fMRI research: Analysis of a sample of Canadian consent documents

 

n

%

Potential benefits*

42

98%

   Better understanding of brain function or dysfunction

31

72%

   No personal benefit

27

63%

   Future benefit to other patients

18

42%

   Technical improvements to existing methods

8

19%

   Clinical benefits

4

9%

   Detection of incidental findings**

4

9%

Potential risks*

43

100%

   Physical risks***

40

93%

   Psychological risks****

24

56%

   Unidentified risks

14

33%

   No risks, minimal, risks or risk minimizing statement

39

91%

   Risk-mitigating strategies

34

79%

   Pregnancy-related risks

9

21%

  1. * Categories in bold indicate a general category of information required by the Canadian Tri-Council Policy Statement (TCPS). Other rows report how consent forms dealt with the general conditions.
  2. ** Protocols described incidental findings as "neuro-abnormalities"
  3. *** See text for breakdown data of physical risks
  4. **** Psychological risks were almost entirely related to claustrophobia
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BMC Medical Ethics

ISSN: 1472-6939

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