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Table 1 TCPS general conditions of informed consent found in approved consent forms

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

General conditions of informed consent according to the TCPS

n

%

A. Individual invited to research project*

32

74%

B. Statement of research purpose, identity of designated researcher, expected duration of study, description of research procedures*

43

100%

   Statement of research purpose

43

100%

   Expected duration of study

43

100%

   Description of research procedures

43

100%

   Screening procedures

39

91%

   Identity of designated researcher

41

90%

C. Description of reasonably foreseeable harms and benefits, consequences of non-action*, **

43

100%

   Potential risks

43

100%

   Potential benefits

42

98%

D. Assurance of freedom not to participate, right to withdraw, identification of continuing and meaningful opportunities to continue to participate*

43

100%

   Right to withdraw

43

100%

   Freedom not to participate

39

91%

   Continuing and meaningful opportunities to participate

11

26%

   Consequences of non-action

36

84%

E. Conflict of interest and commercialization*

9

21%

  1. *Categories bolded (A, B, C, D, E) indicate a general category of information required by the Canadian Tri-Council Policy Statement (TCPS).[13]
  2. ** "Consequences of non-action" designate the consequences of not being enrolled in the protocol. This aspect concerns more directly pharmacological trials or invasive trials.[13] See Table 3 for breakdown data on risks and benefits. "Benefits" also include claims about the non-existence of benefits.