Table 1.

TCPS general conditions of informed consent found in approved consent forms

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%

*Categories bolded (A, B, C, D, E) indicate a general category of information required by the Canadian Tri-Council Policy Statement (TCPS).[13]

** "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.