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

BMC Medical Ethics

Table 3 Additional information that may be required by REBs for informed consent according to the TCPS*

Information that may be required by REBs	n	%
Statement that new information about the study will be provided*	13	30%
Identification of qualified representative to explain research	38	88%
Identification of appropriate resources outside research team for ethical issues	41	95%
Explanation of procedures of confidentiality and access to research data	43	100%
Who has access to data	35	81%
Modalities for the storage of the data	34	79%
Confidentiality in the dissemination of research	31	74%
Disclaimer of non-guarantee of confidentiality	30	70%
Explicit statements about non-guarantee of confidentiality	15	35%
Implied non-guarantee of confidentiality	28	65%
Description of the methods to protect confidentiality of data	12	28%
Description of circumstances for termination of subjects participation	18	42%
No reason needed	15	35%
Subject's best interest	5	12%
Subject is unable or unwilling to comply with study protocol	3	7%
Description of study compensation***	39	91%
Explanation of the ways in which results will be published	29	67%
Ways research will be published	25	58%
Subject access to published results	11	26%

* Information that may be required based on Table 1 of the TCPS (Section D, 2.6)
Categories highlighted in bold indicate a general category of information of the Canadian Tri-Council Policy Statement (TCPS). Other rows report how consent forms dealt with the general conditions. We did not include items 5, 8 and 9 of Table 1 of the TCPS since they concern randomization and biomedical procedures and trials.
**New information about the study conveyed to subject if likely to change subject's decision to participate.
***See breakdown data in the text.

ISSN: 1472-6939