A comprehensive analysis of MRI research risks: in support of full disclosure.
Magnetic resonance imaging (MRI) procedures have been used for over 20 years. This modality is considered relatively safe and holds great promise. Yet, MRI has a number of risks. In order for MRI research to meet the Canadian standard of disclosure, the investigator must communicate and make note of all risks in their research protocols and consent forms. Those creating and reviewing research protocols and consent forms must take notice of the different circumstances under which MRI poses a risk. First, this paper will describe the current standard of disclosure in Canada for research participants. Second, the paper will provide a comprehensive synthesis of the known physical and psychological risks associated with MRI. Third, the paper will provide recommendations concerning areas for further investigation and risk reduction strategies. This information will thus equip researchers and research ethics boards (REBs) with the criteria needed for the composition of research protocols that meet the Canadian disclosure standard.
Marshall
Jennifer
J
Health Law Institute, Dalhousie University, Halifax, NS.
Martin
Toby
T
Downie
Jocelyn
J
Malisza
Krisztina
K
D035843:Biomedical Research / Q000941:ethics / Q000592:standards*; D002170:Canada; D032962:Consent Forms / Q000941:ethics / Q000592:standards; D030881:Disclosure / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D004574:Electromagnetic Fields / Q000009:adverse effects*; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000009:adverse effects* / Q000941:ethics / Q000592:standards*; D016584:Panic Disorder / Q000209:etiology / Q000517:prevention & control / Q000523:psychology; D018579:Patient Selection / Q000941:ethics; D018570:Risk Assessment / Q000941:ethics / Q000592:standards