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A comprehensive analysis of MRI research risks: in support of full disclosure
Jennifer Marshall1, Toby Martin, Jocelyn Downie
1Health Law Institute, Dalhousie University, Halifax, NS.
Abstract:
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.
Insights
Magnetic resonance imaging (MRI) research requires clear communication of all risks to participants. This study synthesizes MRI risks and provides recommendations to meet Canadian disclosure standards for research protocols.
Area of Science:
- Medical Imaging
- Radiology
- Neuroimaging
Background:
- Magnetic resonance imaging (MRI) is a widely used diagnostic tool with a long history.
- While generally safe, MRI procedures carry inherent physical and psychological risks.
- Ensuring participant safety in MRI research necessitates comprehensive risk disclosure.
Purpose of the Study:
- To outline the Canadian standard for risk disclosure in research protocols.
- To synthesize known physical and psychological risks associated with MRI.
- To provide recommendations for risk reduction and future research in MRI safety.
Main Methods:
- Literature review and synthesis of existing research on MRI risks.
- Analysis of Canadian disclosure standards for research ethics.
- Development of recommendations based on synthesized findings.
Main Results:
- Identified specific physical risks (e.g., acoustic noise, electromagnetic fields) and psychological risks (e.g., claustrophobia, anxiety).
- Detailed the current Canadian standard for informed consent and risk communication in research.
- Highlighted gaps in current understanding and areas requiring further investigation.
Conclusions:
- Adherence to Canadian disclosure standards is crucial for ethical MRI research.
- Comprehensive understanding and communication of MRI risks are essential for participant safety.
- Further research is recommended to refine risk mitigation strategies and enhance participant protection.
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