Table 1 Clustering of ethical aspects related to SCA research with observational data

Potential harms

Privacy

• Linkage across datasets in critical care research increases the risk of re-identification of the individual

[41]

Genetic discrimination

• Genetic testing for SCA-associated conditions creates the potential for stigma and discrimination

[30, 31]

Disclosure of individual findings

• Dilemma: whether or not to inform patients with a high risk of SCA who refuse to know their test results

[36]

Research design

• SCA data may be of low quality due to the acute setting and variety of data sources: sound methodology is vital

[38,39,40,41,42]

• Incorrect subject selection may exacerbate SCA knowledge gaps between developed and developing countries

Applications

• The creation of (incorrect) risk profiles (e.g. for hypertrophic cardiomyopathy) may give rise to health disparities

[41, 46]

Protective measures

Informed consent

• Insistence on informed consent for use of data from emergency medical settings would bias research

[18, 41, 53,54,55, 60]

• Deferred consent for data collection is seen by patients as an acceptable consent model in emergency settings

Data governance

• Critical care research without consent requires safeguards (e.g. safe-havens) to protect data security

[41, 54]