Informed consent for record linkage: a systematic review

Abstract

The results of this review show that, in general, individuals tend to consent to the use of their data for record linkage, with exceptions in specific populations or minorities. The authors believe that this, as well as the cited literature, lends support to policies that, while keeping relevant ethical controls in place, do not require individual informed consent for each and every study that relies on secondary data.

Increasing value and reducing waste in biomedical research regulation and management

“…74 Such research is hard to fund and hard to do, but research regulation and management should be informed by empirical research (such as we have found in systematic reviews 22,25,30,38–40,45,47,48,64,66,70,72–74,90,93,94 ) to assess whether processes and procedures serve the interests of research participants and the public. 100,101 Our recom mendations make it clear that this goal is everyone's responsibility.…”

“…One result of changes in regulations and guidelines with time is inconsistency in the methods used in long-term research projects—eg, regulators might decline approval for record linkage to earlier recruits through the application of contemporary regulatory requirements, but a systematic review has shown that most patients consent to the use of secondary data for record linkage. 25 …”

Large panel-survey data demonstrated country-level and ethnic minority variation in consent for health record linkage

“…The potential for selection bias invalidating the study findings has also prompted some researchers to question the universal need for mandatory consent for linkage to medical and other records [38,56,57].…”

Para além da privacidade: direito à informação na saúde, proteção de dados pessoais e governança

“…Beyond the law, the population's general expectation is that health information will allow for better quality of life and the reduction of health risks. Still, individuals display some resistance to furnishing information that may result in some type of control over their behavior, while the reasons cited for the data collection may affect their claim to privacy 4 .…”