GoSHARE-ADR
Research type
Research Study
Full title
Genetics of the Scottish Health Research Register- Adverse Drug Reactions
IRAS ID
156870
Contact name
Colin NA Palmer
Contact email
Sponsor organisation
University of Dundee
Research summary
GoSHARE-ADR is being established as a subcomponent of GoSHARE and will comprise individuals who have had an adverse reaction to particular drugs. Although the incidence of the most severe drug reactions is rare, given the number of prescriptions globally, the absolute numbers of adverse drug reactions (ADRs) is substantial. Studies have shown that ADRs are one of the most common reasons for hospitalisations. Although most ADRs are dose-dependent and pharmacologically predictable, some cannot be predicted from the known pharmacology of the drug. ADRs lead to poor compliance and discontinuation of vital therapies and add to the burden of CVD in healthcare systems worldwide. The current knowledge about possible genetic causes of ADRs is limited. This study will investigate the genetic basis of susceptibility to ADRs and may provide possibilities for identification of susceptible individuals through pharmocogenetic testing. This study will initially focus on patients who have had an adverse reaction to statins or ACE-inhibitors.
Individuals will be recruited from a variety of sources: 1) Participants consented to SHARE/GoSHARE and who provide pre-consent for the generic use of their surplus (or spare) clinical blood samples in genomic research and identified as having experienced an adverse drug reaction to a statin or ACE-inhibitor; 2) Individuals identified by specialist consultants as having an adverse drug reaction to a statin or ACE-inhibitor 3) Individuals may also sign up for the study via the GoSHARE-ADR website or by traditional hard copy Patient Information Leaflets and registration forms.
This study will also provide the opportunity for individuals to “SHARE” their experiences with drugs with the research community, allowing efficient access to this patient group to determine genetic and non-genetic predictors of adverse drug reactions.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
14/ES/1045
Date of REC Opinion
7 Aug 2014
REC opinion
Favourable Opinion