METADAC monitors applications closely to see if there is a likelihood of discovering genetic variations that are clinically significant for the participants whose data METADAC governs.
A full summary of METADAC’s present position on incidental findings is available (word document).
Currently, METADAC gathers information on genetic variants in order to feed back to the Studies and to help them plan future policy. No individual-level information is routinely fed back to participants in any of METADAC’s studies. In some, the consents do not make provision for feedback of personal findings; this was according to best-practice at the time, but this view of best-practice has slowly been changing since the studies were set up.
Some genetic variants are now considered reportable in studies where this is permitted by consents and expected by participants, and METADAC refers to the following published lists:-
- the 2013 ACMG Recommendations for Reporting of Incidental Findings and
- the 100k genome project protocol (p43 of www.genomicsengland.co.uk/wp-content/uploads/2015/03/GenomicEnglandProtocol_030315_v8.pdf )
These are not the only variants you should report to METADAC however. Candidate genetic variants, which are thought to cause significant disease and which may become treatable in future, should also be reported to METADAC who (together with the studies) will maintain a watching brief over developments in this fast-changing field.
The guidelines for METADAC are:-
- Contact the METADAC secretariat at an early stage to discuss whether your findings are ‘reportable’ to METADAC
- Never attempt to contact participants directly
- Never pass participants’ personal data to METADAC. METADAC will log the findings and arrange for the studies to hold any personal information securely.