Research Centre Criteria

In order to participate in the IMPACT study, research centres must obtain ethical approval from their local Ethics Committee to run the study, and Clinical Trial Authorisation from their relevant Regulatory Agency. In addition, each country running the IMPACT study must elect a Sponsor to be responsible for the conduct of the Study within that country.

Research Centres must also be able to:

  • provide access to a full genetic counselling and genetic testing service;
  • provide access to urological and oncological expertise, and psychological support;
  • undertake PSA testing, and prostate biopsies where necessary;
  • access pathological support for prostate-core histopathological analysis.

The genetic counselling and testing facilities must incorporate: accurate assessment of cancer risk based on detailed family history; accurate record-keeping according to local Data Protection Acts; good links with a molecular testing laboratory which also complies with national quality assurance guidelines; a genetic counselling service for the provision of genetic testing; and patient access to additional counselling and/or psychological support where necessary.

If you have any queries with regard to any of the above, please contact the IMPACT coordinator who will be happy to discuss these with you. We are also able to provide some support, through the IMPACT-study collaboration, to aid research centres in meeting these criteria.

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