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Specific Guidance for Northern Ireland Based Studies involving Adults lacking Capacity to Consent (Non-Clinical Trials of Investigational Medicinal Products)

 

Please telephone the ORECNI staff if you have any questions or queries about the process of ethical review, our experienced staff are here to help.

For information on the research ethics application process, submitting an application for ethical review and access to forms required following ethical approval such as substantial amendment forms, annual progress report forms, end of study declarations, please use the link below:

Health Research Authority

This will redirect you to the Health Research Authority (HRA) website. Ethics applications to an HSC REC require use of the HRA forms and processes.

This site also contains guidance documents, and FAQ and Glossary which may be useful. A mechanism for providing feedback is also available.

Please follow guidance available at http://www.hra-decisiontools.org.uk/consent/examples.html to prepare study paperwork to comply with the Mental Capacity Act (Northern Ireland) 2016. The consultee information sheet and consultee declaration form are sample templates. Please note that a consultee does not provide consent but advice.