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


For researchers* and research sponsors involved in research in Northern Ireland, Northern Ireland based Health and Social Care (HSC) research ethics and R&D staff.

Current Position
The Mental Capacity Act (Northern Ireland) became law on 9th May 2016 however it has not yet been implemented in Northern Ireland. The provisions of this Act therefore cannot be relied upon. The most recent timetable suggested the earliest date for implementation would be in or about 2019/2020 however, this is subject to change.
The position therefore remains that there is no specific legislation within Northern Ireland applicable to non-CTIMP research involving adults who lack capacity. All research must be approved by a Health and Social Care Research Ethics committee and must comply with common law principles.
This guidance note applies to non_CTIMP research involving adults lacking capacity aged 16 or over.
In deciding whether to carry out non-CTIMP research with persons who lack capacity (ALC), the common law principle of Best Interests will apply.
Best interests in this sense should consider the subjective best interests of one person rather than the community at large. One must therefore weigh the potential positive impact on a patient against the risk to that patient, not to society as a whole.
To read more please see the guidance.  (updated version 2.0)

*This guidance needs to be followed irrespective of the study occurring only in Northern Ireland or where Northern Ireland is a site in a multi-site UK study non-CTIMP study involving adults lacking capacity to consent for themselves.

Where non-CTIMP studies are currently ongoing in Northern Ireland, involving adults lacking capacity to consent for themselves, a substantial amendment needs to be processed through the main HSC or NHS Research Ethics Committees, including appropriate changes to all study documentation to be compliant with this guidance. The substantial amendment form and any relevant revised study documentation must, in particular,  justify any potential direct benefit to the individual adult lacking capacity involved in the study. Potential benefit to the patient population or disease/condition group to which s/he belongs will not in itself satisfy patient’s best interest.