Type of study
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Approvals needed2
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Studies involving NHS patients, their identifiable data, or their tissue
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NHS REC approval
HRA approval
If the research involves the processing of confidential information outside of the care team without consent you may need to make an application to the Confidentiality Advisory Committee (CAG)
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Studies involving adults (over 16 years old) lacking the capacity to consent for themselves.
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NHS REC approval
HRA approval (if recruited via the NHS)
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Studies involving NHS staff or NHS facilities/premises
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HRA approval
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A Clinical Trial of an Investigational Medicinal Product
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NHS REC approval
HRA approval
MHRA authorisation
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A Clinical Investigation or other study of a Medical Device that is non-CE marked, or is CE marked and is being used outside of its current intended purpose or has been modified
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NHS REC approval
HRA approval
MHRA authorisation
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A Phase 1 Clinical Trial of an Investigational Medicinal Product using healthy volunteers and taking place outside of the NHS
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NHS REC approval
MHRA authorisation
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Social Care research that is:
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Funded by the Department of Health and Social Care (England)
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Involves people lacking capacity (in England and Wales)
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Involves integrated health and social care services
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Involves intergenerational social care research where both adults and children, or families, are research participants.
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Social Care NHS REC
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Staff and/or offenders in prison establishments
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HMPPS National Research Committee (NRC) approval
If health-related, NHS REC approval will also be required
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Research undertaken, funded or sponsored by the Ministry of Defence
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Ministry of Defence REC (MoDREC)
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