Do I need NHS REC review?

Your answers to the following questions indicate that you need NHS REC review for sites in England.

This tool only considers whether NHS REC review is required, it does not consider whether other approvals are needed. You should check whether other approvals are required for your research.

You have answered 'YES' to: Is your study research?

Question Set 1
You answered 'NO' to all of these questions:

• Is your study a clinical trial of an investigational medicinal product?
• Is your study one or more of the following: A non-CE marked medical device, or a device which has been modified or is being used outside of its CE mark intended purpose, and the study is conducted by or with the support of the manufacturer or another commercial company (including university spin-out company) to provide data for CE marking purposes?
• Does your study involve exposure to any ionising radiation?
• Does your study involve the processing of disclosable protected information on the Register of the Human Fertilisation and Embryology Authority by researchers, without consent?

You answered 'England' to: Where is your study taking place?

Question Set 2
You have answered 'NO' to all of these questions:

• Will your study involve potential research participants identified in the context of, or in connection with, their past or present use of services (NHS and adult social care), including participants recruited through these services as healthy controls?
• Will your research involve prospective collection of tissue (i.e. any material consisting of or including human cells) from any past or present users of these services (NHS and adult social care)?
• Will your research involve prospective collection of information from any past or present users of these services (NHS and adult social care)?
• Will your research involve the use of previously collected tissue and/or information from which individual past or present users of these services (NHS and adult social care), are likely to be identified by the researchers either directly from that tissue or information, or from its combination with other tissue or information likely to come into their possession?
• Will your research involve potential research participants identified because of their status as relatives or carers of past or present users of these services (NHS and adult social care)?

Question Set 3
You have answered 'NO' to all of these questions:

• Will your research involve the storage of relevant material from the living or the deceased on premises in England, Wales or Northern Ireland without a storage licence from the Human Tissue Authority (HTA)?
• Will your research involve storage or use of relevant material from the living, collected on or after 1st September 2006, and the research is not within the terms of consent for research from the donors?
• Will your research involve the analysis of human DNA in cellular material (relevant material), collected on or after 1st September 2006, and this analysis is not within the terms of consent for research from the donor? And/or: Will your research involve the analysis of human DNA from materials that do not contain cells (for example: serum or processed bodily fluids such as plasma and semen) and this analysis is not within the terms of consent for research from the donor?

Question Set 4

You have answered 'YES' to: Will the research involve processing confidential information of patients or service users outside of the care team without consent? And/ or: Does your research have Section 251 Support or will you be making an application to the Confidentiality Advisory Committee (CAG) for Section 251 Support?

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