Do I need NHS REC review?

Do any of the following apply to your study?

Is your study a clinical trial of an investigational medicinal product (CTIMP)?

A study investigating how safe, and/or how effective, a drug or potential drug might be when used to treat, prevent or diagnose human illness. This can include studies involving drugs with Marketing Authorisations, healthy volunteers and some pharmacodynamic studies, where the study outcomes relate to safety and/or efficacy of the investigational medicinal product.

For more information please visit the MHRA website

YES

Is your study involving one or more of the following:

A non-CE marked medical device; or
A CE marked device, which has been modified or is being used, outside of its current intended purpose?

You should also answer YES if your study is a post market surveillance study involving a CE-marked device used within its' intended purpose but involving a change to standard care. 'Change to standard care' means that there could be a change to the patient's treatment if they opt to take part in the study, compared to the treatment normally provided outside the study.

YES

Does your study involve exposure to any ionising radiation?

This includes any ionising radiation research exposures, including those that are standard of care.

YES

Does your study involve the processing of disclosable protected information on the Register of the Human Fertilisation and Embryology Authority (HFEA) by researchers, without consent?

"Processing" in this context means using this information, as defined in regulation 2 of the Human Fertilisation and Embryology (Disclosure of Information for Research Purposes) Regulations 2010.

Disclosable protected information means identifying information held by the HFEA, on a database register, about patients who have undergone assisted reproduction treatments and services and any resulting children. Answer YES to this question if it is not practicable to obtain consent for the disclosure of this information.

YES

If none of the above apply, please select NO

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