Introduction
There are other legislative requirements to which research must adhere and some key differences in research related legislation across the UK.
The study-wide reviewer will be responsible for considering the study according to the national legislation of their nation alone. However, the study-wide reviewer must highlight to the other participating UK nations where there are differences in legislation that will need to be considered.
The Ionising Radiation (Medical Exposure) Regulations 2017 and the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018 (both referred to as IRMER)
The regulations state that ‘A person must not carry out an exposure unless […] in the case of an exposure taking place in the course of a research programme under regulation 3(c), that programme has been approved by an ethics committee’ (IRMER 11, 1 (d)). There is guidance in the IRAS website which describes when an exposure is considered a research exposure under the legislation and therefore requires REC review.
To support review by REC of research studies involving research exposures (see ‘1.1 IRAS Application Completed Correctly’) the IRAS form includes a review by MPE(s) and CRE(s) (when the project filter is completed correctly). The information in the IRAS MPE and CRE review also supports site capacity and capability.
There is a UK-wide policy expectation that MPE and CRE review is completed in the IRAS form where a study involves research exposures. Radiation Assurance is a UK-wide process for studies taking place in the NHS/HSC which supports consistent and reliable MPE and CRE reviews being provided to the relevant regulatory bodies and sites (the assurance includes assessing that the risk statements given in the PIS are appropriate). It is expected that applicants of studies taking place in the NHS/HSC seek MPE and CRE review through Radiation Assurance to support regulatory reviews and site activities.
The regulations also give further requirements for regulatory review for research programmes involving the administration of radioactive substances (see section 6.4).
Study-wide considerations
- has the sponsor correctly identified that the study involves radiation exposures and, if it does, have they sought appropriate review from MPE(s) and CRE(s) and has this been recorded in the IRAS application form? It is the sponsor’s responsibility to decide whether a study involves research exposures, taking into consideration the legislation and guidance available by study wide review functions may seek justification from the sponsor of their decisions where this is unclear
- where MPE(s) and CRE(s) review has been obtained through the radiation Assurance process SW review functions should undertake the following. Where Radiation Assurance has not been provided but MPE and CRE review is available in the IRAS form, no further action needs to be taken
- ensure that this is accurately recorded in HARP (a yellow flag with a black border and black text will be enabled)
- state, in the SW review that MPE and CRE review was provided through Radiation Assurance and (in England and Wales) detail this in the initial assessment for REC and HRA/HCRW Initial Assessment and Approval letters
Compliance with the Provisions of the Welsh Language Act 1993 (Studies with participating NHS organisations in Wales only)
If the study team anticipate in advance that study participants will require information in Welsh or any other language, they should make provision for translation as part of the initial arrangements for study set up. They should also be prepared for potential research participants to request patient facing documentation in Welsh and English and make the necessary arrangements to support the request. Therefore, all necessary measures should be taken to provide the translation of written information and interpretation of patient information on request from a patient or carer.
It is highly recommended that researchers seek advice from their local NHS R&D office(s) about the language requirements of the local population and the Welsh language policies in place at the site.
Study-wide considerations
- the sponsor should explain what arrangements they have made to comply with the provisions of the Welsh Language Act 1993