Applications and amendments are checked by a member of staff to ensure you have all the right documents for your application to be reviewed by a Research Ethics Committee (REC).
We call this the 'validation' process.
Once your application or amendment has been validated you will be sent an email letting you know the outcome of the validation.
To help you ensure that your application or amendments is valid we have put together a checklist of the common issues we have come across that prevents us validating first time around.
Competing the application 'project filter' questions
Have your selected the correct study filter questions? Selecting the incorrect filter questions can lead to missing information in the application form.
Below are some examples of questions you need to consider:
- does the study include child who many become an adult over the duration of the research? A child turning 16 years old during the study may require for consent to be taken as an adult. If some of the study population potentially lack capacity this would also require processes and documentation for including Adults Lacking Capacity
- for a clinical investigation or other study of a medical device, when the device provide for free has the filter page correctly stated that the study is sponsored or funded by a device manufacturer or commercial company?
- for studies including anIn Vitro Diagnostic device (IVD) has it been correctly identified as a companion diagnostic?
Completing the application form
Have you considered:
- is the Chief Investigator professionally based in the UK?
- has written evidence of scientific critique been described in, or submitted with the application (except for non-doctoral student research)?
- have details of who has reviewed the statistical aspects of the research been provided for applications (except those involving qualitative methods)?
Completing and submitting the amendment tool
Have you checked if:
- the tool been submitted correctly? For example, if the tool output says that is should be 'substantial for information' it should not be submitted as 'substantial for review'
- the correct options on the tool have been selected? For example, for a minor change to study design that will have resource implications for participating organisations has 'Area of Change: Study Design' been selected? Refer to the 'Glossary of Amendment Options' on the amendment tool for further examples
- a rationale around why the changes are being made has been included in the 'further information' section? For example the 'further information' explains that a new procedure is being added and details about it, but it does not explain why it is being added
Submitting all relevant documents for the type of application or amendment
Have all supporting documents for the study type and participant population been submitted?
For example:
- children need Participant Information Sheets and assent forms for different age groups, as well as parent or carer information sheets and consent forms
- Adults Lacking Capacity in Non-CTIMPS require a Consultee Information Sheet and a Consultee Declaration form, or in a CTIMPS, a Legal Representative Form
- for an amendment to increase or decrease the level of ionising radiation you need a signed declaration by the lead Medical Physics Expert (MPE) and by the lead Clinical Radiation Expert (CRE)
You also need to check whether the participant information materials are compliant with the Participant Information Quality Standards.
For amendments, including those for Combined Review, have the correct documents been submitted relating to the change, including entering version numbers and dates onto the system?
Submitting student research
For student research:
- if an application is for the purpose of obtaining an educational qualification, or includes students, have you used the Student Toolkit to check the suitability of the research?
- has the Supplementary Declaration Form A of the Student Toolkit been submitted as part of the application?
Explaining changes to previously rejected research
If you have previously submitted an application that has been rejected and you have made changes has the application form or a covering letter explained how the new application addresses the reasons given for the unfavourable opinion and highlight changes to study documentation?
Clear evidence of insurance
Have the insurance or indemnity arrangements that will be in place to meet potential liabilities relating to the management, design and conduct of the research (except where NHS indemnity will apply) been specified?
Renewal of research tissue banks and research databases
For a renewal after five years has a covering letter listing all projects for which tissue or data has been released in the previous year been provided?
The list should give the full title of each project, the name of the Chief Investigator, the sponsor, the location of the research and the date of approval by the establishment.