Project approval process

Prior to submitting an ethics application, first-time users of the YNiC facilities, as well as external users, should submit a project proposal form. They may be asked to present their project in a brief talk. After this, they can submit a full ethics application. Experienced users from the University of York can submit their ethics application without submitting a project proposal form.

Research ethics and governance applications

Completed application forms must be returned electronically to rec-submission@ynic.york.ac.uk and will include your unique Project ID in the application. The current application form (REC application form) can be downloaded below.

Applicants for REC approval must also read the REC application form guidance (below), which describes the general principles and procedures for obtaining research approval as well as describing in detail how to complete the form and how to prepare a Participant Information Sheet (below) and a Study-specific consent template (below).

In short - you will need these six documents:

• REC Application (DOCX) - Application form for the YNiC REC.

• REC Guidance (DOCX) - Guidance for completing the YNiC Research Ethics and Governance Form.

• Participant Information Sheet (download template) - A sample (template) of the information sheet provided to participants.

• Sample Study Specific Consent Form (download template) - A sample (template) of the form that participants need to complete to consent to your specific study.

• YNiC Data Protection Impact Assessment (DPIA) - The current data protection agreement by which all studies at YNiC must abide unless they have completed an independent DPIA.
• Research Privacy Notice (download template) - A sample (template) of the statement provided to participants that explains what will be done with their data.

Applicants who have or are obtaining IRAS approval, or ethics approval from a body other than the YNiC REC will also find guidance in the REC guidelines document. These applicants should also complete the External Ethics Form. It should be noted that external ethical approval does not guarantee access to the facilities here. This does not mean that we apply different ethical standards, rather it means that, while entirely ethical, your study simply may not be possible to perform at YNiC. It is essential therefore that you liaise with YNiC to determine whether your study is feasible before seeking external ethical approval. The best way to do this is by completing a Project Proposal Form (DOC).

Applicants seeking approval to work with individuals recruited via clinical routes or participants who are not able to give written informed consent (including children) will also need to read the documentation produced by IRAS which also contains other useful information about the IRAS approval.

Applicants intending to undertake research on individuals who are unable to give informed consent should consult the following documents:

• BPS guidelines

• Handbook for carers of those who can't give informed consent

• University of York Guide to Safeguarding of young people under 18 and vulnerable adults

Under normal circumstances we would expect such research to be reviewed by IRAS.

Applications for REC approval should be sent electronically (in PDF format) to rec-submission@ynic.york.ac.uk - please include the Project ID in the subject line of the email.

REC review

The YNiC REC reviews applications on a rolling basis. At least two individuals will scrutinise your application and supporting documentation. The Chair of the REC will then communicate the decision on your application. Frequently, the REC encounters applications that require minor changes to information sheets and consent forms because they do not conform to up-to-date policies outlined in the REC Guidance (DOCX). To avoid delays, therefore, it is essential to refer to up-to-date guidance.

A decision on your application may take some weeks depending on reviewer availability. Please be aware that communication concerning your application should only be through rec-submission@ynic.york.ac.uk. Every effort is made to get an initial decision to applicants within a month.

Allocation of resources and project initiation: Subject to the REC approving your application and a financial agreement being finalised according to our current charging policy, your project will be allocated resources against the unique Project ID previously assigned. You will now be in a position to begin setting up your experiment under the guidance of the project's PI (principal investigator).

Pilot scanning sessions - getting your project up and running

Once your project is set up and you have received REC approval, your project will be put into pre-scan state. This will allow you access to up to one hour of time on the scanner/lab during which member of YNiC staff will be present to aid you. The PI/student supervisor must attend this session so that any arising queries can be addressed. You will not acquire any human data in this session (we will only scan a phantom), as the purpose of this session is to:

• Get your stimulus code running in synch with the scanners
• Set up your data acquisition protocols (e.g. in MRI, the TE/TR, scan duration, number of anatomical / functional scans, etc.)
• To work out the amount of time you will have to book the suite for scan sessions to ensure you have enough time to acquire your data at each visit.

In order for us to help you get up and running, we expect you to prepare for the pilot session by:

• Having stimulus code that is tested and works - NB this code should not just be a sample of what you intend to run, it should be the code as you want to run it in the scanner. We have 3 different 'Stimulus PCs' in YNiC, which have the same stimulus hardware as those in the scanners. These can be found in: the corner of open plan (next to the interview room), the open-plan interview room, and the MRI corridor interview room. We recommend testing your stimuli on one of these PCs before attending your pilot.

• Having an understanding of how your stimulus code will synchronise with the scanners - will you be sending triggers to the scanner (typical in MEG) or receiving triggers from the scanner (typical in MRI).

• Knowing the duration of your stimuli and how long you want the scanner to run for each scan.
• Knowing what data acquisition parameters you want, e.g. (in MRI) the voxel size you want, the TE, TR, number of slices, how many anatomical and functional scans you want, etc.

• If you (or your lab) has recently run a study in which the scanner settings are very similar to those you would like to use for your current study, please bring information about those projects (especially the project P-number) with you.

To arrange a pilot session, email support@ynic.york.ac.uk. Please include your Project ID and specify which scanner you need to arrange the pilot for.

At the end of the pilot session, your scan should be ready to go and the status of the project will be updated to scanning. If you do not come to the pilot session adequately prepared, or if you make subsequent changes to your stimuli or acquisition parameters that require further testing after the pilot session, any additional testing and development time will be fully charged and will need to come out of the hours allocated to your project by the REC.

Please look through the Project Checklist after your pilot scan to ensure you are familiar with how to run a project at YNiC. Procedural information on preparing participants and booking scans can be found in the user resources.