The YNiC data protection policy is available for users to download here: Data Protection Policy. The current version is 2017-09A.
The policy should be read in conjunction with the overall policy for the University of York which is available from the University website at http://www.york.ac.uk/recordsmanagement/dpa/.
Any requests for information or help regarding Data Protection issues at YNiC should be sent via email to firstname.lastname@example.org, or if email is not suitable, sent via post to:
- Data Protection Officer
York NeuroImaging Centre
- University of York
- York Science Park
- YO10 5NY
Participants and patients
The health and safety of participants and patients is very important to YNiC and is taken very seriously. Before each scan, YNiC staff must explain to participants about the procedures of the scan. The details of the experiment must be explained to the participant by the researcher. Participants must have the opportunity to ask any questions and raise any concerns before the scan. This is especially important when the participant is a young person or vulnerable adult. If dealing with these participant groups, investigators should be aware of and follow University of York policy, detailed here.
Participants have the right to stop the experimental scan at any point in time and should still receive compensation for their time.
Pre-requisites before scanning can occur
Participants and patients must be entered into the YNiC database before they take part in any MEG or MRI experiment. No visitors may enter the MEG or MRI suite without signing the health and safety and consent forms. Before entering the scanning suites, all visitors must first "de-metal". This involves emptying pockets, removing jewellery, watches, wallets, beepers, hairclips and make-up (if appropriate) and leaving pens and clipboards etc. in the locker areas provided.
Care and responsibility for participants and patients within YNiC
In all cases, the principal investigator or their nominee must be present for the entire duration of the scan. YNiC provides everyday first-aid items such as plasters, gauze and alcohol for sterilization. MEG and MRI equipment must be sanitised before and after each participant; any item that comes into contact with the participant must be sanitised or replaced. In case of an emergency, eyewash stations and defibrillation are available.
YNiC policy is that pregnant women may not take part in MRI or MEG studies.
If a pregnant patient or participant wishes to be scanned at YNiC, the Centre must be informed in writing. It is advisable to notify YNiC as soon as possible, because some risks may be higher earlier in pregnancy. YNiC will then carry out a risk assessment. Any risks identified by the risk assessment should be avoided. Note that mental and physical fatigue, standing or sitting for too long, and stress are all recognised as potential threats during pregnancy. European law also protects women who are still breastfeeding. Breastfeeding mothers must be protected from physical hazards in the same way as pregnant mothers, and YNiC is required to provide a private, comfortable space suitable for breastfeeding or breast-milk extraction (not a toilet).
Specific issues that prevent a participant or patient being scanned
Participants and patients need to be aware that certain medical devices can seriously affect the operation of the MEG and MRI scanners. Examples of the type of medical devices that must be excluded from the MEG and MRI suites include cardiac pacemakers, cochlear implants, neuro-stimulators, certain metallic dental work, body jewellery and other metallic foreign objects implanted in the body. If in doubt, please do not hesitate to contact YNiC with individual enquiries.
Preparation of a participant or patient
It is the responsibility of the MEG or MRI operator to prepare a participant or patient for a scan. The operator must go through the health and safety and consent forms with the participant and ask the participants to de-metal. Hospital gowns are provided in cases where clothing needs to be changed. Participants and patients must be informed of the nature and possible outcomes of the experiment and should receive a full debrief at the end of the experiment. It is expected that participants will be compensated for their time by the researchers.
Lifting and handling of participants and patients
It is YNiC policy to minimize any lifting or handling. YNiC staff and users are not expected to lift or handle any people that could be hazardous to their health or that they have not been trained to handle. If a heavy patient must be handled, a risk assessment must be carried out well in advance and certainly before the participant/patient arrives at YNiC. The following equipment is available for assisting with patient and participant handling; an MRI compatible patient gurney and a multi-glide mat for patient movement.
Participant and patient comfort
YNiC staff should make every effort to ensure participants and patients are comfortable during the scan. Cushions, blankets, pillows, knee rests and a bean bag are available. For MRI scans, ear plugs and ear defenders are provided to attenuate the noise generated by the scanner.
Communicating with participants and patients
Participants and patients should be in contact with the MEG or MRI operator throughout the duration of the scan. Two-way intercoms are provided to facilitate communication between the participant and the operator. The operator can also monitor the participant visually through either a window (MRI) or a camera (MRI/MEG).
If the participant or patient is not comfortable with the scanning procedure or experimental paradigm, they may stop the scan at any time. Panic alarms can be used to call the attention of the operator, in the unlikely event that the two-way intercom is not working. Panic alarms are accessible from the MRI and MEG scanners. The MEG and MRI operators also have access to a Centre panic alarm to alert other YNiC staff in the event of an emergency.
YNiC provides equipment for monitoring participants in cases where researchers want to collect physiological data. If it is required, both MEG and MRI can monitor ECG, breathing, eye position and EEG. Additional electrodes may need to be attached for monitoring EEG, ECG and eye positions.
Use of Computer Facilities
The Regulations of Computer use at YNiC.
These regulations apply to all computer users (staff, students and visitors) at YNiC. They are subject to change after the proper notification of users.
All users must abide by the University of York's Regulations for use of computing facilities and the regulations therein.
All users are required to familiarise themselves with the YNiC Data Protection policy and acknowledge that data must not be removed from YNiC without express, written permission from the Data Protection Officer of YNiC. Contact information and the policy are available at https://www.ynic.york.ac.uk/information/policies
YNiC Clinical Diagnostic Policy
The York Neuroimaging Centre is not a clinical diagnostic facility and as such does not have all scans inspected for anomalies by a qualified clinician (e.g Radiologist), however from time to time an anomaly is observed on an MEG or MRI scan. YNiC can only indicate that further advice might be sought. The presence or absence of an anomalous scan is not an indication of the presence or absence of pathology.
The YNiC policy is that all participants are asked, on the YNiC scan consent form, that if an anomalous observation were made, would the participant like their General Practitioner’s practice to be informed?
If the participant answers no to that question on the scan consent form, and prefers not to have their General Practitioner’s practice informed, then YNiC will regrettably be unable to scan that person. This information is stated explicitly on the scan consent form.
If consent to the participant's GP being informed is given, then copies of the scans may be sent to an independent radiology reporting service within the UK.
The participant will be advised that their scan has been sent for clinical evaluation.
The clinical report will be sent to the participants GP for inclusion in their medical records.
The participant will be advised that the clinical report has been sent to their GP for inclusion in their medical records.
All correspondence is digitised and stored securely. All paper copies are securely destroyed.
Scans sent for reporting are not uploaded to the YNiC databases until the participant has signed a release form allowing us to do so.
For the sake of clarity it must be understood that YNiC is not a clinical facility and does not and cannot provide diagnostic services. It cannot and does not accept any liabilities arising from a failure to detect an anomaly or an abnormality., nor does it accept any responsibility for any medical or otherwise consequence of not detecting a subclinical or clinical condition.
Communicating this policy to participants is important. An example of how to prepare a Participant Information Sheet covering the YNiC policies is given in the YNiC REC Guidelines
Cancellation and Overrun Policy
Directly Charged Projects
Please avoid overrunning on your allocation time
- If your scan overruns we will charge you for that overrun at four times the rate of the group you delay in blocks of 15 minutes. This will allow us to compensate any user who is delayed by overrun.
- If you are delayed by overrun, your slot will not be charged if you are unable to use it and we will allocate one additional hour to your scan allocation free of charge. If you use your slot, we will charge you at the normal rate, but please note that if you delay the investigators that will use the centre after you, we will charge you (as per details in 1.).
- You will be charged for all the scan slots you have booked unless they can be rebooked by other users of the centre.
- Please notify the reception staff at YNiC, if you need to cancel a slot and they will remove your booking and attempt to get it rebooked.
- If the rebooked user is charged a lower rate you will have to make up the difference between your rate and the lower rate for the replacement booking. If the scanner is booked by a user at a higher rate you will not be rewarded with the difference between the higher rate for the replacement booking and your own rate.
Projects Associated with Taught Courses
- Under no circumstances will projects associated with taught courses be allowed to continue to scan beyond the end their booking time. In any case where this will occur, the operator will not start the scan and may abort any running scan.
- Projects associated with taught courses may not cancel slots unless they can directly exchange the same time period with another project from the same course. If two projects wish to swap slots, a representative of both projects must see the YNiC reception staff together.
These policies have been approved by the YNiC Research Governance and YNiC Management Committees.