Storage and video-review

Storage and video review were the points that raised multiple questions and required two changes in the research plan before reaching the final version. My initial plan was to store the consent forms, the interview files and the synchronised surgical operation recording at Durham University as it was the standard in university-based- research. I also planned to get the consultants and the surgical SPR to review the surgical operation video recording using the research laptop or tablet, both locked with a password. Durham University ethics committee advised me that if the material was stored in the university or in any place other than the NHS facility I would need an NHS information sharing agreement which was a requirement from

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2015. They also advised speaking to the Caldicott officer at Northumbria Healthcare NHS Foundation Trust as it is the leading trust and to the IT department in the University to make sure that the laptop or tablet had the same encryption level as the NHS standard encryption.

To overcome the material storage problem and the encryption level needed, the plan was modified. The new plan was to store the material at Professor Atwood’s office at Northumbria Healthcare NHS Trust, the operation video recording was to be stored on the supervising consultant’s office desktop computer, and the consultant was to have full ownership of the video as per the NHS regulation. As a result the review was to take place in a locked room at the same hospital in which the procedure took place. This plan was discussed over the phone with the Information Governance Officer at Northumbria Trust and the appropriate Caldicott form was completed. The ethical application form, protocol, information sheets and consent forms were

modified accordingly.

Before submitting the revised forms to the University Ethics Committee I received a call from the Information Security Officer at Northumbria Trust. He returned from his holiday and upon reviewing the Caldicott form he called me to inform me that the revised plan did not satisfy the information security requirement as the NHS desktop computers were not encrypted. He kindly offered to meet me to draw up a revised plan. Together we created a new plan to satisfy the information security requirement in the NHS while allowing the best possible research outcome.

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In this revised plan, the operation recording was to be stored for the review session in a secure folder on the Trust Intranet. This folder contained sub-folders allocated to each supervising consultant. Each subfolder was accessible only by the researcher and the named supervising consultant for the operation. So operation recordings remained as NHS property owned by the Trust. This arrangement was repeated in each trust joining the study (eight trusts in total in the Northern Deanery). An additional copy of the operation-recordings from trusts other than Northumbria was stored in a separate subfolder at Northumbria Healthcare NHS Foundation Trust, the main data analysis site. This additional copy was created with the consent of the supervising consultant, the SPR and the Caldicott Guardian. No copy was taken if permission was denied. The secure subfolder at the Northumbria Trust secure intranet drive, hosting all the video recordings from all trusts was accessible only by the researcher (to support the observational study analysis of the PhD). An NHS encrypted hard drive was used to transport the video recordings (in a lockable case) from the trusts to Northumbria Trust, the main data analysis site. This encrypted hard drive was stored securely in a lockable cabinet in Prof Stephen Attwood’s office at Northumbria Trust. In addition a logbook was used to log the hard drive in and out of the office.

All the forms were modified for a third time and gained the approval of Durham University Ethics Committee (Appendix 58). Forms were then submitted to the NHS North East - York Research Ethics Committee. The NHS committee raised a few points. They wanted more time for the patients to think about research participation and suggested providing the information sheet to all laparoscopic cholecystectomy patients at the pre-assessment time. This suggestion was discussed with the

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supervisory team. We wrote back to the committee to express that we understand the committee’s point about pre-warning the possible patients. However, possible cholecystectomy operation numbers in each trust would be in the range of thousands and we would be recruiting between 25-50 patients in total. In fact the end number was only 14. All patients approached for recording their operation agreed with no hesitation and none withdrew their consent. We were keen to follow the committee’s instruction without raising unnecessary anxiety in the vast majority of patients as most were not to take part in the research. We agreed to add the following additional patient information: All patients attending the nurse pre-assessment clinic for

elective cholecystectomy were to be informed that their operation video might be used for the analysis of training quality. That they might be approached by a

researcher on the day of their hospital admission if their consultant deems it suitable. Further information would be provided and participation would be optional if they were invited into the study. This statement was sent as an email to all nurses involved in pre-assessment.

The second point concerned the research plan in case of identified mal-practice. I highlighted the fact that the supervising consultant was in charge of the operation and the researcher was not to interfere with any treatment plans. I also pointed out the statement at the end of the research protocol: Any hazard identified with their proposed actions would be communicated anonymously to the Trusts and the Deanery. Also the information sheets submitted with the application had the following sentence under “Will my taking part in this study be kept confidential? “ “In cases of litigation we may be legally obliged to disclose any recordings.”

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The committee suggested that the consultant would only be approached if the trainee agreed to take part in the study. Again I responded by appreciating that the

committee did not want to disturb consultants unnecessarily if they would not be recruited in the absence of a recruited trainee. However I stated that such a point would certainly be relevant if consultant/trainee were coupled. Unfortunately the old apprentice training style is long lost and trainees and supervisors rotate within each trust randomly. So a consultant designated trainee no longer exists. Currently any consultant will supervise any trainee within the deanery (usually within the same trust but that is no longer consistent).

The current submitted IRAS application form has the following statement at the third paragraph of question (A27-1) which hopefully covered the point raised by the committee (Higher surgical trainees are the main focus of this study. So consent goes in three stages. I start by trainee recruitment then recruit his/her supervising

consultants (trainees these days work for more than one consultant). Once I have the pair (trainee and trainer) recruited and consented, the consultant will then identify the suitable patient to be recruited. The consultant would take into account theatre list time pressure, trainee skills and operation difficulty judged by patients’

ultrasound scan result; all are points to inform such a decision. If the patient was not happy to join the study another suitable patient would be identified by the

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All forms were further checked, revised if needed and submitted and the committee kindly provided a favourable opinion (Appendix 59). I also attach all forms in the appendix section (Appendix 60, 61, 62, 63, 64, 65, 66, and 67).