NOTICE OF SUBSTANTIAL AMENDMENT

Please use this form to notify the main REC of substantial amendments to all research other than clinical trials of investigational medicinal products (CTIMPs).

The form should be completed by the Chief Investigator using language comprehensible to a lay person. Details of Chief Investigator:

Title Forename/Initials Surname

Miss Ciara Joyce

Work Address Furness College

Lancaster University

Lancaster

PostCode LA1 4YW

Email [email protected]

Telephone 07975564960

Fax

For guidance on this section of the form refer to the guidance

Full title of study: Lived experience of severe and enduring eating disorder: A narrative analysis

Lead sponsor: Lancaster University

Name of REC: North West/Lancaster

REC reference number: 16/nw/0543

Additional reference number(s):

Ref.Number Description Reference Number

IRAS Project ID 210390

Name of lead R&D office: Lancashire Care NHS Foundation Trust

Date study commenced: 28.09.16

Protocol reference (if applicable), current

version and date: 2.25.11.16

Amendment number and date: 1.24.11.16

Type of amendment

(a) Amendment to information previously given in IRAS Yes No

(b) Amendment to the protocol Yes No

If yes, please submit either the revised protocol with a new version number and date, highlighting changes in bold, or a document listing the changes and giving both the previous and revised text.

I am requesting a change to the recruitment process whereby I can circulate information about the study to interested stakeholders in a Division of Clinical Psychology special interest group that has been formed to create a briefing paper about understanding Eating Disorders. I have permission from members of this group to do so but I obviously will not circulate any information in this way without approval from the REC.

(c) Amendment to the information sheet(s) and consent form(s) for participants, or to any other supportingdocumentation for the study Yes No

If yes, please submit all revised documents with new version numbers and dates, highlighting new text in bold.

Is this a modified version of an amendment previously notified and not approved?

Yes No Summary of changes

Briefly summarise the main changes proposed in this amendment. Explain the purpose of the changes and their significance for the study.

If this is a modified amendment, please explain how the modifications address the concerns raised previously by the ethics committee.

If the amendment significantly alters the research design or methodology, or could otherwise affect the scientific value of the study, supporting scientific information should be given (or enclosed separately). Indicate whether or not additional scientific critique has been obtained.

I have currently recruited 5 out of the 8-10 participants I am hoping to recruit. I have recruited through two of the three NHS sites, one of which have not been able to support the project as they have a very small team and are in high demand. I have tried to support recruitment through these sites as best I can but interest seems to have slowed down and I would like to explore alternative options now if possible. I only need another 2 or 3 participants in total but ideally I would need to have them recruited this side of Christmas due to the research thesis deadline being in May next year.

Therefore, I am requesting a change to the recruitment process whereby I can circulate information about the study to interested stakeholders in a Division of Clinical Psychology special interest group that has been formed to create a briefing paper about understanding Eating Disorders. In doing this I hope that I may be able to increase awareness about the project and consequently the number of interested participants. Due to the nature of the experiences I am exploring it may be more likely that service users who have already voiced their willingness to share aspects of their experiences in this forum would be willing to participate in this research. This would also allow for the participants to have experience of more than two specific service sites.

The same safety protocols and procedures will be adhered to, and the only main difference this will make is in terms of creating the potential that future participants may not be currently engaged with services. Consequently I will offer people the options of 1) including people from their support networks at interviews if they would find this helpful, and 2) for me to contact their service provider to enquire as to whether clinical support after the interview would be available if required. I will also still have the option of discussing any perceived concerns about risk to self or others with my academic and field supervisor if necessary. Please see the attached amended protocol with any associated changes highlighted on pages 10 and 14. I look forward to hearing back from you.

Any other relevant information

Applicants may indicate any specific issues relating to the amendment, on which the opinion of a reviewing body is sought. In summary this amendment request regards the expanding the recruitment protocol beyond NHS services by circulating information about the study around a relevant special interest group, with permission.

Document Version Date

Research Protocol SEED 2 25/11/2016

Declaration by Chief Investigator

1. I confirm that the information in this form is accurate to the best of my knowledge and I take full responsibility for it.

2. I consider that it would be reasonable for the proposed amendment to be implemented.

This section was signed electronically by Miss Ciara Joyce on 29/11/2016 13:05.

Job Title/Post: Chief Investigator Organisation: Lancaster Univeristy

Email: [email protected]

Declaration by the sponsor's representative

I confirm the sponsor's support for this substantial amendment.

This section was signed electronically by An authorised approver at [email protected] on 02/12/2016 18:25.

Job Title/Post: Research Support and Systems Manager Organisation: Lancaster University

North West - Lancaster Research Ethics Committee

Barlow House 3rd Floor 4 Minshull Street Manchester M1 3DZ Tel: 020 71048008

Please note: This is the favourable opinion of the REC only and

does not allow the amendment to be implemented at NHS

sites in England until the outcome of the HRA assessment has been confirmed.

05 December 2016

Miss Ciara Joyce Furness College Lancaster University Lancaster LA1 4YT

Dear Miss Joyce

Study title: Lived experience of severe and enduring eating disorder: A

narrative analysis

REC reference: 16/NW/0543

Amendment number: 1

Amendment date: 24 November 2016

IRAS project ID: 210390

Change to recruitment procedures

The above amendment was reviewed by the Sub-Committee in correspondence.

Ethical opinion

The members of the Committee taking part in the review gave a favourable ethical opinion of the amendment on the basis described in the notice of amendment form and supporting

documentation.

The members had no ethical issues with this amendment.

The documents reviewed and approved at the meeting were:

Document Version Date

Notice of Substantial Amendment (non-CTIMP) 1 24 November 2016

Research protocol or project proposal 2 25 November 2016

Membership of the Committee

The members of the Committee who took part in the review are listed on the attached sheet.

Working with NHS Care Organisations

Sponsors should ensure that they notify the R&D office for the relevant NHS care organisation of this amendment in line with the terms detailed in the categorisation email issued by the lead nation for the study.

Statement of compliance

The Committee is constituted in accordance with the Governance Arrangements for Research Ethics Committees and complies fully with the Standard Operating Procedures for Research Ethics Committees in the UK.

We are pleased to welcome researchers and R & D staff at our Research Ethics Committee members’ training days – see details at http://www.hra.nhs.uk/hra-training/

16/NW/0543: Please quote this number on all correspondence

Yours sincerely

Dr Lisa Booth Chair

E-mail: [email protected] Enclosures:

List of names and professions of members who took part in the review

Copy to: Ms Beverley Lowe, Lancashire Care NHS Foundation Trust

Dr Diane Hopkins

North West - Lancaster Research Ethics Committee Attendance at Sub-Committee of the REC meeting on 02 December 2016