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Minimización del máximo arrepentimiento (MMA)

3.3 Detalle de la metodología a utilizar

3.3.4 Minimización del máximo arrepentimiento (MMA)

In this section, personal data means any data relating to a participant who could potentially be identified. It includes pseudonymised data capable of being linked to a participant through a unique code number.

Storage and use of personal data during the study

A36. Will you be undertaking any of the following activities at any stage (including in the identification of potential participants)?(Tick as appropriate)

Access to medical records by those outside the direct healthcare team Access to social care records by those outside the direct social care team Electronic transfer by magnetic or optical media, email or computer networks Sharing of personal data with other organisations

Export of personal data outside the EEA

Use of personal addresses, postcodes, faxes, emails or telephone numbers Publication of direct quotations from respondents

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Publication of data that might allow identification of individuals Use of audio/visual recording devices

Storage of personal data on any of the following: Manual files (includes paper or film)

NHS computers

Social Care Service computers Home or other personal computers University computers

Private company computers Laptop computers

Further details:

Participant confidentiality will be maintained throughout the project and once it has been submitted. Confidentiality of participant data will be maintained by storing consent forms and other personal information using participant assignment numbers. These will either be stored in a locked filing cabinet in the research and development department of the relevant trust separate to audio data or at Lancaster University, depending on trust policy and procedure. Audio data and electronic copies of interviews will be stored and transferred electronically on Lancaster University’s encrypted network. Audio-tape recordings will be transcribed anonymously, and care will be taken when writing up to preserve anonymity of participants. Anonymised typed copies of interviews with participant identifier numbers will be transcribed and analysed on the researcher’s personal laptop under password protection and encryption.

On completion of the research project, research data will be stored in a locked cupboard at Lancaster University for ten years. Confidential, personal data will be destroyed up to three months after the study is completed. Participants will be made aware that direct quotes will be used in the final report and that every effort will be made to ensure that the information used is not personally identifiable. Also, participants will be given the opportunity to use a pseudonym for the final report. Participants will be sent information about the overall findings of the study and can request a copy of the final report.

A37. Please describe the physical security arrangements for storage of personal data during the study? Confidentiality of participant data will be maintained by storing consent forms and other personal information using participant assignment numbers. These will either be stored in a locked filing cabinet in the research and

development department of the relevant trust separate to audio data or at Lancaster University, depending on trust policy and procedure.

Audio data and electronic copies of interviews will be stored and transferred electronically on Lancaster University’s encrypted network. Original recordings will be deleted from the digital recorder as quickly as possible once it has been transferred to the University’s encrypted network. In the meantime, the recorder will be stored securely. Audio-tape recordings will be transcribed anonymously, and care will be taken when writing up to preserve anonymity of participants. Anonymised transcripts will be analysed on the chief investigator's personal laptop under password protection.

Confidential, personal data will be destroyed up to three months after the study is completed.

A38. How will you ensure the confidentiality of personal data?Please provide a general statement of the policy and procedures for ensuring confidentiality, e.g. anonymisation or pseudonymisation of data.

The investigator will adhere to policies and procedures in relation to confidentiality, namely NHS Code of

Confidentiality and the Data Protection Act. Interviews will be transcribed anonymously, original recordings will be deleted from the digital recorder as quickly as possible once it has been transferred to the University’s encrypted network. In the meantime, the recorder will be stored securely. File copies of audio recordings will be deleted once the project has been submitted and examined. Other research data may be retained for up to 10 years within the research department of the Doctorate of Clinical Psychology. The research coordinator will have responsibility for storing and deleting the data once I have submitted the thesis and completed my course.

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Participants will be asked to give a pseudonym to ensure anonymity in the write up. All participant personal data will be kept separately to audio data to ensure confidentiality. Personal data will be stored in site files in the relevant NHS Trust Research and Development department in a locked filing cabinet or at Lancaster University which only the chief investigator and personnel from the research and development department will access.

A40. Who will have access to participants' personal data during the study? Where access is by individuals outside the direct care team, please justify and say whether consent will be sought.

Personal data will either be stored in a locked filing cabinet in the research and development department of the relevant trust separate to audio data or at Lancaster University, depending on trust policy and procedure which only the chief investigator and personnel from the research and development department will access.

The researcher’s supervisors will have access to anonymised transcripts to check analysis. Only the research supervisor may listen to audio recordings of interviews, as the field supervisor may be able to identify the participants voice. Participants will be made aware of this in the participant information sheet and consent form.

Storage and use of data after the end of the study

A41. Where will the data generated by the study be analysed and by whom?

Audio data and electronic copies of interviews will be stored and transferred electronically on Lancaster University’s encrypted network. Audio recordings will be transcribed anonymously. Anonymised copies of interviews with

participant identifier numbers will be transcribed and analysed on the researcher’s personal laptop under password protection and encryption. Anonymised printed copies of transcripts and the results from analysis will be accessed by the chief investigator's supervisors in order to inform analysis.

All personal data will be deleted up to three months after the end of the study. On completion of the research project, research data will be stored in a locked cupboard at Lancaster University for ten years. The research coordinator will have responsibility for storing and deleting the data once the chief investigator has submitted their thesis and completed their course.

A42. Who will have control of and act as the custodian for the data generated by the study?

Title Forename/Initials Surname Professor Bill Sellwood Post Programme Director

Qualifications PhD

Work Address Doctorate of Clinical Psychology Furness College

Lancaster University Post Code LA1 4YG

Work Email [email protected] Work Telephone 01524 593998

Fax

A43. How long will personal data be stored or accessed after the study has ended? Less than 3 months

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A44. For how long will you store research data generated by the study? Years: 10

Months: 0

A45. Please give details of the long term arrangements for storage of research data after the study has ended.Say where data will be stored, who will have access and the arrangements to ensure security.

On completion of the research project, research data will be stored in a locked cupboard at Lancaster University for ten years. The research coordinator will have responsibility for storing and deleting the data once I have submitted the thesis.

Personal data including consent forms will be destroyed up to three months after the study is completed. Original tape recordings will be deleted from the digital recorder as quickly as possible once it has been transferred to the

University’s encrypted network. In the meantime, the recorder will be stored securely. File copies of audio recordings will be deleted once the project has been submitted and examined.

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