CLS Ethics Appendix 10 - Research Records Policy

THE CITY LAW SCHOOL POLICY ON THE SECURE STORAGE, HANDLING, USE, RETENTION AND DISPOSAL OF RESEARCH RECORDS

General Principles

The City Law School complies fully with its obligations under the Data Protection Act 1998 and other relevant legislation pertaining to the safe handling, use, storage retention, and disposal of research records.

Researchers should keep full and accurate records of research projects. These records will:

  • demonstrate good research practice and strengthen the reliability of research evidence
  • safeguard researchers and the College from allegations of research misconduct
  • protect intellectual property rights
  • demonstrate compliance with Data Protection Act 1998
  • demonstrate effective practices and procedures (including financial management) to internal and external auditors and external sponsors

Type of Records

  • Records relating to the administration and financial management of the project (e.g. grant applications, purchase and sales invoices, orders, delivery notes, petty cash vouchers and supporting accounting records).
  • Records of procedures followed and results obtained, including interim results (e.g. protocol documents, risk assessments).
  • Data generated in the course of research (e.g. interview transcripts; diaries; field notes; observational recordings; audio tapes; audio-visual recordings; photographs; press clippings; personal documents; and databases of quantitative data).
  • Records relating to the administration and financial management of the project (e.g. grant applications, purchase and sales invoices, orders, delivery notes, petty cash vouchers and supporting accounting records).

Active research projects

Responsibility for the accuracy, completeness and security of research evidence during a project should lie with the principal investigator. Extra care should be taken to ensure the security of research material containing personal data, which is subject to the provisions of the Data Protection Act 1998.

Completed research projects

Following the completion of a research project, the research project’s records should be stored in a secure environment that enables continued access to the required records regardless of their format or medium. Research projects that have been granted ethical approval must be given to the Secretary to the CLS Research & Enterprise Committee.

  • Data should be encrypted and kept electronically with access strictly controlled and limited to those who are entitled to see it as part of their duties.
  • Paper records must be scanned and saved electronically.
  • Personal information should be stored separately from data.
  • All personal information must be encoded or anonymised as far as is possible and consistent with the needs of the study, and as early as possible after collection;
  • Data should be stored in a way that permits a complete retrospective audit if necessary.
  • Data should be stored safely, with appropriate contingency plans.
  • Data records should be monitored regularly to ensure their completeness and accuracy.
  • In clinical studies, consent forms should be kept securely with the raw data, and normally for the same period of time.
  • Supervisors should regularly review records for completeness and accuracy.
  • Researchers who are leaving the establishment that generated the data and who wish to retain data/copies of data for personal use must get permission from their head of department to do so. Where personal data are involved, the request should be refused unless it is clear that future use will be consistent with the terms of the consent.
  • Publication of the data (including in Masters/Doctoral theses) does not negate the need to retain source data.
  • Information should only be passed to those who are authorised to receive it in the course of their duties.
  • Research data is only used for the specific purpose for which the applicant’s full consent has been given.
  • Once the retention period has elapsed, data is immediately destroyed by secure means.

Retention Guidelines

Description / Retention Period
Records required to demonstrate good research practice / Retain for a period of 10 years after the completion of a research project
Records containing personal information relating to clinical or public health studies funded by the Medical Research Council / Retain for twenty years after the completion of a research project
Records of protocol, consent procedure, subject consent and adverse effects generated during clinical and public health studies, or other projects requiring consent funded by the MRC / Retain for thirty years after the completion of a research project
Records of projects which:
  • are of historical importance
  • first used novel clinical interventions
  • proved controversial
/ A full set of records should be permanently preserved
Primary research data (and where possible/relevant specimens, samples, questionnaires, audiotapes, etc) including Data generated in the course of a project which may have a secondary use for other research and learning / Retain in their original form within the research establishment that generated them for a minimum of ten years from completion of the project.
Accounting records (e.g. purchase and sales invoices, orders, delivery notes, petty cash vouchers) / Destroy six years after the end of the current financial year
Records documenting the registration of intellectual property rights (e.g. patents and trademarks applications and certificates) / Retain permanently
Records relating to IPR licensing agreements / Destroy seven years after the intellectual property rights have lapsed
All other records generated during a research project and not covered by any of the above disposal classes. / Retain for whichever is longer:
  • seven years after completion of the project (statutory limitation period)
  • a period of time determined by the conditions set by the particular research sponsor

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