Archiving

How long should research data be archived for?

Research data must be retained for an appropriate period to allow further analysis and support monitoring. Many organisations have policies on how long data should be archived for. The MRC and the Department of Health provide guidance in this area. For studies that are funded or run by MRC employees, the MRC guidance should be followed. The Department of Health has issued guidance for NHS organisations in England.

Since there are likely to be resource implications for storing large volumes of data for a long time, local research organisations have their own policies on archiving, these should be considered along with the following guidance.

MRC Guidance

• Good Research Practice
• Personal Information in Medical Research

A summary of this guidance is given below (this is mandatory for MRC employees and MRC funded studies, and has been adopted as accepted good practice for some research that is funded by others).

The retention time depends on the type of study:

1. All types of studies
   Primary research data must be retained in their original form (including specimens, samples, questionnaires, audiotapes, etc.) within the research establishment that generated them for a minimum of 10 years after completion of the study – this time is increased if consent was obtained in the study (see the bullet point below). Any primary data that is in paper form can be scanned as appropriate and the original paper copies discarded after 10 years.
   
   
2. In studies where consent was obtained
   A subset of the original records covering the protocol, consent procedure, people who consented to take part and records of adverse events should be retained for 30 years after completion of the study.
   
   
3. Clinical or Public Health Studies
   Records should be retained for 20 years after completion of the study to allow for review, reappraisal or further research, and to allow any concern about the conduct or consequences of the work to be resolved.
   
   
4. Studies with historical importance, novel intervention, or studies which are ongoing or controversial
   Records from these studies should be retained longer than 20 years after completion of the study, but no actual date is specified in the guidance. The researcher should decide on the retention time beyond 20 years based on the individual study.

The following should be noted:

• A custodian should be designated for any archived information.
• Data should be stored in line with other policies e.g. Data Sharing (see Preservation and sharing (3rd party access), for more information).
• Data should be stored in a way that permits a complete retrospective audit if necessary.
• Data should be safely stored, with appropriate contingency plans e.g. saving a back-up copy of the data, in a form that is viable in the future (with advances in technology – you may need to review arrangements regularly during the archiving period).
• Data should be treated in confidence, i.e. kept securely with no unauthorised access.
• Should the research team cease to exist, or the lead moves to another centre, the expectation is that the responsibility for their information passes to the university, hospital, or research centre that hosted their research activity.

Department of Health Guidance

• Research involving the NHS: retention of records

This guidance summarises the requirements of legislation, policies and common practice applying to the retention of records relating to research carried out in the NHS. It focuses on the following:

• Data Protection Act 1998
• Clinical Trials Regulations 2006
• Research Governance Framework for Health and Social Care
• Governance Arrangements for Research Ethics Committees
• MRC guidance (detailed above)
• other considerations