Archiving

How long should research records be archived for?

Research records must be retained for an appropriate period to allow further analysis and support monitoring. Many organisations have policies on record retention. 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 records for a long time, local research organisations have their own policies on archiving, these should be considered along with the following guidance, and any undertakings agreed to when accepting funding.


MRC Guidance

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 MRC’s expectations for retention periods will depend on the type of study and also the type of research data/records.  These are summarised below:

 

Retention Periods

  • Basic research
    • If no restrictions apply, deposit primary/raw data and related material in an appropriate repository and/or publication should be considered.
    • Research records and related material should be retained for a minimum of 10 years after the study has been completed.
  • Population health and clinical studies
    • The retention period for primary/raw data and related material from population health or clinical studies will be informed by the relevant regulatory framework, the legal requirements outlined in guidance from the MHRA and any additional requirements identified by ethics committees or professional codes.
    • For clinical research undertaken in MRC research units and institutes, the MRC expects research records relating to such studies to be retained for 20 years after the study has been completed to allow an appropriate follow-up period.
    • Studies which propose retention periods beyond 20 years must include valid justification, for example, research data relating to longitudinal studies will often be retained indefinitely and archived and managed accordingly.

Research records relating to studies which directly inform national policymaking should be considered for permanent preservation or deposit in an archive or repository.

Where complete retention of all research records is not appropriate, the data must be validated using quality assurance procedures and the justification carefully assessed before any records are destroyed. 

The following should be noted:

All primary/raw data and related materials should: 

  • Be stored in a form that is original, legible and attributable.
  • 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).
  • Be stored in line with other policies e.g. Data Sharing (see Preservation and sharing (3rd party access), for more information).
  • Be stored in a way that permits a complete retrospective audit if necessary.
  • Be treated in confidence, i.e. kept securely with no unauthorised access.
  • Normally be stored within the research establishment that utilised them, or any transfer documented.
  • Be kept in their original formats e.g. questionnaires, audiotapes, etc.

There should be clarity on the ownership and custodianship of archived research data, samples and related material, and agreements in place to clarify responsibilities and arrangements for access or sharing.

 

Definitions of Types of Research Data/Records

  1. Primary/raw data include any information, images, observations, questionnaires, products, devices, procedures and any other data sources that are generated, recorded or used during the project.
  2. Related material includes approvals, information on the consent process (including signed consent forms), meta-data, information relating to analysis and methodology, quality assurance records that demonstrate the validity of the data and/or adherence to experimental protocols, calibration data, collaborative agreements, intellectual property ownership, management and agreements and other relevant correspondence.
  3. Confidential identifiable data comprise any information that relates to an individual (either living or dead) from which that individual can be identified.
  4. The main record refers to the record where the research data are primarily recorded (for example, in electronic or hard copy laboratory notebooks, clinical trial master files).

 

Information Governance Alliance Guidance (for Department of Health)

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