Loughborough University
Ethical Advisory Committee

Guidance Notes for Investigators
Data Collection and Storage

It is the responsibility of investigators to ensure that they collect and store data in accordance with relevant legislation. The following guidelines are intended to highlight specific areas in which the University has identified best practice in relation to the collection and storage of data as part of a research project.

Compliance with this guidance should help to:

 - protect the rights of participants in terms of data storage.
 - protect investigators and enable them to meet their legal and ethical requirements.
 - protect investigators from accusations of research misconduct in relation to the collection and storage of data.
 - ensure University compliance with the Data Protection Act 1998.
  

1. Confidentiality and Anonymity

Confidentiality of data collected during any research project is essential. All personal information should be encoded or anonymised as far as is possible and consistent with the needs of the study. Participants should be assigned a reference number or code as early as possible and data should be stored against this number/code rather than against the names of participants. Investigators may wish to maintain separate lists of people who have taken part in their research, but steps should be taken to ensure it is not possible to relate a particular set of data back to any given participant.

2. Storage of Primary (or Raw) Data

Appropriate and secure storage of all primary data is of paramount importance, for the protection of participants, researchers and the reputation of the University. Clear rights and levels of access to the data should be specified at the outset of any research project. Data should be stored safely with appropriate back up and contingency plans in the event of loss, damage or unauthorised access to the data. Wherever possible a complete duplicate set of the original data should be retained. Where market research companies (or other data collection agencies) have been employed to collect primary (or raw) data, the University is not necessarily responsible for its storage.

The University has adopted specific best-practice guidelines for the storage of different types of data. It is recognised, however, that in relation to some research projects in may be difficult to adhere to these guidelines, and Investigators may decide against their adoption.

  • Numerical/Statistical Data
         Numerical/Statistical data should be stored in raw data format for six years from completion of the project. Unless data is to be used in later studies (see Longitudinal Studies below), the data should be destroyed after this time.
     Note: Work that informs national policy-making should be archived after six years.
  • Interview Notes/Questionnaire Responses/Transcribed Interviews
         Wherever possible, interview notes/questionnaire responses/transcribed interviews should be stored in their original form for ten years from completion of the project. Unless data is to be used in later studies (see Longitudinal Studies below), the data should be destroyed after this time.
     Note: Work that informs national policy-making should be archived after ten years.
  • Images/Audio & Video Recordings
         Images/Audio & Video Recordings should be retained in their original form. This is particularly important where they are subsequently enhanced. Wherever possible, both original and enhanced images/audio & video recordings should be kept for ten years from completion of the project. Unless data is to be used in later studies (see Longitudinal Studies below), the data should be destroyed after this time.
     Note: Work that informs national policy-making should be archived after ten years.
  • Blood Samples
         The University suggests that blood and plasma samples should be anonymised, stored for 3-6 months whilst analysis is conducted, then disposed of in an appropriate manner (in accordance with the Health and Safety Policy on Blood Borne Viruses).
  • Muscle Biopsy and Other Tissue Samples
         The University suggests that muscle biopsy and other tissue samples should be anonymised, stored in special refrigerators for 12 months, then disposed of in an appropriate manner.

  • Longitudinal Studies
         Data gathered as part of a known longitudinal study should be kept for the duration of the study and retained for ten years after the completion of the study. Participants should be kept informed of how long the study is likely to last (as this may not always be known at the outset). If the study is extended, all participants should be contacted and informed that their data is still being stored and may be used. It is important that participants are given the opportunity to withdraw their data at any point during the study. It may not always be possible for researchers to comply with such a request (for instance if preliminary results have already been published or individual data cannot be identified/disaggregated from cohort analysis) but serious attempts should be made on every occasion.

The importance of maintaining data in its original form is a necessary precaution, particularly if published results are challenged by others.

Primary data should be securely stored for ten years in a durable form in the institution of their origin. The principal investigator (or supervisor where student projects are concerned) is responsible for ensuring that data is destroyed and disposed of in an appropriate manner.

Investigators who leave the institution at which data was generated should obtain permission from their Head of Department to retain data/copies of data. Permission should only be granted where it is clear that future use will be consistent with the terms of consent.

3. Recording Methods of Data Collection

Investigators should keep clear and accurate records of all procedures followed (including approvals granted and interim results) during research projects. This is necessary to demonstrate that proper research practice has been followed, but also in case questions are subsequently raised about either the conduct of the investigator(s) or the results obtained. Properly documented studies are also easier to replicate at a later date.

4. Withdrawal of data

All participants should be given the opportunity to request that their data be destroyed/withdrawn from a research project. In all cases, investigators should aim to comply with such a request, but compliand may not always be possible, for example where:

If it is not possible to withdraw an individual's data for any reason, the investigator is responsible for explaining this to the participant. In extreme cases, the investigator may wish to contact the Ethical Advisory Committee for further advice.

5. Obtaining Consent from Participants

Before agreeing to take part in a research study, participants must be provided with full information on:

Ideally, consent should be obtained from all participants and, wherever possible, copies of consent forms should be kept with the raw data, normally for the same period of time.

6. Data Protection Act 1998

6.1 The processing of personal data must comply with the Data Protection Act 1998. The University has a Data Protection Policy and all investigators are expected to familiarise themselves with this policy, especially the eight Data Protection Principles and the Rights of Data Subjects under the Act, as below:

Data Protection Principles

1. Data should be processed fairly and lawfully.
2. Data should be obtained for one or more specified lawful purposes.
3. Data shall be adequate, relevant and not excessive.
4. Data shall be accurate and where necessary kept up to date.
5. Data is not kept longer than is necessary for its purpose.
6. Data shall be processed in accordance with subject rights under the Act.
7. Appropriate technical and organisational measures shall be taken against unauthorised/unlawful processing, loss, destruction, damage to personal data.
8. Data shall not be transferred outside EEA unless that country/territory ensures adequate level of protection for rights and freedoms of data subjects in relation to the processing of personal data.

Data Subject Rights

1. To make subject access requests regarding the nature of information held and to whom it has been disclosed.
2. To prevent processing likely to cause damage or distress.
3. To prevent processing for purposes of direct marketing.
4. To be informed about mechanics of automated decision taking process that will significantly affect them.
5. Not to have significant decisions that will affect them taken solely by automated process.
6. To take action for compensation if they suffer damage by any contravention of the Act.
7. To take action to rectify, block, erase or destroy inaccurate data.
8. To request the Commissioner to assess whether any provision of the Act has been contravened.

6.2 Investigators should note that personal data processed ONLY for research purposes receives certain exemptions (detailed below) from the Data Protection Act 1998 providing: (i) The data are not processed to support measures or decisions with respect to particular individuals AND (ii) None of the data subjects are caused substantial harm or distress by the processing of the data. If these conditions are met, the following exemptions may be applied to data processed for research purposes only:

Other than these exceptions, the Data Protection Act applies in full, and the obligations to obtain consent before using data, to collect only necessary and accurate data, and to hold data securely and confidentially must be adhered to.  Further guidance on information to be provided to participants before the commencement of an investigation can be found here. 

6.3 While the Act states that research may legitimately involve processing of personal data beyond the originally stated purposes (eg longitudinal studies), the University hopes that, wherever possible, investigators will contact participants if they intend to use data for purposes other than those for which they were originally collected. Further, Although the Act allows personal data processed only for research purposes to be kept indefinitely, investigators are asked to refer to the Ethical Advisory Committee's guidance in this area, in 2. above. Investigators gathering sensitive personal data (as defined by the Act) should take extra care to ensure that explicit consent is obtained and that data are held securely and confidentially so as to avoid unlawful disclosure.

6.4 Publication. Investigators should ensure that the published results of their research are anonymised, and that no information is published that would allow individuals to be identified. Research results can be published outside of the European Economic Area, on the internet or by other means, but if the results contain any personal data, the specific consent of the data subject must, wherever possible, be obtained.

7. Further Information

This is not intended to be an exhaustive list of considerations in relation to the collection and storage of data for research projects. However, it is hoped that these guidelines will encourage researchers to adopt best practice and familiarise themselves with the relevant legislation.

The following websites may also be of interest:
DoH Research Governance Framework
Market Research Society Code of Conduct 
Medical Research Council
Information Commissioner's Office
Loughborough University Data Protection Policy

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April 2006
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