Loughborough University
Ethical Advisory Committee

Guidance Notes for Investigators
Compliance with Data Protection Requirements

The Ethical Advisory Committee has approved the following guidance for investigators regarding compliance with the Data Protection Act.

The Data Protection Act states that personal data should be relevant/not excessive (Principle 3) and accurate (Principle 4).

• Investigators should think carefully about the design of their studies/data collection methods to ensure that only relevant information is collected. For example, the generic Health Screen Questionnaire should be carefully customised for each study to ensure that only relevant questions are included. Other data collection instruments should be designed to ensure that only questions relevant to the study at hand are included.
• Investigators should consider what verification procedures are required to ensure that accurate data is collected and recorded.

The following information, regarding processing of personal data should be included in Participant Information Sheets and/or Informed Consent Forms:

• What personal data will be collected and stored.
• How (format) and where (location) the personal data will be stored.
• Who will have access to the personal data (in some cases this should include whether personal data will be transferred outside the EEA).
• What security measures will be in place to protect against unauthorised access.
• Details of any coding/anonymity to maintain participant confidentiality.
• If appropriate, how long the data will be stored.
• How the data will be used in publication (e.g. whether individuals will be identifiable).

Investigators should seek participants’ consent for the processing of their personal information. For personal data (as defined by the Data Protection Act**), an adequate Data Protection Notice accompanied by a signed Informed Consent Form which includes a statement to the effect of “I have read the Participant Information Sheet” should suffice. However, for sensitive personal data (as defined by the Data Protection Act*) EXPLICIT consent should be obtained. Therefore, investigators are advised to include a specific statement on the Informed Consent Form (which participants will sign) regarding the collection, storage, use etc of sensitive personal data.

* sensitive personal data as defined by the Act covers racial or ethnic origin, political opinions, religious beliefs, trade union membership, health, sex life, criminal convictions

** Data (other than sensitive personal data) relating to a living individual who can be identified from that information or from that data and other information in possession of the data controller

Back to Main EAC page

Back to EAC - Additional Information and Resources page

Academic Registry
Copyright © Loughborough University. All rights reserved.