Ethical responsibilities in research data management.
It is essential that ethics approval is obtained prior to the start of any research activity. It is the responsibility of each researcher to adhere to the ethics requirements of their research project.
Obtaining ethics approval
All research involving human participants, their tissue or their data must be subject to research ethics scrutiny by the University's Research Ethics Committee (UREC) and/or the relevant Faculty Research Ethics Committee (FREC). Human Tissue Legislation and NHS Health Research Authority requirements must also be consulted and adhered to where appropriate.
Research conducted with external collaborators, for example, the NHS, should also be referred to their relevant ethics committees.
Research which does not involve human participants, but is sensitive for other reasons (such as potential negative environmental risk, or security sensitive research) may also be considered by the UWE Bristol ethics committees.
It is fundamentally important that a favourable ethical opinion is received from the appropriate ethics committee prior to research data being collected or generated.
UWE Bristol Research Ethics policy, procedures, guidance and frequently asked questions are provided on the research ethics guidance.
Obtaining informed consent
Obtaining freely given informed consent is central to research involving human participants. Consent needs to make clear what the data will be used for and whether it will be shared/preserved. The activities covered by informed consent should be considered prior to and throughout the research lifecycle.
It is important to note that, as far as is practical, individuals have the right to withdraw from a study at any point. When the research data is collected, it is essential that it is made clear the point at which this would become impracticable. You will need to ensure that you comply with what you have told the research participants, and have in place mechanisms to permit this. This will also have implications for the way data is stored and archived and how re-use is permitted.
Sharing or publishing data
The confidentiality of research participants must always be protected in line with the informed consent for the research. This means that what you say to participants in the participant information about how their data may be retained, shared, and/or used in publication is crucial; because you can only do what you have told them you will do.
If data is to be anonymised to permit sharing, this should be made clear at the consent stage. You should also pay careful attention to the extent to which your research data can be truly anonymised.
The UK Data Archive provides a wide range of advice on collecting data which will be preserved and shared including some guidance on anonymisation.
You should always consult with your Faculty Research Ethics Committee if you are unsure whether the data you wish to share or publish can be used.