Informed consent – some general principles
- Participant health and safety:
Research participants must always be protected from any risk or harm arising from research that is greater than, or in addition to what they encounter daily. Prior to submitting an ethics application for review, researchers must ensure that ‘duty of care for research participants’ is considered, and measures for prevention and protection included. If there is a possibility that the participant may suffer negative consequences as a result of participation than this should be highlighted in the application to the review committee and to the participant prior to obtaining consent.
Researchers have a responsibility to ask participants about any factors or pre-existing medical conditions that might create risk or harm them as a result of participating in the research.
Participants must always be advised of the possible implications of participating in a research and how to contact the lead researcher, Chair of College research ethics committee/Head of College or other relevant University contacts if, following participation,they experience physical discomfort or stress, or have any other concerns about the research.
If during research, a researcher obtains evidence of physical or psychological problems of which a participant is, apparently, unaware, the researcher has a responsibility to inform the participant if s/he believes that by not doing so, the participant’s future well-being may be compromised or diminished. If the issue is serious and the researcher is not qualified to offer assistance, then an appropriate source of professional advice should be recommended to the participant. For some types of research the giving of advice will be appropriate, intrinsic to the research, and will have been agreed prior to the person’s participation as part of the consent process.
- Data Protection and Personal Data:
The Data Protection Act (1998) defines “personal data” as data which relates to a living individual who can be identified from that data, or from those data and other information which is in the possession of, or is likely to come into the possession of, the data controller, and includes any expression of opinion about the individual and any indication of the intentions of the data controller or any other person in respect of the individual;
In this Act “sensitive personal data” means personal data consisting of information as to
- the racial or ethnic origin of the data subject,
- his political opinions,
- his religious beliefs or other beliefs of a similar nature,
- whether he is a member of a trade union (within the meaning of theTrade Union and Labour Relations (Consolidation) Act 1992),
- his physical or mental health or condition,
- his sexual life,
- the commission or alleged commission by him of any offence, or
- any proceedings for any offence committed or alleged to have been committed by him, the disposal of such proceedings or the sentence of any court in such proceedings.
Researchers should consider all of the above aspects of the ‘Data Protection Act’ while drafting participant consent forms, negotiating and undertaking consent, saving and storing data, and during writing or publishing reports.
Version 1. Nov 2016