Ethics

‘Research ethics’ is a phrase which encompasses a wide range of activities undertaken by many research staff. It is particularly relevant to those whose research involves human subjects, for instance:

• clinical medical researchers, who might be studying new surgical procedures or monitoring drugs trials
• bioscientists who study tissue samples
• psychologists, social scientists and nurses who gather data by carrying out interviews.

It also encompasses:

• the protection of confidential data
• the appropriate treatment of animal subjects
• working in dangerous environments.

A number of laws and Codes of Practice exist that lay down strict procedures for how these areas of research should be conducted. The UK Research Integrity Organisation’s (UKRIO) Code of Practice for Researchers summarises all these issues in a single document.

Universities and funding bodies will require research in these sensitive areas to be approved by an Ethics Committee before the research can begin. Researchers will also be required to adhere to the UKRIO Code and/or their institution’s own policies and procedures for ethical research. The University of Warwick’s Guidelines on Ethical Practice is a good example.

Research involving human subjects

The main responsibility of researchers is to protect participants from any harm arising from their research. Harm to participants may arise from 'undue stress through participation, loss of self esteem, psychological injury as well as physical harm' (Warwick guidelines).

Researchers are obliged to ensure that, as far as possible, people participating in research 'must not be exposed to risks that are greater than or additional to those they encounter in their normal lifestyles.' Any risk of such harm will require the research leader to obtain advance approval from the university’s Ethics Committee before the research can be undertaken. It will also require the informed consent of those taking part.

Clinical medical research is an area of special sensitivity. Drugs trials and surgical procedures may carry significant risk of harm to participants. These areas are regulated by laws including the Medicines for Human Use (Clinical Trials) Regulations 2004. The guiding principle is that 'research can only take place where the foreseeable risks and inconveniences to the prospective trial participants/patients are outweighed by the potential benefits for them and for future patients' (Warwick guidelines).

Other areas of special sensitivity highlighted by the UKRIO Code include research involving children, vulnerable adults and sufferers of mental illness.

Research involving human tissue

Following a series of high-profile scandals involving retention of human organs without consent, the Human Tissue Act 2004 was passed. The Act requires that human material must only be obtained and stored with the consent of the donor or their representative. Exceptions to the rule occur in the case of ‘residual’ tissue samples (tissue left over from medical procedures) as long as the researcher cannot identify the donor and is unlikely to be able to do so in the future.

Research involving human tissue needs approval from the relevant Ethics Committee.

The Department of Health has produced an informative guide to the Human Tissue Act.

Research involving animals

Animal research is also regulated by legislation including the Animals (Scientific Procedures) Act 1986. All research that falls under the scope of the Act needs to be approved by the relevant Ethics Committee. Staff carrying out the research must be fully trained and must carry Home Office authorisation.

The guiding principles of research involving animals are the ‘three Rs’ – REDUCTION, REPLACEMENT and REFINEMENT of animal involvement. The Association of Medical Research Charities publishes guidance on how these principles should be implemented.

Research involving personal data

The Data Protection Act 1998 lays down requirements for how personal data should be stored, who should have access to it, and when it should be destroyed. Researchers have an obligation 'to ensure the confidentiality and security of personal data relating to human participants in research' (UKRIO Code). The Information Commissioner’s Office publishes a helpful guide to the Data Protection Act.

The informed consent of participants is essential. This also means that participants must be aware that their data will be disseminated, in anonymised form, through reports and/or academic publications.

More guidance on data handling can be found elsewhere on this site.