Specific Issues

This page explains definition and importance of specific issues relating to applications for ethics approval for research.
Consent Student Projects
Vulnerable Groups
Risk to Research Participants
Confidentiality and Data Protection
Risk to Researchers
Use of Human Material Researchers' Responsibilities
Projects Involving External Researchers Complaints Procedures
Dissemination of Research Monitoring


"Informed consent" should normally be obtained. Information should be provided as to the nature and purpose of the research project. Reasonable steps should be taken to ensure that the research participant is aware of the nature of the research and their involvement in it and that they have freely agreed to participate in the research.

In their application for ethics approval researchers should address both how informed consent can be achieved and demonstrated. Good practice suggests that these objectives should be achieved through the provision of an information sheet and the signing of a consent form, copies of which must be provided to the research participant.  However, it should be noted that in some circumstances - for example, where written consent may pose a risk to the research participant - oral consent may be sufficient. In addition, it should not be presumed that the fact that a form has been signed means that the individual has given consent to inclusion in the research.

Participants have a right to withdraw consent to participation in research at any time.

If it is proposed to undertake research in situations in which consent has not be obtained, for example, covert research, then this will require separate justification.

Vulnerable Groups

Criminal Records Bureau

Research involving 'vulnerable groups' may necessitate a Disclosure and Barring Service (DBS) disclosure to ensure that their background is suitable for working with children and vulnerable adults.


Research involving children gives rise to particular sensitivities. A child is defined as any person under 18 years of age.

Normally, consent to a child’s participation in research should be obtained from the person with parental responsibility. However, parental consent itself may not be sufficient, particularly in situations where a child refuses consent themselves. As far as possible, consistent with their capacity, consent should be obtained from the child himself or herself in addition to parental consent. Children may possess decision-making capacity if they are deemed to have "sufficient maturity to do so". (See further Gillick v West Norfolk and Wisbech AHA. [1985] 2 WLR 413.) In addition, in situations in which children are not perceived to possess decision-making capacity, steps should nonetheless be taken to ensure that wherever possible they assent to their involvement.

Adults Lacking Mental Capacity

Research governing intrusive research concerning adults lacking mental capacity is subject to the Mental Capacity Act 2005.

Confidentiality and Data Protection

Researchers may guarantee confidentiality and anonymity to research participants and such a guarantee should be respected. Such a guarantee is likely to give rise to a legal obligation of confidentiality. Failure to maintain such confidentiality may give rise to an action in the civil courts for breach of confidence. In some exceptional situations, confidentiality may be broken and information disclosed where it is in the public interest to do so.

Storage and use of participant information must be undertaken in accordance with the Data Protection Act 1998.  Further guidance on the operation of the Data Protection Act can be obtained from the University's Information Assurance Services.

Use of Human Material (Issues Consequent Upon Human Tissue Act 2004)

The use of human material (including human tissue etc.) is regulated under the Human Tissue Act 2004. This Act sets out a general structure of regulation including mandating consent with regard to use of such material, subject to statutory exceptions and making specific provision for adults lacking mental capacity and children.

While the majority of these issues are envisaged to fall within the remit of the NHS committee this will not necessarily be the case regarding all holdings of DNA/use of archival material etc. In addition, consideration needs to be given to the use of blood samples from non-clinical volunteers.

Projects Involving External Researchers

Where a joint research project with another institution is proposed, the principal investigator is required to secure ethical approval from their own institution. Where research is undertaken outside the jurisdiction of the institution, researchers have an obligation to comply with laws, regulations, and cultural practices of the jurisdiction where the research is being undertaken as appropriate.

Please note that compliance with ethical principles which may be regarded as appropriate in the jurisdiction where the research is being undertaken is not a substitute for ethical approval from the University of Leicester.

Dissemination of research

There is an obligation upon researchers to accurately and appropriately disseminate research.

Student Projects

Students, whether undergraduate or postgraduate, are subject to the University ethical review procedures. They are to be provided with such training in research ethics as is appropriate for their level of study and subject discipline.

Supervisors are required to ensure that students are aware of any ethical issues which may arise consequent upon student projects.

Risk of Harm to Research Participants

When undertaking research, if it is discovered that there is a risk of serious harm to a research participant - for example, a child or other vulnerable person - then this should be disclosed to an 'appropriate authority', which may include the police or social services.

Risk to Researchers

Research projects must be designed in such a way as to minimise risk to the researcher as well as to the participant. Due regard should be given to any possible health and safety considerations when designing the research project.

Researchers’ Responsibilities

Researchers are responsible for obtaining ethical approval for their project. While the Departmental Ethics Officer and/or the Department/College Ethics Committee will provide scrutiny of the proposed research project, it should be noted that it is the researcher who is personally responsible for the conduct of their project. They are responsible for ensuring that the project complies with any legal or organisational requirements which may be applicable. They must ensure that the project is undertaken as approved by the University research ethics approval process.

Any major divergence from the approved project must be subject to further ethical approval.

Complaints Procedures

Staff or students will have reference to complaints procedures regarding the conduct of research or of the University’s ethical review process through the University grievance procedures.


The University Ethics Committee will monitor the ethical approval process. Annual returns are required from Departmental and College committees. In addition the University Ethics Committee will undertake annual sampling of applications considered at Departmental/College level.

The ethical review process does not extend to the period once the project is in operation. As noted above, the responsibility for the conduct of the research falls upon the researcher.

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