The following research examples may involve more than minimal risk and could require a full ethics review.
Potentially vulnerable groups or people
Potentially vulnerable people or groups, for example children and young people, those with a learning disability or cognitive impairment, or individuals in a dependent or unequal relationship. Vulnerability should be considered on a case-by-case basis. Many groups or individuals not conventionally considered as vulnerable could become exposed to issues as a result of participating in research that makes them vulnerable.
Those who lack capacity to make decisions, or who during the research project come to lack capacity, must be approved by an appropriate body operating under the Mental Capacity Act 2005. Normally this will be a research ethics committee (REC) recognised by the Secretary of State and Welsh Ministers and operating under the Governance Arrangements for Research Ethics Committees. Research conducted in Scotland should be reviewed by the Scotland ‘A’ REC, which is operating under the Adults with Incapacity (Scotland) Act 2000.
If you need permission of a gatekeeper
Individuals or groups where permission of a gatekeeper is normally required for initial or continued access to participants. This includes research involving gatekeepers such as adult professionals (eg those working with children or the elderly), or research in communities (in the UK or overseas) where access to research participants is not possible without the permission of another adult, such as another family member (eg the parent or husband of the participant) or a community leader. Permission for access to other groups, for example participants in a longitudinal cohort study, may also need to be requested from the data producer who controls access to the group.
Research where participants are in a dependent relationship with the gatekeeper (for example, employees recruited through their workplace).
Sensitive topics, for example participants’ sexual behaviour, their illegal or political behaviour, their experience of violence, abuse or exploitation, their mental health, or their gender or ethnic status.
Issues with data and privacy
Administrative or controlled data. Appropriate approval within the relevant governance regime(s) is needed for use of these datasets. Issues may arise when data are linked and where it may be possible to identify participants.
Research where participants or other individuals may be identifiable in the material used or generated. For example, visual or vocal methods producing images or sound recordings, or interviews with people holding high office (elite interviews) who may be identifiable.
Linking or sharing of data or confidential information beyond the initial consent (including linked data gathered outside of the UK) – for example where the research topic or data gathering or re-use involves a risk of information disclosure that would require the researchers to breach confidentiality conditions agreed with participants.
Social media and participants recruited or identified through the internet, in particular when the understanding of privacy in these settings is contentious or where sensitive issues are discussed – for example in ‘closed’ discussion groups where there is potential for quotes and visual images to be identifiable.
Access to records of personal or sensitive confidential information, including genetic or other biological information, concerning identifiable individuals. See the Data Protection Act 1998.
Intrusive interventions or data collection methods – for example the administration of substances; involving physical or emotional stress; or techniques where participants are persuaded to reveal information which they would not otherwise disclose in the course of everyday life. Also research which would or might induce psychological stress, anxiety or humiliation, or cause more than minimal distress.
Participatory research where not all persons involved in data collection are members of the research organisation (RO) responsible for the research.
Researchers should follow relevant legislation, ie Human Tissue Act 2004, Human Tissue (Scotland) Act 2006 and the relevant NHS policy requirements for REC reviews. See also NHS Research Scotland (NRS). Guidance for professionals is available on Human Tissue Authority’s website.
Body parts or other human elements. Researchers should follow relevant legislation, ie Human Tissue Act 2004, Human Tissue (Scotland) Act 2006 and the relevant NHS policy requirements for REC reviews. See also NHS Research Scotland (NRS).
Where you do not have consent
Justified deception or research conducted without participants’ valid and informed consent at the time the study is carried out. It is recognised that there are occasions when the use of covert research methods is necessary and justifiable, and consent may need to be managed at a point beyond the completion of research fieldwork.
Risks to researchers and other staff
Research where there may be risk to the safety and wellbeing of the researchers and other staff.
International partners or research undertaken outside of the UK where there may be issues of local practice and political sensitivities. In some cases partnership with a RO in the geographical area involved may prove helpful. It is also necessary to act in accordance with the legal and ethics review requirements in the countries included in the research. Researchers should also consider these issues when undertaking social media research, as data are often drawn from a range of international settings.