adults at risk: Defined by the Department of Health as "those who are or may be in need of community care services by reason of mental or other disability, age or illness; and who is or may be unable to take care of him or herself, or unable to protect him or herself against significant harm or exploitation.” The term 'adult at risk' has been used in place of the term 'vulnerable adult'. This is because the term 'vulnerable adult' may wrongly imply that some of the fault for the abuse lies with the adult abused. The term 'adult at risk' is used as an exact replacement for 'vulnerable adult', as used throughout existing government guidance to local authorities.
adverse event: any event that brings harm or distress to anyone involved in research involving human participants.
Notes: Researchers should think in advance what harm or distress might result from their research and consider whether the research should go ahead despite the risk. If they consider that it should (for example if the risks of an adverse event are very small, or the possible distress very slight compared with the benefit that might result from the research, they should still make plans to deal with the adverse event including logging the event and reporting it to the project leader or supervisor, or, in the case of more serious events, to the IDREC that approved the research. Special plans may be needed to deal with adverse events in research involving children or people with a mental health or neurological condition.
amendment: changes made to the research after ethical approval has been given. Amendments (a description of the content of the amendment along with new or revised documentation) must be submitted to the same ethics committee as reviewed the original application, and cannot be implemented until the relevant approvals are in place, unless immediate implementation is required for safety reasons. For further information, please see question E1 under 'after approval' in the FAQs.
approved procedures (formerly known as 'CUREC protocols'): CUREC procedures address ethical issues and promote good research conduct in specialised areas of research. This includes research with a specialised population or specialised procedures. As with the CUREC 1 and 1A checklists, the main function of CUREC procedures is to reduce the numbers of projects which need to apply using a full CUREC 2 application. They are part of CUREC’s proportional review. Procedures operate by:
- assessing risk in a given specialised research area; permitting projects to proceed “under CUREC procedure” if they can demonstrate minimised risk
- setting standards of good research conduct in these specialised areas.
In this way, CUREC procedures cannot always avoid the need for higher risk or more complex projects to proceed on to a full CUREC 2 application. However, they can be used as part of a CUREC 2 application to mitigate issues as far as they pertain to the procedure(s) in question.
As part of minimising risk, only certain low risk interventions are permitted under a given procedure. As part of setting standards of conduct, procedures may include sections on informed consent and data handling, sometimes even pointing researchers to template informed consent forms or other forms such as safety screening forms. It is common for academic working parties and/or members of CUREC committees to construct procedures. Approved procedures are ratified by committee before they are published for use on the CUREC website.
assent: a term used to express willingness to participate in research by minors (children under 18) who are by default assumed to be too young to give informed consent, but who are old enough to understand the proposed research in general, its expected risks and possible benefits, and the activities expected of them as participants. Failure to object by a child should not, in the absence of affirmative agreement, be construed as assent.
Good assent practice is about the process of involving children and young people meaningfully in decisions about research. The assent process should involve taking the time to explain to a minor, at whatever age they can begin to understand, what the proposed study entails, why the research is being carried out, what this involves for them, and that if they object they do not need to continue to be involved.
It is common to secure assent of a minor and the permission of the parent/carer(s), in place of consent. If a parent/carer grants permission, but the minor does not give assent, then the minor must not take part in the research.
In devising assent processes, researchers should primarily be concerned with how best to develop trusting relationships with children and communicate information appropriately throughout the research.
audit: an investigative activity for which the involvement of human participants does not always require ethical approval.
Notes: Audit sometimes includes quality assurance activity. Audit does not aim to generate new knowledge, but to enquire systematically into the actions of an institution or service with the aim of improving service. It often does not require the collection or generation of fresh data. Its results relate to the particular service provider being audited and are often not generalisable. Its results are often not published, but are principally intended for dissemination within the service. It is generally undertaken by someone within the service being audited. It is sometimes hard to distinguish audit from research. Please consider your project in conjunction with the flowchart:
carer: someone who has primary responsibility for the day to day welfare of people with a mental health or neurological condition: not someone who is contracted to provide personal services for another person. The carer may or may not be related to the people with a mental health or neurological condition in their care.
Notes: Children are people whose ability to give free and informed consent is in question. To determine who should consent to the participation of a child in any particular piece of research, the competence of the child must be weighed against the risk the research poses for the child. The competence of the child to consent to participate in research depends on both the complexity of the particular project and the maturity of the child. The following table shows who should give consent to the participation of the child.
|Research poses no risk to participant||Research poses risk to participant|
|Child incompetent||Parent/legal guardian||Parent/legal guardian|
|Child competent||Child and parent/legal guardian OR child only||Child and parent/legal guardian|
In some cases, 16 and 17 year olds may be classified as ‘competent youths’. Please see our best practice guidance on this. If you are in doubt as to the riskiness of your research and/or the competence of the children discuss the matter with your head of department/supervisor and/or IDREC/CUREC.
If researchers are collecting the personal data of children under 18 and/or wish to disclose these data to third parties they will need the explicit and verifiable consent of the child’s parent or guardian and the child’s assent to do so. The child’s lack of assent will always overrule the parent’s or guardian’s consent. Please see CUREC-approved procedures 15 and 25 for common research studies with children at schools or non-institutional settings.
Where children are judged incompetent to consent to participation in any particular research, it is good practice to ask them their view on whether they want to participate. This view should be sought in advance and respected. Even if appropriate consent has been secured the researcher must stop research immediately if it causes distress to the child and must exclude the child permanently from the research if the distress continues.
Research in schools forms a special case. Where research is to be carried out in a school the researcher must secure the permission of the head teacher. The Children Act (1989) distinguishes between those who have all the rights, duties, powers, responsibilities, and authority of a parent/legal guardian, and those who do not have parental responsibility for a particular child but may assume caring responsibilities. Teachers are in the latter category, simply having caring responsibilities for the child at certain times of the day. Notwithstanding their not having parental authority, the head teacher may permit the carrying out of research on children in their school without seeking parental approval for the children's participation, though they must inform parents/legal guardians of the research so that they can withdraw their children if they wish.
clinical trial: a project to investigate the clinical effects, efficacy, safety, or pharmacodynamics of a drug (specifically an investigative medicinal product – IMP). Clinical trials are subject to specific regulatory procedures through NHS ethics committees and the MHRA (See drugs). Whether a project comes within the legal definition of a clinical trial may be checked by an algorithm (PDF).
(a) understand the nature and effects of the decision
(b) weigh up the information provided and come to a decision about it
(c) communicate the decision.
Notes: Children and people with a mental health or neurological condition may be judged competent or incompetent in any particular situation. They are amongst those people whose ability to give free and informed consent is in question.
complex ethical issues: These are issues that mean that the project is classed as having higher risk. Such issues could include (but are not limited to) recruitment of people whose ability to give free and informed consent is in question, risk to participants of criminal prosecution or use of deception methodology. Projects with complex ethical issues must apply for ethical review to the appropriate subcommittee using the correct full application form. For more information please see the subcommittee process pages, accessed from the Where and how to apply page.
See also straightforward ethical issues
Notes: Where University staff or students conducting human participant research receive data from participants in confidence, that is confidential in nature, or in respect of which assurances of confidentiality have been provided, that confidence should be respected. Whilst such information may be disclosable in exceptional circumstances, for example where there is a risk to an individual or in the course of civil litigation or criminal proceedings, unwarranted disclosure may of itself give grounds for legal action, for example under the Data Protection Act, and may be a serious disciplinary matter.
Personal data may only be processed lawfully if the processing is in accordance with the provisions of the Data Protection Act.
conflict of interest: this arises when a researcher's professional actions may be influenced by considerations of personal gain beyond that simply accruing from successful research in general.
Notes: Gain may be financial or it may be non-monetary, such as political self-advancement. Gain may accrue to the researchers themselves or to their close family or associates. Conflicts of interest may arise through the existence of unequal relationships. It is impossible to avoid conflicts of interest, but the University aims to manage conflicts by requiring disclosure of interests. Where personal interests could directly and significantly affect the design, conduct, or reporting of the research, they must be disclosed and the University may withhold approval of the research or may approve it only after a change in study design or research personnel.
consent form: a paper form that competent human participants sign and date to give their informed consent to participate in research, or which competent adults sign to record their consent to the participation in research of a third party (child or person with a mental health or neurological condition) for whom they have responsibility.
Notes: The form must be signed and dated by the researcher who explained the project to the participant. The researcher(s) who secure consent must be approved by the principal researcher as competent to the task and this must be identified on the CUREC application form if one is completed. CUREC does not require signatures to be witnessed.
The use of a signed consent form is always desirable from the point of view of maintaining appropriate ethical standards, including ensuring data protection, but the University recognises that the use of such a form may sometimes be impossible (for example where participants are illiterate) or impracticable (for example when participants are asked to complete a brief survey in the street) or may itself raise ethical questions (for example in cultures where giving a signature is a matter of great moment and insistence on it may put unacceptable pressure on participants, or in criminological research where participants may be asked about their involvement in illicit activities). Participants may be provided with a copy of the consent form but this is not a CUREC requirement. Where participants are being invited to take part in a postal or web based questionnaire the questionnaire should clearly explain that by completing and return it the participant declares his/her understanding of the project and consent to participate in it.
Notes: This is acceptable only when lack of deception would prevent or impede the gathering of data essential for the achievement of the purposes of the research, or would endanger the safety of the researcher. Participants should if possible be told the true purpose of the research as soon as possible after its completion. However, the University recognises that deception is sometimes necessary and that some such deception must be enduring. It will therefore not withhold approval for research simply because it entails deception. It however will require that no unwarranted harm that could reasonably have been foreseen come to participants as a result of the deception. An approved procedure is available for studies involving deception of participants.
Notes: Giving individuals information about themselves does not constitute disclosure.
DREC: Departmental Research Ethics Committee. The Social Sciences and Humanities IDREC (SSH IDREC) is assisted in its review responsibilities by ratified departmental research ethics committees (DRECs).
drugs: synonymous with ‘medicines’, defined by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) as “any substance or combination of substances presented as having properties for treating or preventing disease in human beings; any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis”.
The MHRA licenses drugs on the basis of their safety, quality and efficacy. A licence is specific to the effective dose that needs to be given, the type of patient (for example, age, sex) and the duration of treatment.
The administration of licensed drugs to healthy research participants in order to manipulate their physiological or psychological state may be approved by CUREC subject to the satisfactory completion of a CUREC 3 combined protocol and application form.
However, if the research constitutes a clinical trial it must be approved through an NHS ethics committee, not CUREC, and given a clinical trial authorisation by the MHRA. Research involving administration of an unlicensed drug must also be approved through an NHS ethics committee.
Some substances are commonly regarded as foods or food supplements and thereby do not come within the legal definition of a medicinal product. However, if such substances are used to manipulate participants’ physiological or psychological state in a research project they must be approved through CUREC by the same procedure (ie submission of form CUREC 3) as for a drug.
financial or other rewards: in this context, some direct benefit to human participants.
Notes: if you offer such a benefit for participation in research, make clear that you are simply compensating people for their time, so that it does not seem that you are inappropriately offering inducements.
human participant: a person who is the subject of study and whose personal information is used in that research. This information may be gathered directly from the individual or obtained indirectly.
Notes: for further guidance on which classes of personal information fall within the scrutiny of CUREC, see personal data.
Informed consent should happen in two stages: an information-giving stage and a consent-obtaining stage. Ideally the potential participant should be allowed as much time as they need between the receipt of the participant information and the request to give consent, but the University recognises that this may not always be possible.
The granting of informed consent is, for most research, a necessary condition for research involving human participants to proceed but is never a sufficient condition. Ethical approval is also necessary before the research can proceed. For more information see our informed consent page.
invasive procedures (class A): These involve physical contact with the participant. Procedures that go beyond contact with the outer body surface, and/or involve probing internal functions using electromagnetic fields or ionizing radiation, are classified as invasive procedures (class A) and require the approval of an NHS research ethics committee, unless they comply with a specific CUREC approved procedure. Examples of such procedures include those for magnetic resonance imaging (MRI), Transcranial Magnetic Stimulation (TMS) and Transcranial Current Stimulation (TCS).
Notes: Examples of class A procedures not covered by any existing procedures would be SPECT or PET scanning. Taking blood or other bodily fluids or tissue by puncturing the skin would also generally come into this category, although some procedures for taking blood samples have been agreed by CTRG to be minimally invasive and can be approved through CUREC. For the administration of drugs or other substances to be ingested, please see drugs.
In cases of doubt, please contact the relevant IDREC for guidance.
invasive procedures (minimally invasive, or non-invasive – class B): These include passive recording of function by contact with the outer body surface without breaking the skin or involving significant transfer of energy across the skin. Examples would be recording of electroencephalogram (EEG), magnetoencephalography (MEG), eye movement recording by electrooculogram (EOG), electromyogram (EMG), Near-Infrared Spectroscopy (NIRS), recording of heart rate or galvanic skin response (GSR). Taking saliva, faecal or urine samples may be included in this category, provided that certain conditions are met.
Notes: CUREC does not class as invasive procedures video or audio recording, still photography, use of headphones, or monitoring of location and action by electronic detection of an external marker.
In cases of doubt, please contact the relevant IDREC for guidance.
licensed drug: see drugs
lone working: see risk assessment
medical device: A medical device is an instrument, apparatus, implant, in-vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a medicinal product or drug). Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, or thermal means.
MS IDREC: The Medical Sciences Interdivisional Research Ethics Committee (MS IDREC) is one of CUREC’s three subcommittees.
OxTREC: The Oxford Tropical Research Ethics Committee (OxTREC) is one of CUREC’s three subcommittees
patients of the NHS: all potential human participants in research recruited by virtue of their past or present treatment by, or use of, the UK National Health Service (NHS). It includes NHS patients treated under contracts with private sector institutions and private patients in NHS or private hospitals.
Notes: Proposals for research that involves human participants will normally undergo peer review, for example by a tutor, supervisor, or funding body. The University regards research that duplicates other work unnecessarily or that is not of sufficient quality to contribute something useful to existing knowledge as ethically questionable, unless its primary aim is the training of the researcher. CUREC does not itself subject proposals to peer review but it needs to be satisfied that appropriate review has occurred or will occur. In the case of CUREC 1 or 1A-only projects, the signature of the head of department suffices as peer review.
people whose ability to give free and informed consent is in question: Such people include incompetent participants, such as young children, people with mental health or neurological conditions, vulnerable participants such as older children, prisoners, people taking medication that affects their capacity, and some people who are not fluent speakers of the language in which the research will be conducted. They are people
(a) who cannot understand the consequences of taking part in research and/or
(b) who cannot communicate a decision about their willingness to participate in research and/or
(c) whose social circumstances call into question their ability to make a free choice about participation.
Notes: Not all people with the characteristics given as examples above are vulnerable: for example, highly intelligent and highly paid business people being interviewed in their second language are not vulnerable. Nor are vulnerable people limited to those with the characteristics above. The judgement of researcher and head of department must be used to identify vulnerable people and act accordingly in designing their research. Section 60 of the Health and Social Care Act 2001 sets out some forms of research where consent cannot be obtained.
people with a mental health or neurological condition: people whose capacity to exercise judgement is impaired because of the current effects of a mental health or neurological condition (eg bi-polar disorder, Alzheimer's disease, severe learning disability) or side-effects of medication being taken for that condition. People with a mental health or neurological condition are people whose ability to give free and informed consent is in question.
Notes: To determine who should consent to the participation of a person with a mental health or neurological condition in any particular piece of research, the competence of the person must be weighed against the risk the research poses for the person. The competence of the person with a mental health or neurological condition to consent to participate in research depends on both the complexity of the particular project and the degree to which the judgement of the person with a mental health or neurological condition is impaired. The following table shows who should give consent to the participation of people with a mental health or neurological condition.
|Research poses no risk to
|Research poses risk to
|Person with a mental health or neurological condition is incompetent||Next of kin or carer||Next of kin or carer|
|Person with a mental health or neurological condition is competent||Person with a mental health or neurological condition and next of kin or carer OR person with a mental health or neurological condition only||Person with a mental health or neurological condition and next of kin or carer.|
Even if people with a mental health or neurological condition are judged incompetent to consent to participation in any particular research it is good practice to ask them their view on whether they want to participate. This view should be sought in advance and respected. Even if appropriate consent has been secured the researcher must stop research immediately if it causes distress to the person with a mental health or neurological condition and must exclude the person permanently from the research if the distress continues.
Whilst a parent or guardian may in law consent to the participation in research of the child for whom they are responsible, the next of kin or carer of the person with a mental health or neurological condition rarely has such clearly defined responsibility. Where the person with responsibility for the wellbeing of the person with a mental health or neurological condition is clear in law (for example where the person with a mental health or neurological condition is under a guardianship order) the consent of this person must always be sought. Where lines of legal responsibility are not clear, it remains ethically important to secure the consent of the next of kin or carer to the participation in research of the person with a mental health or neurological condition where indicated in the table above.
personal data: data that relate to a living individual who can be identified (a) from those data, or (b) from those data and other information that is in the possession of, or is likely to come into the possession of, the data controller (eg through the use of a code devised by, or accessible to, the researchers). In order to comply with the Data Protection Act you must 'be clear from the outset about why you are collecting personal data and what you intend to do with it'. Normally, data must be deleted once it is no longer required for the study. There are certain exemptions specifically for researchers regarding the Data Protection Act:
However, the researcher will need to explain to the participant:
- the identity and contact details of the researcher(s) who will determine how the data is processed
- the identity of persons (or categories of persons) to whom the data may be disclosed
- whether any of the intended data recipients are outside the European Economic Area
- the purposes for which the information is to be used
- the participant’s right to withdraw their consent at any time, without giving a reason
- any further information as to how data are to be processed (for example, data encryption, and where/how long data will be stored). Please also see the University’s research data website on this.
- what happens to the data on completion of the project. Research data should be kept for a minimum of three years after publication, or longer depending on funder requirements.
Notes: Data in the following category do not count as personal data for CUREC purposes and studies using such anonymised, non-traceable data need not be subject to CUREC scrutiny – data that have been collected previously by someone other than the researcher and anonymised and for which neither the researcher nor any other researcher at the University (nor anyone else involved in the project from outside the University) holds a code to identify individuals, or other information from which individuals might be identifiable. Examples include studies involving census data, administrative data, secondary analysis etc. In cases of doubt about whether the project is subject to CUREC scrutiny, please contact the relevant IDREC for guidance. The collection, storage, and destruction of personal data must be carried out in accordance with the Data Protection Act (1998). Information about the university's data protection policy may be found at www.admin.ox.ac.uk/councilsec/dp/index.shtml. Additional guidance is available if required by emailing email@example.com.
principal researcher/supervisor: a person who helps to design and who monitors research carried out by him/herself and/or others, and who assumes responsibility for the ethical standards of that research. This person is often called 'principal investigator'.
Notes: A principal researcher will normally be an employee of the University, or of one of its constituent colleges, or someone who has been given consent by the head of a department within the University of Oxford to conduct research in conjunction with the University, for example a sabbatical visitor from another university, a person whose research grant is being administered by the University etc. If the principal researcher does not fall into one of these categories this should be made clear on the checklist and/or application form.
privacy: Britain has no privacy law as such, but the University is required to ensure compliance with the Data Protection Act (1998) (see personal data) and the Human Rights Act (1998).
Notes: Most research benefits particular groups of people, for example children in schools but it is still in the public interest as there are wider public gains to be derived from improving teaching in schools. Research that is designed primarily to produce benefits to one political party or profit making organisation is not normally research for public benefit. However, there may be public gains from such research and it will be a matter of judgement whether such research could be in the public interest.
relevant material: material, other than gametes, that consists of or includes human cells. It does not include hair and nail from the body of a living person. For further information, see the Human Tissue Authority website.
Notes: Research is to be distinguished from other types of activity which may not require ethical approval. Research aims to generate new knowledge which may or may not have practical applications. It often relies on the collection or generation of fresh data. Its investigations into particular cases may lead to generalised conclusions, its results are normally published and/or widely disseminated by other means, and the researchers have not chosen the topic of enquiry primarily because they are internal to any particular institution. The aim of audit and service evaluation projects is to measure against existing standards.
For guidance on determining whether your proposed project is considered research, please refer to the following links:
|HRA decision tool|
|Social Science Research: Principles, Methods and Practices, Chapter 1 (PDF)|
research data and records: the recorded information (regardless of the form or the media in which they may exist) necessary to support or validate a research project’s observations, findings or outputs. This is not to be confused with personal data. Please also see the University policy on the management of research data and records.
researcher: a person conducting research. This term includes principal researchers and supervisors.
Notes: Researchers must either have the experience, qualifications and competence appropriate to the research, or must be under the supervision of such a person or persons. Researchers should have had appropriate training in ethical matters relating to research.
research involving human participants: research that involves direct personal contact of any kind, including interviewing and/or observing human participants, and research that involves the administration of questionnaires and use of personal data (other than anonymised, non-traceable data) where there is no contact with any individual.
risk assessment: CUREC takes concerns regarding researcher and participant safety seriously. If you are undertaking fieldwork in dangerous or sensitive situations (which can include research in participants' homes), please address this in your CUREC form. You should also arrange a risk assessment through your department. There is some best practice guidance on interviewing participants in their homes (see Best practice guidance 10: home visits. The University’s Safety Office may also be able to advise.
sensitive personal data: personal data relating to race or ethnic origin, political opinions, religious beliefs, physical/mental health, trade union membership, sexual life or criminal activities. Special conditions apply to the processing of this type of information, including an obligation to obtain the explicit consent of the individual. See also personal data.
sites: the places, for example department, laboratory, schools, clinics, or homes, where research is to be carried out.
Notes: if research is to be carried out at health or higher education institutions other than those of the University of Oxford it is likely that ethical approval will be needed from the bodies which cover those sites as well as from CUREC.
sponsor: the individual, company, institution or organisation that takes on ultimate responsibility for the initiation, management (or arranging the initiation and management) of and/or financing (or arranging the financing) for certain classes of clinical research. The sponsor provides insurance for the research, but is not necessarily the funder.
Sponsorship is required for CUREC studies that utilise NHS staff, equipment, premises or data. The University usually assumes sponsorship when a University employee has designed the study and is acting as the chief investigator. The University must actively consent in writing if it is to act as sponsor.
If you need the University to sponsor your study, please contact the Clinical Trials and Research Governance team (CTRG) as early as possible and send your documents to them for sponsorship review prior to MS IDREC or SSH IDREC ethics review.
Please note that for OxTREC studies where the University is sponsoring the research, sponsorship review forms part of the ethical review process. There is therefore no need to contact the Clinical Trials and Research Governance team. For further advice on sponsorship of OxTREC studies, please contact the OxTREC Secretariat.
SSH IDREC: The Social Sciences and Humanities Inter-Divisional Research Ethics Committee (SSH IDREC) is one of CUREC’s three subcommittees. It delegates part of its review responsibilities to ratified departmental research ethics committees (DRECs).
straightforward ethical issues: These are issues that mean that the project is classed as of low or minimal risk. This often means that the research can be reviewed and approved without having to fill a full CUREC 2 application form or OXTREAD application. For more details see individual subcommittee process pages, accessed from the Where and how to apply page.
See also complex ethical issues
Notes: examples are relationships between teacher and student, counsellor and client, warder and prisoner, and employer and employee. The existence of unequal relationships can result in a conflict of interest.
unforeseen events: these are adverse events that have not been anticipated.
Notes: Researchers should act as they would have done with anticipated adverse events but consider whether the research method or should be altered in the light of the unforeseen events. At the least, the plans for adverse events should be updated in the light of the unforeseen event.
unlicensed drug: see drugs