Glossary

* indicates word/term included in this glossary

The following terms are used in CUREC's paper documents and website and refer to the use of the terms in those places. You may not use different or less stringent definitions in order to limit or evade scrutiny of your research by CUREC.

A

adverse event: any event which 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 none the less 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 which 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.

associate researcher: a *researcher who is not a *principal researcher/supervisor.

audit: an investigative activity for which the involvement of *human participants does not require ethical approval.

Notes: This differs from *research for which ethical approval is necessary if it involves human participants. It is sometimes called 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. If in doubt seek guidance from CUREC. If your case is borderline but poses very low risk to participants it might be quickest and safest to complete a checklist.

C

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.

children: legally all those under eighteen years of age are minors.

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

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.

Even if children are judged incompetent to consent to participation in any particular experiment 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 who have the care of the child. Teachers are in the latter category, simply having the care of the child at certain times of the day. Notwithstanding his/her not having parental authority, the head teacher may permit the carrying out of research on children in his/her school without seeking parental approval for the children's participation, though s/he must inform parents/legal guardians of the research so that they can withdraw their children if they wish.

competent participants: *Human participants who are able to give *informed consent to their own participation in *research. A competent participant can

(a) understand the nature and effects of the decision

(b) weigh up the information provided and come to a decision about it

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 doubt.

confidentiality: the privacy attaching to certain information, including personal data.

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 experimental design, or research personnel.

consent form: a paper form which 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 in question 3 of the CUREC application form (CUREC/2) 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.

D

deception: this arises where a *researcher deliberately misleads a *human participant about the purpose or nature of the *research.

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 which could reasonably have been foreseen come to participants as a result of the deception. A protocol is available for studies involving deception of participants.

defining criteria: these define the types of people suitable to act as participants in any study, for example by specifying the age range or sex of acceptable participants in a study.

disclosure: in this context an individual discloses information when he/she releases information to organisations or individuals outside the research project.

Notes: Giving individuals information about themselves does not constitute disclosure.

F

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.

H

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.

I

informed consent: informed consent is the process by which a fully informed competent person participates in the choice of whether to become a *human participant in *research. Informed consent involves

(a) a description of who the *researchers are and what institution they are attached to

(b) an explanation that the potential *human participant has free, rescindable choice about whether to participate in *research, and that refusal or withdrawal have no attendant disadvantages for the potential participant. (It must be made clear where there are practical limits to the participant's ability to withdraw: for example once material has been published in electronic or other format it cannot be withdrawn. Within practical limits participants should be able to withdraw consent for future participation and forbid the use of data previously provided.)

(d) an explanation of the nature of any benefits, risks, and uncertainties for the *human participant in the *research.

(e) an assessment of the competence of the potential *human participant. Only those who are judged to have appropriate competence should be accepted as participants. See *people whose ability to give free and informed consent is in question.

(f) the agreement of the individual to become a *human participant. Consent should be secured and recorded by the use of a *consent form where possible.

Notes: ideally the potential participant should be allowed 24 hours 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 and, in general, peer approval is also necessary before any research can proceed.

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 electric fields or ionizing radiation, are classified as invasive procedures (class A) and require the approval of an NHS research ethics committee.

Notes: Examples would be SPECT or PET scanning, and transcranial magnetic stimulation. Taking blood or other bodily fluids or tissue by puncturing the skin would also come into this category.

In cases of doubt, please contact the relevant IDREC for guidance.

invasive procedures (class B): these do not go beyond passive recording of function by contact with the outer body surface. Examples would be recording of electroencephalogram (EEG), magnetoencephalography (MEG), eye movement recording by electroculogram (EOG), electromyogram (EMG), recording of heart rate or galvanic skin response (GSR) and magnetic resonance imaging (MRI). Taking saliva, faecal or urine samples is included in this category, provided that these are not stored for more than seven days before being destroyed or rendered acellular. Class B procedures require approval by IDREC of the project or of a protocol which covers the procedures to be used in the project.

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.

P

participant information: information given to potential *human participants to help them make an informed decision about participation in *research.

Notes: Participant information includes all the information required under *informed consent (a)-(d). Where possible potential participants should be given a paper information sheet which they can keep. The researcher should in addition verbally seek to ensure that the potential participant has understood the form and give further verbal explanation as necessary. Where the use of a form is inappropriate, for example, when people are to be stopped in the street and asked to complete a short questionnaire, information about the research may be given by verbal means alone.

patients: all potential *human participants in research recruited by virtue of their past or present treatment by, or use of, the NHS. It includes NHS patients treated under contracts with private sector institutions and private patients in NHS or private hospitals.

peer review: scrutiny of the design and methodology of a piece of research by (an) expert(s) in the field.

Notes: Proposals for research which involves human participants will normally undergo peer review, for example by a tutor, supervisor, or funding body. The University regards research which duplicates other work unnecessarily or which 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 scientific/scholarly scrutiny but it needs to be satisfied that appropriate scientific/scholarly scrutiny has been /will be undergone. In the case of projects which pass the checklist and do not need to go for further review the signature of the head of department suffices as peer review. In the case of projects which go to the full approval procedure, CUREC will have the information on the form about the nature of the peer review which the project has undergone/will undergo.

people whose ability to give free and informed consent is in question: such people include incompetent participants, such as young *children, and *people with mental health or neurological conditions which severely affect their judgement, and vulnerable participants such as older *children, people with mental health or neurological conditions which affect their judgement less severely, prisoners, people taking medication which 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

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 (e.g. 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 weighted 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 participant	Research poses risk to participant
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 mentl 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 experiment 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: information about living individuals who are identified or who are identifiable (e.g through the use of a code devised by or accessible to the researchers).

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 which 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. And additional guidance is available if required by emailing data.protection@admin.ox.ac.uk.

principal researcher/supervisor: a person who helps to design and who monitors research carried out by him/herself and/or others, normally undergraduate or graduate students, or postdoctoral researchers, 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).

protocols: CUREC protocols are statements about general research methods which raise particular ethical questions and which specify how risks to participants in projects using those methods are to be minimised.

Notes: Before becoming CUREC protocols, statements must be approved by an IDREC and the IDREC must be satisfied that the method(s) is/are justified and do/does not pose unacceptable risks and that, where possible, appropriate safeguards are described.

Protocols do not themselves refer to a particular research project, but particular projects which use methods AND safeguards outlined in the protocols may take a different route through CUREC approval procedures by referring to those protocols.

Examples might be:

(i) research projects on children's abilities. Arrangements for recruitment of children through schools, gaining parental consent, duration of testing, feedback or otherwise of results to teachers would require detailed scrutiny by IDRECs. This would be done via a protocol describing in detail the ethical concerns raised by this type of project and the procedures to be followed to minimise risk to participants. Different students or researchers in a group, over a period of several years, might follow this protocol with different projects, one testing children's understanding of multiplication, another their ability to apply grammatical rules, a third understanding of legal obligations. Individual projects could be approved via a checklist which referred to the approved protocol number.

(ii) research projects on the effects of sleep loss on cognitive performance. The procedures for sleep deprivation, criteria for accepting participants, necessary warnings about driving, and so on would need IDREC scrutiny via a protocol, but the different procedures for projects testing short-term memory, dual task performance, spatial imagery, etc would need scrutiny only by completion of a checklist which referred to the approved protocol number.

public interest: the common good, as opposed to benefit to individuals, or to special interest groups.

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 which 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.

R

relevant material: material, other than gametes, which 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.

research: an investigative activity for which ethical approval is required if it involves *human participants.

Notes: Research is to be distinguished from *audit or quality assurance activity which do not. 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.

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 which involves direct personal contact of any kind, including interviewing and/or observing *human participants, and research which involves the administration of questionnaires and use of *personal data (other than anonymised, non traceable data) where there is no contact with any individual.

See also *human participants, *research

S

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.

student researcher: a *researcher who is conducting *research as part of work towards a University of Oxford degree or diploma.

T

third party: a person or institution other than the *human participant and the *researcher.

U

unequal relationships: relationships in which there is asymmetry of power, for example where one person is in a position of authority over another/others.

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 which 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.