Ethics Guidance
PRINCIPLE OF CONSENT
This fact-sheet is quite long since there are many issues to cover concerning consent. If you are looking for guidance on a particular issue then hopefully you will find this by scanning down the contents list below. If not then please contact the Secretary to the University Research Ethics Committee (Mr Richard Hudson, , ext.21448) who may be able to provide guidance or at least will know who to consult.
Fact-Sheet Contents:
1Obtaining consent
(written, witnessed, oral, implicit, right to refuse to participate or to withdraw from participation, an ongoing process)
2Informed consent
3Coercion
4Research involving incompetent adults
5Research involving children
6Covert research
7Research in public contexts and with groups
8Guidance on consent relevant to research undertaken in the NHS
9Clinical Trials of Investigational Medicinal Products (‘IMP-Trials’)
The University’s ‘Ethics Policy for Research Involving Human Participants, Data and Tissue’ is at:
1Obtaining consent
Prior to a person being able to participate in research activities the lead researcher is responsible for obtaining that person’s consent to participate. The lead researcher can delegate the duty to obtain informed consent to another suitably qualified member of his/her research team. Whoever is obtaining the informed consent should be completely familiar with all aspects of the research project.
Consent must be givenfreely and voluntarily and under no circumstances must coercion be used to obtain a person’s consent to participate in research.
Prospective participants should be given sufficient time in which to consider whether or not to participate.
1.1Written, oral and witnessed consent
Wherever possible, and proportionate to the nature of the research activity, an individual’s consent should be obtained in writing. The University’s consent form template is at:
Where written consent is not possible oral consent should be obtained, ideally in the presence of at least one witness.
Witnessed consent is required for particularly vulnerable participants who have intellectual or cultural difficulties in speech or understanding, but who are deemed capable of giving consent.
1.2Implicit consent
For research purposes, explicit consent is usually required. However, consent could be implicit. For example, if a person receives, completes and returns a postal questionnaire, the act of completion and return implies that they have consented to participate in the research (provided they have received adequate information to enable them to give informed consent, provided they are competent and understand the information, and provided that their participation is free and voluntary).
1.3Right to refuse to participate and/or to withdraw from participating in research
Researchers should make plain to people, prior to their participation, their explicit right to refuse to participatein and/or to withdrawfrom the research at any stage, irrespective of whether or not payment or other inducement has been offered, and that this right will be respected.
1.4Ongoing process
The consent process should not cease once the initial consent has been obtained. The practice of giving information about the research project to the participants should be an ongoing process performed by the lead researcher and/or by members of the research team. This is particularly necessary following the availability of important new information that may be relevant to the participant’s willingness to continue participating in the research project. Where this is the case it may be appropriate to obtain ‘re-consent’ from the participant (e.g. revised consent form).
2Informed consent
The first step in the process of seeking informed consent is determining if the subject is able to give consent (see sections 4, 5, 6 and 7 for where this is/may be difficult).
Information should be explained in writing (and also verbally where possible).
Informed consent is where a prospective participant, prior to participating in research:
(i)Is fully informed about all aspects of the research project, in which s/he is considering participating, that might reasonably be expected to influence his / her willingness to participate. In addition, the researcher should normally explain all other aspects of the research about which the prospective participants enquire.
Such aspects will include some or all of the following:
- the nature and objectives of the project
- the methodology of the project and conditions under which it is to be conducted
- who is undertaking and who is sponsoring the project
- the potential risks and inconveniences that may arise
- the potential benefits that may result
- why the prospective participant has been approached
- what participation in the research will require
- how confidentiality will be protected
- who to contact if something goes wrong
- alternative treatments (in the case of medical research)
Written information is usually best understood in the form of questions and answers, for example set out in a ‘participant information sheet’:
Written information should be in lay terms.
Note for ESRC-funded research: If you are conducting ESRC funded research, when seeking the consent of prospective participants it should be made clear to the prospective participants that data collected on them may be used subsequently by other researchers on other research projects (i.e. data for secondary use), subject to provisos on anonymity, confidentiality and data protection.
(ii)Freely and voluntarily gives consent to participating.
A potential participant should be free to make a decision as to whether or not to participate in the research without any undue influence. There must be a balance between the giving of advice and allowing the person to make their own decision. The prospective participant should be given every opportunity to ask questions before deciding whether or not to participate.
2.1Giving and obtaining consent is usually a process
Giving and obtaining consent is usually a process, not a one-off event and participants have the right to change their minds and withdraw consent at any time. If a researcher doubts whether a person participating in research still consents to participating s/he should clarify this with the person in question.
3Coercion
The quality of the consent of participants who are in a potentially dependent relationship with the researcher (e.g. employees, patients, students) requires careful consideration, as willingness to volunteer may be unduly influenced by the expectation of benefits or rewards.
When research is being conducted with detained persons (e.g. prisoners) particular care should be taken over informed consent, paying particular attention to the special circumstances that may affect the person’s ability to freely and voluntarily give informed consent.
People volunteering to participate in research may be paid for their inconvenience and time. Payments made to individuals, to enable them to participate in research activities, must not be so large as to induce the individuals to risk harm beyond that which they would usually undertake. Financial payments might cover reimbursement for travel expenses and / or time. Risks resulting from participation should be acceptable to participants even in the absence of inducement.
The promise of compensation and care for damage, injury or loss of income as a result of participating in research activities to participants should not be considered coercion by inducement.
4Research involving incompetent adults
Where a prospective participant (e.g. clinical trial patient) is unable to give informed consent to participate a ‘legal representative’ may give assent on his / her behalf. Such a ‘legal representative’ should be able to give assent for and authorise an intervention on the patient. However, the assent of the participant, who is unable to give informed consent, should also be sought where possible.Special care should be exercised where a prospective participant is unable to give informed consent to participate.
In the case of an adult this could be a person designated by the adult, a relative or an independent person nominated by, for example, the hospital at which the research is being undertaken. If the adult has appointed a representative who is available, then this person must be used to give assent. A relative can only be used if the person has not appointed a representative or if the representative is not available. An independent person should only be used if both the adult’s representative and a relative are not available. Consequently, an independent person should only be used to give assent on an adult’s behalf where the research cannot be conducted if there is delay (i.e. research in an emergency situation), where the person whose representative or relative is not available is indispensable for the research, and where the research is of sufficient importance to justify the giving of assent on behalf of the adult concerned. In such cases the independent person, responsible for the care of the adult, cannot be used if s/he is involved in the research or has any direct interest in it.
5Research involving children
If the involvement of infants and children under the age of eighteen in a research project is justified, where appropriate and feasible the informed consent of one of their parents or their legal guardian should be obtained for inclusion of the child in the research. However, in some circumstances, obtaining the informed consent of a parent may be inappropriate (e.g. research with children who have been abused by a parent) or unfeasible (e.g. research involving homeless children).
Wherever possible, a researcher seeking to undertake research with children under the age of eighteen should also obtain the child’s free and voluntary consent to participate. However, the ability of a child to give free and voluntary consent depends very much on a child’s level of competence and competence varies with age. Other factors include the child’s own experience and confidence, the type of research s/he is being invited to participate in, and the skill with which a researcher talks with as child and helps that child to make free and voluntary, informed decisions. It is important for the child to be given information regarding the research project according to his/her level of understanding (from staff that have experience in liaising with children) and the person taking consent must respect the child’s wishes.
In both invasive and non-invasive research, where a child under the age of eighteen is participating in research, unless a parent / legal guardian is not available and unless it can be sufficiently demonstrated that the research in its entirety is in the best interests of the children, researchers should obtain the informed consent of both a parent / legal guardian and the child.
Within the NHS, the Patient Information Advisory Group (PIAG) has the authority to override the need for consent where it is unfeasible, under section 60 of the Health & Social Care Act (e.g. PIAG has ruled that it is not necessary to have patient consent to use their data in a cancer registry; similar assurances have been made for epidemiological research of CJD).
In the case of research in educational settings, any special school policies or procedures should be followed.
6Covert research
In certain research disciplines (e.g. psychology), to ensure the viability of a piece of research, to ensure that it will contribute to knowledge and understanding, it is sometimes necessary to withhold information on the true objectives of the research from the people participating in it (covert research).
In such types of covert research it is inappropriate to obtain informed consent from the participants.
Wherever possible such covert research should be avoided and University ethics reviewers / NHS Research Ethics Committees (NHS RECs) should pay particular attention to them. However, when such research, requiring consent but not informed consent from participants, is judged to be necessary for the results of the research to be valid, researchers should exercise particular caution.
In such circumstances (i.e. where covert research methods are necessary) the lead researcher has a special responsibility to:
(i)Justify that alternative procedures to avoid the withholding of information or deliberate deception are not available and, if available, are not feasible for the research;
(ii)Justify why the withholding of information, or an element of concealment or deception, is integral to the viability of the research.
7Research in public contexts and with groups
In certain types of research obtaining consent from every individual participating is impractical or unfeasible (e.g. observing a large crowd or observing discussions on the internet). In such types of research, researchers should ensure the following:
(i)That such research is only carried out in public contexts;
(ii)That where possible approval is sought from relevant authorities;
(iii)That appropriate individuals are informed that the research is taking place;
(iv)That no details that could identify specific individuals are given in any reports on the research unless reporting on public figures acting in their public capacity (e.g. reporting a speech by a named individual);
(v)That particular sensitivity is paid to local cultural values and to the possibility of being perceived as intruding upon or invading the privacy of people who, despite being in an open public space, may feel they are unobserved.
The privacy and psychological well-being of people participating in observational research and people participating in research activities in which a researcher may actually be acting as a fellow participant, for example as part of a wider group, must be respected. In such group based, participatory research activities every effort should be made to ensure that the group leader(s), or others in positions of responsibility, as well as other individuals of a group, understand they are being observed for research purposes. In such activities researchers should at least obtain the consent of the group leader(s) or the consent of others in positions of responsibility to undertake the research.
It is recognised that in certain types of observational research or organisational settings it may be more difficult to explain to people participating their right to withdraw at any stage. However, in such types of research, researchers are expected to make a reasonable attempt to do so.
8Guidance on consent relevant to research undertaken in the NHS
See the Department of Health’s web pages on consent:
9Clinical Trials of Investigational Medicinal Products (‘IMP-Trials’)
9.1Delegation of duty regarding obtaining informed consent
Where the duty of obtaining informed consent has been delegated from the Chief/Principal Investigator this must be documented on the IMP-Trial’s delegation log, which should be kept at the appropriate site.
9.2Filing the records relating to informed consent
The original approved consent form should be filed in the Site File and the participant’s details should be recorded on the participant recruitment log. The signed consent form should be filed in the participant’s medical records together with the participant information sheet.
9.3Vulnerable participants
Where a prospective vulnerable adult is unable to give informed consent to participate a ‘legal representative’ may give assent on his / her behalf.
The EU Directive (2000/20/EC) specifies a cascade system:
- Informed consent is first sought from a person whose relationship to the person makes them suitable to act as their legal representative;
- If there is no such person or they are unwilling to take that responsibility, then it will be sought from the doctor primarily responsible for the person's treatment; or
- If the doctor is involved in the conduct of the trial, or is not available or willing to take that responsibility, a person nominated by the relevant health care provider may give informed consent.
- The health care provider is prevented from nominating a person involved in the conduct of the trial. In the last situation, a health service body might be expected to have a list of suitable nominated persons that can be called upon.
If circumstances change, it is good practice that responsibility for continued participation in the study should be transferred back up the chain. Thus, if the person recovers capacity, he/she should be consulted, and if a personal representative becomes available (and is willing to take on this role), the professional legal representative should transfer responsibility for substituted judgement over to that individual.
The legal provisions for incapacitated adults in Scotland are slightly different. Except in cases of emergency treatment, the legal representative will be the person who is able to consent to treatment under the Adults with Incapacity (Scotland) Act 2000.
9.4Children
The interests of the child must always prevail over the interest of science.
Children aged 16 and older can legally consent for themselves in relation to clinical trials. However, this does not apply to clinical trials of devices.
It is essential that the IMP-Trial relates directly to a clinical condition from which the child suffers or is of such a nature that the IMP-Trial can only be carried out on children. The IMP-Trial needs to be designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and the child’s stage of development and continuous monitoring throughout the IMP-Trial of such risks and/or distress must take place. It must be demonstrated that the IMP-Trial will have some direct benefit for the group of children participating and that the IMP-Trial is necessary to validate data obtained in other IMP-Trials involving persons able to give informed consent or by other research methods.
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The University of Sheffield, University Research Ethics Committee