Informed and Voluntary ¦ Voluntary and informed – further considerations ¦ When to seek consent and stages of consent ¦ Competence – consent by proxy ¦ Consent Forms ¦ Exceptions ¦ Retrospective consent ¦ When consent forms are not appropriate ¦ Covert Research ¦ Weighing up the benefits and risks ¦ Further Discussion – Is gaining informed consent always necessary? ¦ Useful sources and references
It is generally held that sane competent adults should be free to make their own decisions. Consequently, respect for the individual right to choose is at the core of ethical research. Gaining informed consent is an essential element of ethically valid social research.
Informed consent is:
“given by a competent individual who has received the necessary information; who has adequately understood the information; and who, after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation”
Council for International Organizations of Medical Sciences
Thus three basic principles apply. Consent needs to be:
- Informed: given in possession and understanding of the principal, relevant information;
- Voluntary: given freely and not as a result of coercive pressure (real or perceived);
- Competent: given by somebody able, in virtue of their age, maturity and mental stability, of making a free, considered choice.
Research staff and subjects must be informed fully about the purpose, methods and intended possible uses of the research, what their participation in the research entails and what risks, if any, are involved. Some variation is allowed in very specific and exceptional research contexts for which detailed guidance is provided in the policy Guidelines.
ESRC Research Ethics Framework (REF), p1, ‘Introduction’
Obtaining legitimate consent necessitates being proactive in:
- Providing accessible and non-technical information about the research to the participants which is relevant to their decisions about whether or not to participate (including the risks, benefits, alternatives and the nature and purpose of the research process);
- Ensuring that participation is voluntary (e.g. by requiring written consent);
- Arranging consent by proxy (e.g. from parents of small children) where subjects are not competent to agree;
- Ensuring that the decision is made by the participant and that the researcher is obligated to respect that decision.
(adapted from Lidz and Roth (1983:147) and Silverman (2000:201))
More specifically, it is necessary to ensure that the potential research participant is fully aware of, and fully understands,
- what the research is about;
- why it is being conducted;
- who it is being conducted for and who is funding it;
- what the purpose of the study is and what will happen to the results;
- where the results will appear and who is likely to have access to them;
- what will be expected of them if they agree to participate and how long their participation will take;,
- what anonymity and confidentiality mean in practice and an understanding that the participant:
- does not have to participate; and
- having agreed to participate can withdraw any time without detriment.
It is important to ensure that participants understand the information given – e.g. by providing information sheets written in subjects’ first language and by using appropriate linguistic codes.
(See the Sample Consent Forms and Information Sheets tab.)
Notwithstanding the above list, it must be emphasised that there is no definitive prescription covering all research situations.
When considering what constitutes voluntary and informed consent in particular situations, researchers need to be sensitive to any available information about the individual situations of potential participants.
For instance, a person suffering from a mental disorder such as schizophrenia or bipolar disorder might be keen to be involved in proposed research. However, the researcher should ask him or herself whether the individual is in a position to decide and whether participation could pose a danger to this person.
It is also important to give consideration to the potential influence of any pre-existing relationship between the researcher and the potential participant, especially in situations where the researcher is an authority figure. An example would be the relationship between an academic supervisor, or senior staff member within an organisation (as researcher) and his or her research student or more junior staff member (as research participant).
When working with communities of research participants, care should be taken to ensure that all participants are informed and that their choice about whether or not to participate is voluntary (i.e. not just presumed by the researcher’s primary point of contact).
Researchers may also need to consider research participants’ networks of relationships (familial and otherwise) with regard to the potential primary effects on the participants and/or secondary effects on other people. It may be appropriate or desirable to encourage participants to discuss the research with others before agreeing to participate.
Informed consent may be necessary to establish:
- Initial participation of an individual in the research;
- Awareness of the possible risks and benefits resulting from the research by the participants;
- How the data may be used (especially if the data has been audio or video recorded);
- Ownership of copyright.
Whilst it is desirable to anticipate issues at the outset, in practice obtaining consent to address these purposes can be a multi-part process whereby participants give their consent for (1) at the beginning of the project. Consent for (2) and (3) may be requested after data collection when the participant is in a better position to judge both the purposes for which the data can be used, and the assignation of copyright. However, it should be borne in mind that repeated requests to engage with consent processes may annoy some participants and discourage them from further participation. An alternative strategy, used by some researchers, is to gain verbal consent in the first instance and defer the written consent seeking process until after the research has taken place, thereby enabling participants give to give or withhold final consent in knowledge of the information which has been collected about them. Longitudinal research may require repeated consent, as participants’ life circumstances may change such that involvement becomes inappropriate.
Note that this is covered more fully in the Vulnerable Groups, Informed Consent: Consent by Proxy section.
Where possible, the real consent of children and adults with impairments in understanding or communication should be obtained. Where real consent cannot be obtained from the research participant, the researcher should consult a person well-placed to appreciate the participant’s reaction and obtain disinterested approval of the research from independent advisors. Where research involves any persons aged less than 16 years, consent should be obtained from parents or those in loco parentis. However, where such consent is gained but the child clearly withholds consent or shows distress, the wishes of the child must prevail.
Engaging children in the consent process is desirable where possible. It may be appropriate to seek consent from the parents of participating children and from the children themselves. Enabling children to engage in a meaningful way requires careful planning, including:
- Specially written information sheets;
- Specially consent forms.
Asking participants to sign a written consent form is a widely accepted method of obtaining informed consent. In addition to ensuring that participants agree to participate of their own free will and understand what they are getting involved in, the existence of signed documentation protects the researcher from subsequent accusations by participants.
Consent forms can vary in content depending on the type of research project. However, the following list provides examples of the type of information that most informed consent forms include:
- Information about the nature and purpose of the research;
- A statement that participation is voluntary, including the choice to opt out of the research at any time;
- Information about the data collection method and the option to agree/refuse to being recorded (if applicable);
- A description of the extent to which confidentiality will be maintained and an option to choose anonymity;
- A description of any possible risks or discomforts to the participant;
- A description of any possible benefits to participant or others;
- Contact addresses and/or telephone numbers for any questions about the research;
- An option to agree or refuse to participate (signature of participant, date, signature of witness/researcher);
- A description of the intended uses, and disposal/storage and documentation procedures for data including an option to agree/disagree with these procedures.
There are occasions when informed consent may be impracticable or meaningless in social research, for example:
- research on ‘public behaviour’, e.g. street or crowd settings
- where it would compromise the subjects of research (e.g. when studying those engaged in illicit or illegal behaviour, such as drug-taking), or
- where written consent could put them at unnecessary risk.
In some contexts consent can be gained retrospectively (and in this case informed consent refers more to consent to use the data gained and an understanding of how the data is to be used) e.g. as in the example of observational psychological experimentation, or where covert research is necessary and warranted – such as work in the field of deviance where it involves immoral or illegal behaviour.
It should be recognised that seeking written consent is not under all circumstances appropriate. For instance, illiteracy may be an issue, such that imposing written consent forms would not be a meaningful or legitimate means of establishing consent. In overseas research there may be circumstances where translation is not feasible; or it may be that asking for written agreement is culturally inappropriate. In such cases the researchers should seek informed verbal consent.
Covert research cannot, by definition, involve informed consent, because informing the subject would render the research overt. If informed consent is ethically required for research, then covert research is impermissible.
Broad principles are that covert research should never be undertaken lightly or routinely. It should only occur where it can provide a unique form of evidence that cannot be gathered in any other way or where overt observation would alter the phenomenon being studied. It should only be used where important issues of social significance are being addressed (e.g. abuse)
Much social science research plays a critical role in questioning and exploring social, cultural, economic and institutional structures and processes – particularly in relation to power, inequality and disadvantage (whether intentional or not). The research results arising from this kind of research may have a negative impact on some of the research subjects, so researchers need to weigh up principles of justice such that any personal harm to individuals is minimised.
Also researchers need to balance up immediate or short-term risks to research subjects over longer term gains to future beneficiaries. These issues need to be weighed up in the ethical review process.
Further Discussion — Is gaining informed consent always necessary? (adapted from a presentation by Neil Manson)
Consent can play a role in waiving rights. This is because consent can render permissible what would otherwise be wrong because it is a violation of a right; but in giving our consent we waive or set aside those rights. So, for instance, we have rights to our physical integrity which are violated if we are assaulted. But if we consent to being assaulted - as we do if we step willingly into a boxing ring- then those rights are waived. Many actions breach no rights. Consent is not required, for example, to observe someone leaving the train station or crowd behaviour at a sports event. In medical research, however, consent is required because the researcher’s actions may involve risk to the subject; the research may breach rights of control of one’s body (or rights against intrusion upon one’s body); or fundamental liberty rights.
Different kinds of social research and different research methodologies involving human participants impinge upon research subjects in different ways. For example, interviews and questionnaires, take up the subject’s time. Researchers (unlike, say, police officers investigating a crime) have no legal right to impinge upon other people’s liberty.
If someone is to participate in research then they are to some extent acting in accord with the aims and purposes of the researcher. At the very least this impinges upon aspects of their liberty and, as such, consent seems to be required.
Observational studies are less intrusive, and arguably impinge less upon the research subject. Different kinds of observational study impinge upon research subjects to a greater or lesser degree.
The following examples illustrate a complex continuum of situations:
Example 1: Anik wants to study crowd behaviour at football matches.
Example 2: Bob wants to do research into politeness. He stops people in a busy street and asks them the time using different forms of speech.
Example 3: Sue wants to go to evening classes to covertly study their role in allowing people to form new sexual relationships.
Example 4: Carl wants to do research into racism in local politics, he proposes that he will shave his head, get tattooed, put on three stones in weight and join a local group of far-right extremists. It is very important for his safety that his cover is not blown.
Example 5: Prof Jones wants to do research into “norm breaching” in the family. She gets some of her undergraduates to respond to polite queries by their parents with “None of your business you nosy old ****”and to then record the way that the conversation immediately develops.
Example 6: Maria wants to do research on phone manners in suicidal subjects. She proposes to train as a ‘Samaritan’ and use her volunteer sessions to gather data.
Example 7: Brian wants to do research on internet paedophile rings by posing as a paedophile.
Clearly actions impinge upon other parties in a greater or lesser way. But it is complex too, in that research can impinge upon various people, in various ways (and not just the research subjects). Such actions can breach a range of norms, rights and obligations: e.g., privacy rights; norms of etiquette; liberty rights.
For each of the above examples matters become even more complex when we weave in details. Take example 3.
- Does it matter if Sue tells the class teacher that she is doing research? Why?
- Does it make a difference if Sue is doing research on her own, or if she is being funded by an institution? Why?
- Does it make a difference if Sue (covertly) records her conversations? Why
- Does it matter if Sue ‘debriefs’ her subjects at the end? Are there likely to be (negative) consequences for Sue?
- Does it make a difference if Sue actively deceives her “friends” with a convincing “cover story”?
- Does it matter whether the results are published? Does it matter how the results are presented?
Are any of the other examples given above ethically permissible without consent? If so, what details would you have to add to make it impermissible?
For those that are not, why not? What is the key difference between those that are, and those that are not? Could changes be made to the research other than gaining informed consent, to render it permissible?
In the examples could it be the case that the research is in principle ethically permissible but such that in practice it shouldn’t be approved by a institutional ethics review board?
Further topic: for those research projects that require consent, what exactly does this imply by way of proactive, explicit, specific, recorded consent? Can subsequent consent (and debriefing) do the job? Can a merely verbal agreement to participate suffice?
Lidz, C.W. and L.H. Roth, 1983. ‘The Signed Form – Informed Consent?’ In Boruch, R.F. and J.S.Cecil (eds) ‘Solutions to Ethical and Legal Problems in Social Research.’ Academic Press. New York, London. pp. 145-157.
Silverman, D. 2000.‘Doing Qualitative Research: A Practical Handbook’ London. Sage.
Neil C. Manson and Onora O’Neill Rethinking Informed Consent in Bioethics. (Cambridge: Cambridge University Press 2007)
Neil C. Manson ‘Consent and Informed Consent,’ Richard Ashcroft, Angus Dawson, Heather Draper and John McMillan (eds.), Principles of Health Care Ethics (2nd ed), London , John Wiley, 297-304
CJ. Herrera ‘Two Arguments for ‘covert methods’ in social research’ British Journal of Sociology Vol. 50 No. 2 (June 1999) pp. 331-343
Carolyn Fluehr-Lobban, ‘Informed Consent in Anthropological Research: We Are Not Exempt’ Human Organization 53, Number 1 / Spring 1994
Rose Wiles, Sue Heath, Graham Crow & Vikki Charles ‘Informed Consent in Social Research: A Literature Review’ ESRC National Centre for Research Methods Review Paper, NCRM/001 (2005) - available at: www.ncrm.ac.uk/research/outputs/publications/methodsreview/MethodsReviewPaperNCRM-001.pdf