Consent

What is freely given informed consent?

Freely given informed consent entails:

• giving sufficient and appropriate information about the research, to allow participants to make a meaningful choice about whether or not to take part
• ensuring that there is no explicit or implicit coercion, so prospective participants can make an informed and free decision on their possible involvement.

Giving information to participants

Information for participants should be provided in an accessible and comprehensive format, typically in written form (or in a form that participants can access after the end of the research interaction).

Time should be allowed for the participants to consider their choices and to discuss their decision with others if appropriate.

Consent

Research should not normally proceed until participants have indicated their consent and this has been recorded. This can typically be done by asking participants to sign a consent form, but in some cases it may be more appropriate (and more ethical) to use alternative approaches to record consent.

Consent, however, is not simply given through the formal signing of a consent document at the start of research. Instead it should, as far as possible, and in an appropriate balance with resources available and researchers’ responsibility to truth-telling, be open to revision and withdrawal throughout the research lifecycle of a project.

Informed consent should take into account the long-term use of participant research data, including the potential for further data linkage and preservation of data when obtaining consent. Participants need, as far as possible, to give specific consent if data are to be archived and shared. In some cases it may not be appropriate to archive data, but this should be discussed at the earliest opportunity with an appropriate ESRC data service provider, for example the UK Data Service.

When eliciting consent, researchers should make clear the limits to confidentiality, particularly when working with potentially vulnerable individuals or groups, for example children, families and vulnerable populations, or individuals involved in illegal activities.

Disclosure of participant’s personal information

If an interview reveals that a participant or another person identified in the interview is in significant danger, the researcher will be obliged to take action in response to that disclosure to protect the participant or third parties.

Research organisations and researchers should have established procedures, necessary systems and appropriate contacts to activate help and support in the event of a disclosure.

If the researcher feels it is necessary to breach confidentiality, the participant should, wherever possible, be informed what action is being taken by the researcher, unless to do so would increase risk to those concerned.

In projects collecting data on criminal behaviour, it may be necessary to explain to participants that confidentiality will be preserved as far as the law permits.

Any disclosures of otherwise confidential information revealed to avert serious harm should be fully justified in the public interest and researchers must be able to defend their actions fully. Disclosures should only be made to parties empowered to act on the information.

What if it's not possible to obtain written consent?

In some contexts verbal consent may be ethically preferable to written consent. Where possible this should include audio-recorded consent. In other circumstances, for example telephone interviews or some ethnographic fieldwork, this may not be possible.

There are also circumstances (such as research with users of illegal drugs or with political activists in some contexts) where written consent might also create unnecessary risks for research participants. Even in this last case a researcher should seek informed consent where possible to secure the trust and confidence of those involved, but care must be taken to ensure that consent processes (for example asking for written signatures) do not pose risks to participants.

Where consent is not to be recorded or explicitly secured, a full statement justifying this approach should be submitted as part of the ethics review.

Is written consent always necessary?

It is sometimes argued that formal written consent is not necessary because by consenting to see the researcher, a participant is in fact giving consent.

However, it is good practice where possible for all participants to be provided with information giving the name and status of the researcher carrying out the study, a brief rationale of the study (including its purpose and value), and an account of why the individual is being invited to take part.

The person interviewed should be made aware what will happen to the data, whether and how it may be shared with others, and whether they will be identified – and asked their preference.

What does it mean that participation should be voluntary and free from coercion?

Researchers should inform participants of their right to refuse to participate or withdraw from research. There should be no coercion or undue influence of research participants to take part in the research

Research participants, however, may be given small monetary reimbursement for their time and expenses involved. Payment should not override the principles of freely given and fully informed consent. Participants should know before they start the research that they can withdraw from the study without losing their payment.

Where monetary compensation is considered, researchers should check whether the payment constitutes taxable income and if it therefore could affect participants’ welfare benefits. The responsibility lies with the researcher to check how this applies to the particular country where the research is conducted and to keep up to date with policy changes.

In some instances it may be justifiable to use techniques such as a free prize draw or book or gift vouchers to encourage survey responses.

Respondents should not be required to do anything other than agree to participate or return a questionnaire to be eligible to enter a free prize draw. It should be clear that participants can enter the prize draw even if they do not answer the questions in the survey. Incentives should not be offered that require the respondent to spend money or which undermine other ethics considerations (such as anonymisation).

The Market Research Society has published useful Regulations for administering incentives and free prize draws. Where children are involved, it may be appropriate to acknowledge their help with personal gifts, for example gift vouchers or gifts to participating schools. Incentives may be permissible, but anything that implies coercion (for example where an individual is compelled to participate in a study that they consider to be against their values or principles as a result of financial payments) is not.

Do specific consent issues arise in multi-disciplinary research?

In cases of multi- or interdisciplinary research the definition of informed consent should be given very careful consideration, especially where the research team includes researchers from non-social science areas or non-academic research organisations.

The relationship between researchers and participants may vary between fields of expertise or in projects using diverse methodologies.

For some approaches, such as participatory social science research, consent to participate is seen as an ongoing and open-ended process.

Highly formalised or bureaucratic ways of securing consent should be avoided in favour of fostering relationships with participants and between members of the research team where regard for the ethical needs of participants is sustained, even after the study has been completed. Review mechanisms will also need to enable this where appropriate.

How do I deal with health-related findings in research?

When undertaking research involving human participants, researchers may make a finding that has potential health or reproductive importance to an individual participant.

A participant may also disclose a health or reproductive finding that is not related to the proposed project. Researchers should refer to the Framework on the feedback of health-related findings in research (PDF), published by the Medical Research Council and Wellcome Trust.

The framework states that when establishing a study involving human participants or re-consenting participants for follow-on research to an existing study, researchers are expected to:

• have a policy that indicates whether or not health-related findings will be fed back to individuals that can be clearly articulated, and be able to demonstrate the reasoning behind their policy to research participants, funders and the research ethics committee
• include clear information on the study policy on the feedback of health-related findings in the consent process
• in cases where the policy is to provide individual feedback on the health-related findings, develop a practical feedback pathway that is adequately resourced.

Do participants have a right to withdraw consent?

In giving consent, participants have the right to withdraw this consent as well as the right not to answer particular questions.

All research should indicate the point at which data will have been anonymised and amalgamated and in certain circumstances cannot then be excluded.

Some projects give a date after which participants cannot withdraw consent or ask for data destruction.

What if it is not possible to obtain informed consent?

Informed consent may be impracticable or meaningless in some research, such as research on crowd behaviour, or where fully informed consent would compromise the objectives of the research.

Deception (ie research that deceives or purposely misleads or misinforms the participants about the nature of the research) and covert research should only be used when no other approach is possible, where it is crucial to the research objectives and design, or where overt observation may alter the phenomenon being studied.

Researchers should also ensure, wherever necessary, they have received the relevant permission from gatekeepers to undertake the research.

The broad principle should be that covert or deceptive research should not be undertaken lightly or routinely. It is only justified if important issues are being addressed and if matters of social and/or scientific significance are likely to be discovered which cannot be uncovered in other ways. Social scientists should, wherever possible, ensure that research participants are aware of and consent to arrangements made with regard to the management and security of data, the preservation of anonymity, and any risk that may arise during or beyond the project itself, and how these might be minimised or avoided.

Any departure from a consent approach should be fully justified and, where appropriate, a protocol developed for full debriefing of participants about the true aims and objectives of the research, and participants should be given the opportunity to withdraw their data from the study (for example, in experimental studies involving deception).

This principle also requires that research staff be made fully aware of the proposed research and its potential risks to them and to participants.

What about accessing non-consented data?

Data not originally collected for research purposes, for example, administrative data collected by government departments and other public agencies during the course of their normal business, are becoming increasingly important as alternatives or supplements to standard data sources for social science research.

As these data were not collected for research purposes, individuals may not have consented to such uses. The ESRC is investing in infrastructures (for example, the Administrative Data Research Network (ADRN) which enable researchers to safely access and utilise these data while robustly protecting citizens’ privacy. The ADRN only processes data where there is a legal basis to do so.

The ADRN has a number of safeguards in place to enable safe access to non-consented administrative data. All of these safeguards are underpinned by data user agreements which researchers’ institutions countersign, and breaches penalties which can be applied on both the individual and institutional level.

If a researcher wants to link administrative data with survey data via the ADRN, it is essential that specific consent is gained from survey participants for their data to be reused for statistical analysis. If the researcher wants to add administrative data to survey data they themselves are collecting, they should seek explicit consent from their survey participants.

Researchers should keep all databases under review for compliance with data protection obligations where, for example, personal data are held or are generated when new data are added or linked to an existing database.

There are several codes of conduct and frameworks for ethical practice surrounding these types of data, and these are likely  to increase in number as the data become more accessible and as more tools and methods enabling their use and linkage are developed.

We expect researchers using these resources to adhere to the policies and guidelines issued by the ADRN.

Further information

Linking and protecting government data – introduction to ADRN (YouTube)

Last updated: 5 January 2024