Risk and benefit - ESRC

What is ethics?

The term ‘research ethics’ refers to the moral principles and actions guiding and shaping research from its inception through to completion, the dissemination of findings and the archiving, future use, sharing and linking of data.

While research ethics has a long history, originating with medical ethics and then extending to other forms of research with humans, it also has a history of evolution and development.

Research ethics in the social sciences initially drew on the ‘patient protection’ model of medical research, but has more recently broadened in scope to include consideration of benefits, risks and harms to all persons connected with and affected by the research and to the social responsibilities of researchers.

Reference to ‘benefits, risks and harms’ suggests a ‘consequentialist’ form of moral reasoning where the consequences of conduct frames ethical practice, but this is not the only philosophical perspective that has been employed.

‘Deontological’ approaches have also been applied, suggesting that guided and rule-governed research practice can serve to fulfil the moral obligations.

‘Virtue ethics’ is a third perspective that stresses a context-dependent and pervasive concern with all aspects of a researcher’s professional behaviour, emphasising a need for rigour in ethics reasoning with regard to the particular circumstances and phases of the research.

Why consider ethics in research?

As a publicly-funded organisation the ESRC has a responsibility to ensure that all researchers and research organisations it supports have rigorously considered any ethics implications arising from the research design, methodology, conduct, dissemination, and the archiving, future use, sharing and linkage of the data produced.

Research councils expect that those who receive funding demonstrate an awareness of the social and ethical implications of their research, and take account of public attitudes towards these issues. It is also expected that they will adhere to UKRI policy and guidelines on governance of good research conduct.

Social research requires a situated and reflective approach to research ethics, helping to identify potential benefits and pitfalls in ways that benefit and  protect participants and researchers alike.

Careful reflection and planning in relation to research ethics should not only benefit participants, but should enhance the quality of the research as a whole. Lack of rigorous reflection around ethics issues and failure to mitigate risks may result in liabilities, reputational damage, negative public attitudes towards research and harm to participants’ and/or researchers’ health and wellbeing.

Ethics issues may not always be obvious from the outset or may arise after an ethics review has been undertaken. Researchers’ awareness of ethics issues and engagement with research ethics committees is vital to ensure that research is conducted and carried out in a manner that achieves the maximum level of benefits for all involved parties and for the benefit of society.

Why consider who will benefit from my research?

Researchers are encouraged to consider who will benefit from their research, especially when the research may involve or affect multiple individuals or groups (for example, beneficiaries, non-academic users, participants and their associates, researchers or research organisations) – particularly where benefit to one individual or group may lead to increased risk to another.

Researchers should aim to achieve a positive risk-benefit ratio, but should also ensure they safeguard the independence and excellence of the research.

Benefit can be defined as the positive impact from the research to the parties directly involved (for example, research participants and those associated with them, researchers and research organisations), as well as the demonstrable contribution of research to knowledge, our economy, individuals and society.

During the development of the research the maximisation of research benefits should hold central position when considering ethics issues.

A study may be considered ethical when there is a positive risk-benefit ratio – that is, the risks and intrusions for people taking part in research are minimised and justified by the expected benefits for the participants, or for science and society.

What ethics issues should I consider when planning research?

The following list of likely areas you will need to explore is not comprehensive, but will provide a prompt for your planning and reflection.

What benefits could arise from your research?

Have you considered benefits to the participants, for example impact of participation or research outcomes?

Have you considered the benefits to the research organisations, project partners and funders involved?

You could look at:

  • wider groups or populations
  • scientific knowledge
  • the research team

Ethics

How will the ethics aspects of the project be monitored throughout the research lifecycle?

Risks

How will unforeseen or adverse events in the course of research be managed? For example, do you have procedures to deal with any disclosures from participants?

Have you considered harm and risk to:

  • the participants, eg harm, deception, impact of participation or of outcomes
  • the collected data, eg storage, considerations of privacy, quality
  • the research organisations, project partners and funders involved
  • wider groups or populations
  • the research team?

How can potential risks be addressed?

Details and recruitment of participants

What types of people will be recruited? For example, students, children, people with learning disabilities or the elderly.

You should consider:

  • how the competence of participants to give informed consent will be determined
  • how, where, and by whom will participants be identified, approached and recruited
  • if any unequal relationships will exist between anyone involved in the recruitment and the potential participants
  • if it is  necessary to check the background of members of the research team who will be in contact with participants, for example through the Disclosure and Barring Service
  • if there is a need for participants to be de-briefed and who should the debrief.

You should consider the role of consent. You’ll need to think about:

  • what information participants will be given about the research
  • the best way to ensure they can make an informed decision about whether or not to take part
  • if you are providing all the information participants need
  • if re-using data, that the consent from the primary data collection covers further analysis that is planned
  • how participants can opt out and withdraw their data
  • how will you gain further consent, if your research changes.

Is participation voluntary? If not, can you justify that? Could anyone feel pressured to take part?

Have you considered anonymity, and confidentiality?

Have you considered all perceived conflicts of interest in undertaking this research, for example, financial reward for outcomes?

Research outside the UK

Are you conducting research outside the UK? Are there any additional issues that need to be considered as a result – for example, local customs, local ‘gatekeepers’, political sensitivities, legal and ethics requirements in other countries or benefit sharing?

Your legal obligations

Have you considered what legislation your project will need to abide by, eg Data Protection Act, Freedom of Information Act, Human Rights Act, Mental Capacity Act?

You will need to think about:

  • how you will protect your data at the research site and away from the research site
  • storing your collected data
  • how you will dispose of data, and after how long
  • making  plans for data archiving and arrangements to support wide access to the data
  • your legal obligations if  you will be collecting information through a third party
  • ethics within your plans for dissemination, impact and knowledge exchange
  • a research ethics protocol approved by your research organisation that would be appropriate to use
  • which research ethics committee is most appropriate to review your research
  • the time you need to secure an ethics review.

How can participants be affected by my research?

Researchers should consider potential physical or psychological harm, discomfort, stress or reputational risk to participants and their associates (and participating groups, organisations and funders).

Research, though it may carry no physical risk, may be disruptive and damaging to participants as individuals, or to whole communities or categories of people impacted by the research. For example, social science research on those affected by HIV infection may impact both those engaged as participants and other individuals or groups affected by the infection.

Social science research raises a wide range of ethics issues that need to be considered by researchers, their research organisation and the appropriate research ethics committee.

These include, but are not restricted to, risk to a participant’s personal social standing, their privacy, personal values and beliefs, their links to family and the wider community, and their position of employment, as well as the potentially adverse effects of revealing information that relates to studied or disclosed behaviours, for example illegal or sexual behaviour.

The ethics review of a research project should be proportionate to the benefit, risk and harm of the research; while research involving high risks or with more questionable benefits must be subject to a high level of ethical review, very low-risk, clearly beneficial research need not be subject to the same level of scrutiny. Each project must be judged and justified on its own terms.

Can all ethics issues be identified?

Ethics implications may be difficult or impossible to quantify or anticipate in full prior to the start of a research project, especially in longitudinal or ethnographic research.

Researchers should endeavour to determine possible ethics issues and how these will be managed (not least through the methodological strategy and instruments they adopt) and the relevant ethics review that will be required.

Where anticipated, we expect researchers to assess the likelihood and magnitude of potential ethics issues that may arise during the research lifecycle and develop strategies and a framework of responsibilities in advance. For example, when doing research in sensitive cultural environments or with populations which are considered vulnerable, researchers may find themselves in situations of increased responsibilities and expectations which may not fall within the research’s objectives and scope.

Researchers should abide by their legal obligations and maintain the integrity of the research project. Guidance and support from research ethics committees and research organisations are valuable resources in dealing with such situations.

Our ethics case studies illustrate how different projects carry potentially different ethics issues. However, not all risks that are identified within a project can or should be avoided, and risks should be measured against the expected benefits of the research. But it is important that researchers, research organisations and research ethics committees develop awareness of potential and emerging ethics issues.

Projects that involve researchers or partners from more than one area of expertise or discipline can have further ethics implications, especially where the research team includes researchers or partners from non-social science areas or non-academic organisations. For example, social science researchers working with medical researchers who undertake qualitative research as part of a non-clinical trial should be aware of potential issues when working in interdisciplinary research.

The form of vigilance required for the management of physical risk in medical or biomedical research is usually inappropriate for the management of the risks that may apply in social science research. Equally, non-academic partners (for example, in some forms of participatory research, or when working with other professionals such as filmmakers) may have different understandings and experiences of ethics requirements.

Research ethics committees should provide guidance and advice to researchers about ways in which risks can be minimised and participants protected from harm, while at the same time offering advice on the different degrees and prioritisation of risk.

Is it legitimate to undertake research expected to have negative impact on individuals or groups?

As recognised elsewhere (for example, Canada’s Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans), research may be ‘deliberately and legitimately opposed to the interests of the research participants or organisations’ in cases where the objectives of the research are to reveal and critique fundamental economic, political or cultural disadvantage or exploitation.

Much social science research has a critical role to play in exploring and questioning social, cultural and economic structures and processes (for example, relating to patterns of power and social inequality, and institutional dynamics and regimes that disadvantage some social groups over others, intentionally or not).

Such research results may have a negative impact on some of the research participants/organisations, but may also have significant societal benefit. Principles of justice should, however, mean that researchers should seek to minimise any personal harm to individuals.

Researchers should consider how to balance potential risk to research participants, including immediate, short-term risks and longer term risks (for example, reputational damage), against the benefits and longer-term gains to future beneficiaries. It is the responsibility of the researchers to make such a case in detail to a research ethics committee. In making a decision, research ethics committees (RECs) should weigh up the benefits of the research and consider safety issues and participants’ protection.

What happens if ethics issues are raised later in the research?

Research can develop in ways that raise unforeseen ethics issues.

Ethics training provided by research organisations should ensure that researchers are able to identify ethics issues throughout the lifecycle of the research.

Research organisations and research ethics committees should have mechanisms in place to ensure provision for future advice and guidance (for example, ethics advisors or ethics advisory panels for individual projects) and serve to maintain ethics standards throughout the course of research projects, and effectively and rapidly support researchers in resolving ethics issues as they arise during research and beyond the initial ethics review process.

The nature and likelihood of unanticipated ethics issues may depend on the research design and methodology, but it is expected that all researchers should be aware of the potential for unanticipated ethics issues to arise throughout the research lifecycle.

What are the ethical considerations of disseminating findings?

Ethics issues may arise in the dissemination, public engagement and exploitation of findings.

The research councils expect researchers to engage actively with the public at a local and national level and appropriately publish results widely.

Impact activities and dissemination may therefore be ongoing throughout the research lifecycle (including these later stages) and members of research ethics committees should have the necessary skills and expertise to ask critical questions when assessing a proposal’s impact and dissemination plans. Any negative events likely to arise from these activities should be referred to the research ethics committee.

The possible impact on research participants, their families and associates, organisations, and populations from which the sample is drawn needs to be thought through – particularly where anonymity may be jeopardised or where there is potential for stigmatisation of individuals or groups, or misuse or misrepresentations of research findings (eg to further political agendas).

Descriptions of participants (for example, in case studies) should not normally lead to those who take part becoming identifiable. This can be particularly challenging if sample sizes are small or participants have distinctive characteristics that may make them recognisable. However, researchers need to respect the rights and dignity of participants, for example where participants may wish to have their views expressed and their identities given.

What should I consider when disseminating research findings?

Do participants know what will happen to the research findings? Have they given permission to be identified, and if not, what steps have been taken to anonymise the data? The Data Protection Act 1998 research exemption cannot be claimed if participants’ personal data will not be anonymous when findings are published (see the Data requirements section).

When findings are released, what is the impact on other areas of participants’ lives, such as their families and careers? Did they give permission for the material to be archived or shared with other researchers?

Political sensitivities may arise when findings are contrary to local or national policy. It may be important to publish critical findings about policies and organisations, but was this within the original remit of the research? Were participants aware that this could be a consequence of their participation?

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