Ethical Considerations and Approval for Research Involving Human Participants

From 1 October 2007 every piece of student or staff research that involves human participants needs to go through a formal process of research ethics review. This is likely to affect researchers in some faculties and departments more than in others, but is applicable throughout the University.

This Study Guide:

  • discusses the place of ethics within society, and within research;
    introduces the research ethics review process within the National Health Service; and
  • gives an overview of the University’s research ethics review process.

The Oxford English Dictionary Online (2007) defines ethical behaviour as being:

“In accordance with the principles of ethics; morally right; honourable; virtuous; decent.”

It defines ethics as:

“The whole field of moral science.”

As well as being integral to our everyday lives, ethics is a major branch of philosophy that has occupied great minds for many centuries. This Study Guide will identify the core ethical principles relevant to research with human participants, and will translate these principles into specific guidance to support researchers.

Relevance of Ethics in Society

Most of us probably feel that we have an in-built understanding of what is meant by ‘ethical behaviour’ at a personal level. It might include:

  • not causing people harm;
  • being honest;
  • being fair.

More widely in UK society there are many topics that give rise to ethical debate, for example:

  • use of non-renewable energy;
  • donation of organs after death;
  • introduction of identity cards.

This shows several characteristics of ethical debates: they often have wide relevance; they often involve sensitive areas; and there tend to be no definitive answers.

Relevance of Ethics Within the Research Process

In their book ‘How to research’, Blaxter et al. (2001) cover the subject of research ethics within their chapter on data collection. To show how widely relevant ethical challenges can be, they give a list of examples of ethical questions from real life research studies, a selection of which is shown in Box 1.

Box 1: Examples of ethical questions within the research process

  • You find a newsgroup on the web that is discussing issues central to your research. Do you ‘lurk’ (listen in without participating)?
  • Your research involves interviews with children under 5 years old. How do you ensure they are able to give informed assent?
  • Your research has highlighted unethical practices in your organisation about the use of expenses claims. Do you report it?

Adapted from Blaxter, Hughes and Tight (2001:159)

Blaxter et al. (2001) suggest that a common cause of ethical challenge is conflicts of interest between the researcher and the researched. The researcher may be excited about his or her research idea, and be keen to collect in-depth high quality data from those most closely affected by whatever they are researching. However, there is a risk that the researcher may be tempted to consider unethical research practice in order to try to obtain and/or retain some of the data.

Risks and Responsibilities

It may be useful to think of ethical review in terms of a review of risks and responsibilities. The responsibilities lie firmly with the researcher; the risks can be on both sides. Researchers are responsible for causing something to happen in relation to the lives of the research participants, and they need to consider:

  • the potential risks that they may be introducing; and
  • how they as researchers will take responsibility for addressing these potential risks.

The risks may be physical or psychological. The researcher is responsible for satisfying him or herself that:

  • the level of risk is justified by the importance and relevance of the research study;
  • the risk is unavoidable within the study’s objectives;
  • in absolute terms, the level of risk is minimized;
  • participants are fully aware of the level and nature of the risk before they agree, freely, to take part in the study;
  • precautions are in place to deal adequately with the effect of participation.

The risks may be physical, but it is more likely that they will be psychological, and associated with such things as: discussion of sensitive topics; maintenance of confidentiality; stirring painful memories; disclosure of personal information; voicing of unwelcome opinion; and discomfort and uncertainty.

It might be thought that ethical issues relate predominantly to interview methods, where participants might ‘open up’ and perhaps say more than they had really wanted to or, when reflecting later, might be very unhappy about something they had said. But there are ethical judgements to be made in all research involving human participants, including questionnaire-based methods, research via electronic communication, and observational research.

A Serious Matter

Breaches of ethical guidance and codes, or significant deviations from the research proposal originally approved, may cause harm to your participant(s). In addition, these are considered serious matters within the University and the wider community.

Typical repercussions could be:

  • failure at examination;
  • removal of professional accreditation;
  • refusal to publish results of the study;
  • insurance being deemed invalid;
  • removal of funding for research;
  • damage to the academic and ethical reputation of yourself and the University.

Basic Principles of Ethical Practice

1. Informed Consent

There should be informed consent from participants before they take part. This means that they should know exactly what they are being asked to do, and what the risks are, before they agree to take part.

An Information Sheet is commonly used to provide potential participants with information about the study. It should be written at the appropriate reading age for your specific group of potential participants. Guidance on the preparation of Information Sheets and Consent Forms may be available within your department, and general guidance is being prepared for the University web pages on research ethics. In advance of the publication of this central guidance the following is useful general advice for the preparation of Information Sheets.

  • Say who you are; where you are from; and what you are doing.
  • Tell the person how/why they were selected to be invited to take part.
  • Inform them that, even if they agree to take part, they can change their mind at any time, without giving an explanation.
  • Tell them what they would be asked to do if they agreed to take part.
  • Tell them the level of anonymity and confidentiality you can guarantee.
  • Say what the information will be used for, how it will be stored, and how long it will be kept.

The storage of data will need to comply with the Data Protection Act and the University’s Data Protection Code.
 
A participant will normally be asked to sign a Consent Form to record informed agreement to take part. It is worth checking with your department whether any guidance has been prepared specifically about writing Information Sheets and Consent Forms.

2. No Pressure on Individuals to Participate

Incentives to take part should generally not be provided. If an incentive is used it needs to be only a token, and not enough to encourage someone to participate who would really prefer not to take part.

You should also not rely solely on the consent of gatekeepers, for example: parents, head teachers, heads of units. Their consent may be needed before you can approach their students/staff, but individual potential participants should also be fully informed, and should have the option of not taking part.

If a participant fails to complete and return a questionnaire, you need to know in advance what you will do. Will you make a follow-up request for its completion and return and, if so, how will this be worded? It is not good practice to pester people. A case would need to be made if you wanted to follow up non-responders.

3.  Respect Individual Autonomy

Autonomy means the freedom to decide what to do. Even when someone has signed a Consent Form, they must be made aware that they are free to withdraw from the study at any time, without giving a reason. They must also be able to request that the data they have given be removed from the study.

You need to be prepared for this possibility, and to have plans for how you would remove the data already given, if this is requested. You would need to retain a link from any code or pseudonym that you use, back to the name of the individual, to enable you to carry this out. This link would need to be kept confidential, and separate from the data.

4. Avoid Causing Harm

The duty of the researcher is not to cause harm. Judgements need to be made about what are acceptable levels of harm: please see section above on risks and responsibilities.

5. Maintain Anonymity and Confidentiality

Making data ‘anonymous’ means removing the contributor’s name. However, you will often need to take more than this basic step to protect a participant’s identity. Other information can help to identify people, for example: job title, age, gender, length of service, membership of clubs, and strongly expressed opinions. The more pieces of information that are presented together, the easier it is to identify someone.  

Organisations, units, and groups may also need their anonymity protected. Geographical information, combined with the type of organisation, can give away identity quite quickly. Take as many precautions as you can to protect anonymity, and only promise the level of anonymity that you can realistically provide.

‘Confidentiality’ relates to the protection of the data collected. Where the aim of your research is specifically to access private feelings, stories, and concerns, you will need to be clear about how the confidentiality of that data will be respected. Again, be clear about the level of confidentiality you can, and cannot, guarantee.

Is it sometimes okay not to be anonymous?

The notion that anonymity should be the default position is challenged in a useful article by Grinyer (2002). She suggests that in some research contexts, for example in oral history, it is possible that participants may be keen for their own voices to be acknowledged, and be happy to have their identity made known alongside their contribution to the research. A guiding principle is that participants need to be in control of the disclosure of their identity and their contribution.

6. Take Particular Care in Research with Vulnerable Groups

Think about vulnerability in its widest sense. Care is clearly needed in research with young children, and with people who are ill, or recently bereaved. However, others may be vulnerable in certain contexts, for example: students; employees; dependents; or people with particular traits that could be subject to prejudice.

More extensive background on the principles of ethical practice in research is given in a document called ‘The Ethics of Social Research’ (University of Leicester 2006).

Research Ethics Review in the National Health Service

The Research Ethics Committee (REC) system that operates within the National Health Service (Department of Health 2005; National Patient Safety Agency 2007) is well established. A research proposal needs to be considered within the National Health Service system if it involves:

  • “patients and users of the NHS. This includes all potential research participants recruited by virtue of the patient or user’s past or present treatment by, or use of, the NHS. It includes NHS patients treated under contracts with private sector institutions;
  • individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above;
    access to data, organs or other bodily material of past and present NHS patients;
  • fetal material and IVF involving NHS patients;
  • the recently dead in NHS premises;
  • the use of, or potential access to, NHS premises or facilities;
  • NHS staff – recruited as research participants by virtue of their professional role.”

An important point to note here is that research on NHS staff, not just patients, is included within the remit of the NHS ethics review process, and cannot be considered solely within the University’s system. For guidance on how to proceed if your research falls into any of the above categories you can consult the website: www.nres.npsa.nhs.uk

Research Ethics Review at the University of Leicester

Other research involving human participants can be taken through the ethics review process within the University. The level of review will match the level of potential harm identified. Most student studies will be considered minimal risk and can therefore be considered solely by a Departmental Ethics Officer (DEO).

If your proposal is judged to have more than minimal risk, the DEO will judge whether he or she can review the application, or whether the application needs to be passed to a Departmental or Faculty REC for closer consideration. This simply means that it concerns particularly sensitive issues and needs more in-depth ethical review by a committee. It does not mean it is badly planned or that it cannot go ahead.

It is important to identify as early as possible whether your research is likely to need the attention of an Ethics Committee as well as an Ethics Officer. The committees meet on set dates only, and you will need to allow for this in your research timetable.

The University research ethics Code of Practice gives the following guidance on research that would normally be considered to involve more than minimal risk:

  • research involving vulnerable groups – for example, children and young people, those with a learning disability or cognitive impairment, or individuals in a dependent or unequal relationship;
  • research involving sensitive topics – for example participants’ sexual behaviour, their illegal or political behaviour, their experience of violence, their abuse or exploitation, their mental health, or their gender or ethnic status;
  • research involving groups where permission of a gatekeeper is normally required for initial access to members – for example, ethnic or cultural groups, native peoples or indigenous communities;
  • research involving deception or which is conducted without participants’ full and informed consent at the time the study is carried out;
  • research involving access to records of personal or confidential information, including genetic or other biological information, concerning identifiable individuals;
  • research which would induce psychological stress, anxiety or humiliation or cause more than minimal pain;
  • research involving intrusive interventions – for example, the administration of drugs or other substances, vigorous physical exercise, or techniques such as hypnotherapy. Participants would not encounter such interventions, which may cause them to reveal information which causes concern, in the course of their everyday life (ESRC 2005:para 1.2.2).

The web address for the store of all University documents and guidance on research with human participants is:  www2.le.ac.uk/institution/committees/research-ethics. Your department may have further guidance.

Ethics Review Process for All Research that Involves Human Participants

flow chart

Figure 1: flow chart representing steps in the ethics review process

Concluding Comments

Research entailing ethical risk is spread across many fields, and the potential for harm may not necessarily be immediately apparent.

The default position needs to be that you consider all research involving human participants to be potentially ethical challenging.

It is important to be honest in completing the ethics form. It is far better to point out a potential ethical problem, and say what you intend to do about it, than to ignore it and hope that the DEO, or the REC members won’t notice. The main research ethics skills you need are:

  • to be able to identify the ethical issues within a research proposal; and
  • to know how to address them.

References and Professional Guidance

Blaxter L., Hughes C., & Tight M. (2001) 2nd edition. How to research. Chapter 6: 153-191. Buckingham: Open University Press.

ESRC (2005) Research Ethics Framework. Swindon:ESRC.

Grinyer A. (2002) The Anonymity of Research Participants: Assumptions, Ethics and Practicalities. Social Research Update: Issue 36. University of Surrey. Accessible here.

National Research Ethics Service; National Patient Safety Agency (2008). Accessible here.

University of Leicester (2007) Research ethics involving human subjects. Accessible here.

University of Leicester, Centre for Labour Market Studies (2006) The ethics of social research. Accessible here.

Association of Social Anthropologists ethics guidance. Accessible at: www.theasa.org/ethics/guidelines.htm

British Education Research Association guidance. Accessible here.

British Sociological Association guidance. Accessible at: www.britsoc.co.uk/user_doc/Statement%20of%20Ethical%20Practice.pdf

British Psychological Association guidance. Accessible at: www.bps.org.uk/the-society/ethics-rules-charter-code-of-conduct/ethics-rules-charter-code-of-conduct_home.cfm

International Council for Museums Code of Ethics for Museums. Accessible here.

Museums Association Code of Ethics. Accessible here.

Socio-Legal Studies Association guidance. Accessible here.

World Archaeological Congress Code of Ethics. Accessible here.

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