Unit 10 Research Ethics

Unit Author: Professor Nick J Fox

Learning objectives

Having successfully completed the work in this unit, you will be able to:

Describe the ethical theories, principles and rules relevant to research using human participants.
Apply these to your own research.
Prepare your research proposal for assessment and approval by a research ethics committee

Introduction

Ethics is a branch of philosophy that is concerned with issues of ‘right’ and ‘wrong’, and with moral judgments (Comstock, 2013: 10). Applied to research, considerations of ethics assess the extent to which positive benefits deriving from a project outweigh any negative consequences for those involved. Various official guidelines and codes can help us in make these decisions, and specially convened ‘ethics committees’ in universities and other organizations will adjudicate on research proposals. However, the problem is that these guidelines can only take us so far, and the principles underlying research ethics are not absolutes.

Research governance is a comparatively new concept concerning the broad range of regulations, principles and standards of good practice in research, and to the intellectual quality of a research project. Its application is primarily in relation to social research with a health or social care content, and we will consider it briefly later in this unit.

As this course is concerned with social research, we will focus on studies involving humans. We will not consider use of animals in research, which is an ethical issue in some laboratory research.

1. Ethics in research

The three main purposes of research are to:

Advance knowledge: This is an ethical requirement for any scientist, although there are profound questions about the uses to which this knowledge is put e.g. atomic bomb.

Produce future benefits: greater knowledge about the nature of social processes may lead to changes in policy and improvements in well-being.

Evaluate current practice: this should be done as a matter of routine. It can be done using historical review or past cases and statistical analysis or with controlled trials.

When applied to research there are four main areas where ethical issues will be of importance. There will be:

Ethical issues for the researcher.
Ethical issues for those in authority where research is undertaken.
Ethical issues related to a person’s involvement in other people’s research.
Ethical issues of using or not using research findings.

1.1 A case study in ethics

The ethics of research needs to cover four areas:

Maintain ethical standards of practice in research.
Protect participants in research from harm.
Preserve participants’ rights.
Provide re-assurance to the public that research is being done to high scientific and ethical standards.

How do we do this in practice? To begin study of ethics and research governance, please read and answer the following SAQ

SAQ 10.1 The ethics of research

Although rates of teenage pregnancy in Western countries have been falling steadily in recent years, there remain differential rates across socio-economic strata (Swann, 2003). You want to conduct a study to find out why there are higher rates in working class and disadvantaged strata, using interviews with teenagers who are pregnant or have young children, and with their parents.What ethical issues does this research pose? Please write down your thoughts before reading further.

2. Ethical theories, principles and rules

We will now start to consider how research ethics has been developed as a process of making rational judgments about research. It helps to think about ethical issues in research by imagining a hierarchy, starting with ethical theories, followed by ethical principles and finally ethical rules.

2.1 Theories of ethics

There are two main theories that underpin ethical thinking about research (Oliver, 2010: 123). The first is called the deontological theory (from the Greek word for ‘duty’). This is based on the idea that we should always follow natural laws and rights. This means that our ethical responsibilities are primarily to the individual and that every human being, including yourself, should be respected, even if this may have some unfortunate consequences. Deontological theory underpins professional responsibility, including codes of conduct for groups such as health and medical professions. Your duty as a researcher is firstly to the individuals who are involved in the research.

The second main theory of ethical thinking is called teleological or consequentialist. This theory states that we should try and produce the greatest possible balance of value over disvalue, for example, by trying to minimise suffering and maximise well-being. However, this theory recognises that discomfort to a few individuals may be justified by the consequences for society as a whole.

It is important to realise that two researchers may come to different ethical conclusions, but both may be considered to have acted ethically. This is because some of the principles that derive from these theories may be in conflict.

Depending on which theory one subscribes to, some principles rate higher than others in importance. These principles are outlined below.

However, ethical decisions in research are also subject to the dictates of validity. It is generally considered that poor quality research is unethical. If a scientific study is fundamentally flawed or guidelines on good clinical practice have not been followed then this is an ethical issue, since one is asking, as the researcher, for co-operation in a study that is unlikely to yield useful results. This principle underpins the processes surrounding research governance, which are concerned with assessing the intellectual worth of a research proposal.

2.2 Ethical principles

The following four ethical principles are derived from the two ethical theories outlined above. They are binding on researchers unless they are in conflict with other principles, in which case it is necessary to justify why one principle has been chosen over the other.

2.2.1 Autonomy: we should respect a person’s right to self-determination

The first principle is autonomy. Our duty as researchers is both to recognise someone’s capacities and perspectives and their right to make choices about whether or not they choose to take part in a research project. We also need to treat that person in ways that permit them to act in an autonomous way. In research, autonomy is protected by ensuring that any consent to participate in the study is informed or ‘real’.

This means that it is not enough to explain something about your project to a particular subject, it is the understanding and free choice whether or not to participate which is the key issue. There must be no coercion of any sort, either direct or indirect, to participate in a particular research project.

For example, paying a subject a relatively large sum of money to participate in a study can be construed as coercion. This is because a subject on a low income may have less choice than someone on a higher income whether or not to take part. Similarly, flattering children by telling them their parents would approve of them taking part in your study to ‘help other people’ could also be considered a form of coercion.

2.2.2 Non-Maleficence: we should not inflict evil or harm

This principle states that we may not inflict harm on, or expose people to, unnecessary risk as a result of our research project. This is particularly important if our subjects may not be competent in some way, such as the ability to give informed consent. It is not an absolute principle like autonomy, but it is clearly important, if for example, we wish to perform some invasive procedure (for instance, a blood test) or ask personal questions that might stir up emotions or unpleasant memories, that may not benefit the subject or may put him or her at some risk of harm.

2.2.3 Beneficence: we should seek to further research participants’ legitimate interests

This principle obliges us to take positive steps to help others to pursue their interests in general well-being. This seems a fundamental aim, but it can conflict with other ethical principles or practical issues in research.

A simple example of conflict over beneficence is where a project involves a degree of deception, such as in psychology studies in which knowledge of the aim of the study can affect responses. Here there is conflict between the principles of autonomy (the right of a person to make a free and informed choice as to whether or not to take part in the study) and beneficence, as arguably, deceiving participants is not in their best interests (though it will not actually cause them harm). Another example of a similar conflict occurs in drug trials when participants receive a ‘placebo’ dose of a harmless compound in place of a drug that might possibly offer therapeutic benefit.

When a principle is over-ridden by another in such a way we must be able to justify that decision in terms of the overall benefit that the research may bring. Such arguments will apply a consequentialist ethical theory.

2.2.4 Justice: we should ensure fair entitlement to resources

This principle is concerned with people receiving their due. This means that people should be treated equally in every way, since not all people are equally competent or equally healthy. An example of this would be that an individual from an ethnic minority should have an equal opportunity to participate in a particular study as everyone else. To achieve this principle, it may be necessary to translate questionnaires into the range of languages used by potential participants.

2.3 Ethical rules

These general principles translate into practical ethical rules for research.

Like principles, the four ethical rules of research are not absolutes, in that one may over-ride another, although clearly this must be justified. These rules are essential for the development of trust between researchers and study participants.

2.3.1 Veracity

All participants in a research project should always be told the truth, and there is no justification for lying. However, as already noted, this rule may conflict with the capacity to conduct some research studies. Another social research example where veracity is compromised involves covert participant observational studies, in which researchers take on a bogus role or identity in order to observe a setting. This practice would need to be justified in advance, in terms of the need for secrecy to enable valid data collection.

2.3.2 Privacy

When subjects enroll in a research study they grant access to themselves, but this does not mean unlimited access, and they should retain their fundamental rights to sustain their privacy, in terms of access to their bodies, personal beliefs and personal information. If a study will infringe these limits, participants should be asked at the outset of the study to give informed consent that they understand the access that will be required.

2.3.3 Confidentiality

Although someone may grant limited access to him or herself they may not relinquish control over any information obtained. Certainly, no information obtained with the patient’s or subject’s permission from their medical records should be disclosed to any third person without that individual’s consent. This applies not only to written records but also conversations. Confidentiality can therefore be violated if one talks about one’s subjects to friends or colleagues not involved in the study or if their medical records or research records are left in a public place by mistake so that others can read them.

Again this rule can be challenged. If in the course of a study we learn of a potential crime, or of risk to a vulnerable individual (for example, poor quality care being delivered to a child or older adult), we have an obligation to over-ride the rule of confidentiality and inform an appropriate authority.

2.3.4 Fidelity

Fidelity means keeping our promises and avoiding negligence with information (as above). If we agree, for example, to send a summary of our research findings to participants in a study we should do so.

2.4 Managing conflicts in research ethics

As we have seen, there are circumstances in which the principles and rules of ethical conduct conflict with each other, or with the need to undertake useful and valid research. Weighing up these issues is a key part of the research process, and you will need to prepare your arguments before you present your proposal to an ethics committee.

If you wish to conduct research that breaks one or more ethical principles or rules because you believe this is the only way to conduct the study, you will need to justify this – either in terms of other principles, or by showing that the value that will derive from your research will outweigh the costs of breaching ethical rules. Bear in mind that an ethics committee will not necessarily share your convictions, or be convinced that what you are proposing is the only way to successfully conduct the research.

To assess your grasp of the materials studied so far, please now complete the following SAQ before reading on.

SAQ 10.2 Principles and rules of research ethics

Imagine you are a member of an ethics committee. Which of the principles or rules of ethics would you apply in the following applications that come before your committee?

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3. Obtaining research ethics approval

When undertaking any social research it is important that the study is independently reviewed and scrutinised on both ethical and intellectual grounds.

For most research using human participants, gaining ethical approval is now formalised through the provision of ethics committees in universities and health services. Almost all social research that involves human participants needs to be approved by such a committee. In the UK and many other countries, social research that uses participants recruited on the basis of being ‘patients’ will need ethics approval via a specialist health research ethics committee (NHS ethics committee in the UK). If you are a UK social researcher doing such research, read through the box below to check if you will need NHS ethics approval.

3.1 Do you need NHS ethical approval?

Generally NHS research ethics committees should be asked for approval when research 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;
foetal material and IVF involving NHS patients;
the recently dead in NHS premises.

For more information on NHS ethics approval, see: http://www.hra-decisiontools.org.uk/ethics/

If in doubt, check with the research office in the NHS Trust where you plan to do your research , to ensure you do not begin gathering data without a necessary approval.

3.2 Applying to a Research Ethics Committee (REC)

For most social researchers who do not need ethical approval for health or social care research from an NHS or equivalent ethics committee, ethics approval will be gained from a research ethics committee (REC) located in a university. The first step is therefore to identify the procedures and arrangements for ethical review in your place of work. Independent scholars may need to consult their local university or professional association, as failure to gain ethics approval for research can sometimes prevent publication in academic journals.

Clearly, when writing a submission for a research proposal to the local research ethics committee, one needs to bear in mind the four principles derived from the two theories and the four rules of ethical research outlined above. All of our specific actions and judgments when doing research are justified by these rules, principles and theories.

Whilst one needs to meet the requirements of the ethical principles and rules, it is also important to bear in mind the scientific aspects of the study, such as research design. Poorly designed research is considered by many people to be equally unethical. Researchers should not be surprised if questions are directed towards some scientific aspects of the study since as stated in the introduction, validity is an important component of ethical review. Consulting a statistician prior to submission could be very helpful if your study involves statistical analysis.

While the specifics of what a particular REC will require in terms of information may vary, it is probable that you will need to provide information about:

Who you are, including qualifications, job title etc.
The title and aims of your research.
A summary of the research accessible by lay reviewers.
A scientific justification for the research (why it is worth doing).
The study design/methodology
Details of the methods you plan to use to sample, collect and analyse the data.
Where the research will be conducted, and over what timescale.
Who your respondents will be, and how you will recruit them to your study.
How consent will be gained from respondents and how you will protect their privacy and confidentiality.
Whether there are risks (physical, mental, emotional) to participants or to the researchers, and how these will be managed.
How you will manage your data and keep it secure during and after the research.
What research staff will be involved in the research, and what access they will have to the data and to respondents.
Any potential conflicts of interest.
Sources of funding.

You should also provide supporting documentation, which may include consent forms, information sheets for respondents, copies of the research instruments (e.g. questionnaires) etc.

If you are a student, the committee will also need to know about your supervisors and how they will ensure you adhere to the ethical standards of your institution.

Most RECs will assign independent reviewers to assess your application. They will advise the committee whether your proposal can be approved or if there are any further requirements that you will need to meet in order for your research to be approved.

A substantial proportion of ethics applications need some revisions before approval, and this may entail a re-submission and re-review of your proposal before approval is granted.

4. Other issues in research ethics

4.1 Research governance

Research governance is a term developed to describe the overall conduct of research, in order to assure high standards. In the UK, social research that has a health or social care content requires research governance approval, in addition to ethical approval. The main issue here concerns the intellectual quality of the research, and this is normally obtained by means of an independent review of the research proposal by an established researcher. It will also assess if health and safety regulations have been taken into account, and how service users are to be involved in the research programme.

For research that requires NHS ethics approval, research governance approval will be handled via the NHS organisation where the research is to be conducted. You should check with your NHS Trust Research Office precisely what documentation will be required. It is likely to include some or all of the following.

Electronic copies of your ethics application and ethics approval letter.
Copies of all documents provided for the ethics review (protocol, consent form, participant information sheets).
Evidence of sponsorship and written confirmation from the organisation acting as sponsor that they have agreed to accept the responsibilities. The sponsor (the funder, university or care organisation) has overall responsibility for ensuring adequacy of design and management including ensuring appropriate arrangement for conducting and monitoring the research. In this context, “sponsor” does not necessarily equate to “funder”.
Evidence of independent peer review.
Thought given to service user involvement.
Service management approval for each organisation in which research is going to take place. Copies of honorary contract/honorary contract application form and accompanying information (where applicable).

Other health and social care research not requiring NHS ethics approval (see 3.1 earlier) needs to gain governance approval via the university where it will be undertaken.

4.2 Scientific misconduct

Having carefully designed your study and obtained ethical approval you now start to collect and analyse data. There are numerous examples in the scientific literature of authors behaving unethically during the process of doing their research. There is a spectrum of inadvertent error through to outright fraud. There may be scientific errors such as inappropriate and inadequate observations, poor quality data analysis and selective quotes from references. Further along this spectrum there may be substantial bias in the selection of the sample or frank abuse of statistics.

Gift authorship may also be considered an example of scientific misconduct whereby favours are returned in kind by including one’s partner, supervisor or professional colleague on a publication as a reward, even though they have made no substantial contribution to the paper.

Salami publication is also thought to be a form of scientific misconduct whereby the same piece of work is simply sliced and repeatedly published in different journals with differing emphases.

Further along the spectrum towards outright fraud are activities such as manipulating data or suppressing inconvenient data, or not declaring an interest in the results (such as pressure from a pharmaceutical company to produce a `good result’ for their drug for which the researcher receives a `bonus’). Finally, at the extreme end of this spectrum, outright fraud may indeed take place and this would include plagiarism of other people’s original work or indeed piracy of their results.

4.3 Intellectual property

Research may produce intellectual property (IP), both in terms of the ideas or theories generated, and in some case products or patents that derive from it. Before you start a piece of work, check who will own the IP. The law concerning intellectual property rights is complex and beyond the scope of this unit. If you are a student, you should discuss these issues with your supervisor as it may affect the use to which you can put your research.

4.4. Responsibilities of the researcher

Once ethical approval has been obtained for a research project the work does not stop there! The researcher will still have ethical responsibilities that include:

ensuring conditions imposed by the ethics committee are met;
ensuring all involved have the research protocol;
providing progress reports if requested by the committee;
reporting adverse or unforeseen events associated with research to the committee; and
ensuring any significant changes during research are approved by the committee.

Ethics is thus a state of mind and an outlook on research activity, rather than a paper exercise or chore to be completed before the real research begins.

Summary

Ethical principles are based on two theories: deontological and consequentialist.
Research studies should be judged ethically on three sets of ethical criteria, namely: ethical principles, ethical rules, and scientific criteria. The latter is often neglected but is important since if a study design is poor or the sample size insufficient then the study is not capable of demonstrating anything and consequently could be regarded as unethical.
The four key ethical principles are autonomy, non-maleficence, beneficience, and justice.
The four key ethical rules are veracity, privacy, confidentiality and fidelity.

References

Comstock, G. (2013) Research Ethics: A Philosophical Guide to the Responsible Conduct of Research. Cambridge University Press.

Oliver, P. (2010) The Student’s Guide to Research Ethics. London: Open University Press.

Swann C et al, (2003) Teenage Pregnancy and Parenthood: A review of reviews. London: Health Development Agency.

Reflective Exercise 10.1

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Answer to SAQ 10.1

This proposal poses a number of ethical challenges.

Research is needed if we are to progress in our knowledge, and in areas concerning social processes must involve human participants. However, these participants can be vulnerable or relatively powerless, and may make it difficult to ensure that their independence and rights are honoured, and harm (including mental or emotional) avoided.

The question that arises is: who should be our research subjects? Should pregnant teenagers be invited to take part in research that will not benefit them, though it may benefit others in due course? Is it possible for a researcher to obtain informed consent for research if the participants are under 18?

What effects might the research have on those interviewed? Might questioning teenagers who are already in a difficult social situation increase feelings of lack of control or lowered self-esteem? Might participation in the research have financial costs to subjects? These are the kinds of questions that a researcher needs to think about when designing a research project, and will also be the things that a research ethics committee will address, based upon ethical theories, principles and rules.

Answers to SAQ 10.2

You should raise the issue of autonomy. The covering letter could be interpreted as coercion of the children.
Here the issue is beneficence. -The study will not benefit the individuals taking part. The researchers should justify it on basis of consequentialist theory, in that the result of the study will be of benefit to the wider society.
The research team needs to justify their covert design, which breaches the ethical requirement for veracity. Is there any other way to conduct this research without this deception?
It is proposed that data collected from a previous survey is used in this study. This breaks confidentiality agreements, and the right to privacy of the original respondents as they did not give consent for their data to be used in the second study.
This breaches the principle of justice as non-English speakers may not have the chance to participate in the study.

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