Impact of public involvement on the ethical aspects of research

Researchers conducting most types of research in the NHS in England are required to submit their study for ethical review by a Research Ethics Committee (REC) within the UK Health Departments’ Research Ethics Service.

A study that looked at RECs’ decisions showed the most common concerns they raised were about: informed consent; care, protection and recruitment of research participants; and the quality of information such as information provided to participants and lay summaries of the research (Angell et al. 2008).

Since 2010 a joint Health Research Authority and INVOLVE study has, on a biennial basis, analysed the nature and extent of public involvement in applications for ethical approval assessed by RECs (Tarpey and Bite 2014, Updated analysis to include data from applications in 2014 will be available later in 2016). This work suggests that the information provided by researchers on whether or not they have involved or plan to involve the public in their work can provide assurances to RECs which greatly assist their ethical review. The HRA is reviewing how it can put greater emphasis on assessing public involvement as part of ethical review.

Drawing on literature reviews (Wilson et al 2015; Brett et al 2014; Staley 2009) and other relevant articles and reports this briefing illustrates how public involvement throughout a study can help to make research ethical by:

Making research more relevant

• so that the research results are more likely to be useful and of benefit patients and the public

Helping to define what is acceptable to participants

• particularly in controversial or sensitive research

Improving the process of informed consent

• making it easier for prospective participants to understand the research and potential risks

Improving the experience of participating in research

• checking that the practical arrangements for participants are appropriate and a respectful use of people’s time

Improving the communication of findings to participants and the wider public

• providing information on the progress of the research as well as the final results

Making research more relevant

Patients and the public frequently prioritise topics for research that are different to those of academics and health professionals (Boers et al 2015; Crowe et al 2015). People living with a health condition are often in a better position to know what questions remain unanswered about their treatment or condition, and what research would most likely improve their quality of life (Evans et al 2011). Patients are also frequently consulted on the most meaningful and relevant outcome measures in clinical trials (COMET Initiative 2016).

Public involvement right at the beginning of a project helps researchers to identify new research topics and to modify their research questions (Whear et al 2012). It can help shift the focus of the research design to become more in line with the public’s interests and concerns. Working with members of the public means researchers need to be clearer about why they want to conduct their research and how it is relevant to the public (Staley 2016; Boers et al 2015). It may challenge researchers’ aims and assumptions.

Public involvement can also influence what research outcomes are measured as well as how they are measured (Andrews 2015; Ennis and Wykes 2013; Boers et al 2013) helping to make the research findings more relevant and valuable to the people who want to use them (Blackburn et al 2015; Carter et al 2013).

Taking part in research that is more likely to benefit the participants and / or other patients and society more generally is a more respectful and ethically acceptable use of people’s time (Staley 2016; Cossar and Neil 2015; Blackburn et al 2010).

Helping to define what is acceptable to participants

Sometimes the risks involved in researching a new treatment make it questionable whether the research should go ahead (Cossar and Neil 2015; Illffe et al 2013; Evans et al 2011). By working with patients and carers and communities who might be asked to take part in high risk projects, researchers can find out:

• whether they would be willing to participate given the risks involved; and
• what potential participants consider to be the most serious risks and how best to explain these.

Involving the public early on during a project also helps researchers to design and conduct their research in a way that potential participants consider to be ethically acceptable (Caldon et al 2010; Carter et al 2013; Littlechild et al 2015). It helps researchers to identify:

• processes for obtaining consent that are acceptable to potential participants, for example when consent may need to be taken at difficult times (Morris 2004) or the process is unusual for example needing people to opt out of a trial (Boote et al 2016);
• the trial design that is most likely to be acceptable to potential participants (Boote et al 2011; Edwards et al 2011; Nuffield Council on Bioethics 2015);
• the most appropriate times to contact patients to invite them to take part in a study or for followup interviews / assessments; based on their own experience, patients will know when this is least likely to cause anxiety or distress (Boote et al 2016);
• any ethical concerns that may be specific to a particular community, which is important when carrying out research with people from diverse cultural backgrounds (Blackburn et al 2010; Salway et al 2015); and
• when and how it is appropriate for researchers to collect information which may be sensitive in nature or potentially distressing (Carter et al 2013; Nuffield Council on Bioethics 2015).

Improving the process of informed consent

Public involvement plays an important role in producing good participant information sheets. Many studies do not get a favourable opinion first time around because their participant information sheets are poor. Public involvement is also valuable in shaping the entire consent process because it is as much about the conversation between the researcher and the potential participant as it is about the written information (Jenner et al 2015; Kennedy et al 2011; Langston et al 2005).

Involving the public in designing the consent process ensures that:

• potential participants receive the information they want and need;
• the information is delivered in a way that reflects their interests and concerns; and
• any written or verbal information is clear and accessible.

This makes it more likely that consent will be genuinely ‘informed’ and that people fully understand what taking part in a project will involve (Carter et al 2013: Jenner et al 2015). When carrying out research with people from diverse backgrounds, public involvement ensures that the process of obtaining consent is culturally appropriate and is sensitive to a community’s concerns. For example, public involvement can check that the language used is not stigmatising to people with mental health difficulties or to people with a disability. Involving the public at this stage helps to make sure that the recruitment process is understood by potential participants (Faulkner 2004; Salway et al 2015).

Improving the experience of participating in research

Public involvement in research design is likely to make sure that the practical arrangements meet the needs of the participants (Ennis and Wykes 2013 ; Jenner et al 2015). This makes it easier for patients and members of the public, including children and young people to take part in research and ensures they are not unduly burdened by their participation. It also demonstrates that researchers respect and value the time given by the participants (Nuffield Council on Bioethics 2015; Staley 2016), for example, by helping to ensure that:

• questionnaires are an appropriate length, relevant and accessible;
• appointments are scheduled at times and places that are convenient for participants to attend;
• participants are not asked to undergo too many assessments or invasive tests; and
• participants are not out of pocket as a result of taking part in research including paying for their travel expenses (unless advised to the contrary before taking part).

Improving the communication of findings to participants and the wider public

It is important that the progress and findings of the research are communicated to participants and the wider public as well as the research community (Evans et al 2011; Fairbrother et al 2013). To inform participants, some research teams produce newsletters to keep people informed of progress, as well as publicising the findings by giving talks to patient groups and publishing lay summaries. This ensures that participants interests are recognised and addressed (Staley 2016).

Public involvement in drafting Plain English and other summaries of the findings helps to ensure that information is presented in a variety of accessible and useful formats, and that the questions that patients and other members of the public may have are properly answered (Supple et al 2015; Littlechild et al 2015; Evans et al 2011: COMET Initiative 2016).

Implications for practice

This briefing provides an overview of how the information on public involvement provided by researchers can facilitate ethical review of research studies by RECs. The earlier researchers start to involve the public in designing their studies the more likely they are to address the range of issues covered in this briefing prior to submitting their application for ethical review. This should reduce the likelihood of researchers being asked to change and resubmit aspects of their documentation and enhance the likelihood of recruiting participants to their studies to time and target.

The section below provides more information on public involvement in research to help researchers successfully find and involve patients and the public in their work.

About this briefing

Authors

Maryrose Tarpey (independent consultant, formerly INVOLVE Coordinating Centre), Kristina

Staley (TwoCan Associates), Andrea Horwood (Health Research Authority) and Jim Elliott (Health Research Authority).

Acknowledgements

Thanks to colleagues at the Health Research Authority: Clive Collett, Bill Davidson, Katherine Guerin, Amanda Hunn, Janet Wisely and members of the National Research Ethics Advisers Panel; and to Doreen Tembo at the NIHR Evaluation Trials and Studies Coordinating Centre, for contributions to this briefing and the HRA / INVOLVE joint statement.

This publication is an update of a previous INVOLVE 2012 publication

Public involvement in research: impact on ethical aspects of research, authored by Kristina Staley (TwoCan Associates), Maryrose Tarpey (INVOLVE Coordinating Centre), Helen Hayes (INVOLVE Coordinating Centre) and Sarah Buckland (INVOLVE Coordinating Centre).

This publication should be referenced as: Health Research Authority / INVOLVE (2016), Impact of public involvement on ethical aspects of research.

Health Research Authority

The HRA protects and promotes the interests of patients and the public in health and social care research. We work to make the UK a great place to do research where more people have the opportunity to participate in health and social care research and continue to feel safe when they do.

INVOLVE

INVOLVE is a national advisory group that is funded by and part of the National Institute for Health Research (NIHR). INVOLVE supports public involvement in NHS, public health and social care research. If you would like to know more about what we do, please see the contact details on the back page.

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