A simple guide to gaining ethical approval for perioperative nursing research.
Abstract: Research ethics relate to three groups of perioperative nurses: those who undertake research within the clinical area, those clinically responsible for patients taking part in research studies or trials, and finally the students and qualified staff who critique research articles and want to ensure that the standard of ethical rigour is acceptable. This article contains guidelines based on essential research ethical principles for each of these three groups and outlines the application process for gaining ethical approval.

KEYWORDS Research ethics / Research governance / Research approval process Provenance and Peer review: Commissioned by the Editor; Peer reviewed; Accepted for publication January 2011.
Article Type: Report
Subject: Surgical nursing (Licensing, certification and accreditation)
Author: Rees, Colin
Pub Date: 04/01/2011
Publication: Name: Journal of Perioperative Practice Publisher: Association for Perioperative Practice Audience: Academic Format: Magazine/Journal Subject: Health; Health care industry Copyright: COPYRIGHT 2011 Association for Perioperative Practice ISSN: 1750-4589
Issue: Date: April, 2011 Source Volume: 21 Source Issue: 4
Topic: Event Code: 930 Government regulation; 290 Public affairs; 940 Government regulation (cont); 980 Legal issues & crime Advertising Code: 91 Ethics; 94 Legal/Government Regulation Computer Subject: Government regulation
Organization: Organization: Royal College of Nursing; Royal College of Nursing
Geographic: Geographic Scope: United Kingdom Geographic Code: 4EUUK United Kingdom
Accession Number: 272168010
Full Text: Research and perioperative nursing

Perioperative nursing has embraced evidence-based practice to the point where its relevance to practice is not in question. However, the availability of research articles to answer key clinical questions is a problem. There is a gap between the need for evidence and the supply of good quality research that looks at problems from a perioperative nursing perspective.

One reason for this lack of evidence is the small number of perioperative nurses involved in research. There are many reasons why little research is produced and therefore applied to practice: time, skills and support - especially financial support - are some of the obstacles. There is also a reluctance to enter the 'system' of applying for ethical approval and have ideas scrutinised by others in what is seen as a challenging way. This problem may be reduced through a clear understanding of the issues related to ethics in research, and knowledge of how to apply for ethical approval.

Ethics in the context of research has been defined by the Economic and Social Research Council as follows:

'Research ethics refers to the moral principles guiding research, from its inception through to completion and publication of results and beyond--for example, the curation [safekeeping] of data and physical samples after the research has been published.' ESRC 2010

In other words, research is not simply the technical aspect of the research process; it concerns the ethical responsibilities and obligations that must be demonstrated by the researcher. This can be summed up as the researcher's integrity in how they think and behave whilst carrying out the research.

The aim of this article is to identify essential ethical principles underpinning research and to provide a simple guide to applying for ethical approval. It is hoped that this will encourage more perioperative nurses to consider carrying out research.

The need for research

More than ever, nursing has to think smarter rather than work harder. It needs to ensure that nursing interventions and priorities are effective, and contribute to improved patient outcomes, and that new ways of working are convincingly demonstrated to be better than previous methods. Such knowledge is more accurately derived from research than other sources, such as custom and practice, personal opinion or experience, all of which can mislead nursing actions. There is then a need for more nurses to be involved in producing research, and more nurses with knowledge and skills in assessing whether available research is sound.

It is worth emphasising that research is distinct from audit and practice development in that it requires ethical approval prior to data collection (NRES 2009). In this article, research describes those systematic activities which result in knowledge that contributes to our wider understanding of a topic. This differs from audit where the results are compared to a standard or baseline, and are relevant only to the local area and cannot necessarily be applied to other areas. The results do not increase our understanding of a topic only its quantity or comparison to a standard. A clear definition of this point is provided by the Department of Health:

'Research can be defined as the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods'. DH 2005 p3

In summary, we need research evidence, but research must be carried out in accordance with processes that create dependable findings and which follow ethical principles.

Why the focus on ethics?

Although the need for research evidence is clear, it cannot be collected at any price. Holland and Rees (2010) emphasise that data gathering is not the right of the researcher but has to be scrutinised as being justified and carried out in an acceptable manner.

Over the last decades a number of research ethics charters and codes, such as the Declaration of Helsinki and the Nuremberg Code, have been developed to protect the human rights of those taking part in studies (see for example, Rees 2011). In research, the ends do not justify the means, and the individual's free will and autonomy must always be respected. The ethical principles derived from those ethical codes have been summarised by the RCN (2009) and can be seen in Box 1. Each of these issues will now be examined before we consider the process of application for ethical approval.

Informed consent

A useful starting point is to consider all research as being potentially harmful, either physically or emotionally, to the individual (RCN 2009). Therefore, a possible participant in research can only give consent if they are aware of the risks and are free to make an informed choice to take part. According to the Research Governance

Framework (DH 2005) informed consent is at the heart of ethical research. However, this does not simply mean that someone must say 'yes' they will take part in a study. The important word is 'informed' sometimes referred to as 'valid' consent. This has been defined by the RCN as follows:

'Informed consent is an ongoing agreement by a person to receive treatment, undergo procedures or participate in research, after risks, benefits and alternatives have been adequately explained to them.' RCN 2005 p3

This definition indicates the kind of information that should be discussed with an individual in order for them to make a meaningful judgment on whether to participate. The information should include:

* Full disclosure of details about what will happen to the individual.

* A statement that there is no obligation to take part, and that there are no consequences if the decision to participate is 'no'.

* Assurance that the individual can withdraw at any time without any negative consequences.

* Confirmation of confidentiality and anonymity.

* Care that all the information concerning involvement is understood.

* Meaningful provision of the opportunity to ask questions.

* Absence of pressure, unfair inducements or coercion to take part.

RCN 2005

All these conditions are built on the assumption that an individual is conscious, and can understand what is being said. In many circumstances, such as those who are deaf or hearing impaired, unconscious or where English is not a first language, an individual's comprehension of information about a study can be compromised. Consideration may need to be given to gaining consent from a relative in the form of 'proxy' consent, or assessing ways of overcoming challenges to communication in order to gain consent.

Ethics committees will expect the researcher to produce clearly written information sheets for those taking part in research. A written informed consent sheet, to be signed by the individual, needs to be included when making an application for ethical approval. Time must then be allowed for a considered judgment to be made.

Confidentiality

As with patient information, any information collected on an individual should be seen as confidential in terms of who has access to it in its raw form. The researcher should take steps to anonymise the information and to use code numbers rather than names as far as possible. When the data are presented in the form of results it should not be possible to recognise the individual by name or identifying characteristics. This is why in some studies, such as qualitative research, individuals are given a pseudonym or number to protect their identity.

Data protection

There are clear guidelines to follow when protecting data collected through research. The rule is to ensure safe and secure storage as in the case of patient information. Clear systems and processes need to be developed and explained when making research applications. Electronic data has to conform to the data protection act, and care needs to be taken where data are stored on such things as data sticks or discs, for example, by using encription.

Right to withdraw

The right to withdraw covers issues regarding how an individual is recruited into a study and their rights to refuse, or later withdraw, at any time without their care being affected in any way. These aspects must be made clear to the individual and no undue pressure or suggestion as to why they must take part can be applied, as this is clearly coercion.

Potential benefits and the potential harms

The most important principle in research is that participants must not come to any physical or emotional harm. The researcher must consider, and make clear, possible benefits and potential harm that may be an inevitable or foreseeable aspect of a study. It is not acceptable for the level of harm to outweigh any possible benefits.

These principles are reinforced and extended by research governance introduced in 2001 and updated in 2005 (DH 2005) in England, with equivalent legislation in Wales and Scotland. Government regulation of research contains a number of essential prerequisites that researchers and their employing organisations must demonstrate before a research study can be supported. Much of the application for approval system, outlined below, is to ensures that these prerequisites have been satisfied.

Professional journals now often refuse research articles that have not been approved by ethics committees and so been shown to conform to legislation. All of these steps share the intention of improving the standard of research and the ethical rigour of studies.

This sounds as though it is very difficult to carry out research because of these ethical constraints. In reality, research governance has simplified the process and achieved a greater level of parity across different geographical areas. The application for ethical approval has now been made easier as everyone must follow an on-line pathway using forms that are more 'fit-for-purpose' than those that were available previously.

Applying for ethical approval

How then, does the researcher gain ethical approval? The following details assume that you will be the 'lead Investigator' and so the key 'form-filler'. The first stage is to develop a research idea into a research proposal that can be considered by an ethics committee. Although the form is available on-line the various elements that should be considered are outlined in Box 2 as a way of preparing for the process.

To be ready to gain ethical approval, you need to have a clear outline for a study, funding or support from your managers/organisation, and the time to undertake the study. The process then involves the following stages:

* Informing yourself about the process (if this is your first application)

* Preparing the application for approval

* Making the application

* Follow-through.

Informing yourself about the process

Applying for research approval is a painstaking process, and there are good reasons for this. Research is about the integrity of the researcher and the need to protect individuals and employing organisations from poor research practices. It is also about ensuring the quality of the research produced by those applying for permission. The process invovles:

* a local research and development (R&D) office--this can be located by accessing your local information sources for your nearest department

* a local ethics committee (LREC), again you should be able to locate this using your usual information resource systems

* the Integrated Research Application System (IRAS), which is the national body responsible for helping individuals make applications for healthcare research (Available from: www.myresearchproject,org.uk)

* for those undertaking a study in England (not Scotland, Wales or Northern Ireland) approval is also required through the National Institute for Health Research Coordinated System for gaining NHS Permission (NIHRCSP) (DH 2010) - available from: www.crncc.nihr.ac.uk.

A preliminary visit to some key websites will help you to identify the information you will need to supply, and the process you will need to follow. For instance, the National Research Ethics Service (NRES) site has information on 'defining research', and 'the application process flowchart'. The latter has a number of hyperlinks to valuable information. Both of these can be accessed at: www.nres.npsa.nhs.uk/applications

In particular, look at the IRAS e-learning module Getting the Best from IRAS (www.myresearchproject.org.uk/ELearning/module.html). This will take you through all the information you will need, and provides tips and details to make the processes easier.

A further useful source of information is the NHS Research and Development Forum where the section on Guidance is especially helpful--www.rdforum.nhs.uk/011.asp.

It is also worth making an informal approach to your local R&D office for guidance and discussion on your particular project. The earlier you are able to do this the better, but they will expect well developed information on your study. When making your application on-line you will also have to give information about your local research ethics committee, so it is worth an informal phone call to them to check what they might require or any further information that you may not have considered.

Preparing the application for approval

This stage includes collecting and producing the information that will be needed at the application stage. You will need a signed and dated hard copy of your CV emphasising your research knowledge and experience, to be sent separately by mail, and electronic copies of the following to be pasted into the online forms:

* The name of the individual/organisation acting as your sponsor

* Clear details of the intended study including purpose and method

* Information sheet for those participating

* Consent form

* Costing and project timetable.

The NRES site contains templates of information sheets and consent forms (www.nres.npsa.nhs.uk/applications/guidance/consent-guidance-andforms/? esctl1431725_entryid62=67013). The site also has a template for your CV.

Throughout this stage it is worth ensuring that you have cleared the way for your study by gaining support from your managers, and by carefully costing the study and assessing the time it will take to complete. It is worth finding others who have undertaken studies of a similar nature to talk with them about cost, resources and time taken. Learn from the experience of others. You will also be expected to have had your research proposal study scrutinised from a 'scientific' point of view to ensure that your design will produce accurate, reliable and valid information. There may be local systems for this process and your R&D office may provide advice on this.

An important consideration will be in some way to consult the public and patient representatives concerning the content and processes of the study. One example is using the public/patient's help in examining the information sheet and the consent form given to those in the study to ensure that all the required information is present and is in easily accessible language. Patients and the public can also be invaluable in commenting on the tool of data collection to ensure that relevant items are not omitted or are likely to be unacceptable in their present form or wording.

Making the on-line application

This stage involves following the procedure for on-line applications at the IRAS site (www.myresearchproject.org.uk). You will need to register with the site by giving your email address and a password. As you go through the process you will be able to cut and paste material you have already prepared. If you need to stop and go back at any time you can 'save now' and return to the form at a later date.

One of the major parts of the process is the 'project filter questions' that enable you to specify exactly the kind of study design you are using. It is on the basis of this information that the forms you will complete, and the different bodies who will be involved in granting you permission will vary, depending on the requirements for different study designs. In other words, there are different pathways through the process that are triggered by this filter stage.

Follow-through

Once the form is complete and you have satisfied the requirements of IRAS, the form is then used to submit to the local R&D department for approval and to the local research ethics committee.

The common response from R&D departments and particularly ethics committees is a request for more information or for some changes to be made to the project. It is imperative that any such requests are complied with immediately and any guidance followed. You will be invited to attend the ethics committees when your project is examined. This is advisable as it might save a lot of time. You may, for example, be able to give reassurances on details or provide explanations on points not included or those that are vague or ambiguous.

Conclusion

This article has provided a guide to the process of seeking approval for undertaking research in perioperative nursing, and made links with the principles of research ethics. This should allow those who are thinking of research to pursue their ideas with confidence. The details will also help those whose patients are involved in research to ensure that the correct processes have been followed. Similarly, it will help those who critique research to consider the ethical issues involved.

Understanding the ethical aspects of research and incorporating these into research activities will enable perioperative nursing to move forwards and make a real contribution to evidence-based practice and the care of patients.

No competing interests declared

References

Department of Health 2005 Research Governance Framework for Health and Social Care 2nd edition DH, London Available from: www.dh.gov.uk/prod_consum_dh/groups/ dh_digitalassets/@dh/@en/documents/digitalasset/dh_4122427.pdf [Accessed January 2011]

Department of Health 2010 Gaining NHS Permission for Clinical Research: A guide for researchers National Institute for Health Research Coordinated System for gaining NHS Permission (NIHRCSP) Available from: www.crncc.nihr.ac.uk/OneStopCMS/Core/CrawlerResourceServer.aspx?resource= 7140d21ac9844dc3a8d99464346b1bb3&mode=link&guid= 40016c77dffa42529a44726f0780e322 [Accessed January 2011]

Economic and Social Research Council 2010 Framework for Research Ethics London, ESRC Available from: www.esrc.ac.uk/_images/Framework_for_Research_Ethics_tcm8-4586.pdf [Accessed February 2011].

Holland K, Rees C 2010 Nursing: Evidence-based practice skills Oxford, Oxford University Press National Research Ethics Service 2009 Defining Research: Guidance to help you decide if your project requires review by a research ethics committee Available from: www.nres.npsa.nhs.uk/applications/ [Accessed January 2011]

Rees C 2011 Introduction to Research for Midwives 3rd edition Edinburgh, Churchill Livingstone

Royal College of Nursing 2005 Informed Consent in Health and Social Care: RCN guidance for nurses London, RCN Available from: www.rcn.org.uk/__data/assets/pdf_file/0010/78607/002267.pdf [Accessed January 2011]

Royal College of Nursing 2009 Research Ethics: RCN guidance for nurses London, RCN

Correspondence address: Colin Rees, School of Nursing and Midwifery Studies, Cardiff University, Ty Dewi Sant, Cardiff, CF14 4XN. Email: reescb@cardiff.ac.uk

About the author

Colin Rees MSc, BSc (Hons), PGCE Lecturer, School of Nursing and Midwifery Studies, Cardiff University, Cardiff
Box 1 Basic research ethical issues

The essential elements that must be
observed by all researchers include:

* Informed consent

* Confidentiality

* Data protection

* Right to withdraw

* Potential benefits and the
potential harms

Source: Royal College of Nursing 2009


Box 2 Useful elements in a research proposal for consideration
prior to application for ethical approval

* Title. Keep this simple, do not go for jokey titles, make it
fit perfectly what the study is about

* Why the study needs to be undertaken

* Current knowledge or understanding available in the literature

* The specific question the study will answer

* Methods that will be used in terms of research design (e.g.
survey, randomised controlled trial, qualitative study) and
research method (e.g. scales, questionnaires, interviews,
bio-physiological measures)

* Data analysis method (statistical methods e.g. SPSS, or other
computer statistical package or content analysis in the case
of qualitative data)

* How those in the sample will be selected, the inclusion and
exclusion criteria, and approximate sample size

* Ethical issues highlighted by the design and how they will be reduced

* Possible benefits and hazards of the study

* Details of research applicant and team members, especially their
research experience

* How the study will be supervised by experienced research supervisors

* Costs of staff and resources and funding body or source of funding

* How findings will be disseminated

* Involvement of representatives of the public or patient group in the
design and implementation of the research proposal.
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