Research, quality improvement and evidence-based practice: Ethical implications

Recently I've begun to ask myself the question as to whether within the 'school-research/evidence community'  there is a shared understanding of the similarities and differences between - research, quality improvement and evidence-based practice, and the ethical implications of these similarities and difference.  This is a critical issue because if schools and school leaders are not fully aware of the ethical issues, there is a real-risk that pupils will be disadvantaged by well meaning, but ultimately flawed attempts at randomised control trials masquerading as quality improvement or evidence-informed practice.  Unfortunately, this cannot be put down to ignorance - as the knowledge exists in the health-care sector of how to conduct ethically sound quality improvement interventions.

So to help school leaders begin to explore the ethical implications of seeking to develop the research/evidence based school, this post will:

• define research, quality improvement and evidence-based practice; 
• provide school-based examples for each term; 
• explore the overlaps between each terms, with particular reference to ethics;
• outline BERA's guidance on the ethical conduct of research;
• highlight future posts which will seek to provide schools with guidance on the ethical conduct of quality improvement activities.

What do we mean by research, quality improvement and evidence-based practice?

Without wishing to get into the scientific paradigm wars, I would like to offer the following definitions to allow us get some purchase on what is meant by each of the following.

Research can be defined as the process of creating new generalisable knowledge, and which could include both the generation and testing of hypotheses.

Quality Improvement  can be defined as systematic, data-guided activities designed to bring about immediate improvements in local settings.  (Lynn et al., 2007)

Evidence-based practice can be defined as the making of decisions through the conscientious, explicit and judicious use of the best available evidence from multiple sources in order to increase the likelihood of a favourable outcome. (Amended from Barends et al., 2014)

Hicks (2016) writing about health care, usefully summarises the differences as follows : Quality improvement seeks to improve care, research seeks to generate new knowledge, and EBP allows clinicians to have the best available evidence at the point of care.    So how does this translate into  an educational context.  One possible way to rewrite Hicks summary of differences between quality improvement, research, and evidence-based practice is to say:  Quality improvement seeks to improve the individual school or multi-academy trust, research seeks to generate new knowledge, and EBP allows educators to have and use the best available evidence when making a decision.

Examples of research, quality improvement and evidence-based practice

Table 1 seeks to summarise the differences between research, quality improvement and evidence-based practice by using examples of typical activities, which might be found in research, data or evidence-informed school.

Table 1 Examples of  research, quality improvement and evidence-based practice.

Type of activity	Examples
Research - the process of creating new generalisable knowledge, and which could include both the generation and testing of hypotheses	Participation in an Education Endowment Foundation randomised control trials in mathematics Working with a university department of educations on a study to into teachers' use of new technology Individual member of staff conducting doctoral research under the supervision of a  higher education provider.
Quality Improvement - systematic, data-guided activities designed to bring about immediate improvements in local settings	Interviewing a range of colleagues about examination performance in a particular department and production of associated action plan Making changes in pupil enrolment systems  An internally devised  school-based trial on a new approach to providing individual support prior to external examinations.
Evidence-based practice - the making of decisions through the conscientious, explicit and judicious use of the best available evidence from multiple sources in order to increase the likelihood of a favourable outcome.	Undertaking a review of existing evidence - research, school, stakeholders, personal experience - on graded lesson observations and making a decision on whether to move to a non-graded approach. Undertaking a review of existing evidence - research, school, stakeholders, personal experience - on the effectiveness of marking homework and adopting a new school-wide policy.

The overlapping relationships between research, quality improvement and evidence-based practice

Nevertheless, there are overlapping relationships between the three terms and which is discussed by Newhouse (2007)  Research may be driven by questions that arise from quality improvement and evidence-based practice, arising from deficiencies in the existing  research knowledge.  Research and quality improvement may inform evidence-based practice, with quality improvement providing contextual data.  Research and evidence-based practice both inform quality improvement,  as when identifying strategies to bring about improvement both research evidence and practitioner expertise will be reviewed.

Hicks (2016) argues that in the context of health care the maturation of quality improvements has led to some to improvement efforts having similarities and overlaps with research which creates the opportunity for confusion.  Hicks argues that it is a regular occurrence for quality improvement initiatives to have a clear purpose, scope, data-collection methods and sophisticated approaches to data analysis.   Indeed, in the UK we have the Education Endowment Foundation's The DIY Evaluation Guide which uses the language of research, for example, interventions, measures pre-tests, post-tests random allocation, matched control groups, effect-sizes, analysis and reporting of results.  In the US we have Bryk et al (2015) writing about the application of  improvement science to education state:

Improvements typically entails a sequence of inquiries, where the results from each test of change offer guidance for the next test. Formally each test is akin to a small experiment; the overall arch of activity is an improvement investigation (p16)

So it would appear that there are some clear overlaps between the methods associated with research and those with quality improvement.

However, the key area of overlap relates to ethics. As Lynn et al (2007) state: Ethical issues arise in QI (quality improvements) because attempts to improve quality may inadvertently cause harm, waste scare resources, or affect some patients unfairly (p666).   In other words, just because an initiative or intervention is designed to bring about  immediate improvements in local settings, does not they do not have a very strong ethical components.   As such, if we take the stance there is a significant overlap between research and quality improvement, with many quality improvement interventions having the features and characteristics of research, a useful starting point is the guidance BERA provides for the ethical conduct of research

BERA's Ethical Guidelines for the conduct of research

BERA's guide to the ethical conduct of research outlining the researcher's  responsibilities to: participants; sponsors of research; responsibilities to the community of educational researchers; and. responsibilities to Educational Professionals, Policy Makers and the General Public.  For a moment, let's just focus on the responsibilities to participants, and pose the following question : to what extent have the following issues been considered when you have designed a specific quality improvement activity:

• Voluntary Informed Consent - participants understand and agree to their participation without any duress, prior to the research getting underway

• Openness and disclosure - researchers must avoid deception or subterfuge unless their research design specifically requires it to ensure that the appropriate data is collected or that the welfare of the researchers is not put in jeopardy.

• Right to withdraw - researchers must recognize the right of any participant to withdraw from the research for any or no reason, and at any time, and they must inform them of this right. In all such circumstances researchers must examine their own actions to assess whether they have contributed to the decision to withdraw and whether a change of approach might persuade the participants to re-engage.

• Issues specific to Children, Vulnerable Young People and Vulnerable Adults - researchers must comply with Articles 3 and 12 of the United Nations Convention on the Rights of the Child. Article 3 requires that in all actions concerning children, the best interests of the child must be the primary consideration

• Incentives - researchers’ use of incentives to encourage participation must be commensurate with good sense and must avoid choices which in themselves have undesirable effects (e.g. the health aspects of offering cigarettes to young offenders or sweets to school-children)

• Detriments arising from participating in research - researchers must make known to the participants (or their guardians or responsible others) any predictable detriment arising from the process or findings of the research. Any unexpected detriment to participants, which arises during the research, must be brought immediately to their attention or to the attention of their guardians or responsible others as appropriate. Researchers must take steps to minimize the effects of designs that advantage or are perceived to advantage one group of participants over others e.g. in an experimental or quasi-experimental study in which the treatment is viewed as a desirable intervention and which by definition is not available to the control or comparison group respectively.

• Privacy - The confidential and anonymous treatment of participants’ data is considered the norm for the conduct of research. Researchers must recognize the participants’ entitlement to privacy and must accord them their rights to confidentiality and anonymity, unless they or their guardians or responsible others, specifically and willingly waive that right

• Disclosure -  Researchers who judge that the effect of the agreements they have made with participants, on confidentiality and anonymity, will allow the continuation of illegal behaviour,which has come to light in the course of the research, must carefully consider making disclosure to the appropriate authorities.  (extracts from BERA's Ethical Guidelines for Educational Research

If these issues have been considered, addressed and been subject to some form of internal review, then that is great.  On the other hand, if these issues have been dismissed or ignored, then there is a real risk that pupils may be harmed by badly designed quality improvement activities which take insufficient account of the determents a pupil might experience by participating in the intervention.
If this is the case, this cannot be put down to ignorance, claiming that we don't know how to put in place ethical frameworks; first, there are clear ethical guidelines provided by BERA; second, there is extensive literature in the health-sector on the ethical considerations of quality improvement, with clear guidelines as to how to proceed (Lynn et al, 2007).

To summarise

• There would appear to be the potential for a lack of understanding of the differences and similarities between research, quality improvement and evidence-based practice.
• Much of the 'so-called' research or evidence-informed practice being undertaken in schools, could be classified as quality improvement
• Ethical considerations are just as relevant to quality improvement as to research
• Unfortunately, there is a real risk of teachers are not aware of the ethical implications of quality improvement activities, and which may place pupils at avoidable risk.
• This cannot be put down to ignorance of what works - as the knowledge exists in the health-care sector to design ethically sound quality improvement interventions
• This knowledge can easily be applied to schools to ensure quality improvement interventions are ethically sound.

Next-time

I will further explore the ethical implications for schools of the overlay between research and quality improvement, and in particular whether the notion of 'equipoise' provides pupils with  sufficient protection from harm.

REFERENCES

BARENDS, E., ROUSSEAU, D. M. & BRINER, R. B. 2014. Evidence-Based Management : The Basic Principles. In: MANAGEMENT, C. F. E.-B. (ed.). Amsterdam.

BRYK, A. S., GOMEZ, L. M., GRUNOW, A. & LEMAHIEU, P. G. 2015. Learning to improve: How America's schools can get better at getting better.

COE, R., KIME, S., NEVILL, C. & COLEMAN, R. 2013. THE DIY EVALUATION GUIDE.

HICKS, R. W. 2016. Maintaining Ethics in Quality Improvement. AORN journal, 103, 139-141.

LYNN, J., BAILY, M. A., BOTTRELL, M., JENNINGS, B., LEVINE, R. J., DAVIDOFF, F., CASARETT, D., CORRIGAN, J., FOX, E. & WYNIA, M. K. 2007. The ethics of using quality improvement methods in health care. Annals of internal medicine, 146, 666-673.