Main principles of ethics

There are three overriding principles of ethics that are often cited as being the

cornerstones of ethical behaviour in research; the minimisation of harm, (Holloway and Wheeler, 2013); informed consent (Goodwin 2006); confidentiality and anonymity (Webster et al., 2014). These concepts are further explored below.

4.6.2.1 Minimisation of harm

As noted, the basic tenet of research ethics is that the research should not cause harm to any participant and all harm should be minimised (non-maleficence) (Cunningham et al., 2013). When referring to harm it predominately applies to both physical and psychological harm, and in many ways it is minimised through the other two principles of ethics.

However, harm does not just relate to personal harm in a physical or psychological sense, but extends to other aspects of harm such as; reputational harm to a participant or other they have a personal relationship with; hardship caused such as loss of employment; the negative impact caused to the study or the researchers’ organisation or company (Traianou, 2014).

A further aspect of harm, is potential harm that may be caused to the researcher as a result of carrying out the study, and thus which they and their organisation need to be aware of (Webster et al., 2014). Mitigation against such potential harm to the researcher can be achieved through an awareness of factors such as; the place where the research is to be conducted e.g. is it safe for the researcher and whether the researcher has the skills to address possibly sensitive topics of discussion ensuring that professional boundaries are maintained (Holloway and Wheeler, 2013). There is clearly a need to protect the

researcher by providing support and training where difficult topics are to be addressed to minimise personal harm. One also needs to keep in mind the interests of the profession and the institution for whom the research is being carried out and ensure that no harm befalls them (Holloway and Wheeler, 2013).

Even with all factors taken into account it can be very difficult to avoid all harm, as some studies carry greater risk that others, for examples those in which the data to be collected is of a more sensitive nature or whereby participants are more vulnerable (Traianou, 2014). This is an indication as to why a clear assessment of harm is needed for all parties involved in a research study, so that appropriate steps are taken for it to be minimised. Such an

97 assessment will be carried out and all efforts will be made to ensure that no harm is caused to any participant or institution in this study.

4.6.2.2 Informed consent

Informed consent must underpin participation (Webster et al., 2014) for research to be ethical. Informed consent is the process whereby participants are provided with enough information about the study to allow them to make an informed decision as to whether they wish to participate (Fisher and Aushlio, 2008). Information is provided to the participant following which they decide if they wish to be a participant in the study. The process of informing the participant about the study must also be free from either deception by omission (withholding important facts from participants) or deception by commission (purposely lying to or misleading the participant), to allow them to make a decision (Cunningham et al., 2013). Following the provision of information, no form of coercion by either the researcher or any other person should take place as it is paramount that participation should be undertaken as an expression of free will (Holloway and Wheeler, 2013) (Stark and Hedgecoe, 2010).

As an illustration of a person’s acceptance to participate a consent form is usually signed. Whether a signature is needed is debatable as some state that agreement to consent does not always have to be written as long as there is verbal agreement which is recorded by the researcher (Stark and Hedgecoe, 2010, Traianou, 2014). Others regard signing the consent form as a positive, stating that it creates a contract compelling people to participate and making it less likely for them to withdraw (Webster et al., 2014). Yet, the expectation that someone will sign a form needs to be carefully considered as there are a number of reasons why this may not be appropriate; there may be a cultural reason not to sign, one cannot assume that all participants are literate, refusal to sign may be a way of asserting oneself, as well as not really understanding the reason or need to sign (Stark and Hedgecoe, 2010, Traianou, 2014).

In order for the study information, which underpins the process of informed consent, to be delivered appropriately a system for providing information and receiving consent in return needs to be in place (Holloway and Wheeler, 2013). The following are the main key points that need to be disclosed to participants as part of informed consent;

a) The purpose of the research, its aims, who is funding it, who is conducting the study, how and who to contact if the participant has any questions,

98 b) Participation is voluntary and participants have a right to leave at any time during the study without giving a reason,

c) What is expected of participants and whether there are any risks involved in taking part, d) Confidentiality, anonymity, data storage.

(Webster et al., 2014, Holloway and Wheeler, 2013, Stark and Hedgecoe, 2010).

This information is usually presented in a letter, to be read by participants but that can be read to them if necessary. Once the information has been relayed, an opportunity should be given for the participant to ask questions and for more information to be provided whether it be verbal or written. One may not automatically assume that the provision of information occurs just once as sometimes information needs to be given on more than one occasion, such as at different stages of a research project, to ensure that participants’ understanding of participation is maintained (Webster et al., 2014). The concept of when to provide such information is one that is debated as some say that the timing of the data provision can bias the study, for example with information for a focus group, it may be seen as directing the course of conversation (Stark and Hedgecoe, 2010).

In addition to the gaining of consent, thought and planning needs to be given to the possibility that someone may withdraw consent after data has been collected. If this was to occur then the data would need to be removed unless permission was given by the participant to retain any data given up to that point in time.

The above concepts will be used to shape the informed consent to be given to participants of this study, ensuring openness and transparency. Written consent will be requested for; participation in the focus groups, at more than one time point for each set of interviews (pre and post) and observation during the guideline development group.

4.6.2.3 Confidentiality and anonymity

Confidentiality and anonymity are two concepts that are central in maintaining ethical standards in all types of research. However, it is important to be clear about what each entails and to what level they can be maintained during research. Although confidentiality and anonymity are concepts that are associated with each other, they are not

interchangeable. Confidential pertains to the notion that information is “intended to be

99 unless with the permission of the participant (Wiles et al., 2008). Anonymity originates from the Greek work “anōnumos” meaning ‘nameless’ (Oxford Dictionary, 2017 ) and means just that, ‘not known’, which in the context of research, this means the identity of the participant remains unknown.

i) Confidentiality

Maintaining full confidentiality can be challenging, for example when using direct quotations in the documentation of findings (Traianou, 2014) (Wiles et al., 2008) and therefore some argue that full confidentiality can never be promised as it is unattainable (Holloway and Wheeler, 2013). However, there are various steps that can be taken to maintain confidentiality such as respecting the wishes of the participant, for example they may agree to being recorded but may request not to be quoted in text (Webster et al., 2014) and explaining exactly what will be reported and how. In addition, if data collection is taking place in a group context such as a focus group or observation then it needs to be made clear that participants must respect the confidentiality of each other (Webster et al., 2014, Traianou, 2014). Furthermore, all those who handle research data must maintain confidentiality (Wiles et al., 2008).

Although these practices can be put into place to uphold confidentiality, there are situations in which data does need to be disclosed, such as if the participant divulges that they are in danger or have committed a crime (Stark and Hedgecoe, 2010). Confidentiality also relates to how participants are accessed as it is often achieved through a third party or gatekeeper e.g through a lead consultant in a hospital (Webster et al., 2014). Therefore, maintaining confidentiality in such circumstances must be considered as the gatekeeper is in a position whereby they can identify who is participating (Traianou, 2014).

Confidentiality is not just about the way in which data is reported but also the way in which it is handled and stored. This is largely covered by legal and regulatory standards, in particular the Data Protection Act in the UK (1998) which addresses principles on handling and storage of data, the use of data, the transference of data and length of time for which data should be kept. Areas that are particularly relevant to research data are factors such as the importance of storing personal information that can be used to identify a person separately to recorded data (Wiles et al., 2008), storing data files in locked cabinets or if electronic ensuring files are encrypted / password protected and making sure when sharing data electronically appropriate precautions are taken such as using shared folders and not

100 emailing documents (Webster et al., 2014). In addition to the Data Protection Act (1998), organisations such as universities have their own regulations on how long information should be kept for and therefore it is important to adhere to the regulations of the organisation in which one works.

ii) Anonymity

Anonymity can be operationalized by ensuring that all identifiable characteristics are removed from the reporting of a study, information that does not impact on the study can be altered such as inventing a place name where the study took place and of course making the individual anonymous (Holloway and Galvin, 2017, Wiles et al., 2008). If any of these actions are taken then it must be documented and not altered to a point that accuracy of reporting is questioned (Traianou, 2014).

All aspects of confidentiality and anonymity as outlined here will be respected within this study. Maintaining anonymity will be of particular importance as the population of Malta is small and healthcare professionals of medical specialties are easily identifiable. Thus reporting will need to ensure that individuals can not be identified by not discussing individual healthcare professions.

4.6.2.4 Respecting ethics

Adherence to research ethics applies no matter where the research is being carried out and should not differ when working in a cross cultural environment. Whilst the ethics do not change, there may be a need for awareness of additional factors, as the concept of ethics in research and explaining its processes and principles is not necessarily a concept that has cross cultural applicability (Stark and Hedgecoe, 2010). Examples of where greater

consideration may be needed are in situations where; the concept of ethics does not exist; an assumption of the applicability of specific components of research ethics such as

autonomy cannot be made; it may not be usual for the individual to decide to participate or to provide consent as this may reside with another within the culture e.g. the head of a family, tribe or organisation (Traianou, 2014). Difficulties may then follow for example deciding the extent to which one should insist on gaining individual consent (Traianou, 2014) at a risk of undermining the cultural views of the population one wishes to engage with. When considering ethics in a cross cultural environment, the aspects of cultural sensitivity that have been previously outlined also apply, particularly a knowledge and understanding of the culture within which one wishes to work.

101 In application to this study it is imperative that all the ethical principles as outlined above are adhered to and that cultural norms are respected.