The PhD study underpinning this thesis was funded by the Ministry of Education and Research in Norway and conducted with the approval of the Norwegian Social Science Data Services (Project No. 27543, see appendix 1).
The study did not involve patients, patient information or next-of-kin and was therefore not obliged to seek approval from the Regional Committees for Medical and Health Research Ethics. Ethical considerations related to information and consent-seeking activities needed to be taken for the individual research participants, hospitals and the certification body involved in the study.
These activities are described in more detail in sections 4.4. A data processing agreement under the Personal Data Act was signed with the company transcribing research interviews. To ensure ethical expectations for this thesis,
Methodology
In the following I present some of the ethical dilemmas that needed special attention.
4.7.1 Entering the empirical field - dilemmas
Matters of concern involved in all entries into the field are the negotiation with gatekeepers and physically entering the field [188]. The first ethical dilemma was to balance strategic negotiations with protecting the integrity of the study, when interacting with those controlling the entry to the certification body and hospitals. For me this involved establishing trust and rapport with the organizations involved (see also section 4.6.1 credibility). I therefore met with representatives of the hospital in case 1 and of the certification body in case 2 several weeks in advance of data collection. In these meetings I presented the objectives and relevance of the study, we discussed possibilities for data collection and how information and results would be treated, protected and reported. I obtained signed written agreements from all organizations involved in data collection (see appendix 2 for an example). The certification body claimed the right to read my work and if necessary, remove business-sensitive information before I published it. They also claimed the right to remove specific statements from informants if these were not in agreement with what the informants had tried to express, or if statements were not in agreement with the certification body’s policy. After consultation with my supervisor I accepted these terms. This is a commercial industry that has been difficult for researchers to get access to. In dialogue with the certification body it became clear that any conclusions made by this thesis should be attributed to the researchers.
Two ethical dilemmas needed special attention during my observations in the hospitals. The first arose from my presence in certification auditing meetings with hospital personnel. The auditors had been informed and had given their consent in advance of observation. The dilemma was how to ensure that all meeting participants knew about my presence as a researcher, that they consented to my presence and were confident that the confidentiality of whatever they discussed during the audit meetings would be protected (See chapter 4.4.2).
The second dilemma was how to be present in hospitals but not in clinical settings where patients were being treated. The audit activities observed did not
Methodology
allow auditors to observe clinical practices. All transfers and walk-arounds in the hospital took place in corridors and rooms reserved for personnel and visitors. I did not enter clinical settings where patients were being treated. In one hospital I sign a declaration of confidentiality before doing observations.
4.7.2 Research participants - Proper information, voluntary participation and confidentiality
Research within organizations with limited participants raised two central dilemmas. The first was to safeguard confidentiality internally in the organization while reporting findings. The second dilemma was to ensure voluntary participation while using managers to recruit participants. I needed to ensure that participants were properly informed about the study and their voluntary participation before, during and after data collection. Another strategy to strengthen informed voluntary participation was to let all informants read a late draft of articles I and II. One quote was removed from the manuscript in response to concerns from informants. The interpretations of the findings in the manuscript were not affected.
Special considerations were taken for case unit 1 (article II) where only three participants (lead auditors) were observed and interviewed. The auditors risked having their conduct during the audit revealed to their employer when the research was published. To ensure that they saw how they were represented in the results and had the option of withdrawing from the study, each auditor was allowed to review a late draft of the manuscript that showed the results only from their own contribution. Only after all the auditors had given their response, was the full manuscript sent to the certification body.
Findings
5 Findings
To fill the knowledge gaps related to certification in health care, this thesis develops knowledge about external drivers and internal processes in hospitals certification, the scope, understanding and practice of certification processes and the possible contributions to performance improvement from certification processes in hospitals. I therefore explored ISO 9001 certification processes from the perspectives of a hospital, a certification body, and the international standards and guidances. Table 3 demonstrates how the three articles contribute to the aim of the thesis.
Table 3: The connection between the thesis’s articles, the empirical perspectives to ISO 9001 certification processes and the elements in the aim of the thesis. The parentheses represent a weak or an indirect connection to the theme in the aim.
Elements in the aim Contributing articles
- (Certification body – auditors) Scope, understanding
and practice of certification processes
II, III (and I) - Certification body – managers and auditors
- International standards and guidances
- (Emergency department in a hospital)
Possible contributions to performance
improvement from certification processes
III (I and II) - Certification body – managers and auditors
- International standards and guidances
- (Emergency department in a hospital)
This chapter describes what research questions are addressed in each article, summarizes the findings, and discusses the articles’ relationship and connection to the aim of the study.
Findings