The Health Research Act authorises the Norwegian Board of Health Supervision to monitor medical and health research as well as the management of research biobanks. In 2012, this inspectorate therefore undertook an assessment of the vulnerability involved in such research (11). The report by the Norwegian Board of Health Supervision states, inter alia: «The risk assessment did not reveal any major risk that research participants could be inflicted with serious physical harm in Norway. The risk is to a greater degree associated with inappropriate management of health information and biological material, with consequent violations of the research participant’s integrity.»
In the period from October 2010 to December 2012, the department received 17 requests for provision of diagnostic biobank material for research projects. In five cases, required project documentation was missing. In five of the 12 remaining cases, significant errors or omissions were detected, and one further project had undergone so many changes that no real assessment was possible. In none of these cases did the project manager or the ethics committee address the issue of how to handle new findings of possible clinical significance emerging as a result of a re-investigation or a new examination of the diagnostic material. For example, if new sections are taken from paraffin blocks in which severe dysplasia was detected in the initial diagnostic examination, invasive cancer may be detected. In our opinion, such issues must be addressed in a transparent and predictable manner, thus to safeguard the interests of the project participants (10). The project manager should explicitly discuss this issue in the project protocol and the application form to the ethics committee. The committee should similarly address this issue in their decisions.
Quality improvement is a continuous process, in which systematic evaluations should entail adjustments of procedures as required. In addition to formal administrative measures, the first revision included information efforts targeting the department’s consultants, since many of them maintain contact with internal as well as external research groups. During the second revision, a stronger focus was placed on routines associated with prospective retrieval of tissue for research purposes. As regards the administrative management of tissue requests, the biobank coordinator has seen it as an advantage that the routines have been included in an internal quality assessment system which has been approved by the head of department. In situations involving occasional vehement exchanges of opinion with researchers who strongly object to what they regard as interference in their projects, it was opportune to be able to refer to the internal quality assurance system. In our experience, very few project managers contacted the pathology departments from which they planned to acquire their material before elaborating the project protocol and submitting it to the regional ethics committee.
In cases where the project manager receives feedback indicating a need for changes regarding the collection and use of the biological material, a project protocol amendment must occasionally be submitted to the regional ethics committee. In the second revision of the internal quality assurance system, attention was therefore paid to guiding project managers at the planning stage, to ensure that the protocol describing the collection and use of diagnostic material will be realistic and comply with the department’s operational routines.
The establishment of the internal quality assurance system described above has been resource-intensive and occasionally conflict-ridden. In our opinion, however, such an establishment has been organisationally necessary. The quality assurance system has raised the quality of the department’s routines, and has also introduced more predictability in the department’s requirements to requests for tissue. We also believe that at least in some cases, project managers have received feedback that has helped improve the quality of the projects.