The entity or person responsible for research has overarching responsibility for ensuring that the research is conducted in accordance with good research practice

In 2020, the Norwegian Board of Health Supervision conducted an audit which examined how institutions engaged in medical and health research manage and organise their activities. The audit was carried out as a self-assessment audit, in which 20 institutions participated. The institutions were asked to decide whether there was conformity between their own practices and the requirements of the Health Research Act and the associated regulations regarding selected checkpoints. A total of 512 research projects were reviewed and 22 breaches of the law reported.

Our principal impression from the audit is that medical and health research is largely being carried out in accordance with the provisions of the Health Research Act. The impression is that most project managers are aware of the statutory requirements and that most requirements are being complied with.

However, a number of institutions had inadequate systems (internal control) in place to ensure compliance with the provisions of the Health Research Act. Shortcomings were identified in several areas. Amongst other things, the audit’s findings included:

• Not all institutions responsible for research have systems in place to ensure that advance approval is obtained from the Regional Committees for Medical and Health Research Ethics (REC).
• Half of the research managers reported that they did not monitor projects to ensure that the conditions imposed by the RECs were being followed.
• A majority of the research managers reported that they did not monitor projects to ensure that written consent had been obtained.
• Almost half of the research managers responded that they did not monitor research projects to ensure that they were concluded in accordance with the applicable legislation.
• Too much of the responsibility for research projects being carried out in accordance with the regulations was left to the project manager/department/faculty, when this should have been followed up by the institution responsible for the research.

Although many responded that they were aware of the obligation to report in the Health Research Act, the responses showed that many research managers were confusing the obligation to report under Section 3-3 of the Specialist Health Service Act with the obligation to report under Section 23 of the Health Research Act.

The offences identified in the research projects primarily occurred in institutions with widespread shortcomings in the organisation and management of their health research. Most institutions responsible for research have provided an account of the measures that they will implement in order to reduce the number of offences and the other shortcomings that the audit revealed.

As a contribution to the quality and improvement work of the institutions concerned, the Norwegian Board of Health Supervision has made the self-assessment forms available to all health trusts and research institutions.