The national bioethics committee (VSN) and the ethics committees for health research supervise the scientific research in the field of health that they authorize.

The Icelandic Medicines Agency (IMA) supervises clinical drug trials according to the Medicines Act and also the clinical testing of medical devices according to the Medical Devices Act.

Personal data protection authority supervises the processing of personal data in scientific research.

The national bioethics committee and the ethical committee for health research shall monitor the conduct of studies which they have approved. The responsible researchers are obliged to provide them with the necessary data.

If the ethics committee considers that the conduct of a study is not in accordance with the submitted research plan and data or that it no longer complies with the laws and regulations on scientific research in the field of health, the ethics committee shall make recommendations for improvement to the responsible person. If the recommendations for improvement are not met or there is a serious breach, the ethics committee may revoke the authorization for the study. If the authorization is revoked, the study shall be discontinued immediately.

The investigator and others who are involved in the conduct of an investigation shall grant supervisors access to the premises of the operation and shall, despite the obligation of confidentiality, provide them with all information and documents they consider necessary to carry out their supervisory duties under Act No. 44/2014. Supervisors and those acting in their behalf are bound by the obligation of confidentiality under Article 6.

The national bioethics committee takes the following approaches to this provision:

• In case of a malignant event or unexpected event in clinical pharmaceutical studies, prompt action and information is sought from investigators according to the conditions for authorization for such studies.

• If the national bioethics committee is aware of deviations from the approved research plan, the committee may order the definitive or temporary suspension of the research.

• Comments from the participants and the public are answered.

A notice of investigation's termination and a summary of the investigation results is always requested. When a notice of investigation's termination is received, the ethics committee's authorization for the investigation is cancelled by letter to the responsible person.

• Five years after the study program has been approved, the Secretariat of the national bioethics committee examines the study in a letter to the responsible person.

• Responses to the Committee's comments on the applicants application are processed 3-6 months after they were sent. Two letter of injunctions are sent.

• If no answers are received, the investigation is considered to have been discontinued and the case closed.

Ethical committees under Act No. 44/2014 supervise scientific research in the health field and monitor the implementation of studies that they have approved.

The ethics committees may remind investigating bodies if the committee concludes that the conduct of an investigation was in breach according to the data submitted as the basis for the authorisation, without giving rise to the withdrawal of the authorisation.

It carries a fine or imprisonment of up to three years, if the higher penalty is not for an offence under other laws, to infringe the following provisions of laws nr. 44/2014 and where applicable, rules established on the basis of them:

1. Articles 6 and 32 on confidentiality.

2. Article 7 on the preservation of health data.

3. Article 12 on the authorisation of scientific research in the field of health by the scientific ethics committee or the ethics committee for health research.

4. Article 17 on the obligation to report unexpected events.

5. Chapter V on the approval of scientific research in humans.

6. Article 20 on changes to the research programme.

7. Article 31 on the obligation to provide information, data and access to premises to the supervisors.

It also carries the same punishment if people do not stop an investigation when the national bioethics committee or the ethics committee for health research has revoked the authorization for a scientific study, see Article 29(5).

Participation in an offence is punishable according to the general penal law unless a heavier punishment is available under other laws.

Now there is a violation in the operation of a legal entity, and the legal entity can then be fined according to the provisions of II. section A of the General Penal Code.