Duties of the project manager
The project manager must ensure that ethical, medical, health, scientific, privacy and information security issues are addressed in the day-to-day operations. These aspects include planning, pre-approval, implementation and completion with publication of research results and subsequent management of research data. The project manager must have sufficient scientific expertise. Where required by the nature of the research project, the project manager must also have necessary and relevant clinical experience and expertise, or ensure that such expertise is associated with the research team.
- The project manager must ensure that an application and a research protocol (PDF) are prepared in accordance with good scientific practice and the requirements of the Health Research Act (English translation: http://www.ub.uio.no/ujur/ulovdata/lov-20080620-044-eng.pdf) with regulations.
- The project manager is responsible for safeguarding the health, welfare, dignity and privacy of the research participants. During the planning of the research project, a thorough assessment must be carried out to determine the risks and burdens for participants, and the need for the project. The risks and burdens must be proportional to the expected benefits for the participant personally or for other people. Children as well as people who lack competence to give their consent and who cannot themselves expect health benefits as a result of their participation may only be subjected to insignificant risk; see Section 22 and Section 18.
- The project manager must ensure that the application and protocol are submitted to the regional committee for medical and health research ethics (REK) using REK's portal for applications (in norwegian)
- The project manager must submit applications to other agencies in addition to REK where this is required.
- The project manager must involve the person/entity responsible for research (RR, "forskningsansvarlig") in the project. The project manager must present the application and protocol in connection with spot checks carried out by the RR, and otherwise at the RR's request.
- The project cannot be started until the RR has considered whether the project is consistent with the unit's strategy and whether the necessary resources are available.
- The project manager has a duty to provide information to participants in the research project. Participation in research projects should normally be based on documented consent from the participants.
- The project manager must ensure that the project is conducted according to the research protocol that REK has approved.
- If substantial changes are made, the project manager must submit a new application to REK. Substantial changes are defined in more detail in the Health Research Act (English translation: http://www.ub.uio.no/ujur/ulovdata/lov-20080620-044-eng.pdf). New consent must normally be obtained if substantial changes are made; see Section 15 of the Act.
- The project manager must have access to all research data included in the project, and is responsible for the data that the project collects and uses. The project manager assigns access to the data and keeps track of who has access to the data. The project manager must inform project team members about their duty of confidentiality.
- The project manager must ensure that research data are handled appropriately, both during the project period and in storage after completion of the project.
- The project manager must immediately stop or rectify research that is medically, ethically or legally improper or in violation of the permission granted and the other requirements of the research; see handling of non-conformances. The research project must also be stopped if there is adequate evidence of positive and beneficial results for the participants, so that all participants can be offered the best treatment that has been documented.
- The project manager must notify the person/entity responsible for research and the Norwegian Board of Health (Statens helsetilsyn) of serious as well as adverse and unexpected medical events. If research participants have sustained injuries or if complications have arisen because of the research project, the participants must be informed immediately.
- The project manager must provide the supervisory authorities with information about situations that might jeopardize the safety of the research participants. The police must be notified immediately in the event of death from unnatural causes.
- The project manager must ensure that research participants who request information about themselves receive access to the information. The requests must be dealt with on an ongoing basis, and answered within 30 days.
- The project manager must ensure that research results are published in accordance with good scientific practice, and must comply with the rules for authorship stated in the Vancouver Convention.