Roles and responsibilities in health research projects - health research - Kunnskapsbasen
Roles and responsibilities in health research projects - health research
Norsk versjon: Roller og ansvar i helseforskningsprosjekt - helseforskning
Also see: Guidelines for health research
Responsibilities and duties of the project manager, project owner and project team members in health research projects.
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 and associated 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 (REC) using
- Where required, the project manager must submit an application to other approval authorities for health research in addition to the REC.
- The project manager must involve the person or body 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.
- Before the project can start, the RR must assess the project and decide whether it is in line 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 must normally be based on documented consent from participants in health research.
- The project manager must ensure that the project is conducted according to the research protocol that the REC has approved.
- If substantial changes are made, the project manager must submit a new application to the REC. Substantial changes are defined in more detail in 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; see: Storage and release of data from health research
- 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 or body responsible for research and the Norwegian Board of Health Supervision (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 put the safety of research participants at risk. 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 get 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.
Person or body responsible for research - RR (“forskningsansvarlig”)
The person or body responsible for research (RR) has the overall responsibility for all research projects that take place at the organization. The duties and authority assigned to this role can be delegated.
- The RR must ensure that the internal control system is implemented and followed in practice.
- Before or after consideration by the REC (before the project starts), the RR must assess whether the project is consistent with the unit’s strategy and whether the necessary resources are available. See Evaluation by the person or body responsible for research
- The RR must .
- The RR must take steps to resolve non-conformances and must stop or rectify research that is medically, ethically or legally indefensible, or that is in conflict with the permission that has been granted.
- The RR must take systematic measures to promote good research and to ensure that research is planned, organized, conducted and completed in accordance with the Health Research Act and Regulations. The person or body responsible for research can ask the project manager for detailed information such as applications and change requests, protocols, information letters, consent forms, risk assessments, final reports and data storage.
- In the management communications with their line manager, must report on research activities at the unit, compliance with legislation and procedures, and the quality system used.
Project team member
Project team members include anyone who is involved in the project: researchers, PhD candidates and students. A student who does not have a doctoral degree must be a project team member and cannot be a project manager.
- Researchers at NTNU who work with medical and health-related projects must familiarize themselves with the applicable to their research and must follow the procedures specified in this system.
- Researchers must conduct the project in accordance with good scientific practice and the research protocol that has been approved in advance for the project.
- Researchers have a duty of confidentiality and must take steps to prevent other parties (including researchers outside the project and health professionals) from obtaining access to or knowledge of data unless there is a legal basis for disclosing the information.
- Researchers must report serious as well as adverse or unexpected medical events immediately to the project manager or the person or body responsible for the research. The same applies to research that they regard as medically, ethically or legally improper or in violation of the permission granted and the professional requirements of the research.
- Researchers must provide the supervisory authorities — the Norwegian Board of Health Supervision (Statens helsetilsyn) and / or the Norwegian Data Inspectorate (Datatilsynet) — with information on factors that may put the safety of research participants at risk. The researcher must also inform the project manager or the person/body responsible for research. The police must be notified in the event of death from unnatural causes.
- Research results must be published in accordance with good scientific practice, including the criteria for authorship recommended in the Vancouver Convention.
Division of responsibility in collaborative projects
Collaborative projects between NTNU and St. Olav’s Hospital
In projects where
- patient data are involved in the study and
- the project manager has a combined position at NTNU and St. Olav’s Hospital or
- the project is conducted with project team members from both NTNU and St. Olav’s Hospital
both institutions must be responsible for the research (“forskningsansvarlig”) for the project and must state this in the application to the regional committee for medical and health research ethics (REC).
At St. Olav’s Hospital, the head of the clinical division is responsible for research. At the Faculty of Medicine and Health Sciences (MH) and the Faculty of Social and Educational Sciences (SU), the head of department is responsible for research. The persons or bodies responsible for the research are jointly and severally liable (share the legal responsibility).
The institutions jointly designate a project manager. The project manager and the institution where they are employed have formal responsibility for the application and research protocol to the REC. The application must identify the collaborating partners, the persons or bodies responsible for the research, and the project team members. The project manager must inform both institutions about the project progress and developments, and must report any changes, non-conformances and adverse events.
A multi-centre study is a research project based on one research protocol, but where the project is conducted at several organizations. Authority and duties in such studies must be clarified before the project begins.
Each participating centre has an independent responsibility for the part of the project that takes place at its unit. Before the study starts, it must therefore be reported to the person or body responsible for research at each participating institution.
There must be one project manager with responsibility for the day-to-day operations of the whole project. International multi-centre studies must always have a Norwegian project manager who is responsible for the parts of the project that take place in Norway.