Responsibility for research
The entity responsible for the research needs to make sure that no research subject to the Ethical Review Act is carried out without an approval.
Entity responsible for research (Forskningshuvudman)
The entity responsible for research is the natural or legal person in whose activities the research is carried out, such as a higher education institution, municipality, region, government agency or private enterprise.
Once a research project has begun within the activities of such an entity, it means that the entity is participating in the project. This circumstance is crucial for whether an entity responsible should be listed as a participating entity in an ethics review application. If data and samples are collected within the framework of a healthcare provider’s work but analyses and further processing are intended to take place within the framework of a higher education institution’s activities, for example, this indicates that there are two entities responsible for the research. However, this is an assessment the entities concerned must make. The Swedish Ethical Review Authority can and may not issue an advance notification regarding the question of how many entities responsible for the research will be participating in a particular study.
It is the entity responsible for the research that bear ultimate responsibility for the research conducted and that must apply for ethical review. The entity responsible for the research must also ensure that applications are complete. The entity responsible for the research needs to make sure that no research subject to the Act is carried out without an approval. It must take measures to prevent this from happening as well as to prevent research from taking place in breach of conditions given in connection with the approval.
The entity’s responsibility is organisational: a matter of implementing necessary measures within their own organisation. These measures include, for example, ensuring the existence of proper information, monitoring and inspection routines concerning issues of ethical review within their own organisation. The entity responsible for research must also ensure that researchers receive the necessary training about the Ethical Review Act and its requirements.
When several entities responsible are participating in a single research project, they must jointly task one of them to apply for an ethical review of the project on behalf of them all, and to inform the others of the Ethical Review Authority’s decision. The entity tasked is listed as being in charge, while the others are classified as “other entities participating in the project”. Every entity is in charge of the part of the research project that is implemented within its own activities.
Authorised representative (Behörig företrädare)
Examples of authorised representatives of entities responsible for research are the head of a department or unit and an operations manager. The entity itself decides, through internal work or delegation arrangements, or by power of attorney, who to authorise to represent the entity.
An application for ethical review must be signed by an authorised representative of the entity responsible for the research and by the principal investigator.
Principal investigator (Ansvarig forskare)
The principal investigator (PI) bears overall responsibility for the research and is the point of contact towards the Swedish Ethical Review Authority and must also be the person to whom the research participants can subsequently address their queries. The PI must normally have sufficient research expertise and ensures that other investigators taking part in the project also have the requisite skills (scientific and clinical). There is only one PI responsible for the whole project, even when several entities participate. The entity submitting the application is often linked to the person that will be the PI and subsequently the point of contact for the project.
The main principle is that the PI must have a PhD in a relevant subject area. This rule is required primarily because the Swedish Ethical Review Authority needs to be sure that the PI’s expertise is adequate in order to protect the research participants. The PI’s CV must therefore be submitted. However, a PhD is not a legal requirement.
Those without a doctorate degree can be allowed to be principal investigators in a project if they provide evidence that they have sufficient experience and expertise, and the conditions regarding the project are such that this is deemed acceptable.
Even a person lacking adequate expertise can be a PI. There must then be someone else with the requisite skills to actively supervise the research. In this case, that researcher’s skills must also be reviewed and his or her CV must be submitted with the application.