Research environment grant for follow-up studies of COVID-19 vaccines

The following requirements must be fulfilled in order for you to be eligible to apply for the grant. We carry out checks and reject applications that do not fulfil the requirements.

Focus

The research shall be clinically based and assumes access to healthcare structures and resources. National collaboration is a requirement, and the main part of the research in the application shall be conducted in Sweden.

Central questions for health and medical care include the protective effect and safety of approved COVID-19 vaccines in the long and short term, for example for different age, risk and patient groups, for persons who have had COVID-19 with or without measureable antibodies, for persons previously treated in intensive care for COVID-19, or for the general population.

The questions for health and medical care also include how outcomes have been affected by different strategies and approaches for the vaccination, and whether there are specific safety profiles for different vaccines in differing risk, patient or age groups. The Swedish Medical Products Agency’s website External link, opens in new window. has information of the follow-up studies planned by the Medical Products Agency.

Those who are awarded grants are expected to contribute to the build-up of infrastructure for follow-up studies. The infrastructure shall primarily be based on existing local and regional structures, as far as possible be made available nationally, and shall in the future be possible to use to conduct other follow-up/phase IV studies, or other clinical studies.

The infrastructure may include tools, processes, sample collections or databases enabling follow-up studies of COVID-19 vaccines. It may relate to digital consent formats, processes for sample collection, structured collection of samples or personal data/health data from primary healthcare, specific biobanks, or development of functions to support research in quality registers.

Applicant

The applicant for a research environment grant for follow-up studies of COVID-19 vaccine shall be an individual researcher. You shall be the project leader and have scientific responsibility for the project. The time you set aside for the project (your activity level, that is the percentage of a full-time equivalent) must be suited to the task and its implementation throughout the grant period.

You must hold a Swedish doctoral degree or an equivalent foreign degree, awarded no later than the deadline for this call. The degree award date we use is the date you fulfilled all the requirements for a doctoral degree, such as mandatory courses, oral defence and an approved doctoral thesis. For applicants with Swedish doctoral degrees, the award date listed in Ladok applies.

You must hold a clinical position in Sweden at the time of application and throughout the grant period, that is be employed and carry out clinical work. The scope of this employment must correspond to a minimum of 20 per cent of a full-time equivalent. You must describe the clinical work in your application (see instructions under “Clinical position” below).

Grants from the Swedish Research Council shall be administered by a Swedish higher education institution (HEI) or another Swedish organisation that fulfils our criteria for administrating organisations Opens in new window.. Your organisation must therefore be approved as an administrating organisation for you to apply. The administrating organisation must sign your application in Prisma no later than 7 calendar days after the deadline for this call.

If you are awarded a grant, you must be employed by the administrating organisation at the start of and throughout the grant period and any additional availability period, unless the Swedish Research Council approves an exception from this requirement. The employment must equal at least 20 per cent of a full-time equivalent. You do not have to be employed by the administrating organisation at the time of applying.

Number of applications and previous grants

The requirements described in this section only apply to applicants (project leaders).

General information about overlaps between applications and grants

Your application must not cover costs for purposes that are already funded by the Swedish Research Council or any other funding body. Overlaps with other grants may impact on the grant amount you are awarded, or be a reason for us to reject your application.

What grants may I apply for simultaneously from the Swedish Research Council?

You may only submit one application for this grant under this call. However, you may participate in other applications. Please note also that if you are applying for other grants from the Swedish Research Council during 2021, including another grant for a research environment or a grant under the distinguished professor programme, you are also eligible to apply. Your application must then clearly explain how the various applications relate to each other, and how you will be able to carry out all your research undertakings. We will consider your joint resource requirement, which may impact on the amount of funding you are awarded.

What requirements apply if I already have a grant from the Swedish Research Council?

If you are a project leader for an ongoing grant, including another grant for a research environment or a grant under the Swedish Research Council’s distinguished professor programme, you are also eligible to apply. Your application must then clearly explain how the various grants/applications relate to each other, and how you will be able to carry out all your research undertakings according to plan. We will consider your joint resource requirement, which may impact on the amount of funding you are awarded.

Note: If you have been the project leader for previous grants from the Swedish Research Council that have ended, a final financial statement for all of these must have been submitted within the permitted time frame in order for you to apply for a new grant. Please contact your administrating organisation if you are unsure whether all your final reports have been submitted.

What applies for applications to or grants from other funding bodies?

If your application to the Swedish Research Council relates to the same project idea as a grant you have already been awarded by, or are applying for to another funding body, please describe this.

Participating researchers

You must include a minimum of 3 and maximum of 10 participating researchers in your application. Participating researchers are other researchers with a doctoral degree or equivalent competence, whose scientific competence will be crucial for the implementation of the planned research. They do not have to be employed by a Swedish HEI.

Participating researchers shall provide the necessary information themselves in Prisma, and upload these to the application. Any further collaborating partners and their roles shall be described in the research plan (please see instructions under “Research plan” below).

Costs and grant amounts

You can apply for a grant for all types of project-related costs (including costs for build-up of infrastructure relevant for the call), such as:

• salaries (including your own salary), however no more than corresponding to the person’s activity level in the project
• premises
• running costs (such as consumables, travel including stays at research facilities, publication costs and minor equipment)
• depreciation costs

Grants must not be used for scholarships. If a doctoral student participates, project funds may not be paid out as salary during teaching or other departmental duties.

The minimum amount you may apply for is 10 000 000 SEK, including indirect costs. The maximum amount you may apply for is 25 000 000 SEK.

The Swedish Research Council assumes that the administrating organisation will cover any costs in excess of the amount received.

Grant period

You can apply for a grant for a minimum of 3 years and a maximum of 4 years, starting in June 2021. The first payment will be made during June 2021 at the earliest. The entire grant amount will be paid during 2021.

National collaboration

National collaboration is a requirement for applications for this grant. National collaboration entails collaboration between a number of Swedish regions, and may include universities. This collaboration is important to ensure the study and its results produce impact. The requirement for national collaboration may be fulfilled either through active patient recruitment in several regions, or through collaborators in several regions (for example if patient recruitment is not done actively). The collaboration shall be based on an actual need for interaction. The need may, for example, consist of ensuring sufficiently large patient numbers. Other needs for collaboration may relate to access to high-quality data sources or equipment.

The collaboration must include a minimum of 4 regions, unless there are special reasons why this requirement cannot be fulfilled. If the requirement for at least 4 regions cannot be fulfilled, you must justify this in the application, and this justification will be weighted into the assessment of whether the application fulfils the requirement for national collaboration.

Reporting and follow-up

If you are awarded a grant, you must submit a follow-up report to the Swedish Research Council no later than 31 January 2022. The purpose of the follow-up is to ensure that the project is running as planned, for example that the time plan is kept to, that patients are recruited at the expected rate, and that the quality of the data material is sufficiently high. The Swedish Research Council will also request information to ensure ethical approval has been given for the planned study.

Please refer to the application form in Prisma in parallel with reading the instructions below, which describe the call-specific content of the application. More information on what to do in practical terms is available in our Guide for applicants Opens in new window..

Language

Foreign experts are involved in the scientific assessment of the applications. To ensure fair and equitable assessment and efficient processing, please therefore complete your application in English.

Sections of the application

The application form includes the following tabs:

• Descriptive information
• Research description
• Call-specific information
• Budget and research resources
• Publications
• Administrating organisation
• Participants
• CV

The information we request under each tab is described below.

Descriptive information

Abstract

In the abstract, please describe in brief the following:

• what is to be done: purpose and aims
• how the research problem is to be studied in a summary project design, including patient sample, choice of variables, data collection and analysis methods, plus time plan
• what is important about the planned research.

The abstract shall provide a summary picture of the purpose and implementation of the research. Please use wording to ensure persons with another subject specialisation can understand the information.

The description may cover a maximum of 1 500 characters including blank spaces. This is approximately one third of an A4 page in Arial, font size 11, single line spacing.

Popular science description

Describe the project in such a way that a person who is not a researcher can understand it. Do this by answering the following questions:

• What is the project about?
• Why is it important to research this?
• In what way may the new knowledge be important?

The text must be in Swedish and cover a maximum of 2 000 characters including blank spaces. This is approximately one half of an A4 page in Arial, font size 11, single line spacing. The popular science description is important when we inform about the research funded by the Swedish Research Council.

Research description

Ethical considerations

Describe the ethical issues raised by your project or corresponding. You must also describe how you plan to address ethical dilemmas that may arise. Please justify why the research should be carried out against the background of the ethical issues you have identified. How do your research questions and expected results measure up in relation to the ethical issues? Please also state whether the research involves any handling of personal data, or experiments on animals or human subjects. If no ethical issues are raised, please justify this.

The justification may cover a maximum of 4 000 characters including blank spaces. This is approximately one A4 page in Arial, font size 11, single line spacing.

Sex and gender perspectives

Please state whether sex and gender perspectives are applicable in your planned research, and justify your decision. Please note that we are not asking for information about the composition of the research team (men/women). Read more about sex and gender perspectives in research content Opens in new window..

The following applies:

• If you answer “Yes”: Justify your answer, and describe also how you take account of sex and gender perspectives in the research plan (see further instructions under “Research plan”). If you have stated that sex and gender perspectives are applicable, but still choose not to include them in your research plan, you will need to justify this here.
• If you answer “No”: Please justify your answer.

The justification may cover a maximum of 4 000 characters including blank spaces. This is approximately one A4 page in Arial, font size 11, single line spacing.

Research plan

The research plan shall be forward-looking and consist of a brief but complete description of the research task. It shall cover a maximum of 4 page-numbered A4 pages in Arial, font size 11, single line spacing and 2.5 cm margins, including references and any images.

The research plan must include the following headings and information, listed in the following order:

• Purpose and aims: State the overall purpose and specific aims of the research project, and provide brief background information and justification for the project.
• Study design: Describe the design of each sub-study/question and justify why the proposed study design is the most suitable one for answering the question.

For cohort/observation studies, any confounders shall be identified and the treatment of these described. For longitudinal studies, the choice of repeat follow-up occasions shall be justified.

Equally detailed description of the data collection shall be provided for register-based studies when patient data is collected from one or several different registers. All outcomes shall be stated. For subjectively-based outcomes, such as PROMs (patient reported outcome measures), it is not sufficient to state the name of the questionnaires. It is important to take into account the fact that register data for the same outcome may have been registered using different types of measuring instruments/assessment forms, which result in non-comparable data.

The study design must include the following information under separate headings, listed in the following order:

• Research questions: Structure the purpose of the research into questions. Define the outcome variable.
• Material: Study population, sample: Define the characteristics of the study population, and state inclusion and exclusion criteria for selection of the research participants in the study/sub-studies. Describe also how the participating clinics/regions contribute to the patient selection.
• Estimated sample size and power, and statistical methods: State the power of the study for the planned sample size. The distribution of study patients at the collaboration clinics/regions shall be taken into account when choosing sample size. Describe the statistical analysis plan.
• Time plan: Describe briefly the time plan for the study in relation to the national vaccination programme.
• References: Include references, but limit them to maximum 1/2 A4 page.
• Project organisation: Describe the project organisation and the participating clinics/hospitals/regions. Clarify the contributions of yourself and any other researchers and/or key persons to the implementation of the project, including a description of competences and roles in the project. Explain in particular how the time allocated by you (that is, your activity level) as project leader is suitable for the task, including the relationship with your other research undertakings.

Provide the following information also. If a heading is not relevant to your application, please state this under the heading.

• Contribution to research infrastructure: Describe the infrastructure the project intends to construct, plus a management plan. Describe also how the infrastructure will be made available nationally.
• Other applications or grants: If you are applying for or intend to apply for other grants from the Swedish Research Council, please clarify the relationship between the projects. This applies also if you are receiving ongoing grants from the Swedish Research Council with grant periods that wholly or partly overlap with the grant you are now applying for. You should also justify why you are submitting one or several further applications. Describe also the relationship with other applications to or grants from other funding bodies for the same project idea (from you or another researcher).

Call-specific information

National collaboration

State which Swedish regions and other researchers will be collaborating on the project. Describe the positive effects the collaboration may lead to. These may relate to factors such as ensuring a sufficiently large patient sample, access to high-quality data sources, equipment or specialist competency within several disciplines.

If the requirement for at least 4 collaborating regions is not fulfilled, please justify this.

The description may cover a maximum of 1 500 characters including blank spaces. This is approximately one third of an A4 page in Arial, font size 11, single line spacing.

State the number of Swedish regions that are contributing to patient recruitment and the names of the participating Swedish regions in the separate text fields in the application form. Please make sure the number of regions corresponds to the number of names selected for participating regions.

Clinical work

Confirm that you are working clinically, and describe how you fulfil the requirement for clinical work in Sweden (see under the heading “Requirements for applicants”) and what your clinical work involves.

The description may cover a maximum of 750 characters including blank spaces in Arial, font size 11.

Budget and research resources

Project personnel

State the activity level (per cent of a full-time equivalent) of all personnel active within the project, that is to say yourself, any other researchers and other personnel. Please also state the salary you are applying for, for yourself and/or other personnel active within the project, both as a percentage of a full-time salary and as actual annual amounts (including social security contributions). Please state the amounts in Swedish krona, rounded to the nearest 1 000 SEK.

Other costs

Describe any other costs of the project (premises costs, running costs and depreciation costs). Please state the amounts in Swedish krona, rounded to the nearest 1 000 SEK.

You may include depreciation costs for equipment to be used in the project, provided that:

• the equipment has an economic life of at least three years
• the equipment has an acquisition value above a certain amount
• the need cannot be satisfied through use of national or international infrastructure supported by the Swedish Research Council and thereby open to all.

You may only include the proportion of depreciation costs that corresponds to the use of the equipment in the proposed project, and you may not include depreciation costs for equipment that is wholly funded by other grants. Please contact your administrating organisation for information about what is included in local research infrastructure, acquisition values or how to calculate depreciation costs.

Total cost of the project

Prisma will automatically add up your budget items in a table. The total amount you are applying for shall also include indirect costs. You will have to add these to the table yourself. Here you can also add any additional costs that the project entails (for which you are not seeking funding under this call).

Please contact your administrating organisation if you have any questions about what constitutes indirect and direct costs.

Justification of the budget applied for

Justify briefly each cost applied for in your budget. The description may cover a maximum of 4 000 characters including blank spaces. This is approximately one A4 page in Arial, font size 11, single line spacing.

Other funding

Please state your or any other researcher’s funding for the project over and above what is applied for in this application. Please state the amounts in Swedish krona, rounded to the nearest 1 000 SEK.

Publications

All (applicant’s and participating researchers’) publication lists

Attach the applicant’s and all participating researchers’ publication lists joined up into one file. The list for each researcher shall include the 10 publications that are the most relevant to the research described, and shall cover a maximum of 1 A4 page in Arial, font size 11, single line spacing and 2.5 cm margins. The name of the researcher in question shall be highlighted in bold and also be included in the page header of each list.

Please only include articles or equivalent that are published or accepted for publication at the time of applying. The author name order shall be identical to that of the published work. The application cannot be supplemented with publications after the deadline for the call.

The publications shall be of the types: Peer-reviewed original articles, conference contributions, edited volumes, research review articles, books and book chapters, and other publications including popular science books/presentations.

Administrating organisation

Please state the administrating organisation and project site.

Participants

Under this tab, you shall invite the participating researchers and any participating administrators to your application.

CV

Under this tab, please upload your relevant CV information from your personal account in Prisma. Participating researchers must upload their own CV information to the application.

The following information (where available) must always be included in each CV:

• Education: First, second and third cycle higher education and specialist degrees.
• Work: Current employment (including employment form) and longer relevant employment held, postdoctoral visits (also included as employment if relevant), research exchanges relevant to the research described and any longer interruptions in the research that have impacted on your opportunity to gain merit as a researcher.
• Merits and awards: Docentship/associate professorship, supervisees (postdoctoral and doctoral students; state the number of persons in each category and list the names of the up to 10 most relevant to you), up to 10 of your most relevant grants awarded in competition, up to 10 of your most relevant prizes and awards, and up to 20 other merits relevant to the application.
• Intellectual property rights: For example, patents and open access computer programs developed by you; state up to 10 of your most relevant.

Scientific quality is the fundamental criterion when the Swedish Research Council allocates grants to research. Your application is evaluated in competition with the other applications on the basis of the following evaluation criteria.

Evaluation process

Your application within Research environment grant for follow-up studies of COVID-19 vaccines is evaluated by a review panel where the members are Swedish and international researchers with expertise within the area of the call. External reviewers may be used.

At least three reviewers assess and grade your application individually. Next, an overarching panel meets to discuss and prioritise the applications on basis of the needs of health and medical care and finally makes a proposal for a decision to the Director General.

Review panel Opens in new window.

Following the grant decision your application will receive an individual final statement containing the grades and a summary of the review panel’s overall assessment of the scientific quality of the application.

Here you will find a more comprehensive description of the Swedish Research Council's assessment of applications Opens in new window..

Evaluation criteria and guiding questions

The evaluation of the scientific quality of your application is made based on two criteria (Relevance for the call and Feasibility). Both criteria are assessed on a three-grade scale.

For each criterion, there are guiding questions to support the panel members’ evaluation of your application. These can also function as guidance for you when you write your application.

Relevance for the call (1–3)

1 = Not relevant, 2 = Relevant, 3 = Very relevant

Guiding questions:

• Does the project address any knowledge gap in the effects and/or safety of covid-19 vaccines identified by health and medical care?
• Will the project develop tools, processes, sample collections or databases that contribute to infrastructure for follow-up/phase IV-studies?
• Is there a plan for implementation and for how to make the infrastructure accessible nationally?
• Are the project organization, the selected methods, and the availability of equipment and infrastructure adequate for the proposed project?
• Is the proposed study design, including data analysis and statistics, the most adequate design to address the objectives? Are there any limitations of the study design?
• Is the study population/sample size adequate to address the objectives?
• Is the budget requested reasonable for the implementation of the proposed project?
• Is the project nationally coordinated? Please refer to the call text indicating that collaboration and/or patient recruitment from a minimum of four Swedish county councils/regions is a prerequisite to apply.

Feasibility (1–3)

1 = Not feasible; 2 = Partly feasible; 3 = Feasible

Guiding questions:

• Do the applicants and the team as a whole have the experience, know-how and clinical resources to facilitate and conduct a clinical study within the area of the call?
• Do the team (applicant and the participating researchers) have sufficient research experience, expertise, and scientific network for performing the proposed project?
• Does the project include the availability and accessibility of relevant personnel, including statistician, skills, equipment, facilities/ infrastructures and other necessary resources?
• Is the recruitment of patients into the study feasible within the time frame of the project and of the national vaccination programme?
• Is it feasible that results will be delivered within time frame of the project?

The subsidiary criteria are not weighed together into an overall grade.