Choosing the right role for ORU and RÖL

Use this role when the organisation:

• Performs core scientific or clinical action tasks that are central to achieving the project’s objectives (as described in Annex 1 of the Grant Agreement)
• Exercises scientific or clinical judgement, including responsibility for study design, methodology, or interpretation of results
• Generates, owns, or exploits project results, including data, methods, software, or clinical evidence, and therefore requires access rights under the Grant Agreement
• Has primary responsibility for specific work packages or deliverables, including leadership of tasks that shape project outcomes
• Participates in project governance and decision‑making, such as steering committees, ethics oversight, or technical coordination

Use this role when the organisation:

• Performs scientific or clinical action tasks as part of the action, under the responsibility of the beneficiary and without independent contractual standing towards the granting authority
• Carries out tasks under the beneficiary’s responsibility, with the beneficiary assuming full legal, financial, and compliance liability
• Contributes to project results in accordance with the Grant Agreement, with IPR and access rights governed through the beneficiary–affiliated entity relationship
• Is structurally linked to the beneficiary, reflecting a stable, long‑term relationship rather than a market‑based or transactional arrangement
• Does not sign the Grant Agreement and does not report directly to the Commission, but must monitor, document, and manage its own project costs in line with Horizon Europe rules to enable accurate reporting and audit readiness

Internal principle (ORU–RÖL)

The default position is to use affiliated entity status whenever activities between ORU and RÖL would otherwise fall under subcontracting and the work relates to scientific or clinical activities.

Use this role only when all of the following conditions are met:

• The task is an action task that is limited in scope, strictly predefined, and non‑collaborative, and does not involve scientific or clinical judgement, discretion, or influence on study design or interpretation
• Any results or outputs produced are generated on behalf of the beneficiary and are fully attributed to, and owned by, the beneficiary under the Grant Agreement
• The subcontracted task is explicitly described in Annex 1, and the related costs are budgeted in Annex 2
• The subcontract is awarded in accordance with procurement rules and best value for money principles

As a general rule, ORU and RÖL do not use subcontracting between each other for action tasks. Where the work relates to scientific or clinical execution, the default and preferred configuration is affiliated entity status, rather than subcontracting.

 Use this role when all of the following conditions are met:

• The tasks are routine, predefined, and non‑collaborative, and are carried out strictly according to specifications
• The provider does not exercise scientific or clinical judgement and does not influence study design, methodology, or interpretation
• The tasks do not generate project results and do not require access rights to background or results
• Routine laboratory or diagnostic tests, provided they are standardised, fully predefined, and do not contribute to scientific interpretation or generation of new project results
• The relationship is purely commercial, with the provider acting as an external supplier rather than a project participant
• Procurement rules apply.

Typical examples include:
transcription services; routine laboratory or diagnostic tests; equipment rental; software licences; standard IT or data hosting services; printing and dissemination services.

As a general rule, ORU and RÖL do not use subcontracting between each other for action tasks. Where the work relates to scientific or clinical execution, the default and preferred configuration is affiliated entity status, rather than subcontracting.

Recommended configuration

ORU: Beneficiary
RÖL: Affiliated Entity (Article 8 AGA)

Rationale

ORU leads the scientific design, analytical methodology, and exploitation of results.
RÖL contributes integrated clinical action tasks that are essential to the research, but these tasks can be implemented under ORU’s responsibility, without RÖL requiring independent contractual standing towards the granting authority.

ORU action tasks (beneficiary)

ORU has primary scientific responsibility for the action, including:

• Digital biomarker and feature development
• Study design
• Algorithm development and model validation
• Ethics, data protection, and data‑processing leadership

Scientific interpretation, validation, and exploitation of results

RÖL action tasks (affiliated entity)

RÖL provides embedded clinical research contributions, including:

• Access to Parkinson’s disease patient cohorts
• Performance of predefined clinical assessments
• Collection of sensor‑based and observational data
• Lead on  protocol development

Why this configuration fits Horizon Europe (AGA)

• RÖL performs action tasks, so it cannot be treated as a subcontractor or purchase of services
• ORU retains overall scientific leadership, interpretation responsibility, and exploitation responsibility
• ORU can assume full legal, financial, and compliance responsibility for RÖL’s tasks and costs, as required under Article 8 of the AGA
• The collaboration reflects a structural research partnership, not a market‑based service relationship

Grey‑area clarification

If RÖL were to require independent contractual standing—for example to lead governance, independently interpret results, or exploit results in its own right—then RÖL would need to be a beneficiary rather than an affiliated entity.

Why ORU is an affiliated entity

RÖL leads the clinical innovation and implementation of the action, while ORU provides methodological and analytical contributions that are implemented as action tasks under RÖL’s responsibility and without ORU requiring independent contractual standing towards the granting authority.

RÖL action tasks (beneficiary)

• Design and pilot implementation of integrated care pathways
• Clinician training and change management activities
• Collection and monitoring of clinical and service‑level indicators
• Interpretation and exploitation of implementation results
• Health‑economic modelling and cost‑effectiveness assessment

ORU action tasks (affiliated entity)

• Development of evaluation of methodology
• Conducting qualitative interviews with patients and professionals
• Statistical analysis of clinical and service data

Why this configuration fits

• RÖL performs the core action tasks and leads clinical implementation → beneficiary
• ORU performs action tasks listed in Annex 1 under RÖL’s responsibility → affiliated entity
• This structure is consistent with AGA Article 8, which allows affiliated entities to implement action tasks without independent contractual standing towards the Commission

Grey‑area clarification

If ORU were to require independent contractual standing towards the granting authority in relation to governance, exploitation, or enforcement of access rights to results, ORU would need to be a beneficiary rather than an affiliated entity.

Scope of activities

• Blood sampling from 200 patients
• Routine laboratory tests (e.g. CRP, lactate, cultures)
• Delivery of anonymised datasets

Two possible configurations

Option 1 — RÖL as Affiliated Entity (Action Tasks)

Use this configuration when:

• Patient sampling and laboratory testing are integral parts of the scientific protocol
• Laboratory outputs contribute directly to generating or validating project results
• Clinical procedures require scientific or clinical judgement (e.g. protocol‑driven sampling, quality decisions, inclusion/exclusion handling)
• RÖL’s tasks are explicitly described as action tasks in Annex 1

Why this configuration fits

RÖL is contributing to the generation of scientific results and performing action tasks under the beneficiary’s responsibility. Subcontracting or purchase of services is not appropriate under the AGA for this type of contribution.

Option 2 — RÖL as Purchase of Services (Non‑Action Tasks)

Use this configuration only when:

• Tasks are routine, standardised, and fully predefined
• RÖL does not influence scientific design, methodology, or interpretation
• The work is provided as a standard clinical service, identical to routine care
• Outputs are technical or factual only (e.g. raw measurements), with no scientific or clinical judgement

Why this configuration fits

In this case, the activities support the project but do not constitute action tasks and therefore fall under Article 6.2.C (purchase of goods, works, and services).

Grey‑area clarification (ORU–RÖL internal rule)

If any part of the sampling or laboratory work involves scientific or clinical judgement or contributes to project results, the activity must be treated as an action task, and the default configuration is Affiliated Entity, not purchase of services.

Scope of the example

The correct support role (Affiliated Entity or Purchase of Services) depends on whether statistical analysis and usability testing constitute scientific action tasks contributing to evidence generation, or purely technical execution supporting the project.

Two possible configurations

Option 1 — Affiliated Entity (Action Tasks)

Use this configuration when the organisation performing the work (ORU or RÖL):

• Exercises scientific or clinical judgement
• Influences the analytical methodology, statistical models, or evaluation criteria
• Interprets outcomes affecting clinical validity, effectiveness, or performance
• Contributes to the generation of scientific or clinical evidence
• Performs tasks explicitly described as action tasks in Annex 1

Why this configuration fits

In this call type, statistical analysis and usability testing directly shape the validation and clinical evaluation of the digital tool. Such activities constitute scientific action tasks under the AGA and must therefore be performed by a beneficiary or an affiliated entity, and are not appropriate for purchase of services or subcontracting under the AGA.

Option 2 — Purchase of Services (Non‑Action Tasks)

Use this configuration for ORU or RÖL only when the analysis or usability testing is:

• Fully predefined and non‑collaborative
• Executed strictly according to detailed instructions
• Free of scientific or clinical judgement or discretion
• Not influencing interpretation, conclusions, or validation outcomes
• Producing technical outputs only (e.g. raw logs, click streams, pre‑specified metrics)
• Not requiring independent contractual standing in relation to project results

Why this configuration fits

In these limited cases, the activity supports project implementation but does not constitute an action task and therefore qualifies as a purchase of services under Article 6.2.C.

Grey‑area clarification (ORU–RÖL internal rule)

If the organisation performing statistical analysis or usability testing contributes in any way to scientific or clinical interpretation, the task must be treated as an action task, and Affiliated Entity status is the default configuration.

Both organisations make essential and independent scientific and clinical contributions that directly shape the project’s objectives, methods, and results. Each organisation is responsible for its own work packages, which are critical to achieving the overall project goals.

In practice, this typically means that ORU and RÖL implement distinct project tasks using their own personnel, with separate lead researchers representing each organisation.

Each organisation therefore requires direct contractual standing under the Grant Agreement in order to implement its tasks, manage its budget, and exercise its rights and obligations.

Where only one organisation provides overall scientific leadership and the other contributes in a supporting role under its responsibility, affiliated entity status may be appropriate—provided that the conditions of Article 8 AGA are fulfilled.

ORU action tasks (beneficiary)

ORU is responsible for the core analytical and methodological innovation of the project, including e.g.:

• AI modelling and predictive analytics
• Machine‑learning algorithm development
• Data harmonisation and federated learning approaches
• Development of exploitable software, methods, and analytical tools

RÖL action tasks (beneficiary)

RÖL is responsible for the core clinical research and primary data generation, including e.g.:

• Recruitment of patient cohorts and eligibility assessment
• Clinical investigations (imaging, ECG, biological sampling)
• Biobanking and quality‑control procedures
• Generation, curation, and validation of primary clinical datasets

Why this configuration fits Horizon Europe (AGA)

• Both organisations implement core action tasks described in Annex 1
• Both exercise scientific or clinical judgement that influences study design, methodology, and interpretation
• Both generate project results and therefore require access rights and IPR arrangements under the Grant Agreement
• In Horizon Europe Health calls, clinical partners that perform substantial research action tasks are typically included as beneficiaries, rather than as affiliated entities or service providers, because they generate project results and require contractual standing under the Grant Agreement.

Grey‑area clarification — when RÖL could be an affiliated entity in a similar project

In a closely related personalised prevention project, RÖL could instead be included as an affiliated entity if its role were limited to protocol‑driven clinical execution rather than independent clinical research leadership.

For example, affiliated‑entity status would be appropriate if:

• The overall study design, prevention strategy, and analytical framework were fully defined and led by ORU
• RÖL’s role were restricted to implementing predefined clinical procedures, such as recruiting patients strictly according to inclusion/exclusion criteria set by ORU
• Clinical data collection followed fixed protocols, without discretion to adapt procedures or influence methodological choices
• RÖL did not lead work packages, independently interpret results, or require independent exploitation of project results
• All RÖL tasks were implemented under ORU’s responsibility and explicitly described as action tasks in Annex 1

In such a scenario, RÖL would still be performing action tasks (and therefore could not be treated as a subcontractor or service provider), but affiliated‑entity status under Article 8 of the AGA would be appropriate.