All research carried out with external funding at HUS that involves HUS patients and/or resources is administered at Clinical Research Institute HUCH.
All research carried out with external funding at HUS that involves HUS patients and/or resources is administered at Clinical Research Institute HUCH. A representative of the party commissioning the research and the CEO of the Institute sign the research agreements with the researcher.
Research agreement and budget preparation process
The researcher and the contact person responsible for agreements at the company/other external organization must ensure that sufficient time is set aside for the drafting of the agreement (at least three weeks) before the planned date of submitting the hospital research permit and starting the planned research.
A research agreement and research budget often require lengthy negotiations with both the researcher and commissioning party. These negotiations are generally held by email and over the telephone. To ensure rapid progress in research projects, the lead researcher and commissioning party must reply promptly to all correspondence and contacts concerning the project.
Starting a new research project:
The commissioning party should submit the following electronic documents concerning the planned research project:
- research protocol
- draft research agreement prepared by the commissioning party and
- a draft research budget, if available, together with
- a laboratory manual, if required.
- In addition, the details of the contact person/HUS researcher, and
- the current status of project permit processing (ethical committee statement).
- Due to the new EU General Data Protection Regulation, it is also important to submit a patient briefing during the research preparation phase.
Appointing the responsible Study Management Coordinator:
Once the aforementioned written background material has been submitted to the Institute, the Head of Research Services appoints a Study Management Coordinator for the project from his/her team (based on the current workloads of the Research Service Team) and informs the responsible person and commissioning party/sponsor and the lead researcher.
Research project processing phases at Clinical Research Institute HUCH:
When project processing begins, the Study Management Coordinator agrees on a kick-off meeting with the research team, at which they discuss issues such as the roles and responsibilities of different parties (researcher/the Institute), the schedule and objectives of the research, the costs of the research, remuneration of the research team and the content of the research agreement. At the same time, they review the contents of the research protocol and make additional clarifications as necessary.
The Study Management Coordinator opens an internal project number at Clinical Research Institute HUCH for the new research project and creates the project in the electronic Tutkijan Työpöytä -application. After that, the Study Management Coordinator prepares the research budget to be administered in the application on the basis of the research service requirements in line with the research protocol, the profit unit service fees and the remunerations/salaries agreed on with the research team. The Study Management Coordinator submits the draft budget to the lead researcher for approval, and then to the commissioning party/sponsor. The agreed research expenses and the terms and conditions of payment are entered in the draft research agreement by the Study Management Coordinator.
The Clinical Research Institute’s service margin is 18 %. A non-refundable start-up fee of 1000 Euros will be invoiced with every new research project and 150 Euros per each amendment to an Agreement.
Negotiating research agreements:
The Study Management Coordinator and the contract lawyer of the Institute review the draft research agreement submitted by the commissioning party. Any corrections and amendments required to the research agreement by our contract lawyer in accordance with HUS and Finnish/EU acts and decrees are negotiated by the responsible Study Management Coordinator with the commissioning party. Once all the details of the research agreement have been completed and finetuned, the contract lawyer of the Institute does a final review of the agreement before it is signed. The Study Management Coordinator obtains signatures from the parties to the research agreement and saves the agreement in the electronic Tutkijan Työpöytä application with the other documentation of the project.
HUS hospital/Research Services invoicing:
Different HUS profit units (HUSLAB, Medical Imaging Center, etc.) invoice Clinical Research Institute HUCH on a monthly basis for research services used and on the basis of internal HUS project entries made by the research team in question. The Financial Administration of the Institute allocates these project-specific HUS costs as expenditure on the project.
Invoicing the commissioning party:
Agreed-on start-up costs are invoiced from the commissioning party once the research project agreement has been signed. Payments received from the commissioning party are allocated as income for the research project in question. During the research phase, the commissioning party is most often invoiced on a quarterly basis on the basis of actual patient visits and additional costs incurred. The grounds for invoicing the commissioning party are compiled in the electronic Tutkijan Työpöytä application and in accordance with the visits reported by the research team to Tutkijan Työpöytä.
Head of Research Services Raimo Skottman, tel. +358 40 660 2290, ext-raimo.skottman (at) hus.fi
Clinical Research Institute HUCH’s Study Management Coordinators provide information on the administration of external research funding and prepare research agreements and budgets in cooperation with the researcher, the commissioning party/financier and the Research Service Team lawyer.
Preparation of a research agreement is generally started when a commissioning party or future lead researcher contacts Clinical Research Institute HUCH by email.
Further preparation of the research project is carried out by and under the firm supervision of the appointed Study Management Coordinator. The appointed Study Management Coordinator serves as the coordinator and contact person for the new research project on behalf of Clinical Research Institute HUCH during the entire duration of the research and also supervises the invoicing of the commissioning party.
Termination of the research:
When the research project ends, the commissioning party/lead researcher must submit a research termination notification to the Study Management Coordinator at Clinical Research Institute HUCH. The final invoice to the commissioning party can be drafted on the basis of this notification. Agreed-upon archiving of research materials will also be invoiced at that time.