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Compliance with Rules & Regulations

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​​When conducting research, you have to comply with internal and external legislation and take into account safety, privacy and quality aspects. Several services are available within the UMCG to assist you in this process.

Service​​ overview

UMCG Tools for Research guide researchers through the external and internal legislation in each phase of a study performed in human subjects (concept, preparation, review, conduct, closure) and facilitate the set-up of the project by providing several documents (checklists to be filled, relevant information, Standard Operating Procedures (SOPs) for scientific research, templates and forms).  Service Desk CRO  can provide support and information on the use of the tools for research.

The UMCG Research Register is a database containing all research projects carried out by UMCG employees. Only research projects in the database will be assessed by the Medical Ethical Committee (METc). Registering is mandatory for WMO (projects that fall under the scope of the Medical Research Involving Human Subjects Act – WMO) and non-WMO projects, investigator-initiated and sponsored projects as well as projects with healthy volunteers, patients, their biological samples and/or medical data. Contact  the Service Desk CRO  for information about registering your research project in the UMCG research register.

Approvals an​d evaluations

Research studies that fall under the scope of the WMO and/or the Embryo Act (Embryowet​​​) must first be submitted to an accredited medical research ethics committee or the Central Committee on Research Involving Human Subjects (CCMO),  which reviews research protocols in accordance with the WMO. Research is allowed to start only after the approval by an independent committee of experts.

The Medical Ethical Committee (METc) of the UMCG is the reviewing committee for UMCG researchers. If the research has been reviewed by another committee (e.g. in case of multi-centre studies), the Board of Directors of the UMCG needs to approve the study before it can start. Before the approval, the METc office performs an administrative oversight to evaluate local feasibility.

The Central Review Committee (Centrale Toetsings Commissie, CTc) evaluates scientific research that is outside the scope of the WMO and fits within the scope of the nWMO Kaderregelement UMCG. For more information see ‘Ethics review non-WMO’​.

Mo​nitoring

Monitoring should be performed for all WMO compliant medical research involving human subjects within the UMCG. The initiator of the study (the sponsor/“de verrichter”) is responsible for assigning a trained monitor. For clinical research projects with negligible risk, the pool of monitors within the UMCG can be used to find a monitor. An overview can be found at the intranet page of Service Desk CRO. For clinical research projects with moderate or high risk, the Service Desk CRO  can arrange monitoring if required; an offer can be requested via the Service Desk CRO.

The Service Desk CRO provides training for monitors in studies with a negligible risk. The courses are organised in cooperation with the Wenckebach Institute. If you are interested, please contact the Service Desk CRO.

Data​ validation 

Data validation ensures quality of the research and protects the scientific integrity of a study through the data management plan, the data management report and the data validation plan. These tools ensure the quality of your research by documenting the data entry process (i.e. 'who enters or modifies a particular data element at what location and time' mandatory for clinical trials) or implement a method for validating data after the initial entry. For more information, please check the site Data Management & Research IT . 

Safety man​​agement 

Adverse Events (AEs), Serious Adverse Events (SAEs) reporting and Data Safety Management Board (DSMB) reporting for clinical research ensure safety management in scientific research. 

For pre-clinical research it is obliged to have a permit for working with genetically modified organisms (GMO) and animal by products taking special caution considering biological agents, genetically modified organisms and animal by-products. Safety measures related to working with radioactive substances and devices emitting ionizing radiations are regulated by the Stralingshygiene, which promotes the safest working environment possible.

Service Desk CRO  can provide support with AE, SAE and DSMB reporting if required; an offer can be requested via the helpdesk. Please contact the biosafety officer for research with GMO contact. See intranet page Compliance with rules & regulations for contact details.

Privacy i​ssues 

Due to national and international legislation (e.g. General Data Protection Regulation – GDPR), researchers need to protect the privacy of study participants (e.g. by pseudonymisation, by using suitable software). When the potential risks for study participants are high, a Privacy Impact Assessment should be performed to identify the appropriate privacy measures. For advice and questions about privacy issues and PIA, please contact the Privacy Werkorganisatie at Contact.

Contract research 

When working with research groups or external parties, a solid legal basis can ensure solid and fair collaboration and valorisation activities among all parties. Legal support may be useful throughout all the phases of the research by creating confidentiality agreements among parties, drafting a grant agreement, arranging IP contracts, licenses for third par​ties to exploit research results/technology and more.

If you encounter legal issues, need to draft a contract or have questions, please contact Loket Contract Research in the UMCG at Contact.