Amsterdam UMC research policies
Good research flourishes in an academic climate characterized by honesty, scrupulousness, transparency, independence and responsibility. Those five principles form the basis of the Amsterdam UMC Research Code.
Amsterdam UMC Research Code
The Amsterdam UMC Research Code defines local guidelines and expectations that researchers and staff are expected to follow when conducting research at Amsterdam UMC.
Research Integrity Policies
Shared values and principles of honesty and integrity lay the foundation of responsible teaching and conduct of research. Amsterdam UMC continuously works on a research environment that promotes and guarantees good research practice and has endorsed The European Code of Conduct 2023 as well as the The Netherlands Code of Conduct for Research Integrity 2018 which articulates broad values and principles that characterize an integer research culture.
Furthermore, specifically governing financial conflict of interest for all via NIH, PHS-sponsored Investigators of Amsterdam UMC the Amsterdam UMC Financial Conflict of Interest Policy is appliclable.
For every employee various confidential counselors, also for specific research integrity issues or questions, and an Ombudsman are appointed within Amsterdam UMC.
Inducements and/or external activities
Inducements are prohibited, but there are exceptions under certain conditions. All Amsterdam UMC employees, including those who perform research tasks e.g. full professors must declare their external activities in the HR registration systems.
Policy on scientific research involving human subjects
The interests of human subjects involved in medical research are protected by a number of (supplementary) laws, decrees, regulations, directives and codes of conduct. Applicable legislation may depend on the specificities of the research (such as research using a medicinal product or medical device, trials with embryos, population screening, or research involving children or incapacitated subjects). To ensure that scientific research with human subjects is conducted responsibly at Amsterdam UMC the 'Policy on scientific research involving human subjects' is applicable.
This Policy on scientific research involving human subjects includes two annexes::
Annex 1. Framework Quality Documents Research with Human Subjects
Annex 2. Clinical Investigations with medical devices - Amsterdam UMC
Clinical Trial Standard Operating Procedures (SOPs)
The policy on scientific research involving human subjects is downdrilled into General Clinical Trial (GCT) SOPs applicable to all staff conducting research involving human subjects at Amsterdam UMC.
- GCT SOP 01 Informed Consent Procedure
- GCT SOP 02 Reporting deviations & escalations in research involving human subjects
- GCT SOP 03 Management and archiving of essential documents in research involving human subjects
- GCT SOP 04 Safety reporting in research involving human subjects
- GCT SOP 05 Central Data Safety Monitoring Board
The most relevant Research Data Management (RDM) procedures:
Policy on research with(out) animals
Amsterdam UMC is committed to replace animal testing with animal-free research where possible. Check our Amsterdam UMC policy on animal testing. Models and techniques to replace animal testing are continually improving and we hope to rely less and less on animal testing in the coming years. However, animal testing is still necessary for studying many diseases and developing new medications. Animals at Amsterdam UMC receive careful treatment as stipulated by the law on animal testing (WOD). In compliance with the WOD, both Amsterdam UMC locations have an institutional license to perform experiments on animals. Moreover, for each project responsible researchers have to apply for a project license at the Central Authority for Scientific Procedures on Animals (CCD). Project permission is based on ethical assessment by an independent local committee of experts known as the Animal Ethics Committee (DEC).
Quick links to (Inter)National laws and legislation
- Medical Research Involving Subjects Act (WMO)
- Good Clinical Practice (ICH-GCP)
- EU Clinical Trial Regulation (CTR)
- Medical Device Regulation (MDR)
- In Vitro Diagnostics Regulation (IVDR)
- General Data Protection Regulation (AVG)
- Embryowet
- Geneesmiddelenwet
- Wet op Geneeskundige Behandelovereenkomst (WGBO)
- Wet op Bevolkingsonderzoek
- European regulation on ATMPs
- NFU Richtlijn Kwaliteitsborging Mensgebonden Onderzoek
- NFU Guideline Quality Assurance of research involving human subjects
- Wet op Dierproeven (WOD)