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.
Talent policies and services
Here you can find information on both general and specific talent policies.
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
- GCT SOP 06 Vendormanagement (draft)
The most relevant Research Data Management (RDM) procedures:
Quick links to (Inter)National law 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