Policy framework
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). Amsterdam UMC is working on a research environment that promotes and guarantees good research practice and has endorsed The Netherlands Code of Conduct for Research Integrity which articulates broad values and principles that characterize an integer research culture. A comprehensive list of national laws and regulations you find at the bottom of this page.
Amsterdam UMC research policies
In order to ensure that scientific research with human subjects is conducted responsibly at Amsterdam UMC the following generally applicable policies have been compiled.
Shared values and principles of honesty and integrity lay the foundation of responsible teaching and conduct of research. Amsterdam UMC is working on a research environment that promotes and guarantees good research practice and has endorsed (see 'Downloads').
In addition to the Code of Conduct for Research Integrity the Amsterdam UMC Research Code defines local guidelines and expectations that researchers and staff are expected to follow when conducting research at Amsterdam UMC. Good research flourishes in an academic climate characterized by honesty, scrupulousness, transparency, independence and responsibility—five principles that form the basis of the Amsterdam UMC Research Code
- Amsterdam UMC Financial Conflict of Interest Policy specifically governing financial conflict of interest for all via NIH, PHS-sponsored Investigators of Amsterdam UMC
Policy on scientific research involving human subjects including:
Annex 1. Framework Quality Documents Research with Human Subjects
Annex 2. Clinical Investigations with medical devices - Amsterdam UMC
Standard Operation Procedures (SOPs)
General Clinical Trial (GCT)
- 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)
Research Data Management (RDM)
(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