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 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').
- Amsterdam UMC Research Code
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
- HRP policy, including Clinical Investigations with medical devices - Amsterdam UMC In order to ensure that scientific research with human subjects is conducted responsibly at Amsterdam UMC the following generally policy was compiled (based on e.g. the ECTR, MDR the Medical Research Involving Human Subjects Act (WMO), the JCI Human Subjects Research Programs standards (JCI, International Accreditation Standards for Hospitals), ECTR, MDR, ICH-GCP guidelines):
Standard Operating Procedures (SOPs) are an important component of the quality assurance system ensuring that research is prepared, conducted and completed in accordance with the research protocol, Good Clinical Practice (GCP), as well as other relevant regulatory measures.
A set of SOPs is available within Amsterdam UMC for the standard performance of certain tasks and activities in the research process.
(Links under maintenance)
- SOP Informed Consent
- SOP Reporting deviations & escalations in research involving human subjects
- SOP Management and archiving essential documents
- SOP Safety reporting
- SOP Central Data Safety Monitoring Board Amsterdam UMC
- SOP Research Data Management
(inter)National law and regulations
- The Netherlands Code of Conduct for Research Integrity
- Algemene informatiebrochure medisch-wetenschappelijk onderzoek
- Wet Medisch wetenschappelijk Onderzoek met mensen (WMO)
- European Clinical Trial Regulation (ECTR)
- Inspectie Gezondheidszorg en Jeugd (IGJ)
- NFU richtlijn kwaliteitsborging mensgebonden onderzoek
- ISO 14155
- ICH-GCP E6 (R2) richtsnoer
- Verklaring van Helsinki
- Code Goed Gebruik