Quality assurance
CAPHRI values the quality of its research and has therefore established a quality assurance system, with a quality officer and guidelines for research conduct and auditing. This quality assurance system serves to help researchers at CAPHRI to do their research according to the existing rules and regulations.
Often it is difficult to find out exactly which regulations apply to your research, especially when your research is non-WMO. This page gives an overview of the key information, and you can click the links below to find out more about each topic. If you have questions, comments or suggestions regarding quality assurance please send your email to caphri-quality@maastrichtuniversity.nl, or contact David Shaw (Quality officer CAPHRI) or Laure Wynants (chair of the CAPHRI Quality Assurance Committee).
Scientific integrity is also an extremely important aspect of research, but does not fall under the CAPHRI quality assurance system as UM has its own regulation and guidance on integrity, as well as a Platform for Research Ethics & Integrity.
"CAPHRI Quality Assurance system helps foster greater trust in research"
Read the interview with Laure Wynants and David Shaw
CAPHRI values the quality of its research and has therefore established a quality assurance system, with a quality officer and guidelines for research conduct and auditing. This quality assurance system serves to help researchers at CAPHRI to do their research according to the existing rules and regulations.
Often it is difficult to find out exactly which regulations apply to your research, especially when your research is non-WMO. This page gives an overview of the key information, and you can click the links below to find out more about each topic. If you have questions, comments or suggestions regarding quality assurance please send your email to caphri-quality@maastrichtuniversity.nl, or contact David Shaw (Quality officer CAPHRI) or Laure Wynants (chair of the CAPHRI Quality Assurance Committee).
Scientific integrity is also an extremely important aspect of research, but does not fall under the CAPHRI quality assurance system as UM has its own regulation and guidance on integrity, as well as a Platform for Research Ethics & Integrity.
Ethics approval
Every study that is carried out at CAPHRI and that falls under the WMO law should be approved by an accredited ethics committee. If your study is not subject to WMO you should seek ethics approval from the FHML ethics committee.
The researcher is responsible for obtaining ethical approval before data collection. Most journals also ask for ethical/research approvals once you submit your manuscript (please note that you cannot ask for ethical approval retrospectively). Dutch law requires ethical approval from a medical ethics committee if your research falls under the WMO law.
Check if your study falls under the WMO
What to do if your study falls under WMO
What to do if your study does not fall under the WMO
Participant information and informed consent
Every person who is asked to participate in a study should be informed about the study, before he/she decides whether to participate or not (participant information). Every person who is asked to participate in a study should give informed consent before study enrollment (informed consent).
WMO templates for participant information and consent
Informing and consenting subjects in non-WMO research
Studies involving use of data from non-enrolled subjects (non-WMO data studies)
Insurance for participants
For research that falls under WMO, the researcher should take out insurance. For research that does not fall under WMO, it is not necessary to take out insurance.
The first step is to decide whether insurance for participants is required. In general, for studies involving human subjects (WMO) the researcher should take out insurance for the participants. The insurance is taken out in order to cover any damage to the research subjects. This is the so-called direct damage insurance or WMO subject insurance. In addition, liability insurance must be taken out. For research that falls under the scope of the WMO, two insurance policies must be provided, namely the WMO subject insurance and liability insurance.
More on WMO insurance
WMO subject insurance and exemptions
Liability insurance
Protocol registration
Every clinical trial that is carried out at CAPHRI must be registered at an official registry. It is strongly recommended to register observational (hypothesis testing) studies.
Data protection and storage
Researchers at CAPHRI are required to design and conduct their research that deals with sensitive personal (medical) information in a way that privacy is respected.
European, Dutch and local laws, regulations and guidelines share a commitment to the protection of research subjects’ privacy and require researchers to produce and handle personal data carefully, refrain from sharing it beyond the research team and store and retain the data safely. At the same time, norms prescribing responsible research invite researchers to share data to allow reproduction and verification, and to store data for extended periods, to allow reanalysis or reuse.
Maastricht University’s Data Management Code of Conduct explains how long you need to store data and where, whose property research data is and who can be granted access under which conditions. As a general rule, retain your data 10 years after the last publication and store it safely on UM servers. Researchers are free to grant other researchers access to their data, provided this does not breach other contractual obligations. Read the full text here. Practically, this means that members of the research team need to live up to a series of requirement
Researchers’ responsibilities
Data permissions
Data handling and encryption
Storing and transporting data
Logging processes
Every WMO study at CAPHRI should keep a logbook. For non-WMO studies we strongly recommend keeping a logbook or other record of research decisions, such as minutes of meetings.
Analyses and syntaxes
For each publication, the final data (on which the reported analyses are based) should be stored. Syntaxes should be available for all results reported in the publication. Co-authors should be able to see the original data and syntaxes on which a study manuscript is based.
Audit
The CAPHRI research quality audit is designed to ensure that all research conducted within the Institute adheres to quality standards, and to help researchers achieve these standards. The audit has two main parts, one document-based and one meeting-based. If invited to take part, all the projects for which you are principal investigator/project leader will be audited.
Reporting
All research results should be reported to ensure transparency and avoid wasteful duplication of research.
More on useful resources regarding best practice in reporting results
Statistics
Using the right statistical methodology is very important. Therefore we provide a statistics checklist to help researchers. This checklist is limited to quantitative empirical studies.
