Dealing with human subjects involved in research

Researchers have a responsibility to ensure the well-being of research subjects and their voluntary participation in research. Moreover, researchers must be aware of the potential conflict between the interests of the research subjects and the interests of the research.
An absolute prerequisite for research involving human subjects—both patients and healthy volunteers—is that they are treated with respect, and have their health and rights protected.

Regulatory framework

Two types of research: WMO and nWMO

Two types of research involving human subjects can be distinguished:

1. WMO research: scientific research that is subject to the Medical Research Involving Human Subjects Act. A study is subject to the WMO if both of the following criteria are met:

  • It concerns medical scientific research, and
  • Participants undergo procedures or are required to follow rules of behavior.

2. nWMO research: scientific research with human participants that does not comply with one or both of the criteria is not subject to the WMO..

The CCMO provides guidance to determine whether or not a study is subject to the WMO. All proposals for WMO research to be carried out by Amsterdam UMC must be approved by an accredited independent medical research ethics committee (MREC). The accreditation of the MREC is granted by the competent authority. Amsterdam UMC has an accredited independent MREC; METC Amsterdam UMC. In Amsterdam UMC, all investigator-initiated studies subject to the WMO must be monitored. The Clinical Monitoring Center can be consulted for monitoring services. After completion of a research study, the principal investigator has the ethical obligation to make the research results publicly available, irrespective of the study outcomes. For research involving a medicinal product, study sponsors are legally required to publish the results in the EU Clinical Trials Database (EudraCT) within one year after the end of a clinical trial.

nWMO research may concern retrospective analysis of data from patients’ medical records as well as prospective research in which data is obtained from human subjects through direct interactions, such as use of questionnaires, without infringement of the physical and/or psychological integrity of the subject. To satisfy important legal and societal preconditions for nWMO research, Amsterdam UMC in principle assesses all nWMO research according to certain predefined ethical and legal criteria. This assessment is performed by a dedicated review board under the responsibility of the MREC. Applicable legislation and regulations include the Medical Treatment Contracts Act (Wet Geneeskundige Behandelingsovereenkomst; WGBO), General Data Protection Regulation (GDPR or AVG in Dutch), the Code of Conduct for the Use of data and human tissue in Health Research.

For research involving human biomaterial, the following requirements apply. The collected biomaterial was either explicitly obtained for the purpose of research (de novo biobank or primary use), or obtained in the course of diagnosis or regular treatment (‘further use’). De novo biobank research may be subject to the WMO. A specific legal framework is currently not available for the use of human tissue for medical research. The Ministry of VWS is currently preparing a Control over Body Materials Act (Wet zeggenschap lichaamsmateriaal; WZL) which will serve as a legal framework in the future. The executive board of Amsterdam UMC has developed a regulation to ensure that setting-up a biobank or conducting research with material from an existing biobank is reviewed for legal and ethical aspects in accordance with the Code of Conduct for Responsible Use. In accordance with this regulation, proposals to create a biobank and/or using materials from an existing biobank has to be submitted to BioBank Assessment Committee of Amsterdam UMC

Research involving the processing of personal data is regulated by the GDPR. See also Chapter 'Research data management' on proper handling and organization of research data, ownership of data and data protection. The Standard Operating Procedure (SOP) Reuse of care data for the purpose of research describes the requirements for reuse of patient data for research purposes at Amsterdam UMC. Personal data and biomaterial collected for scientific research at Amsterdam UMC could also be transferred to third parties in case of a research collaboration, provided that it is used in accordance with the original objectives. Obviously, all arrangements with third parties should also be in accordance with the applicable laws and regulations. See also Chapter 'Research collaboration agreements'.

Training

All Amsterdam UMC clinical investigators performing research that is subject to the WMO are obliged to follow the e-learning module Basic course on Regulations and Organisation for Clinical investigators (Basiscursus Regelgeving en Organisatie voor Klinisch onderzoekers; eBROK®), provided by the NFU, which teaches researchers about the specific laws and regulations that govern research involving human subjects. Information about the eBROK® course and the Amsterdam UMC center-specific meetings is provided here.

Amsterdam UMC employees other than clinical researchers who are involved in clinical research (such as research nurses, data managers, students and study coordinators) are obliged to follow a Good Clinical Practice (GCP) course.

Support

For the aspects discussed in this chapter, the following Amsterdam UMC support teams can be contacted for expert advice and support:

Furthermore, the Research Roadmap contains numerous useful guidelines related to various types of research involving human subjects.