Jansen, Tom
von den Benken, Myrthe
Lunansky, Gabriela
van Moll, Evi
Lammers, Marre
Funding for this research was provided by:
Rijksinstituut voor Volksgezondheid en Milieu (S/080004/01/PR)
Article History
Received: 6 January 2025
Accepted: 4 November 2025
First Online: 25 November 2025
Declarations
:
: This study was carried out in accordance with the principles of the Declaration of Helsinki. The study was registered (VLH-544) at the study register for human-related research at the Dutch National Institute for Public Health and the Environment (RIVM). The Centre for Clinical Expertise assessed whether the study complies with the specific conditions as stated in the law for medical research involving human subjects (WMO). The committee concluded that this study (1) does not constitute medical-scientific research, (2) does not subject participants to burdensome procedures, and (3) does not impose behaviour on participants. The committee therefore concluded the study is exempted by National and European law from ethical approval by an ethical committee in accordance with the National Law on medical research involving human subjects (WMO), Paragraph 1, article 1b and the European Clinical Trial Regulation 536/2014, Article 4. Because no other formal ethical frameworks were in place at time of the study, an (non-medical) ethicist was consulted about the research design, for the drafting of information letters, and post-research consultation for participants regarding possible health effects of long-term work with silica dust. All participants received information on the study goals and participants’ rights before providing written consent to participate in the study.
: Not applicable.
: The authors declare no competing interests.