Molenaar, Joyce M. http://orcid.org/0000-0002-8025-040X
Boesveld, Inge C. http://orcid.org/0000-0002-1250-325X
Struijs, Jeroen N. http://orcid.org/0000-0002-7493-6720
Kiefte- de Jong, Jessica C. http://orcid.org/0000-0002-8136-0918
Funding for this research was provided by:
Ministerie van Volksgezondheid, Welzijn en Sport (project numbers V/010038/01 and V/060438/22, project numbers V/010038/01 and V/060438/22, project numbers V/010038/01 and V/060438/22)
Article History
Received: 24 April 2023
Accepted: 3 August 2023
First Online: 30 August 2023
Declarations
:
: All methods were carried out in accordance with the Declaration of Helsinki. All study participants received an information letter and were informed that participation was voluntary. Additionally, participants were reassured that all information they shared was treated confidentially. The results were reported anonymously, without any personal identifying information that could be traced back to individuals or organizations. Prior to the start of each interview or FGD, all participants provided written or oral (recorded) informed consent. Municipalities received an invitation explaining that the results and publications would not be traceable to individual municipalities, and theyprovided informed consent by completing the online questionnaire.At the start of the national Solid Start monitor in 2019, we checked by the Medical Research Ethics Committees United whether medical-ethical approval was necessary according to Dutch legislation. They stated and confirmed that the monitor does not fall within the scope of the Medical Research Involving Human Subjects Act (in Dutch: Wet Medisch-Wetenschappelijk Onderzoek, WMO), hence it was exempted for further approval by the ethical research committee (reference number: W19.063). By that time, only FGDs were planned and included in the proposal. Next, we checked whether this exemption also holds for the additional interviews with stakeholders in 2021 at the Clinical Expertise Centre of the RIVM as part of their legal task. The Clinical Expertise Centre confirmed that this specific study as described in this manuscript, which is part of the national monitor and includes both FGDs and interviews, was also exempted for further approval by the ethical research committee according to Dutch legislation as the study does not fall within the scope of the Medical Research Involving Human Subjects Act (reference number: VPZ-574).
: Not applicable.
: The authors declare that they have no competing interests.