Smeitink, Jan
van Maanen, Rob
de Boer, Lonneke
Ruiterkamp, Gerrit
Renkema, Herma
Funding for this research was provided by:
European Regional Development Fund (NA)
Foundation Road4Energy (NA)
Foundation Energy4All (NA)
Foundation Join4Energy (NA)
Tim Foundation Ride4Kids (NA)
Article History
Received: 1 February 2022
Accepted: 18 April 2022
First Online: 27 April 2022
Declarations
:
: Before initiating the study, the investigator will submit the protocol, protocol amendments, ICFs (separate ICFs for children younger than 12 years, children aged 12 to15 years, children aged 16 up to and including 17 years, and for parents/caregivers), investigator’s brochure, and other relevant documents such as patient-facing materials, patient instructions’, DSMB charter, etc. to an IEC/IRB for review and approval. Except for changes required to eliminate an immediate hazard to study subjects, any amendments to the protocol will require IEC/IRB approval before implementing changes made to the study design. The protocol has been approved by the local ethics committee, CCMO [Central Committee on Research Involving Human Subjects; registration number: NL75221.091.20].The investigator or his/her representative will explain the nature of the study to the potential subject and the parent/caregiver and answer all the questions regarding the study. Informed consent, co-consent, and, wherever possible, assent will be obtained in written form by the investigator or appropriate designee and documented by a dated signature of the parent/caregiver, the subject (wherever feasible), and the investigator or appropriate designee on the ICF. Subjects and their parents/caregiver will be requested to sign a statement of informed consent that meets the applicable regulatory requirements and local regulations of the IEC/IRB or study centre (i.e., the ICF). The authorized person obtaining the informed consent (i.e., investigator or representative/delegate) will also sign the ICF The subject and their parent/caregiver will receive a copy of the signed ICF A statement that written informed consent and/or assent was obtained before the subject was enrolled in the study and the date of the written consent will be added in the subject’s medical record.A written informed consent to participate will be obtained from the parents or legal representatives of any subject under the age of 16. In the Netherlands, children between the age of 12 and 16 years, however, have an official role in deciding about participation in medical-scientific research. They must provide a shared consent (co-consent) together with their parents/legal representatives. Patients below the age of 12 years can provide ‘assent’ in addition to the written informed consent provided by parents/legal representatives. Informed consent will be obtained directly from subjects aged 16 years and older. A separate, age appropriate, subject information form (in addition to the information form provided to the parents/legal representatives) for all age groups is legally required.The research data will be stored using a study identification code for each participant. It will be documented and safeguarded by the principal investigator according to research guidelines after completion of the study. Any publications related to the trial will not report patient identification details.
: Not applicable as the manuscript does not contain individual personal data.
: Gerrit Ruiterkamp and Herma Renkema are employees of Khondrion, Rob van Maanen is a former employee of Khondrion, and Jan Smeitink is the founding CEO of this mitochondrial medicine company.