YOUth quality controls
YOUth aims for high-quality research and data. To this end, various measures have been taken to promote quality in the broadest sense of the word.
YOUth is subject to the Medical Research Involving Human Subjects Act (WMO). This means it must undergo a review by an accredited Medical Research Ethical Committee (METC). All the research we do must be submitted in advance to the METC of the UMC Utrecht. At the start of YOUth, we submitted two framework protocols, one for the sub study Baby & Child and one for the sub study Child & Adolescent. These protocols outline the framework of the research that we intend to carry out in 10 years. The protocols provide an overview of the methods and time for the different measurements. The measurements itself are described in less detail in these framework protocols. This is because a description of age-dependent measurements for all different measurement moments would yield a top-heavy protocol. In addition, as a result of new insights and the rapidly developing field of neurocognitive brain research, there will be changes in tasks and measurements. For each separate measurement moment, therefore, an amendment is submitted to the METC in which the details of the task characteristics and the specific rationale of the cognitive tasks and brain dimensions are further explained. Various flows have been developed within YOUth, including a flow for the start-up of a new measurement round.
In addition to amendments per measurement round, participant information and consent forms are submitted to the METC for approval. Every year we also submit a progress report to the METC.
Monitoring is an essential tool for quality assurance in human-related research. YOUth receives a monitor visit every year. It serves to check whether the rights and well-being of the participants are protected, whether the data is accurate and fully verifiable in source documents and whether the conduct of the study is in accordance with the approved protocols and amendments, with the GCP (Good Clinical Practice) and with the relevant legal requirements.
Personnel and Procedures
All our employees follow an online Good Clinical Practice training. In addition, we have trained in-house emergency responders and staff members are trained in children’s first aid. For the research assistants, we have training protocols per task/measurement. We are developing training videos that will be available online and we regularly offer training days.
In addition, we have developed several Standard Operating Procedures (SOPs). These documents describe the course of action in specific situations, such as (suspected) incidental findings among participants. Our SOPs are only in Dutch.
Because YOUth is human-related research and we work with vulnerable groups (i.e. pregnant women and young children), we are extra critical on hygiene and safety at our research location. For example, we have cleaning procedures for lab set-ups, baby materials and toys. In addition, all our rooms meet specified technical specifications.
Within YOUth we have many different tasks and measurements: fMRI, sMRI, DTI, EEG, Eye tracking, IQ, Penn, Parent Child Interaction, Biological Material, Questionnaires, 3D ultrasounds, MRI measurements in pregnant women and baby’s, and Dual Eye tracking measurements. Domain responsible persons have been appointed for all these tasks and measurements. They are responsible for the data quality, the lab setups and the scripts. A specific training protocol describes how and with which frequency quality checks are performed for each task. We make a distinction between the quality of the performance of research assistants (in administering the task), the quality of the lab room and lab setup, and the quality of the research data itself. On all these fronts, there is monitoring, feedback and adjustment where desirable.
Data storage, management and access
Collecting, analyzing and distributing YOUth data requires a robust data management infrastructure, including agreements, procedures and support. Our Data Management Plan and Data Access Protocol provide for this. We have drawn up various guidelines for data management. There is, for example, the YOUth Data Management and Use Directive, a code of conduct for YOUth employees. Furthermore, we have a document on Rights and Obligations regarding Research Data, a protocol and scenario for Biological Material, Publication guidelines and Data Access guidelines.
We are currently working on all facets to make FAIR and Open data possible. For example, meta-data is written for all data we collect to make our data ‘findable’. Furthermore, for each separate data release, we are working on a functionality that generates specific pseudocodes based on the original pseudocodes. So, when we release datasets, each dataset has different pseudocodes instead of the ‘basic pseudocode’. This prevents data from being undesirably linked to each other and it reduces the chance that coupling of (social) media data can make a relation between pseudocode and person. In addition, these pseudocodes provide a unique “watermark” that can be useful for e.g. references from publications or a potential data leak.
Within YOUth we also aim for a high quality of data requests and publications on YOUth data. To this end, we have prepared “conditions of data use” and are working with pre-registering all data requests on the Open Science Framework (OSF) of the Center for Open Science (COS). All our approved data requests are already being made public on our website.
We published a paper about how we produce FAIR, safe and high quality data at the YOUth cohort study