The GHS has defined clear framework conditions for the access and use of its study data and biomaterial. These are anchored in the GHS rules of procedure.
Goals and principles
Primary objective: Utilisation of study data for scientific purposes and provision for research
Concern: Maximising the benefit of the collected data and sample material for health-related research
Availability: Broad accessibility of data and sample material for internal and external scientists
Access regulations for external researchers
External researchers can apply for the use of data and biomaterial if they: 1. enter into a cooperation with the GHS, 2. make a contribution to the study (e.g. generation of secondary data), or 3. contribute special scientific expertise.
Terms of use
The use of biomaterial and/or study data is subject to strict regulations laid down in the rules of procedure in order to protect the rights of the study participants:
These guidelines ensure that the valuable resources of the GHS are handled responsibly and at the same time promote scientific progress through broad utilisation options.
Process of data utilisation in the Gutenberg Health Study (GHS, Area A)
A1 Application
Scientists submit a data utilisation application (proposal) containing the following information:
There are special applications for academic qualification projects as part of a funding programme for academic careers.
A2 Authorisation procedure
The GHS Executive Committee reviews all projects for the utilisation of study data. The Executive Committee meets approximately once a month and assesses the feasibility and possible overlaps with existing projects. If approved, the applicant becomes a member of the GHS Research Consortium and undertakes to comply with the rules of procedure. In the event of rejection, the application may be revised, taking into account the Executive Committee's comments.
A3 Statistical analysis plan
Once the application has been accepted, a statistical analysis plan must generally be submitted.
The statistical analysis plan serves as the basis for compiling the data set. Advice on the statistical analysis plan is recommended and offered in particular for early career researchers.
A4 Legal basis
If required, a data transfer agreement regulating the legal aspects of data use will be drawn up and signed.
A5 Data provision
Once the data transfer agreement has been signed, the requested study data will be made available.
A6 Data analysis
Statistical analyses are usually carried out by the central statistics unit of the GHS. Scientists with the appropriate expertise can carry out the analysis themselves. GHS statisticians are available for consultation.
A7 Manuscript preparation
The results are summarised in a manuscript for publication. Authors are determined according to the guidelines of Good Scientific Practice and the ICMJE.
Further information on the publication of results can be found here.
A8 Manuscript review
Before publication, the Executive Committee formally reviews the manuscript, e.g. for correct presentation of the study and naming of all sponsors.
A9 Publication
The manuscript is published in a scientific journal.
Access to (bio)material and use of the study for applications (area B)
B1 Application
Scientists submit an application for the use of (bio)material, generation of secondary data or the use of the study for applications (projects) containing the following information:
B2 Authorisation procedure
The GHS Executive Committee reviews and approves all projects in regular meetings (approximately once a month). If approved, the applicant becomes a member of the GHS Research Consortium and undertakes to comply with the rules of procedure. In the event of rejection, the project can be revised taking into account the comments of the Executive Committee.
B3 Legal basis
If required, a material data transfer agreement is drawn up and signed to regulate the legal aspects of data utilisation.
B4 Material transfer
Once the material data transfer agreement has been signed, the (bio)material applied for is transferred.
B5 Data generation
Scientists generate secondary data based on the (bio)material provided.
B6 Return transfer
At the end of the project, all newly generated secondary data and any remaining material will be returned to the GHS. The return of the data and material enables the sustainable utilisation of resources for future research projects.
B7 Data integration
GHS data management integrates the secondary data into the study database for further use by other researchers.