The GHS has established clear guidelines for access to and use of its study data and biomaterials. These are enshrined in the GHS’s rules of procedure.
Objectives and Principles
- Primary Goal: Use of study data for scientific purposes and provision of such data for research
- Objective: Maximizing the benefits derived from the collected data and sample material for health-related research
- Availability: Broad accessibility of the data and sample material for internal and external researchers
Access Policies for External Researchers
External researchers may apply to use data and biomaterial if they: 1. enter into a collaboration with the GHS, 2. contribute to the study (e.g., by generating secondary data), or 3. bring specialized scientific expertise to the project.
Terms of Use
The use of biomaterial and/or study data is subject to strict regulations set forth in the rules of procedure to protect the rights of study participants. These guidelines ensure the responsible use of GHS’s valuable resources while promoting scientific progress through a wide range of usage options:
- Approval is granted after the submission and review of a clearly defined research question.
- A standardized application process applies to all parties involved, regardless of whether the project involves the generation of secondary data or the analysis of existing data.
A1 Proposal Submission
Researchers submit a data use proposal containing the following information:
- Principal investigator
- Background and objectives of the project
- Required study data
- Sample size considerations
- Project team
For projects undertaken as part of academic qualification, specific application forms are available within the Academic Career Development Program.
A2 Approval Process
The GHS Executive Committee reviews all projects involving the use of study data. The Executive Committee meets approximately once a month and assesses the feasibility of the proposed project as well as potential overlaps with existing projects. Upon approval, the applicant becomes a member of the GHS Research Consortium and agrees to comply with its Rules of Procedure. If a proposal is rejected, it may be revised and resubmitted taking into account the comments of the Executive Committee.
A3 Statistical Analysis Plan
Following approval of the proposal, a Statistical Analysis Plan (SAP) is generally required.
The Statistical Analysis Plan serves as the basis for compiling the study dataset. Consultation on the Statistical Analysis Plan is available and particularly recommended for early-career researchers.
A4 Legal Framework
If required, a data transfer agreement is prepared and signed to govern the legal aspects of data use.
A5 Data Provision
Once the data transfer agreement has been signed, the requested study data are made available.
A6 Data Analysis
Statistical analyses are generally performed by the GHS Central Statistical Unit. Researchers with the appropriate expertise may conduct the analyses themselves. GHS statisticians are available to provide methodological and statistical support.
A7 Manuscript Preparation
The results are summarized in a manuscript for publication. Authorship is determined in accordance with the principles of Good Scientific Practice and the ICMJE recommendations.
A8 Manuscript Review
Prior to publication, the Executive Committee formally reviews the manuscript, including the correct presentation of the study and appropriate acknowledgment of all funding sources.
A9 Publication
The manuscript is published in a scientific journal.
B1 Proposal Submission
Researchers submit a proposal for the use of (bio)materials, the generation of secondary data, or the use of the study for research proposals and projects. The proposal contains the following information:
- Principal investigator
- Background and objectives of the project
- Planned measurements
- Required (bio)materials
B2 Approval Process
The GHS Executive Committee reviews and approves all proposed projects at regular meetings (approximately once a month). Upon approval, the applicant becomes a member of the GHS Research Consortium and agrees to comply with its Rules of Procedure. If a proposal is rejected, it may be revised taking into account the comments of the Executive Committee.
B3 Legal Framework
If required, a material and data transfer agreement is prepared and signed to govern the legal aspects of data and material use.
B4 Material Transfer
Once the material and data transfer agreement has been signed, the requested (bio)materials are transferred.
B5 Data Generation
Researchers generate secondary data based on the provided (bio)materials.
B6 Return Transfer
At the end of the project, all newly generated secondary data and any remaining material are returned to the GHS. Returning the data and materials enables the sustainable use of these resources for future research projects.
B7 Data Integration
The GHS Data Management team integrates the secondary data into the study database for further use by other researchers.
The following rules apply to manuscript approval and publication:
- The researcher responsible for the project coordinates the manuscript with the project group.
- Authors are given an appropriate amount of time to review, comment on, and contribute to the manuscript.
- The final manuscript is submitted to the Executive Committee for formal review. At least ten working days must be allowed for the review process.
- Final approval of the manuscript is communicated in writing to the principal investigator by the GHS Study Management.
As a general rule, the GHS Research Consortium is included in the author list of all publications. The following provisions apply:
- For projects using the structure and data of the GHS, the GHS Research Consortium is included in the author list.
- All members of the GHS Research Consortium who meet the criteria for authorship in accordance with the principles of Good Scientific Practice and the recommendations of the International Committee of Medical Journal Editors (ICMJE) must be individually named in the author list to ensure appropriate recognition of their scientific contributions and indexing by third-party databases.
- An author may be listed both in the main author list and in the list of members of the GHS Research Consortium in a separate section of the article.
- The GHS Research Consortium is included in the author list in recognition of its contribution to the development and conduct of the scientific study. This applies regardless of whether all members of the consortium actively contributed to the specific research project and therefore formally meet the criteria for authorship.