Access and use of study data and biomaterial

 

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:

  • Authorisation is granted after submission and examination of a clearly defined research question
  • A standardised application procedure applies to all participants, regardless of whether secondary data is being generated or existing data is being analysed

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:

  • Project management
  • Background and aims of the project
  • Study data required
  • Case number considerations
  • Project group

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:

  • Project management
  • Background and aims of the project
  • Planned measurements
  • Required (bio)material

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.