MORGAM Manual, Material and data transfer agreements

Material and Data Transfer Agreement (M&DTA) between the National Institute for Health and Welfare (THL) and MORGAM Laboratories: on the Use of DNA samples for Research into the Genetic Epidemiology of Cardiovascular Disease Form: 52 Version: 2 Date: 28.3.2009

© National Institute for Health and Welfare and the MORGAM Project investigators Last updated: 28 March 2009 For more information, please contact Kari Kuulasmaa (firstname.lastname@thl.fi)

MORGAM is a multinational study of the epidemiology and genetics of cardiovascular disease morbidity and mortality. It is coordinated by Prof. Alun Evans, Department of Epidemiology and Public Health, Queen's University Belfast, in consultation with the MORGAM Management Group (MMG). The Project brings together DNA samples and phenotypic data from population cohorts in a number of countries; the samples and data in different countries have been collected by MORGAM Participating Centres (MPCs). The MORGAM Central Laboratory at the Department of Chronic Disease Prevention at THL collects DNA samples from MPCs, when necessary prepares DNA, undertakes genotyping and transfers aliquots of DNA to MORGAM Laboratories where additional genotyping is carried out. The MORGAM Data Centre (MDC) at THL obtains phenotypic and genotypic data from the MPCs and MORGAM Laboratories, and provides phenotypic and genotypic data to MPCs and MORGAM Laboratories for data analysis.

The Department of Chronic Disease Prevention at THL hereby enters into a research collaboration with

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(hereafter called the "Laboratory"). This agreement covers the transfer of DNA samples ("Samples") from the MORGAM Central Laboratory to the Laboratory, the use of these Samples in the Laboratory, and the subsequent transfer of genotypic data derived from the Samples ("Genotypic Data") to the MDC:

1. The parties mutually agree to carry out a Project called MORGAM (as defined above), which aims to publish high quality peer-reviewed papers.
2. The specification of the Samples to be transferred and specific details of the work performed in the Laboratory, including the genotyping plan, are given in Annex I of this Agreement.
3. The researchers additionally agree to the following conditions:
   • The Laboratory will send the Genotypic Data to the MDC without undue delay.
   • The Samples can only be used in line with Annex I of this Agreement; any other use of the Samples will be the subject of a fresh and separate Agreement.
   • The Laboratory reports to the MMG on the progress of the Project at every meeting of the MMG, on completion of Project and whenever reasonably requested to do so by the MORGAM Coordinator or the Head of the MDC.
   • Upon completion of the MORGAM Project or when requested by the MORGAM Coordinator or the Head of the MDC, the Samples and Genotypic Data will be sent to THL. Alternatively, if agreed with the MMG, the Samples and Genotypic Data can be destroyed, archived or sent to an MPC.
   • In the event that the Laboratory receives phenotypic data relating to the Project it undertakes not to make any linkages to the DNA samples obtained for genotyping.
4. Any results generated by the Laboratory are for research purposes only.
5. The Samples may be transferred to other MORGAM Laboratories subject to the authorization of the MMG. The Genotypic Data may be transferred from the MDC to MORGAM Laboratories and MPCs for data analysis according to the procedure specified in the MORGAM Publication Rules (see http://www.thl.fi/morgam/manual/contents.htm). A representative of THL and the recipient will sign a separate Agreement before any such transfer can occur.
6. Following approval by the MMG, the Laboratory may subcontract genotyping to another laboratory. There must be a written contract for this, and the subcontractor shall have no rights to the samples or the resulting data.
7. For any transfer of Samples or Genotypic Data, other than specified above, special arrangements will be made in conjunction with the MMG and the MPCs concerned.
8. The MORGAM Publication rules will be followed for all publications derived from the Genotypic Data (see http://www.thl.fi/publications/morgam/manual/contents.htm).
9. The intellectual property rights concerning results derived from the Genotypic Data and/or Samples belong jointly to the MORGAM Centres (MPCs, MORGAM Laboratories and the MDC) that directly contributed to the results.
10. The Laboratory undertakes to ensure that all persons dealing with the Samples and/or the Data are familiar with this Agreement.

IN WITNESS WHEREOF the parties have executed this Agreement by their respective Officers hereunto duly authorized:

Laboratory

Date:

Signature:

Printed name:

Position in organization:

Address:

THL/Department of Chronic Disease Prevention

Date:

Signature:

Printed name:

Position in organization:

Address:

A copy to be sent to each MPC concerned.

Updates to this form: