MORGAM Manual, Material and data transfer agreements

Material and Data Transfer Agreement (M&DTA) between an MPC and the National Institute for Health and Welfare (THL): on the Use of Data and/or DNA Samples for Research into the Epidemiology of Cardiovascular Disease Form: 54 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 MPC"). This Agreement covers the transfer of data ("Phenotypic Data") from the MPC to the MDC, the transfer of samples of DNA material ("Samples") from the MPC to the MORGAM Central Laboratory, and the subsequent transfer of genotypic data derived from the Samples ("Genotypic Data") to the MPC:

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 Phenotypic Data and Samples to be transferred from the MPC to the MDC and the MORGAM Central Laboratory respectively are given in Annex I of this Agreement. If DNA extraction is performed at THL, any DNA in excess of the amount specified will be transferred back to the MPC within six months after extraction.
3. The researchers additionally agree to the following conditions:
   • The Phenotypic Data, Samples and Genotypic Data can only be used in the MORGAM Project under the supervision of the MMG. Any other use of the Phenotypic Data, Samples and/or Genotypic Data will be the subject of a fresh and separate Agreement.
   • THL reports to the MPC on the progress of the Project annually and on completion of the Project. This report can alternatively be given by the MORGAM Coordinator.
   • Upon completion of the MORGAM Project or when requested by the MPC, all Phenotypic Data, Samples and Genotypic Data will be sent to the MPC. This concerns all Phenotypic Data, Samples and Genotypic Data available at the MDC, all MORGAM Laboratories and other MPCs. Alternatively, if agreed with the MPC, the Phenotypic Data, Samples and Genotypic Data can be destroyed or archived.
4. The Samples may be transferred to the MORGAM Laboratories in Paris, Dublin, Belfast and Neuherberg subject to the authorization of the MMG. The Phenotypic Data and Genotypic Data may be transferred from the MDC to MORGAM Laboratories and other MPCs for data analysis according to the procedure specified in the MORGAM Publication Rules (see http://www.thl.fi/publications/morgam/manual/contents.htm). A representative of THL and the recipient will sign a separate Agreement before any such transfer can occur. The MPC will receive a copy of each form pertaining to it.
5. Following approval by the MMG, a MORGAM 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.
6. Genotypic data will be given back to the MPC on request, where their storage and/or dissemination to participants will depend on local circumstances in discussion with the local Ethics Committee. In the MPC it should be constantly borne in mind that the genotypic results generated in MORGAM are for research purposes only. They are subject to error in the form of labelling problems, replicatability etc, and are, therefore, quite unsuitable for clinical application at the individual level. Any result which the MPC sees as having clinical implications, must be repeated on a fresh sample of the patient's DNA before any advice is given.
7. For any transfer of Phenotypic Data, Samples and 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 data (see http://www.thl.fi/publications/morgam/manual/contents.htm).
9. The intellectual property rights concerning results derived from the Phenotypic Data, Samples and/or Genotypic Data belong jointly to the MORGAM Centres (MPCs, MORGAM Laboratories and the MDC) that directly contributed to the results.
10. The parties undertake to ensure that all persons dealing with the Samples, the Phenotypic Data and/or the Genotypic Data are familiar with this Agreement.

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

MPC:

Date:

Signature:

Printed name:

Position in organization:

Address:

THL/Chronic Disease Prevention

Date:

Signature:

Printed name:

Position in organization:

Address:

Updates to this form: