MORGAM Manual, Material and data transfer agreements

Material and Data Transfer Agreement (M&DTA) between an MPC, MORGAM Biomarker Laboratory (MBL) and the MORGAM Data Centre (MDC): on the Use of samples for Epidemiological Research Form: 55 Version: 2 Date: 30.10.2012

© National Institute for Health and Welfare and the MORGAM Project investigators Last updated: 30 October 2012 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. Kari Kuulasmaa of the MORGAM Data Centre at the National Institute for Health and Welfare (THL), Helsinki 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 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 MPCs and MORGAM Laboratories are assigned by the MMG and they are posted at   http://www.thl.fi/morgam/participant_list.html.

The use of data and DNA samples in MORGAM is covered by the M&DTA between an MPC and THL on the Use of Data and/or DNA Samples for Research into the Epidemiology of Cardiovascular Disease (Form 54). This agreement (Form 55) covers the extension of MORGAM to transfer serum or plasma samples from an MPC to the MBL for analysis and the transfer of the resulting data to the MDC.

The Department of Chronic Disease Prevention at THL and Universitätsklinikum Hamburg-Eppendorf / Department of General and Interventional Cardiology / University Heart Center (UKE, hereafter called "MBL") hereby enter into a research collaboration with

(name of organization:) _______________________________________________________________

(hereafter called "the MPC"). This Agreement covers the transfer of serum or plasma ("Samples") from the MPC to the MBL, the use of these Samples in the MBL, and the subsequent transfer of phenotypic data derived from the Samples ("Data") to the MDC and 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. Samples will be transferred from the MPC to the MBL for the analysis of biomarkers in the BiomarCaRE Project (Biomarker for Cardiovascular Risk Assessment in Europe, EU Grant agreement no: 278913). Any Sample in excess of the amount needed for the analysis will be transferred back to the MPC within six months after the laboratory analysis unless otherwise agreed.
3. The MBL will send the Data to the MDC without undue delay. The Data will be considered in the MDC as "Phenotypic data" as specified in the M&DTA between an MPC and THL on the Use of Data and/or DNA Samples for Research into the Epidemiology of Cardiovascular Disease (Form 54).
4. The researchers additionally agree to the following conditions:
   • The Data and Samples can only be used in the MORGAM and the BiomarCaRE Projects under the supervision of the MMG or the BiomarCaRE Steering Group, whichever oversees the specific use. Any other use of the Data and/or Samples shall be the subject of a fresh and separate Agreement.
   • MBL reports to the MMG on the progress of the Project at every meeting of the MMG, on completion of the 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 MPC, the Samples and the Data will be sent to the MPC. This concerns all Samples and Data at the MBL, MDC and other MORGAM Centres, excluding data in system backups which are necessary for assuring the security of the data, but where the removal of the data is impossible without setting other research data under risk. Alternatively, if agreed with the MPC, the Samples and Data can be destroyed or archived.
5. On approval of the MMG, the Samples may be forwarded for analysis to another Laboratory. In such a case, no data on the subjects shall be transferred to the Laboratory, and the Laboratory shall have no rights to the Samples or the Data derived from the Samples. Any such analysis of the Samples will be the subject of a separate Agreement signed by MBL, THL and the Laboratory. The MPC will receive a copy of each form pertaining to it.
6. The 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). The MPC will be informed prior to any such data transfer and the data transfer will take place unless advised otherwise by the MPC within 28 days of the posting of the notice. 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.
7. The Data will be given back to the MPC on request.
8. For any transfer of the Samples and Data, other than specified above, special arrangements will be made in conjunction with the MMG and the MPCs concerned.
9. The main aim of the results generated by the MBL are for research purposes. The intellectual property rights concerning results derived from the Samples and/or Data belong jointly to the partners that directly contributed to the results. At no time will the industry have access to the individual level MORGAM data.
10. The MORGAM Publication rules will be followed for all publications derived from the Data (see http://www.thl.fi/publications/morgam/manual/contents.htm). However, depending on the negotiations with industry (see item 9), the industrial partner may be given access to the results up to 90 days prior to submission for publication in a journal in order for them to evaluate potential commercialization.
11. The parties undertake to ensure that all persons dealing with the Samples and/or the Data are familiar with this Agreement.
12. The MPC certifies that the necessary ethical approvals are in place.
13. The Parties to this Agreement shall adhere to all applicable European, national and local data protection laws and regulations.

Where the above conditions are in conflict with the BiomarCaRE Consortium Agreement, the latter takes precedence.

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:

Universitätsklinikum Hamburg-Eppendorf:

Date:

Signature:

Printed name:

Position in organization:

Address:

THL/Department of Chronic Disease Prevention:

Date:

Signature:

Printed name:

Position in organization:

Address:

 

Updates to this form: