The Norwegian Institute of Public Health hosted the meeting at Hotel Opera, Oslo (Norway)
Participants:
|
Helena |
Anderson |
(HA) |
Karolinska Institutet, Sweden |
|
Ingunn |
Brandt |
(IB) |
Norwegian Institute of Public Health, Norway |
|
Alun |
Evans |
(AE) |
Queen’s University Belfast, Northern Ireland |
|
Elisabeth |
Hagen |
(EH) |
Norwegian Institute of Public Health, Norway |
|
Jennifer |
Harris |
(JH) |
Norwegian Institute of Public Health, Norway |
|
Homa |
Hasan |
(HH) |
Norwegian Institute of Public Health, Norway |
|
Jenny |
Jonsson |
(JJ) |
Uppsala University, Sweden |
|
Mats |
Jonsson |
(MJ) |
Uppsala University, Sweden |
|
Kirsten |
Ohm Kyvik |
(KK) |
University of Southern Denmark, Denmark |
|
Jan-Eric |
Litton |
(JEL) |
Karolinska Institutet, Sweden |
|
Kirsten |
Møyner |
(KM) |
Norwegian Institute of Public Health, Norway |
|
Thorbjørn |
Rønning |
(TR) |
Norwegian Institute of Public Health, Norway |
|
Kaisa |
Silander |
(KS) |
National Public Health Institute, Finland |
|
Anne Maria |
Skrikerud |
(AS) |
University of Oslo, Norway |
|
Anne |
Cambon-Thomsen |
(AT) |
Directorate of CNRS Epidemiology and Public Health, France |
|
Gunnel |
Tybring |
(GT) |
Karolinska Institutet, Sweden |
|
Mikko |
Virtanen |
(MV) |
National Public Health Institute, Finland |
Ethics Meeting Programme
|
Time |
Topic |
Presenter |
|
12.00 |
Welcome, Introductions and Purpose of the meeting (lunch served during meeting) |
Jennifer Harris |
|
12:30
|
Overview of current status (consents and approvals and renewed consents) Problems and Dilemmas faced by centres |
Homa Hasan |
|
12:50 |
Genetic analyses & procedures to date |
Kaisa Silander |
|
13:20 |
Break |
|
|
13:30 |
Data base structure and procedures to date |
Jan Eric Litton |
|
13:50 |
Genotypic data How will genotypic and phenotypic data be linked? What data security measures are needed? What will data base look like? Where will data be stored? Who will have access to the data? Who owns the data during the project? What happens when the project is finished? Reporting information back to participants |
Chaired by: Jennifer Harris & Jon Eric Litton |
|
15:10 |
Coffee Break |
|
|
15:20 |
Biosamples Country specific regulations for transfer, returning and destroying of samples Length of time to be stored? Consents for shipping out of the country Intellectual rights issues after project end |
Chaired by: Homa Hasan |
|
16:00 |
Procedures & Guidelines for: What can we learn and adopt from MORGAM? (incorporating information discussed during meeting) |
Chaired by: Alun Evans |
|
17:00 |
Wrap up |
|
|
17:30 |
Adjourn |
|
JH described the structure of the GenomEUtwin Ethics Core and the purpose of the meeting. This included an overview of the current status of the project with emphasis on consents, genetic analysis and the database structure. The main purpose was to discuss ethical and regulative issues related to handling, analysis, and access to data and biosamples.
HH presented an overview of the currents status for consents, approvals, and renewed consents in the participating centres. In summary, Finland, The Netherlands and Denmark have completed all approvals. Sweden must obtain consent for molecular genetic analysis. Italy is in process to obtain consent from new participants, and Norway is almost complete with the Ethics Committee approval and in process with the Data Inspectorate application and obtaining consents from participants. Two new pieces of Norwegian legislation, which came into force since the beginning of the GenomEUtwin project necessitated additional information material and consents for participants. This required new applications to both the ethics committees and the Data Inspectorate.
KS gave an overview of the procedures involved in handling biological samples and the genetic analyses in GenomEUtwin and MORGAM. Specific guidelines are present on the GenomEUtwin website regarding practical information on sending samples to Helsinki (labelling etc). KS pointed out that no material transfer agreement forms (MTAs) are completed to accompany samples that are sent to the DNA core Centre in Helsinki. The importance of developing such MTA forms, establishing routines for filling out MTAs when samples are transferred between the participating centres and for outlining general guidelines for transfer of samples were discussed. Standardised procedures need to be developed for transferring biological samples and genotyping results for GenomEUtwin. Forms need to be developed for:
· Samples sent from PCs to the genotyping core in Helsinki
· Transferring sample from Helsinki to Uppsala
· Transferring remaining sample and data from:
- Helsinki to PCs
- Uppsala to PCs
The national regulations on transfer of data material between countries were discussed. Each representative of the GenomEUtwin countries present commented on the regulations in their respective country.
Compare national regulations on transfer of data material between countries (HH)
Review the MORGAM handling procedures for transfer of samples (HH Liason with AE+KS)
Outline Material Transfer Agreement Forms (MTAs) and set up a document that lists requirements by sample (HH/JH with liason with AE+KS).
JEL presented an overview of the database structure and outlined solutions for long and short-term data handling and storage. JEL emphasised co-ordination between the Epidemiology, Database, Statistical and Ethics core. (link to presentation)
He summarised four key requirements for the GenomEUtwin database solution:
1. Genotype and phenotype data should be kept in separate databases
2. Phenotype data must be in full control of national centres
3. Anonymous genotype data is less sensitive and can be collected into one repository under conditions of limited access
4. Secure database infrastructure
· Discussion – Genotypic data (Chaired by JH/JEL)
The purpose of the discussion was to highlight ethical and regulative issues related to transfer and handling of data, access to data, ownership of data, and data security measures. Several agenda items came up during the discussion.
- Handling of data in long term and short term perspectives was discussed in length. This was highlighted in the case of the length of storage of datasets specifically constructed for use in manuscripts. It was agreed that it is important to outline guidelines for both long and short-term solutions. JEL’s key requirements will be implemented in both solutions.
Establish a committee who will outline guidelines for long and short-term data handling - JH will contact people for inclusion.
Sub-question: Who has access to the data outside GenomEUtwin?
- The routines for handling and storing data vary in the participating institutions. It was agreed that it is important to develop common standards for storing raw material data.
Outline a backup plan for raw material data (ideally housed in another country)
JEL suggested that one PI for GenomEUtwin should be appointed who would co-ordinate and give the ‘go ahead’ regarding data accessing.
Find out more about the IBM Scholar Programme to submit to the steering committee – JEL
· Discussion – Biosamples (Chaired by HH/JH)
During the discussion regulative and ethical issues on transfer and handling of samples was brought up. Storage of samples, national regulations for shipping samples out of the country, and intellectual property rights were also discussed.
- In many of the participating countries the participants in a study have the right, according to national laws, to ask for and receive information about their samples and their results. Communicating results back to the participants in GenomEUtwin poses many ethical and practical questions.
The GenomEUtwin protocol states no results will be routinely given to participant, however, it further states a request for information will be dealt with on a case-by-case basis.
AT commented on the possibility of tracking twin samples through the GenomEUtwin process on request by a twin. No follow up action taken at this point due to procedural difficulties.
HH to contact PCs to find out if there are (and the nature of) routines for communicating results back to the participants. This information will be evaluated to see if further procedures need to be developed
Follow up procedures for putting lay-level information (results) and activities of GenomEUtwin on the webpage – HH liaison with a representative of all PCs and webmaster
AE presented experiences from the MORGAM project on ethical issues, material and transfer agreements, intellectual property rights, and rules for release and ownership of data. The experiences in MORGAM can be helpful for meeting many of the problems discussed in the meeting. The documents and forms used in MORGAM are available on the internal pages on the MORGAM website. These pages will be made available to GenomEUtwin ethics core members.
Discussion on handling Intellectual Property Rights (IPR) looked to MORGAM guidelines but these were not universally encompassing, in the end IPR issues are dealt with on a case by case basis. Under the 6th European framework, a policy on IPR is obligatory. Universities in Denmark are obligated to file patents where possible
Longitudinal research studies (in the future) may be obliged to clarify to participants the financial status of results generated (possibly in the consent form or information letter).
The steering Committee must take steps to address this issue, liaison may be needed with the EU Scientific Board