Issuing of data and/or biological samples
Pseudonymised data and/or biological samples are issued for the purpose of research by the Institute of Genomics of the University of Tartu (hereinafter referred to as the Estonian Biobank). This is based on the Human Genes Research Act.
The Estonian Biobank issues the following materials:
- descriptions of state of health and lifestyle (phenotype data)
- genetic data
- biological samples:
1. Preliminary request
In order to use the data and/or biological samples of the Estonian Biobank, a preliminary request must first be submitted via the e-mail address releases [ät] ut.ee.
The following data must be submitted in a preliminary request:
- information about the applying institution;
- the objective of the request (wish to obtain data and/or biological samples);
- the phenotype criteria or other features on the basis of which the sample of data and/or biological samples to be issued is prepared;
- the amount of biological sample requested per gene donor;
- the sample size;
- the specific nature of the research for which the data and/or biological samples will be used;
- a description of and justification for the research project:
o the title of the research project;
o the institutions participating in the research project;
o the responsible researchers and main performers of research;
o the duration of the research;
- the name and title of the applicant.
The preliminary request is processed by the coordinator of data issuing in cooperation with the applicant and researchers and analysts from the Estonian Biobank. The coordinator shall send the applicant a response to the preliminary request stating:
- whether it is possible to issue data and/or biological samples from the Estonian Biobank that comply with the preliminary request criteria;
- the approximate cost of issuing the data and/or biological samples.
The information provided by the Estonian Biobank based on the preliminary request works as an input for preparing the request for assessment to the Estonian Committee on Bioethics and Human Research.
2. Request to the Estonian Committee on Bioethics and Human Research
Data and/or biological samples can only be requested to be issued if the Estonian Committee on Bioethics and Human Research (hereinafter referred to as the Committee) has positively assessed the research. Processing of the request by the Committee takes approximately 1-3 months. In the case of research conducted by a legal person, international research involving multiple centres or applied research, the fee for reviewing a request is 250 euros. There is no fee for public research or development institutions. If a request is solely for statistical summaries, the Committee’s assessment is not required.
If it is requested that biological samples (DNA, blood plasma) be stored and studied outside of the Republic of Estonia, the permission of the Senate of the University of Tartu is required in addition to the positive assessment of the Committee. The Senate’s permission must be applied for in cooperation with the Estonian Biobank.
3. Request to the Estonian Biobank
A request to issue data and/or biological samples must include all of the data submitted in the preliminary request and the Committee’s positive assessment of the research.
The request must be submitted via the e-mail address releases [ät] ut.ee.
4. Contract for issuing data and/or biological samples
The Biobank and the person requesting the data and/or biological samples shall enter into a contract.
5. Issuing of data and/or biological samples
The Estonian Biobank shall prepare the data and/or biological samples and issue them to the applicant on the basis of an issuing protocol.
Following the completion of the research, it is the contractual obligation of the performer of the research to:
- send the Estonian Biobank the data resulting from the analysis conducted during the research;
- return or destroy any remaining biological samples;
- destroy the data.
The research results enrich the database of the Estonian Biobank.