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In the LifeLines Biobank, biological materials like serum and urine are a limited resource. This article describes the application to use these materials.
For the use of biological materials, highest priority will be given to studies that:
a. Are using existing data and results according to the purpose of LifeLines (so without any use of additional samples)
b. Have the highest scientific merit
c. Can not be covered as fully using alternative sources of biological materials (e.g. a blood bank) or a single survey
d. Require low demand of LifeLines resources and amount of materials consumed
In addition, priority for studies requesting biological samples will be highest if they:
a. clearly state their choice for and number of samples to be analysed using adequate power calculations
b. use the laboratory and / or DNA facilities of the LifeLines Biobank and / or UMCG to perform the requested additional analyses
c. do not make use of samples from those participants with the fewest samples
d. in case of additional analyses: use the smallest sample volume possible, and use samples which have been thawed earlier whenever possible
e. desire assays which can be done on more than one sample type to allow selection of the most abundant type available (e.g. EDTA plasma)
f. can be integrated with other studies to conserve sample or limit freeze-thaw cycles.
The proposed Scientific Project must not interfere with other parts of the LifeLines Cohort Study, nor hamper continued participation of LifeLines participants. The investigators must have adequate resources to effectively complete the full project, including sufficient budget and staff having the requisite expertise to meet the objectives of the project, as deemed justified and sufficient by the director(s) of the LifeLines Study and Biobank.
LifeLines reserves the right to limit the transfer of specific data when they can jeopardize the strict anonymity, confidentiality and other aspects of protection of human subjects.
Applicants who are based at foreign research institutions must have a Dutch collaborator and document that the project may contribute to scientific development in Dutch research.
In the rare occasion that analyses are performed outside of the UMCG, the investigators must agree to return the complete set of data and results of all determinations back to the central database of the LifeLines Cohort Study, in order to maximize the results of analyses performed in the materials, and to avoid duplicate measurements. All quality assessment and quality control data need to be disclosed to LifeLines. Samples can only be shared with scientific research institutions, and direct commercial use or use by an outside for-profit entity is not allowed based on legal and informed consent agreements. All samples will be de-identified, but are marked with specific laboratory codes. By this, results of analysis and any remaining materials may be returned to the database. It is not allowed to perform any measurements or determinations outside those agreed upon in the contract. The applicant must show that it is analytically possible to solve the stated problem by analysing the requested biological materials from LifeLines, and also document the skills and capacity to carry out the specified analyses in an acceptable manner and within a reasonable time. In addition it is mandatory to show that the volume and sample type for which is applied is necessary and sufficient to perform the analyses.
The samples that are available for almost all participants, are:
1. serum (taken either with or without gel separator)
2. EDTA plasma
3. citrate plasma
4. DNA
5. early morning urine sample
6. urine samples of 24-hour urine collection
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