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. 2016 Dec 21;25(3):293–300. doi: 10.1038/ejhg.2016.172

Table 2. Access criteria.

Main category No. of access policies addressing this category No. of access policies specifying this category      
  Explicit Implicit N.a. Yes No Criteria Subcriteria Count
1. Scientific quality 33 26 15 52 22 Quality safeguard Peer review 13
              Quality management 2
              Reliability of preanalytical measurements methods 1
            Methodological quality Sound methodology 17
              Sound sample size 13
              Feasibility 10
              Relation to existing research 10
              Sound research question 5
              Reproducibility 2
              Consistency 1
            Capacities and infrastructure Relevant expertise of researchers 19
              Sufficient resources and funding 16
              Sufficient infrastructure 8
              Possibility for cooperation and networking 7
2. Value 12 19 43 25 49 Scientific value Scientific research purposes only 24
              Contribution to scientific knowledge 12
              Novelty and innovation 9
              Proportionate sample size 3
              Typology of resources 3
              Potential to increase the quality of the samples or data sets 1
              Expected audience for results 1
            Health-related value Expected impact on clinical practice 4
              Expected impact on public health 1
              Utilitarian value 1
              Individual benefit for participants/donors 1
3. Ethical soundness 14 42 18 54 20 Adherence to ethical principles Independent ethical approval 43
              Conformity with biobank statutes 16
              Conformity with current ethical standards, laws and regulations 13
            Participant/donor protection Conformity with donor consent 24
              Risk of identification of participants/donors 7
              Data protection 8
              (Re-) Contacting 6
              Potential harm to donor compliance 3