Scientific Concept of the National Cohort (status ... - Nationale Kohorte

Contents
A.6.4.2 Minimally detectable odds ratios in main effects models ..............181
A.6.4.3 Interaction effects between genetic and nongenetic
(“environmental”) risk factors ...................................................... 184
A.6.4.4 Effects of random measurement errors and
use of repeat measurements ........................................................185
A.6.4.5 Statistical power for studies of sensitivity and
specificity of diagnostic markers for early detection ......................187
A.7 EThICAl ASPECTS ..........................................................................................191
A.7.1 Invitation letters and informed consent ................................................. 191
A.7.1.1 Information for potential participants ..............................................191
A.7.1.2 Informed consent ...........................................................................191
A.7.1.3 Voluntariness and withdrawal ........................................................193
A.7.1.4 Risks ..............................................................................................193
A.7.1.5 Expense allowance ........................................................................195
A.7.1.6 Participant insurance .....................................................................195
A.7.2 Procedures for ethical clearance of National Cohort proposals ........ 196
A.7.2.1 Regulatory framework .................................................................. 196
A.7.2.2 Data protection ..............................................................................197
A.7.2.3 Data handling ................................................................................197
A.7.2.4 Data access ................................................................................. 200
A.7.2.5 Provision of health information to participants .............................. 203
A.7.2.6 Communication of study results ................................................... 204
A.7.2.7 Value for the public and strategy to involve the public .................. 205
A.7.3 Pre-evaluation of the proposed study from an ethical perspective ... 205
B mANAGEmENT Of ThE NATIONAl COhOrT ............................................ 207
B.1 Background ................................................................................................ 207
B.2 Scientific and administrative management ........................................... 208
B.2.1 Scientific management ................................................................ 209
B.2.2 Legal entity providing the managerial backbone
for the National Cohort .................................................................214
B.3 data use and access policies ................................................................... 218
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