L
Lactating. SeeBreastfeeding
Legally authorized representative 37, 54, 61 - 63, 65, 67
Local 3 - 5, 13, 17, 21 - 23, 26, 30, 35, 41, 45, 47, 52 - 54, 73, 78, 80, 87, 89, 90
Long-term studies 33, 35
Low-resource settings viii, ix, 3 - 5, 7, 17, 19, 22, 23, 26, 45, 47, 52, 75 - 77, 80, 89, 92
M
Management (of risks) 8, 42, 45, 48, 51, 85, 95 - 97
Material Transfer Agreement 41, 45
Minimal risk 9, 13, 15, 16, 18, 38, 62, 65, 66, 71, 72, 80, 88, 100
Minor increase above minimal risk 13, 18
Mitigation 11, 15, 76, 85, 95, 97
Modication of informed consent 33, 37
Money 54, 103
Multi-centre research 87, 89
O
Observational ix, xii, 16, 53, 72, 78
Online 27, 83 - 85, 106
Opt-out/opt-in. SeeInformed opt-out/opt-in
P
Parent 65, 67, 68, 101
Payment 54, 88, 101
Permission 35, 38, 54, 58, 59, 61 - 63, 65, 67 - 71, 79, 80, 81, 83, 101
Placebo 9, 15 - 19, 35, 78, 80
Post-trial access. SeeContinued access
Pregnant women 7, 8, 58, 70 - 73, 101
Privacy 68, 83 - 85, 92, 93, 100, 101, 104, 106
Procedures xi, 9 - 12, 15, 17, 19, 23, 26, 33 - 35, 37, 38, 42, 53 - 55, 59, 61, 62, 65 - 67, 71,
76 - 80, 87 - 90, 95, 97, 100 - 103
Protocol 2, 12, 18, 23, 25, 35, 36, 43, 49, 55, 56, 58, 76, 83, 87 - 90, 92, 96, 99, 101, 102, 105
Public accountability 11, 13, 29, 31, 51, 91
Publication ii, 29, 31, 84, 91, 92, 95, 102
R
Registries 36, 38, 39, 47, 49, 51, 72, 91
Rehabilitation 55, 104
Reimbursement 53, 54
Research ethics committee 2, 9, 10, 12, 15, 17, 18, 23, 25, 27, 33, 34 - 39, 41, 43 - 45, 47,
49 - 51, 53, 54, 56, 58, 61 - 63, 65, 68, 71, 73, 79, 85, 87 - 91, 95, 96, 98, 102, 103, 105
Residual tissue 41, 43, 44
Responsiveness 3, 4, 17, 19, 63, 75, 76
Return of results 44, 45, 51
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INTERNATIONAL ETHICAL GUIDELINES FOR HEALTH-RELATED RESEARCH INVOLVING HUMANS