Figures
- Figure 1
Flow chart of parental permission requirements.
- Figure 2
Flow chart of child assent requirements.
Tables
- Table 1
Conditions to be met in emergency clinical study
• Subjects affected by a life-threatening condition • The treatment is experimental • The clinical research allows verification of both the effectiveness and safety of the treatment • It is impracticable to obtain consent • The waiver of informed consent is needed for the clinical trial • The researcher will contact the legally authorised representative • The family members can decline the patient’s participation in the study - Table 2
Conditions to be met in research studies involving pregnant women and fetuses
• In vivo studies have also been conducted on pregnant animals • Clinical studies have been conducted on nonpregnant women • Clinical findings assessing potential harms to pregnant women and fetuses are available • The risk to the fetus is minimal and caused exclusively by the procedure/intervention • The study will achieve crucial knowledge not obtainable by any other means • The researchers will have no part in any decision influencing fetal viability or pregnancy • No incentive will be provided to influence the course of pregnancy - Table 3
Consent signature requirements for pregnant women and children
For pregnant women Direct benefit to mother Mother# Direct benefit to mother and fetus Mother# Direct benefit to fetus Mother and father# For children Direct benefit to individual subjects One parent or guardian# No direct benefit to individual subjects Both parents# No direct benefit to the subject or societal (indirect) benefit Both parents# Medical care related to pregnancy Parental consent is not needed Medical care related to mental health treatment, or the diagnosis or treatment of infectious, contagious or communicable diseases Parental consent is not needed Self-sufficient minors Parental consent is not needed Aged ≥15 years Living alone Managing their own financial affairs Emancipated minors Parental consent is not needed Married or divorced On active duty in the US armed forces By a court Having the legal right to consent on their own behalf to medical, dental or mental health treatment #: consent requirements are the same whether the risk is “no more than minimal” or “more than minimal”.
- Table 4
Studies that may involve prisoners
• Studies on the possible causes, processes and effects of incarceration • Studies on prisons as institutional structures or on prisoners as incarcerated persons • Studies on special conditions affecting prisoners • Studies on practices of improving the health or well-being of the prisoners • Epidemiological studies
Vol 14 Issue 2
Table of Contents
How to obtain informed consent for research
