Research ethics and ethics review

This branch covers the ethical standards research on people is held to and the ethics review a study goes through, and its parts divide by the question a reader brings: the standards and the hard cases they leave open, or the review of a particular study, from whether it needs review to how a report states its approval. It leaves good clinical practice, what ICH E6(R3) makes each party answerable for and the quality a trial's conduct is held to, to good clinical practice and trial quality, the information a participant consents from to informed consent materials for a clinical trial, participants' personal data to data protection in clinical research, what a sponsor must make public about a trial to transparency and disclosure, and the honesty and credit of the published record to research and publication integrity.

• Ethical standards in human research — where the codes governing research on people came from, and the hard cases they leave open: weighing the participant against society, asking for participation where trust has eroded, research where the trial is the only route to care, allocating an experimental drug in short supply, consent to the use of tissue and cell lines, investigators who experiment on themselves, editing the human germline, and the questions no rule settles
• Ethics review — deciding whether a study needs review and which standards apply, how committees are organised and reason, writing the application, and stating approval and compliance in a report or manuscript