Ethical standards in human research

This branch covers the principles that govern research on people and the hard cases they leave open, and its members divide it by the question a reader brings: where the codes came from, or which hard case is at stake. It leaves ethics review of a particular study and what a report states about it to the branch on ethics review, the information a participant consents from to the branch on informed consent materials for a clinical trial, the ICH guideline itself to the topic on good clinical practice as a standard, what that guideline makes each party answerable for to the topic on roles, responsibilities and oversight in a clinical trial, and participants' personal data to the topic on data protection in clinical research.

• Where the codes governing research on people came from — the codes from the Ten Commandments to ICH good clinical practice and the tragedies and abuses many of them answered, informed consent before the Second World War, the abuse of vulnerable people in postwar vaccine research, the move to committees of experts, and privacy in EU regulation
• Weighing the participant against the society a study serves — what a participant accepts for society's benefit, trial design in cancer, the burden of data that will never be used, and how many participants a trial enrols
• Asking for participation where trust in research has eroded — trust eroded by bad research and misinformation, encouraging participation without coercion, and the Gelsinger gene therapy case
• Research where the trial is the only route to care — coercion when a trial is the only care on offer, consent and approval in the field, whether a study should run without full protections, what a prevention trial owes its community, and the protections and consent a study placed in another country owes its participants
• Allocating an experimental drug in short supply — who received the few doses of an experimental remedy in the 2014 West African Ebola epidemic, the reasons given, and why scarce drugs tend not to reach people from developing countries
• Consent to the use of tissue and cell lines — the HeLa and WI-38 cell lines taken without consent, consent and privacy under UK tissue law in 2012, and who owns tissue once it is removed
• Investigators who experiment on themselves — what self-experimentation is, the discoveries it led to, that review boards would be unlikely to approve it, and the question they should still ask researchers
• Editing the human germline — editing somatic cells against editing embryos, the debate and rules on embryo research, the line drawn at enhancement, how safe a first trial would have to be and who decides, effects on people and society, and the first gene-edited births
• Ethical questions no rule settles in research on people — the gray zone left to the professionals who conduct, market and recruit for a study and to physicians, whistleblowing, whether more research should study how regulations work, questions unique to long-term space research, and citing a valid source of unethical origin