Final answer:
The ICH documents are based off of ethical standards including integrity, informed consent, patient rights, institutional review boards (IRBs), record-keeping and confidentiality, and humane treatment of animals.
Step-by-step explanation:
The ethical standards that the ICH documents are based off of include:
- Integrity: Clinical trials must be conducted with integrity.
- Informed Consent: Patients and research subjects must provide informed consent, demonstrating an understanding of the study's purpose and risks involved.
- Patient Rights: Patients' rights must be respected.
- Institutional Review Boards (IRBs): Procedures must be approved by an IRB to ensure compliance with ethical principles.
- Record-Keeping and Confidentiality: Accurate record-keeping, honest communication, and confidentiality are paramount when working with patients.
- Humane Treatment of Animals: Animals used for research must be treated humanely and protocols must be approved by an institutional animal care and use committee.