Final answer:
The question refers to the ICH guidelines that dictate the documentation an IRB or IEC should review before approving clinical research to ensure subject safety and ethical conduct. The documents required often include informed consent forms and comprehensive research plans.
Step-by-step explanation:
The query pertains to ICH (2016) E6 Section 3.1.2, which outlines the documentation requirements for Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs) involved in clinical research. According to this guideline, the IRB/IEC needs to review several critical documents before approving a research proposal. These documents often include informed consent forms, research plans, and protocols that ensure the safety and ethical treatment of human subjects. The informed consent forms are particularly vital as they provide subjects with detailed information on the research, including its risks and benefits. Additionally, for studies involving minors, these consent forms must be signed by parents or legal guardians.
For research that includes animals, an Institutional Animal Care and Use Committee (IACUC) ensures compliance with the National Institutes of Health (NIH) guidelines, which includes regular inspections of laboratories.
It is essential to note that the IRB process at a university level is part of a broader effort to safeguard research participants, ensuring that the risks are minimized and informed consent is obtained, which is a key protection mandated by law. This ensures that research ethics are strictly followed respecting the integrity and welfare of human participants in scientific studies.