Final answer:
The ICH requires that clinical trials demonstrate substantial benefits to human health, balancing these benefits against the risks of the research. This includes advancing medical treatments and knowledge. Locally, research involving human subjects and animal testing must be reviewed by IRBs and IACUCs respectively, to ensure ethical compliance.
Step-by-step explanation:
The International Conference on Harmonisation (ICH) guidelines require that clinical studies, such as those relating to an Investigator's Brochure (IB) for a Clinical Trial, demonstrate clear benefits to human health. These benefits might include new treatments, improved therapeutic strategies, or increased knowledge around a particular medical condition.
While ICH guidelines primarily address how clinical trials should be conducted, they set a standard for how the benefits to patients and society must outweigh the risks involved in any clinical study. The ICH also has set parameters defined in various modules such as E8 and Q2(R1) that speak to the consideration for clinical trials and the validation of analytical procedures, respectively.
On a more local level, facilities using animals for research that receive federal funding must adhere to guidelines set by an Institutional Animal Care and Use Committee (IACUC) whereas research involving human subjects is overseen by an Institutional Review Board (IRB). These bodies are designed to ensure ethical research practices and to confirm that the benefits of the research justify any associated risks.