Final answer:
Both the ISO 14155:2011 GCP standard and the FDA regulations address the informed consent process, ensuring research participants are properly informed about a study before agreeing to participate.
Step-by-step explanation:
The issue addressed in both the ISO 14155:2011 GCP standard and the FDA regulations is the informed consent process. This process involves informing a research participant about what to expect during an experiment, any potential risks, and the implications of the research, and then obtaining their consent to participate. This ensures respect for the individual's autonomy and protects their welfare and rights during the research. The FDA also has guidance documents which outline similar expectations regarding the informed consent process, highlighting this as a matter of compliance in clinical research involving human subjects.