Final answer:
Only subjects capable of informed consent may participate in non-therapeutic research studies according to ICH and FDA guidelines. Violations occur when participants are misinformed or undue incentives are offered. Informed consent involves clear communication of study risks, the voluntary nature of participation, and may require parental consent for minors.
Step-by-step explanation:
The requirement that only subjects who are capable of giving informed consent may enroll in non-therapeutic clinical trials is a foundational principle of both the International Council for Harmonisation (ICH) and the U.S. Food and Drug Administration (FDA). Informed consent ensures the principle of autonomy by requiring that participants have a clear understanding of the study's risks and lack of direct benefits. Potential violations of this requirement could include offering inmates in correctional facilities incentives for participating in a study, withholding information about the distribution of a new medication during a trial, or improperly informing participants about the nature of a study, such as exaggerating the potential benefits of a medication without disclosing the use of placebos or traditional treatments.
To ensure informed consent, an Institutional Review Board (IRB) must approve a study before commencement. Researchers must also adhere to guidelines like obtaining written consent from participants after fully disclosing the details of the study. This includes risks, benefits, and the voluntary nature of participation. For pediatric studies, parental or guardian consent is necessary. In America, the process for FDA approval of new therapies involves thorough testing, including collecting preclinical lab data and submitting an Investigational New Drug (IND) application. The drug undergoes clinical trials to establish effectiveness and safety before a New Drug Application (NDA) submission. Any safety concerns can lead the FDA to impose a clinical hold.