Good Clinical Practice (GCP) is international guideline to ensure that clinical trials are designed, conducted, implemented, monitored, audited, recorded, analyzed, and reported scientifically and ethically. It also aims to protect human subject rights, integrity, and confidentiality. In 1997 GCP became effective, though not legally acknowledged at that point. In 2004, in the United Kingdom/Europe GCP became a legal obligation for all clinical trials involving investigational products which the FDA requires today.
According to the GCP guidelines all clinical trials should be conducted in compliance with ethical standards, clear scientific proof, and benefit overweigh risk; and a clear well-documented protocol is required. Obtaining an informed consent and affirming confidentiality. The trial staff should receive adequate training along with their appropriate qualifications. Data should be documented accurately and easily accessible and available. Manufacturing the investigational products should be in accordance with Good Manufacturing Practice (GMP) guidelines
Informed consent requirements in clinical trials
The process of informed consent is tailored to inform the subject of rights, risks, and benefits when participating in a clinical trial. Informed consent is an essential element for conducting an ethical research that involves human subjects. As an outcome of the 1974 National Research Act Belmont Report was issued in 1979 in the United States. This report serves as guidance for biomedical and behavioral researchers to find a summary of the basic ethical principles to protect human subjects basically: beneficence, justice, and respect for individuals. The process of informed consent is crucial in achieving these principles. However, to further protect human subjects, the informed consent process involves the verbal discussion with the possible subject along with the paper document. The Principal Investigator is accountable to explain the informed consent and determine that the subject has understood the information clearly and given his/her voluntary approval for participating in a particular trial .
When obtaining the informed consent from the subject or their legally guardian, the possibility of coercion or undue influence must be minimized. The informed consent document (ICD) should contain information in an understandable language to the subject, thus ICD, advertisements, and other study-associated documents may require translation as well, if necessary, having a person on site to answer queries. The ICD language should not seem to disregard or ignore any subject rights or exempt any of the clinical research stakeholders from liability for negligence. The aim, the expected length of the study, and all required procedures the subject will go through should be stated clearly in the ICD. In addition, ICD should describe the risks, the benefits of the research for subjects or others, other treatment options, and confidentiality of subjects’ data