Compliance In Focus

The informed consent process is arguably one of the most important parts of a clinical research study. From the Principles of ICH GCP: the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. Proper informed consent ensures that the patient is aware of the risks and requirements of being in a research study and has voluntarily agreed to participate in research.  The regulations, CFR part 50 also cover the importance, rules and process of informed consent.

As we enter 2013, how often do you find yourself in a city different from your relatives? In an emergency, many hospitals have policies and procedures to obtain consent for treatment from your legally authorized representative by phone, email or fax.  When a research subject is unable to participate in the informed consent process, and their Legally Authorized Representative cannot physically sign for them, should this automatically exclude them from participating in clinical research? Can a discussion via video chat or phone, well documented, satisfy the requirements?

The informed consent process is arguably one of the most important parts of a clinical research study. From the Principles of ICH GCP: the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. Proper informed consent ensures that the patient is aware of the risks and requirements of being in a research study and has voluntarily agreed to participate in research.  The regulations, CFR part 50 also cover the importance, rules and process of informed consent.