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.
The regulations for emergent use of an investigational device do not pertain to non emergent situations. In a highly mobile society, a patient’s legally authorized representative may not be locally accessible.
Can informed consent for use of an investigational device be obtained by electronic communications- phone, fax, e-mail, video chat?
The regulations, 21 CFR Part 50.25 lists all the elements to be included in an informed consent. And 21 CFR subpart B – informed consent of human subjects does not exclude oral consent, however 21 CFR Part 50.27 states… “use of a written consent form Approved by the IRB and signed and dated by the subject or the Subject’s legally authorized representative.”
All parties in research from the sponsor, to the primary investigator and research coordinator, including the monitor should be well aware that “Informed Consent” is a process not just a document.
So can this process occur by phone?
Documentation of Informed Consent, 21 CFR Part 50.27, requires a written informed consent approved by the IRB, but can this be read to the Legally Authorized Representative?
Does having a third person witness the discussion and agreement to participate in the research, satisfy this requirement?
As we embrace technological advances in all aspects of our lives, should we incorporate technology (email and video chatting) in the informed consent process? We are eager to hear your thoughts on these questions.
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