The Informed Consent Process I - The start of a Series

Today’s installment kicks off a series concerning the informed consent process. ICH-GCP defines informed consent as a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.


Informed Consent for the purpose of Clinical Trials is something completely different than Informed Consent for the purpose of regular medical practice. Regular informed consent can be defined as a legal procedure to ensure that a patient or client knows all of the risks and costs involved in a treatment. The elements of informed consents include informing the client of the nature of the treatment, possible alternative treatments, and the potential risks and benefits of the treatment.

It is absolutely crucial to distinguish well between the two. Here is the core of the difference:

Medical practice Informed Consent is a practice to protect primarily the healthcare professional, documenting that the patient was informed of all aspects of a treatment, reducing the chance of a law suit at a later time.

Clinical Research Informed Consent is a practice to protect primarily the potential trial subject, documenting the that subject was informed of all aspects of a trial, which parts are experimental, what are the potential risks and possible benefits, etc., to enable the subject to make an informed decision on whether or not to take part in a clinical trial.

Industry representatives are likely to talk about the latter, clinical professionals are likely to think about the first, in countries where the medical practice informed consent is a very common part of practicing medicine. It is up to up all to ensure we are all talking about the same thing, when discussing Informed Consent.wow gold

Source Documentation for Legally Acceptable Representative

In a trial where Legally Acceptable Representatives (LARs) are being used to obtain consent on behalf of the potential subject, it is important to maintain proper source documentation of the procedure.

To demonstrate that valid consent was obtained, the site should request and keep a copy of legal documentation to support that the LAR indeed is legally acceptable as a representative for this potential subject.

Reagan's 'Trust, But Verify' can here be adapted to 'Trust, Verify and Document'. Informed consent is too important a topic to take lightly, and consent by LAR without documentation of the legality of the representative is inadequate consent.wow gold

Legally Acceptable Representative vs Impartial Witness

ICH-GCP describes a 'Legally Acceptable Representative' as 'an individual or judicial or other body authorised under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.' (1.37)
A Legally Acceptable Representative (LAR) only consents on behalf of a prospective subject if the subject is unable to give consent. (4.8.5).
The LAR is distinctly different from an impartial witness. in 4.8.9 ICH-GCP clearly indicates that an impartial witness is used if a subject (or the LAR) is unable to read.
Sponsor companies may request the counter signature of a witness more often than ICH stipulates, and some request it as a matter of standard procedure. Doing more than the miminum standard of ICH-GCP is certainly allowed.
The easiest way to distinguish between the function/use of the Impartial Witness vs the LAR is to think about who really consents. If it is the subject himself who consents, and is able to consent, no LAR is needed. The LAR is only intended for those situations where the subject is unable to consent. For example in case of underage (not 'of the age of consent') subjects, mentally impaired subjects or trials set in emergency situations.
In all the situations where a subject is unable to consent and still included in the trial, it was foreseeable. We don't do trials including vulnerable subjects (and a subject who is unable to consent is by definition vulnerable) unless we have no alternative, and in which case the IRB/IEC has specifically approved of the use of such subjects and of the informed consent procedure used.
A witness never consents on behalf of a subject. A witness, by signing, attests that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject's LAR and that the consent was given freely.wow gold