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
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
Many medical professionals undergo GCP training. In abroad it is taken as a compulsory training along with the medical practices.
ReplyDeleteI am very happy to find your post!!
ReplyDeletecurrently I am getting good clinical Practice training from home.