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Is a signed informed consent document legally binding or not?

  • jmueller Jenny Mueller 30 May 2012

    The ‘Informed Consent’ to participate in a clinical trial on a medicinal product is legally binding in European member states, based on the European Directive 2001/20/EC, and the US according to 21 CFR Part 50, as the requirement is imbedded in their laws. As a law is only binding within the jurisdiction (eg a state), the question whether the informed consent is legally binding or not can only be answered in my opinion for a certain country or region. In Germany, for example, investigators can be prosecuted if they fail to obtain informed consent in clinical trials on medicinal products.
    The above mentioned European Directive defines informed consent as ‘decision, which must be written, dated and signed, to take part in a clinical trial, taken freely after being duly informed of its nature, significance, implications and risks and appropriately documented by any person capable of giving consent (…). To my knowledge there is no legal requirement to assess the comprehension of the information provided.

  • graciousjojo George Odhiambo Awino 29 May 2012

    By asking a participant to enroll into a study and obtaining informed consent is to ensure that participants are capable, hence must be given the opportunity to choose what shall or shall not happen to them. Other than showing respect and seeking legal bond with a participant, the researcher still must observe ICH GCP guidelines and regulatory requirements for the conduct of Clinical Trials to guarantee safety of participants. this will complement the informed consent.

  • Htorres Htorres 28 May 2012

    Hello everybody. I am very glad to have stumbled across this thread!!

    I am a doctor based in South America but I work on some multicentre studies, and I was actually discussing this in relation to standard care (rather than research) recently with a colleague so this is very timely and I am interested in what others might think about the crossover from SOC to clinical work! In our discussion, we came across this article from the Journal of Medical Ethics http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2598120/ - extract as below:

    "Under pressure from the academic community, patient advocacy groups and European Union institutions, informed consent is gradually being introduced into clinical practice in the Czech Republic. First and foremost, the consent of the patient for all surgical procedures and participation in clinical trials is formally confirmed by a document of informed consent. At the formal level, the principle of informed consent is therefore perceived as binding, but on the other hand a great many experiments are being made with regard to its content, and above all it is being made to serve a purpose other than the one for which it was intended. Rather than for the protection of the patient, informed consent has been considered far more important for the legal protection of the doctor. ... Situations have even been recorded in which the informed consent is formulated as a priori agreement to anything that turns out to be necessary in the course of the operation."

    n.b. the artivcle is about informed consent in the Czech Republic but I think that in general the information is applicable across countries.

    I think this is a very interesting point, about informed consent applying not just to be legally binding for the patient but also serving a dual purpose as a safety net almost/for the legal protection of the doctor. I am interested in what others think about this!

    Thank you, Global Health Trials colleagues!

    Helmutt

  • pdiaz Dr P Diaz 28 May 2012

    This is very interesting, and thanks for your informed opinion Nino! It seems that the answer to this question is not well-known, and I myself am also unsure. I do know that any refusal to enter a trial IS of course legally binding, so this makes sense in line with what Nino suggests earlier about the binding applying to the participant's understanding of the trial process.

  • nshiukashvili Nino Shiukashvili 25 May 2012

    Hi Magata

    I'm really new here, but think soon will be very familiar to all of you.
    What about "legally bound", I have discussed this issue with lawyer when first our company initiated to conducted clinical researches. Informed Consent word by word means the consent from one part (patient, client, research participants) to be aware of all the potential risks and costs involved in a treatment or procedure.
    Of course after giving this Consent volunteer/patient has obligation to subordinate the rules described in Consent. And there is a point in this Consent about volunteer/patient rights of withdrawal.

  • cmagata C Magata 25 May 2012

    Hi Nino

    nice to hear from you (and I can see from the members list that you are a new member - a very warm welcome to you!).

    I am really interested in what you say about informed consent. What is actually 'legally bound', then? Is it legally binding the participant to agreeing they understand the trial and what is involved? So the 'binding' is just in the sense of binding them to agreeing that they understand, and cannot later say that it was not fully explained to them, for example?

    Of course they retain the right to withdraw from the trial so therefore they aren't in any way 'bound' to the trial.

    Thanks!

  • nshiukashvili Nino Shiukashvili 25 May 2012

    OK. Informed Consent is absolutely legally binding document. It is a summary of the clinical trial (with procedures, hazards, benefits and etc volunteer/patient must expect) explaining the rights of volunteer/patient and by signing the document volunteer/patient gives official consent to participate in the trail. It is one of the mandatory documents for clinical trail and in case the patient is not able to give it (children, unconscious patients and etc.), the legally acceptable representative must sign it.

  • cmagata C Magata 23 May 2012

    Hello,

    this is a very interesting question. Like Amina, I don't know the answer - however, I would have thought not because the participant can withdraw from a study at any time, so even if it was legally binding presumably it would not actually apply in a trial situation?

    I am interested to hear other's thoughts on this metter!

  • aawasthi amina awasthi 22 May 2012

    Well what an interesting and challenging question to set us as a global clinical trial community. Well done - and very important and informative. I am based in India and I can honestly say that I do not know the answer! Does anyone? My assumption is that it varies from country to country. Maybe it is a legal document in the US or EU. So please colleagues let us know?