groups » Informed Consent and Community Engagement » Therapeutic Misconceptions &Legal Informed Consent

Depending with the country the researcher is conducting a Clinical Trial; the subject of IC can be quite an issue. Because Clinical Trials take place in hospitals, clinics, or some such other place where communities do normally receiver health care services, participants find it VERY difficult to have a paradigm shift and understand that a Clinical Trial is investigating a drug/device that may not work, that may have severe side effects and in some studies one can actually be on a placebo. Now such a mind set creates a crisis of expectation, what we then call therapeutic misconception – that the new ‘treatment works’. What are some of the pitfalls the investigator may fall in due illiteracy and Therapeutic Misconceptions? Here is one of many test cases - An illiterate participant is enrolled in a Clinical Trial with the help of an impartial witness. After some time in the follow-up phase, the witness dies. Participant eventually gets severe side effects, not yet observed/documented in the IB. After an investigation, it is concluded that the previously unobserved serious drug reaction is probably related to study drug. Participant sues the investigator on account of not having agreed to participate under these terms & possibilities. The investigator reverts to the signed IC document, but the participant says he never heard all these things the investigator is reading from the IC record. The literate witness has passed-on, and cannot testify to the authenticity of the document and the X made by the illiterate participant. Participant actually says he does not remember making that X!! The counselor who obtained IC is not an objective witness as she is on the side of the investigator, and is an interested party!! Is the investigator innocent or guilty of unethically including this man in the study without proper consent? This is based on a true occurrence. Before I give you the outcome of this particular case, give your own verdict!!!

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consent informed &legal misconceptions therapeutic

  • cdiaz cdiaz 3 Jan 2011

    This is a good point and this discussion is important. In our area we too experience this but I dont think it is understood well. We need to keep in mind when we write consent forms to explain all the benefits and also make clear that they have choice and still the same treatment. Some studies do provide better treatment, how can we get round this?

  • rravinetto Raffaella Ravinetto 23 Dec 2010

    I also agree that the point raised by Dorcas is very relevant. In the (even recent) past, I met monitors or auditors who thought that the Investigator must always be in charge of the consent process.
    However, the article 26 of the 2008 Helsinki Declaration says that "When seeking informed consent for participation in a research study the physician
    should be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent should be sought by an appropriately qualified individual who is completely
    independent of this relationship."

    Best wishes, Raffaella

  • akupella akupella 22 Dec 2010

    Dorcas you a very correct and make good points. We need to think about these matter carefully when asking for consent. We have often experienced confusion from our patients about what they are agreeing to and what they could expect in normal care of their condition. I am sure many times patients agree as they think all the proceedures are within research

  • Dorcas Dorcas Kamuya - Expert Committee 20 Dec 2010

    Hi Peter,
    This is a very interesting case and raises a number of issues. Often consenting process is discussed/seen/viewed as a once-off activity, and often at the point where the IC is signed. While this may work in some settings, in settings with high illiteracy levels and high likelihood of therapeutic misconception (TM); other supportive mechanisms of information giving, communication and interactivity are encouraged throughout the study period. Information in IC is repeated at almost every follow-up/encounters with the participant. Simple information and sign-posting of key messages and issues for consideration are key elements of this continuous communication. While this maybe seen as heightening and over-emphasizing some elements of research, it allows for interactive discussions throughout the study period, and requires genuine investment in time, right skills, personnel etc.

    A point for discussion is whether the study clinicians are the right people to administer informed consent in clinical trial? This is an area of much debate and will appreciate some insights. Would they, through this act (and in settings of high likelihood of TM), be making the situation worse for participants to understand and differentiate clinical care and research participation?

    While these points are not directly addressing the legality of what transpired, they point to issues that need to be considered seriously in clinical trials, and other health research.

    Looking forward to more discussion.
    Dorcas

  • rravinetto Raffaella Ravinetto 1 Dec 2010

    Hi Peter,

    it seems to me that, if the IC procedure was followed correctly, the investigator is not guilty of unethically including this man in the study without proper consent. I would add that the problem could have appeared even if the witness was still there (the patient could still contend that he does not remind having undergone the IC interview and put that X).

    However, it also seems that something went wrong with the informed consent procedure, because the patient had not properly understood the risks related to the study. This could be the "fault" of the person who administered the consent (too quick? Too focused on getting the signature asap? Unable to notice the patient's fears and doubts that were not expressed in words?); but it could have be due to/exacerbated by other barriers, for instance the difficulty to translate CR concepts into a local language. Maybe, to prevent these mistakes, the partecipation of a social scientist or cultural mediator have improved the communication to the patient?

    On a different line: was the patient treated for the adverse effects promptly and free of charge? Did he receive an indemnity (e.g., out of a no-fault policy insurance) for any long-term outcomes he suffered? This is his right, and if he has somehow felt that this right was not been satisfied, this could explain his reaction.

    Waiting now to hear of the outcome... best wishes,

    Raffaella

  • Kimbute Omari Kimbute 16 Nov 2010

    Was the procedure of obtaining IC adhered to,did the illiterate participant provide a thumb print,was the community around aware of the trial,what was a recall period?

  • kabjoana kabjoana 8 Nov 2010

    This is something I have not thought of before and I have looked at some of our consent forms, many do seem to be suffering from this misconception. It is not clear and we need to re look at our forms. Good to have made this clear to us.

  • jagarwal jagarwal 2 Nov 2010

    We have a similar experience with this business of what is a trial and what is standard care. We had a TB trial were we had put taking of x-ray in the consent form. Of course an x-ray is needed as diagnostic standard care. We found we had mistakenly made it appear in the consent form that this was part of research and therefore in the situation when they could say no to research and at the same time saying no to a proceedure they need for standard care.

  • mamulla Moses 22 Oct 2010

    This is a common problem and we need to have clear guidance on consent form writing to help researchers set out clearly what is being asked of them for research and what is already needed as standard of care.

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