Hello everyone. I work in clinical trials in urban slums around Rio in Brazil. We work mainly on infectious diseases and with mothers and children. I wanted to raise some of the issues that we face during the consent process.

Many of the sponsors we work with provide us with very long information sheets. We find these difficult to work with as there is too much information. Whilst I personally agree with all that ICH-GCP says needs to go in these forms there is often much more detailed information that goes beyond these and I think is counter productive.

We also run other sorts of clinical research studies and trials that do not involved a new drug or vaccine and for these studies we are not sure what we should be including in the consent forms. We tend to keep these forms much shorter, and still put in those main points that GCP requires. Our experience with these forms is that they are much easier to work with and that we seem to get a better level of understanding from the mothers. Our staff certainly feel more comfortable working with them.

Do others have similar experiences and maybe some examples of consent forms that they would be happy to share?

Reply

  • Hallo, I think this is quite an ubiquitous problem. I have heard many times, for instance, European AIDS activists complaining about the lenght and complexity of informed consent forms, which sometimes seem to be written by a Legal Department rather than by medical persons, as if they were there primarily to protect the sponsor (!).
    The Ethics Committees in the study countries should, in my opinion, play a key role in checking that the consent form reaches a good balance between completeness of the information and "understandability" for the target population. Did you often get comments from the ECs on the format and contents of long informed consent forms?

  • jchandra jchandra 2 Aug 2010

    I entirely agree. Most forms are too long and that we come to expect them to be pages and pages as that is what we are now used to. It would be good if anyone has examples to show us of good short ones. We also have many types of study and they all do not need the same detail. This is a difficulty we experience.

  • pwmuchina Patricia Njuguna 3 Aug 2010

    In our study we have a consent committee which reviews the consents and advises us. What has been the effect was that they recommend making the information concise so the parents would understand the messages rather than have a 15 page booklet sign but informed consent not obtained

  • Roma Roma Chilengi 4 Aug 2010

    Dear Palma,

    This is indeed a common challenge especially when we have to work with "not so literate" communities.

    Developing generic consent templates which are adjusted to fit in study specific information does help. As Patricia says, we are endowed with a support mechanism through the consent committee that developed such templates and also help review the ICF information for each protocol.

    But you are right that we need to base our procedures on fundamental ethical principals. In this regard, ensure that sufficient information is provided, in an appropriate language and if your can squeeze information to two pages or less.

    It is a difficult issue.

    Best regards,

    Roma

  • Waweru Waweru 10 Aug 2010

    this is very interesting and thank you for bringing it up. i think the primary objective of the informed consent is to provide the participants with the relevant information they require to make a decision whether or not to participate in the trial. usually the detailed consent forms have a lot of technical information that may not easily be understood by the participants, ore so where you are dealing with the "not so literate" community. one way of breaking down this information is by having video clips with basic information about the study and study participation that participants can watch while in the waiting area. It then becomes easier for them to understand the consent information.

  • jchandra jchandra 11 Aug 2010

    That is a new idea, I have not come across the use of video before. Do you have any examples that you could place on this website? It would be good to see how you do this. Do you have to show this to the ethics committees and what is their view? Thank you for this nice idea

  • srpfranzen Sam Franzen 15 Sep 2010

    Our consent forms for studies that do not involve investigative products are fairly short (about 3-4 pages) but cover all the main points of GCP. In the waiting room, we show participants videos giving general education on the study topic and then individually show them a video of the informed consent form being read by a native speaker. I have an example consent form which our group is happy to share for those that are interested. Alternatively many research governance offices and institutions have example forms to help you design your own. The NIH Clinical Research Guide Toolkit provides lots of resources and information on this: http://www.nhlbi.nih.gov/crg/toolkit.php

  • sunnyoyakhirome Sunny Oyakhirome 2 Dec 2010

    the law has no problem with the lenghten document: there is just a problem of operationalizing it and I think this lies with industry, researchers, EC, RA and systems in place, I will talk about this in my next communication

  • sunnyoyakhirome Sunny Oyakhirome 2 Dec 2010

    the law has no problem with the lenghten document: there is just a problem of operationalizing it and I think this lies with industry, researchers, EC, RA and systems in place, I will talk about this in my next communication

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