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CancerGuide: Clinical Trials and Experimental Treatments

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A Guide to Informed Consent for The Active Patient
A Guide to Informed Consent for The Active Patient

What is Informed Consent?

Any doctor who wants to treat you on a trial is required to inform you that the treatment will be in a clinical trial and that you can choose whether to participate. More importantly the doctor is required to give you information about the trial to help make your consent informed. Gaining informed consent from all participants is a legal, ethical and regulatory requirement for conducting any clinical trial. Informed consent is part of every legit trial.

This article is different because it is a guide to informed consent for the active patient who has been researching the options. As an active patient you already know far more than the average patient about any trial you are considering. For you, the informed consent process is an opportunity to make sure of your understanding of the trial and... to go further.

The Standard Informed Consent Process

The informed consent process involves an extended meeting with the doctor who will treat you on the trial, and possibly other staff, such as the research nurse. The process culminates in signing of the informed consent document (or your turning down the trial). Signing means you intend to take part in the trial.

The informed consent document should include information on:

  • The nature of the treatment
  • Side effects and risks
  • Possible benefits
  • Alternatives to taking part
  • Costs
  • Your rights as a participant

Informed consent documents are necessarily written for people who don't know anything about the trial or about cancer medicine. They are also simplified to make them understandable to people with marginal literacy. If you've been researching the literature, the informed consent document should have no big surprises and you will have much additional knowledge.

The informed consent documents I've seen strongly emphasize making sure you are aware of every known risk. Truth be told, informed consents often read a bit too much like the lawyer inspired label which graces your extension ladder. Seeing every known risk in writing can be scary even if you already have a good understanding of the treatment. It was for me. It helps to keep in mind the difference between likely side-effects and rare complications and between temporary side effects and permanent damage. The better informed consent forms will make these distinctions.

The informed consent document typically doesn't discuss the prior evidence for the treatment in any great detail, and I have never seen one which actually attempts to give you significant information about other options. They normally just say other treatment may be available and leave it for you to discuss with your doctor. In short, no one could be informed just by reading the informed consent document.

Despite all of this, the informed consent document is worth a careful read. No matter how much you think you know, you don't know it all. Chances are you'll learn something from it. I certainly did!

Informed Consent Versus Informed Choice

The informed consent process is focused on one particular trial. Informed consent is not designed to give you detailed information about all your options and allow you to make an informed choice. To be able to make an informed choice you need to research all of the available standard treatments and clinical trials. You can always ask about other options at the informed consent meeting but you can't realistically expect to get an objective survey of all of your options there. For one thing, a doctor who wants to treat you on a trial may have less than an objective view of the merits of that trial as treatment.

Active Informed Consent

While you should read the informed consent document carefully, the major opportunity in the informed consent process is an extended chance to ask questions and get additional detailed information about the trial. In no way is the informed consent discussion limited to the document or to discussing what is in the document. Anything you want to know is fair game.

How To Get the Most Out of the Informed Consent Meeting:

  • Confirm Your Understanding of the Trial

    • As you no doubt realize, it's easy to misunderstand technical literature. I recommend you use the informed consent meeting to carefully confirm your understanding of the data with respect to both efficacy and side effects. This mainly means discussing it with the doctor in detail. Details about efficacy especially, aren't likely to be discussed in the informed consent document.

  • Ask for the Protocol Document

    • This would be an excellent time to ask for a copy of the protocol document if you don't already have it. The protocol document the complete plan for the trial and defines every aspect of how the trial will be run. It is both incredibly informative and incredibly technical. The protocol document is not the informed consent document. The protocol document starts with a scholarly introduction to the treatment describing its history and rationale - complete with references to the technical literature. It's just the information you need if you're trying to understand the treatment and the evidence for it. You'll also find all the details on side effects, dose and schedule, and more.

  • Ask for Papers

    • Most doctors involved with clinical research have the relevant papers in their files. My experience was that they were quite willing to share these papers with me as soon as it was clear that I was into reading the literature. I suggest asking the doc for copies of the major papers he's got on the treatment. Even if you have some of them, you might not have all of them - and remember, abstracts you may have gotten from MedLine or elsewhere are not the same as complete papers.

  • Take Your Time

    • Don't feel pressured to make your decision at the first meeting. You have every right to take as much time as you need to think about it. If you're not ready to decide at the end of the first meeting, don't hesitate to ask for a second meeting. If you've gotten a stack of new papers or the protocol document, you're sure to need time to read and digest this information, and when you're done you'll probably have more questions.

      Even if you don't come away from the first meeting with new documents to read, other questions may occur to you after the meeting is over. Even if you did sign at the first meeting, you can and should ask any questions which occur to you afterwards. And remember that you can change your mind about participating at any time, even if you've already signed the informed consent.



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This CancerGuide Page By Steve Dunn. © Steve Dunn
Page Created: October 10, 2002, Last Updated: October 1, 2003