- Is Longer Always Better?
A team of researchers proposes to conduct a study in which participants will be randomized to one of two versions of an informed consent form in order to compare their usefulness. Many argue that consent forms for research studies are often seriously flawed. They are growing in length and complexity, becoming ever more intimidating, and perhaps inhibiting rather than enhancing participants’ understanding. Participants may not even read them, much less understand them.
The study is part of a larger project aimed at developing a new treatment for avian influenza. The goal of the protocol is to find ways of generating and collecting viral antibodies from the blood of healthy subjects after injecting them with an avian flu vaccine. The vaccine—already approved by the Food and Drug Administration at a lower dose—has been studied in about 450 people. The approximately 150 people participating in the new study will receive the highest dose used in previous studies, which about fifty people have received without serious side effects. They will be randomized to have the vaccine injected into either their buttocks or an arm to see which location is better for producing viral antibodies. Blood will later be drawn on three or more occasions so that researchers can extract antibodies.
The primary risks of participating are side effects from the vaccine. Most subjects will have mild pain and tenderness at the injection site. Based on what happened in earlier studies, some subjects will develop severe pain and tenderness and flu-like symptoms. More serious risks, including allergic reactions, are possible, though none occurred in previous studies. Participants will also be exposed to the risks and discomforts of having their blood drawn.
The initial consent form developed by the avian flu vaccine researchers is ten pages of single-spaced text. In the sub-study comparing consent forms, participants would be randomized to receive either the regular consent form or a concise form that is about three and a half pages but covers all of the categories of information required by applicable federal regulations.
The investigators propose that the usual informed consent requirements be waived for the substudy. Prospective subjects will be told that a consent sub-study is taking place, but they will not be presented with an additional form or have a separate consent interview. They will simply be asked if they are willing to be randomized to one of two consent documents. If they agree, they will receive one of the forms, but will not be told which one. If they decline, they will be sent the longer form.
Should the institutional review board agree and let full informed consent be waived?
As described here, both substudy consent documents satisfy the disclosure elements delineated in the U.S. federal regulations. The forms differ only in that one uses a simpler and shorter presentation. A study that seeks to empirically assess whether a more concise consent document improves research participants’ understanding poses no risk, as long as the document provides information on the specific elements required by current human subjects regulations.
This is a bold claim. Why accept it? First, substantial data indicate that current consent documents are less than optimal. They are usually written at least at a high school reading level, are frequently repetitious, and contain many technical terms. More importantly, on many measures, research participants do not fully understand the research protocols they are enrolled in. While the level of participants’ understanding may be sufficient for what is commonly considered informed consent, many do not grasp randomization, cannot name important side effects, or do not know their alternatives. There is clearly room for improvement.
Second, there is no “gold standard” for informed consent documents. Empirical research has not demonstrated what style, form, or length of written document enhances participant understanding. Consequently, we have no reason to believe that longer, more detailed forms are better than concise, less detailed forms, or vice versa. Nor do we know whether repeating certain information enhances or undermines understanding. Additional research to learn [End Page 10] how to improve research participant understanding is therefore essential.
Consequently, there is no known...