Informed consent has degenerated from an important and respectful act to a cumbersome, meaningless regulatory process that impedes research. That bluntly is the opinion of many researchers, and so a large group of them started listening with scepticism to a talk on informed consent from a bioethicist from the National Institutes of Health, Joseph Millum, last week in Washington.
Millum started from a premise that it is essential when including somebody in a research study to gain their informed consent, and there are five stages in gaining informed consent: capacity, disclosure, understanding, voluntariness, and indication of agreement. With his interest in research in developing countries, Millum concentrated on understanding and voluntariness.
It is impossible for people in studies to understand everything about a study, but it’s important that they understand and appreciate everything that applies directly to them at the time when they give consent.. Researchers have studied people’s understanding of studies for which they have given consent using a wide variety of methods. These researchers recognise that people may recall information about studies without having understood the implications and they may have understood at the time but be unable to recall much.
Millum quoted studies showing that understanding is highly variable in people giving consent for research. Between 26% and 100% of people understood the point of the trial for which they gave consent and between 18% and 100% understood the risks. Understanding of randomisation and placebo was appreciably poorer, but the studies show no categorical difference between people from developed and developing countries.
Researchers have tried to improve understanding using multimedia presentations and modified consent forms, but most studies of these interventions show little improvement. In contrast, testing whether people have understood and extended discussions did improve understanding.
Turning to voluntariness, Millum said that a highwayman stopping you, holding a gun to your head, and saying “Your money or your life” is clearly coercion. But if you have acute appendicitis, and the surgeon says “An operation or your life” is that coercion? In a sense it is, but the highwayman will gain from your money, whereas the surgeon will not gain personally from the operation. Coercion is about making people worse off.
Studies show that between 2% and 75% of people perceived pressure when giving consent for research—from family, researchers, or their illness. Then between 10% and 90% of people understood that they had the right to withdraw from a study, and here there was a clear difference between people in developed and developing countries. Those in developing countries were less likely to understand that they had the right to withdraw—which is clearly a matter of concern.
There are no general tools for ensuring that patients consent voluntarily, and it may be a particular problem in societies where the heads of households or communities traditionally give consent for everybody. It could be argued, it seems to me, that if that is the way a culture is organised then it might be acceptable for the head to give consent, and maybe researchers are imposing Western values on these societies by insisting on individual consent–but that point wasn’t addressed.
Instead, Millum described an example where researchers had found a way to get individual consent without the individual angering the head of the household by dissenting from his overall consent. The researchers wanted a specimen of blood from members of a family, and the head of the family had consented for all of them. But then the researchers saw each individual in private, and if the individual didn’t want to give blood then they stuck on a plaster anyway—so that the head would not know that the individual had declined. This act does, of course, involve deception, something that philosophers like Millum generally abhor—but here it was judged acceptable.
Having given an excellent and very clear talk, Millum then faced the wrath of several researchers infuriated by the growth of bureaucracy around research. But everybody was actually on the same side, believing in consent but wanting to minimise bureaucracy. I did, however, elicit a cheap laugh by pointing out that with the form of consent most familiar to everybody—standing at the alter and saying “I do”–you have no idea what you’re getting into.
Millum is interested to collect examples of ways in which researchers in developing countries have improved the quality of consent. If you have an example, please send it to him at firstname.lastname@example.org