Interview with Harriet Washington (Part IV): Erosion of Informed Consent and Using Poor Patients to Test Drugs They Cannot Afford to Purchase

Consent and Non-Consent

I learned a great deal from the section of your book on informed consent and other forms of consent. Anyone who has been to a health practitioner’s office in recent years is at least somewhat familiar with signing an informed consent form. Could you explain this concept and also the related but very different concepts of presumed consent and community consent?

Informed consent is more than a signed piece of paper. I don’t blame people for thinking that it is because even some physicians tend to equate informed consent with the signature on that paper. The signature is one piece of evidence that you could offer in support of your claim that there is informed consent, which for a research study requires a detailed discussion that runs down all the information that’s known about the study, what it’s trying to do, how and why it was designed, and what the patient’s options are if they choose not to participate in the study. You must reveal to them all the known risks and logically anticipated risks.

As the study progresses, when new developments occur (perhaps it’s that the medication is especially helpful for one group of people, or that some people are having some awful adverse effects), all of this needs to be conveyed to the research subjects. Also, patients need to know that they have the right to leave the study at any time.

So this is about preserving the rights of the patient or research subject, allowing him or her to make choices freely, based on accurate information.

Yes. With true informed consent, the patient is in the best position to determine whether participating in the study is the best course for him or her. But even the best job of informed consent can’t tell one everything. There are things the investigator may not know about a drug or a device — that’s why it’s being tested. So informed consent is not a guarantee, but it’s your best possible avenue for preserving the subject’s right to making an informed decision. It’s about protecting people.

But unfortunately, in this country, we have started falling away from informed consent in ways that lack transparency. People assume that in every medical research study, you are going to be given the benefit of informed consent. In reality, we now have exceptions written into the law. In certain emergency medicine studies, you do not have to tell the person what you’re doing. You don’t have to explain and you don’t have to get permission.

This is what’s known as “presumed consent?”

Yes. Actually there are a variety of forms of consent that are misleading. They have the word “consent” in their name but they do not constitute informed consent. Presumed consent means that if there is a study going on, the researcher does not even have to tell you that they are involving you in the study. This not only applies to research studies; it can pertain to the taking of tissues.

In half the states of this country there are cities where if you die, the coroner has the right to take parts of your body and use them for research or transplantation. There are large fees paid; a great deal of money changes hands. No one has to tell your family that this has been done. In Philadelphia, corneas are routinely taken from people who have passed away and this is sanctioned by law. The families of the victims are not informed that this has been done. That is presumed consent.