'Just Sign the Form': Informed Consent, Medical Research and You

May 14, 2010 | Updated Nov 17, 2011

Log onto any website for plane tickets, theater tickets, or books and invariably you'll get the screen: "Scroll down to read the terms, and click 'I accept.'"

We all get it, and most of us end up blindly accepting, rather than wading through screenfuls of legalese.

But what do we do when the agreement concerns informed consent, our own health and who has access to our DNA or sensitive medical information?

"I didn't really understand the form," a man recently told me in my office. "I just signed it. I trusted the doctor."

This man had recently decided to enter a medical study. Researchers had then proceeded to put an experimental substance into his body. His comment disturbed me, but I also understood it completely, having myself given up reading every disclaimer that comes with modern day living.

The recently announced settlement between Arizona State University and the Havasupai Indians, however, brings the difficulties of informed consent documents into sharp focus. A researcher had drawn blood from the Indians, who live in the Grand Canyon, saying she would study why the tribe had high rates of diabetes. Instead, other researchers from her university had obtained the samples, and published studies about rates of schizophrenia, and the fact that the tribe originated from Asia, not the Canyon itself, as the group traditionally believed.

Some of the issues in that case are relevant to the decisions that millions of patients face each day when asked to sign various kinds of consent forms in doctors' offices -- to receive care or participate in research concerning genetics or other areas.

To resolve these problems, some critics feel that we simply need more regulations, or that researchers should merely provide more information to subjects over extended periods of time.
These approaches may help, but several key problems remain that we all need consider and address.

Many regulations concerning informed consent already exist. But these guidelines are invariably somewhat ambiguous and open to interpretation. It is not clear, for instance, how to measure, weigh, and accurately describe "possible future risks."

Perhaps more importantly, critical underlying tensions also persist: how much detail should physicians and researchers provide to "inform" patients without overwhelming them? How informed is "informed enough?" Who should make these decisions, and how? Researchers need to provide more details to many subjects, but some consent forms are already 45 pages long!

Moreover, science of course involves uncertainties. Studies are increasingly complex, involving experimental drugs and tests with possible but unclear side effects. Researchers clearly don't yet have all the answers. If they did, they wouldn't need to perform the study. As a result, vast ambiguities remain that then have to be explained - concerning risks, and precautions that are being taken to prevent these.

We also don't know what new technologies, tests, and questions will emerge in upcoming years. Hence, we simply don't know all the future possible uses of blood samples. This fact does not justify carte blanche by any means. Many pharmaceutical and biotech companies would like to obtain as many DNA samples on as many people as possible, to look for profitable, patentable discoveries. This motive could potentially lead to abuse.

Researchers could try to recontact all participants, but at times that is impossible -- patients can move, get sick, or die. Moreover, even when scientists do locate participants, dilemmas clearly remain as to what exactly should be explained, and how.

Ethical conflicts exist, too. Science can offer enormous social benefit, but can also pose harms. At the core then, lie key questions for our polity to decide: Should we give scientists some flexibility -- in order to discover treatments that may help humanity in ways that we cannot even yet imagine -- and if so, how much, in what ways, and when? Who should decide, and how?

Furthermore, consent forms are supposed to require no more than an 8th grade reading level -- the level at which the average American reads -- but it is not clear how to explain complicated scientific procedures and uncertainties in a way an 8th grader would understand. The vast majority of these documents are far too advanced.

Though computer programs analyze these forms to measure reading grade levels by counting the number of words per sentence, and the average number of syllables per word, some researchers find it easier to "game" the system. They simply shorten the length of their sentences and avoid long words, rather than actually making sure that people can understand the text.

Recently, researchers have begun to explore the use of video and 'picture books' to help explain to patients the details involved. Several of these new approaches show promise. But we still have a long way to go.

Another tension is whether these forms are legal contracts or educational documents. Some say a document can readily be both. But that is often not the case.

Unfortunately, we live in an increasingly overly litigious world. Doctors and researchers get sued even when they have done nothing wrong. If these documents are legal, a lawyer may feel that key details are lost in simplification. A legal contract also can't include all possible details and unforeseeable events.

In addition, health insurance still under-funds time spent between doctors and patients to communicate. The average visit to the doctor is only 11 minutes, including a physical exam. Research grants similarly are often cut in ways that minimize time spent between investigators and patients.

The NIH has begun to provide small amounts of funding to study how best to communicate with potential research subjects to figure out what patients find is important to know. But this funding needs to drastically increase, in order to help address these tensions. Many NIH institutes fund little if any research concerning these issues. Some critics have argued that a National Institute of Bioethics should be created within the NIH. Cases such as this one should at least encourage consideration of such an approach.

Ultimately, trust is crucial here, but is increasingly fragile and rare. Our health care system remains fractured, and multi-national drug companies seek to profit from research participants. Whether intentionally or unintentionally, this trust has at times been violated and betrayed, as with the Havasupai.

We need far more public debate and discussion about these issues - about the role of scientific research in our everyday lives.

In the mean time, what should we do? Participants should not be afraid to speak up, ask questions, and first take the document home to show a friend or family member. Or ask for the doctor or researcher to mail them a copy in advance. They need to be aware that they have a right to withdraw at any time, and if they feel something is amiss, to speak to the investigators or even, if need be, the IRB. Researchers at times fear and resist the exercise of these rights, and act defensively. But instead investigators should welcome openness and transparency.

In the end, all of us as individuals -- as scientists, physicians, patients, family members, and citizens -- and as a society need to work together far more to address these issues, to rebuild and maintain trust. It will not be easy.

But in the end, both we and future generations of researchers and patients can gain.