When Opting Out Is Not an Option

Henrietta Lacks did not give researchers permission to take her cancer cells and study them. After she died in 1951, her family was not asked permission as her immortalized cells were used in countless laboratories. This month, the National Institutes of Health finally took a step in righting that wrong, announcing that the Lacks family would help decide who can access Henrietta’s DNA.

Today, getting a patient’s permission, often in writing, is standard in experimental medical research. Well, not always. Currently, there are at least nine ongoing studies involving 62 U.S. cities and towns with a combined population of more than 45 million that do not involve getting permission. They take place during emergencies, such as when ambulances arrive at an accident where patients are too injured to give permission.

For example, imagine this scenario based on a recent study sponsored by the University of Washington. You are involved in a car accident. Paramedics find you bleeding severely. They give you fluids to keep your blood pressure up, but they intentionally give you a bag of fluid that is smaller than the standard. Then they monitor your medical outcome and compare it with patients who received the larger amount of fluids. During the emergency, neither you nor your family know about the study.

Vital research

Research on medical emergencies is vital in determining how to care for people with life-threatening injuries because we often do not have proof that standard methods are the best. People involved should be told that is how their records are being used.

In 1996, the Department of Health and Human Services and the Food and Drug Administration passed regulations allowing research about emergency treatment to occur without permission. For a study to qualify, patients need to have a life-threatening conditioncurrent standards of care must be unproven or performing poorly, and obtaining permission must not be feasible (such as an unconscious patient or a patient whose condition does not allow time for informed consent).

Since that time, the field has been growing. There are now large studies that span multiple cities. One federally funded study looking at medications given in cardiac arrest involves more than 10,000 emergency medical service providers in Dallas, Seattle, Birmingham and seven other cities in the U.S. and Canada, serving a population of nearly 15 million.

Because victims in emergencies are vulnerable, federal regulations require researchers to first hold discussions with the public to hear concerns. How this is done is left to individual research teams and the local institutions that oversee them. Despite researchers’ best efforts, the word doesn’t get out very well.

In a 2007 survey by the Society for Academic Emergency Medicine, after researchers held five community meetings, took out local radio, television and newspaper ads, and distributed thousands of brochures, only 8% of emergency room patients in that community had heard of the study.


Skeptical public

Many Americans are already leery about medical research. Being involved in any research without permission is unacceptable to some, no matter what the benefits.

In one emergency research study on uncontrolled seizures, 17% of patients and surrogates found inclusion unacceptable without permission.

To help ensure people are informed and given a choice:

  • People, particularly those who oppose being part of medical research, should find out whether they are among the target population for an emergency research study in their community.
  • There should be a clear, separate listing of all emergency research studies that do not involve obtaining consent. The National Institutes of Health’s clinicaltrials.gov registry needs to be improved to make this information easily available. and then additional steps need to be taken to widely disseminate the information, for instance, to primary care doctors’ offices.
  • All studies should have an opt-out option. Currently, some emergency research studies have an opt-out option for people who wear a wristband or some other notification to signal that they do not want to be included. (Government does not require the practice, however.)

There is little doubt that such research has saved lives, but at the same time, we also know that some people have received care that didn’t turn out to be best for them without ever knowing that was a risk.

Any experimental subject, like all of us, should have an informed choice. The medical research community, regulatory agencies and the public need to take steps to make that happen.

Katherine Chretien, MD is an associate professor of medicine at George Washington University. This post originally appeared at USA Today on August 25, 2013.