Professional Translation of Informed Consent Forms for Clinical Trials
There is a growing need for multilingual professional translation services for clinical trials. In 1951, Henrietta Lacks was admitted to a Baltimore hospital with abdominal pain. She was poor and uneducated. After performing a series of tests on Henrietta, doctors determined that she had cervical cancer and took a tissue sample.
Although Henrietta died of cervical cancer a few months later, her cells from that sample are still living today. Called HeLa cells, the cells have been grown and sold to laboratories all over the world over the last six decades. The cells have been used in 74,000 studies. But Henrietta never gave informed consent. She was illiterate and was never offered the chance to decide if her cells could be used for scientific purposes.
The Lack family threatened to file a lawsuit against the Centers for Disease Control and several laboratories, but an agreement was reached in 2013. Work based on the study of the HeLa cells could continue, but data about the cells’ genome could not be made publically available. The family was concerned that mapping of the genome could be used against Henrietta’s descendants.
Fast Forward to Today
As a result of the Henrietta case, informed consent translation in clinical trials for new pharmaceutical drugs or other experiments that involve human participants is standard today. However, the procedures for informed consent actually have their origins in the Nuremberg Code, which were developed after World War II because the Nazis experimented on Jews without their permission. The code states that: “voluntary consent of the human subject is essential”.
The goal is to inform people who are interested in participating in a human study, allowing them to make an informed decision. Participants are told about the nature of the experiment and are required to sign a consent form before taking part in the study.
But even today with these standards in place the issue of informed consent still comes up. For example, in 2012, a Texas woman sued Bristol-Myers Squibb Co. She participated in a trial for an experimental hepatitis vaccine. After participating in the clinic trial for just over a week, the woman experienced heart problems. She underwent tests and doctors determined she had a malfunctioning heart. She continued to participate in the study, but was eventually diagnosed with irreversible heart damage
In the suit the woman claims the experimental vaccine caused her heart problems. She says she never gave informed consent, because researchers never properly told her about the potential of a life-threatening side effect.
Language Translation and Informed Consent
A researcher’s ability to provide enough data for informed consent is complicated and can be made more complicated when language barriers are added to the equation. Often, experiments are complex scientific endeavors, meaning it can be difficult to put them into common language.
The guidelines were last updated 15 years ago, and scientific research has changed considerably since then. So in July, the Food and Drug Administration issued a draft of new guidelines on informed consent in clinical trials.
The guidelines contain a section on non-native English speakers. They state that informed consent “must be in language understandable to the potential subject or legally authorized representative.” This means legal documents for informed consent must include a foreign language translation into the native language of the participants and must use words participants can understand.
Informed consent is particularly important in clinical trials with vulnerable populations. In March of 2014, a St. Louis woman filed suit against Washington University in St. Louis. The woman, who is low-income, had participated in a program called “Contraceptive CHOICE.” The program made birth control available to low-income residents in the city.
The lawsuit claims the program was also involved in clinical trials for a new contraceptive device called Mirena. The device is inserted in the uterus and releases hormones to prevent pregnancy. The woman believes the device permanently damaged her heart as she underwent two heart surgeries. The lawsuit said that additional safeguards should be put in place when giving informed consent to vulnerable populations.
The same could be said for a lawsuit filed by Native Americans of the Lakota Sioux tribe. Researchers were administering a non-FDA approved hepatitis vaccines to newborns on the reservation as part of a clinical trial. The lawsuit claimed that the Native American people were not properly informed about the nature of the experiment and said that several babies became ill after vaccines were administered.
The key to proper informed consent is quality information and making sure that information is available in a way that participants can understand and in their native language.