Oprah’s HBO movie The Immortal Life of Henrietta Lacks, based on the New York Times bestseller, highlights the issues between ethics, race, medicine and the right of privacy. Henrietta Lacks, a poor, black, cancer-stricken woman had tissue taken from her without her consent in the 1950’s. Her cells, known as HeLa, became an important part in medicine, vital for developing the polio vaccine, in vitro fertilization, cloning and gene mapping and have been used in the medical field since the early 1950’s for medical research. For years her own family had no idea her cells were being used in this way.
It took more than 60 years, but in 2013 the National Institute of Health recognized this ethical dilemma and placed restrictions on the use of HeLa cells for future accessibility and research. The use of HeLa cells in medical research illustrates the ethical dilemma between the right of privacy and science.
When you go to a doctor for a routine test or medical procedure, the residual blood sample or tissue doesn’t always get discarded. Doctors, hospitals and laboratories often keep it indefinitely.
In 1999 the RAND Corporation published a report noting there are more than 300 million tissue samples at biobanks throughout the United States, tissues from close to 200 million people, often without their “informed consent.”
Many argue the samples can be “de-identified” when the researcher never learns the identity of the individual. The argument is if the samples are de-identified, it is not considered human research and informed consent is not required.
Studies have indicated de-identification is not fail-safe. Studies even in 2010 illustrated that de-identification is an insufficient method for protecting patients’ privacy rights, according to the National Institute of Health.
The informed consent by individuals entails not only knowing that their tissues are being used in research, but also allowing individuals the right to say what they want, and do not want, the tissues used for.
While science has come a long way since Henrietta Lacks’ situation in the 1950’s, there are still issues of scientists using tissues and blood samples without informed consent. In 2005 an Indian tribe sued Arizona State University because scientists used tissue samples the tribe had donated for diabetes research. The tissue samples were being used without their consent to study schizophrenia and other diseases.
Since 2009 there have been two class action lawsuits by parents in Minnesota and Texas to stop the practice of storing and conducting research on fetal blood samples without informed consent. In Bearder v. The Minnesota Department of Health, the Minnesota Supreme Court issued a decision in November of 2011, ruling written informed consent is required for storage, use and dissemination of any remaining blood samples or test results after the completion of newborn screenings. The Minnesota Department of Health secretly established a biobank of blood samples and test results left over after newborn screening. The Minnesota Department of Health collected over 1,100,000 blood samples and 900,000 test results. The lawsuit recognized the privacy rights of parents and children in Minnesota. The Minnesota Department of Health was required to destroy all blood samples and illegally obtained test results.
While the story of Henrietta Lacks highlights the medical, scientific and ethical issues, the right of informed consent is still raising questions today.