My Body, My Choice?
How far does HIPPA and informed consent go? In previous years, before the advent of HIPPA, there were three notable incidents regarding the use of tissue samples without the consent and/or knowledge of the individual.
Incident #1: In 1918, tissues from a victim of the flu pandemic were saved and used in later years to promote great advances in multiple avenues of illness prevention and research. These advances could not have even been imagined in 1918, thus making informed consent unrealistic for the (deceased) donor.
Incident #2: In 1951, as recounted by the book The Immortal Life of Henrietta Lacks by Rebecca Skloot, physicians removed cervical cells without first notifying Ms. Lacks or obtaining her informed consent. The cells were labeled with the first two letters of her first and last name, “HELA.” Since HELA cells never die, they launched a medical revolution. Her family found out by chance more than 20 years later, and the discovery changed their lives. Finding out their mother’s cells were still living changed their lives.
Incident #3: In 1976, John Moore was diagnosed with hairy cell leukemia. His physician patented John’s cancer cells to make valuable proteins, supposedly valued at 3 billion dollars. Because his physician held the patent, Moore was unable to sell his own cells in order to take advantage of some of the revenue. The court ruled in the subsequent lawsuit that tissues are no longer that person’s personal property after they leave the person’s body.
Would you be willing to have your tissues utilized for scientific and medical research without your knowledge and/or consent? In her book, Ms. Skloot reports most Americans have their tissue on file somewhere. If you have had a mole removed, a tonsillectomy, or an appendectomy here in the USA, your tissue may be stored in any number of places, namely military facilities, the FBI, or the National Institute of Health (NIH).
I am a regular blood donor, registered in the bone marrow bank, and an organ donor. I would be thrilled to save another’s life. Imagine one day, as you administer the routine CURE for cancer, you notice the active ingredient is derived from your own cells! You swell with pride to have played a vital role in curing millions, but suddenly realize the drug company has become incredibly rich from marketing your cells as you struggle to pay your day-to-day bills. You did not know and were never compensated.
Yet, it was perfectly legal for the physicians to do this then and it still is today. Storing blood and tissue for research does not require consent. Courts have failed to hold up the popular notion of “My Body, My Choice” once the tissue is no longer attached to your body.
The Federal Policy for the Protection of Human Subjects (The Common Rule) does require informed consent for all human subject research. Apparently, tissue research is not covered because it is not federally funded and the researcher does not know the identity of the donor. Gathering tissue strictly for research would require informed consent but storing tissue from diagnostic procedures does not. Consent forms typically have a line that tissue may be used for education or research or stored for future research.
I don’t know about you, but I would want to know how and why my tissues are being used. Others may want to be able to opt their tissues out of research on issues they find morally reprehensible such as nuclear weapons, abortion, racial differences, and intelligence. In addition, the issue of anonymity has become a pipe dream. The technology to sequence genes makes it virtually impossible to make specimens anonymous, so could the genetic information potentially lead to serious breaches of privacy?
And yet, many people may see tissue research as a duty–a moral obligation to benefit society.
This issue will not go away as we make technological advances. We will need to set clear guidelines and nurses must be involved. What is our obligation as health care providers? What are our rights as health care consumers?
~Post coauthored by Katie Morales, MSN, RN