“Before Standards were Standards” by Patricia Terstenyak


            Henrietta Lacks was an African-American woman diagnosed with cervical cancer in 1951. Her story is told in the book, “The Immortal Life of Henrietta Lacks” by Rebecca Skloot. The reader is confronted with many ethical situations that surround Henrietta and HeLa, the cells that made her famous. She endured many medical appointments and tests; her cells (cancerous and non-cancerous) were removed without her permission. Henrietta was only 31 years old when she died of uremic poisoning – kidney failure.

            Existing policies such as informed consent, HIPPA (Health Insurance Portability and Accountability) and PHI (Protected Health Information) were not in existence at the time of Henrietta’s medical appointments, surgeries, and radiation treatments. Skloot informs the reader of how the research, science and medical fields have progressed over time.  She provides significant historical facts, such as the founding details of Johns Hopkins Hospital.  She describes work conditions, policies and governing agencies that may help readers have a little understanding, even perhaps sympathy, for the medical professionals and researchers of that time.

            Today, unfortunately, informed consent may simply be viewed as a sheet of paper that patients and research subjects have to sign for any medical testing, exam, procedure and/or research activity. Informed consent forms are scanned over, maybe loaded with legalese, small print, and overall, not very health literate. However, for research on humans, there are several required components including:  the explanation of the research procedures, related risks and possible benefits, alternatives to participation, and the rights of research participants.  These requirements are filled with ethical and legal obligations.

            So, exactly what is informed consent?  The goal of the informed consent process is to provide people with sufficient information so they can make informed choices about whether to begin or continue participation in research. The process involves a dynamic and continuing exchange of information between the research team and the participant throughout the research experience. 

            When researchers move forward with their ideas, they must receive approval from the Institutional Review Board.  This diverse committee approves all research projects.  They review research projects in thorough detail to ensure the safety and protection of the people involved.  Institutional Review Boards address any ethical issues with the research study and reviews the informed consent process.

                  When Henrietta signed her informed consent, did she feel involved in the process?  If she did not agree to another test, did she think her health would be in greater jeopardy?  Did her doctors disclose all of the risks of her radiation treatments?  Did researchers have oversight to their experiments?

                  We may not know the exact answers to these questions.  We know the importance of having protocols, policies and ethical standards.  Skloot’s thorough research of several fields makes this a comprehensive work; cancer, biology, ethics, research, health policy, and history.  After reading the story of Henrietta Lacks, we are compelled to act with care, compassion and integrity.  Let’s not permit history repeat itself.