WHAT IS INFORMED CONSENT?
Informed consent is necessary for conducting ethical research by ensuring that participants are making free and informed choices for themselves. It can only be given after patients have understood complete and accurate information about the risks, benefits, and alternatives of procedures or studies being offered. It was not always required of physicians to acquire informed consent, but the importance of giving patients the final say about what they participate in has become more and more recognized over time. Let’s take a look at some incidences in the past that have brought the concept of informed consent into the spotlight.
EDWARD JENNER AND SMALLPOX – 1800’S
Known in the 18th century as the “speckled monster”, smallpox caused 400,000 deaths annually in Europe. At the time, there was a notion that survivors of the disease became immune, and there were also stories of dairymaids that were inexplicably protected after having suffered from cowpox, a related but less dangerous virus. Edward Jenner, an English physician and scientist, sought to prove that cowpox could protect people from smallpox infection. The experiment that has raised the most uneasiness from critics involves Jenner’s inoculation of his gardener’s 8-year-old son, James Phipps, with matter taken from a dairymaid who had fresh cowpox lesions on her hands. After the boy recovered from the cowpox infection, Jenner then inoculated him with matter from a smallpox lesion. Phipps did not acquire the disease and was deemed to be immune. Jenner was able to coin the term “vaccination” (vacca is Latin for cow) but to this day, there are still debates on the ethical justification of Jenner’s studies.
TUSKEGEE STUDY – 1930’S
The Tuskegee Study was launched by the U.S. Public Health Service in 1932 when syphilis was garnering attention as a major public health concern. To recruit participants, flyers offering food, blood tests, and treatment of “bad blood” — all free of charge – were put up around town. Six-hundred African-American men (399 with and 201 without syphilis) were enrolled into the study but none were aware of the real objectives behind the investigation; in actuality, the goal of the study was to investigate the progression of what was, at the time, a lethal STD. One of the last known survivors of the project, Charles Pollard, explained that the researchers kept telling him he had “bad blood” but never mentioned the word “syphilis”.
Shockingly, even when penicillin was established as an effective treatment for syphilis in 1945, participants were still not provided with any therapy. In 1972, forty years later, the study finally ended (the men were initially told it would take 6 months) but the effects of it and studies like it may be contributors to the lack of trust some African-Americans have in medical institutions today. Since then, a $10 million settlement has been reached and the U.S. government was also required to provide lifetime medical benefits to all survivors. Furthermore, President Bill Clinton issued a public apology on May 16th, 1997 and created the National Bioethics Advisory Commission to oversee policies aimed at protecting research volunteers of the future. The Tuskegee Study continues to be one of the most recognized cases regarding informed consent and the ethics surrounding population studies.
HENRIETTA LACKS: HELA – 1950’S
On January 29th, 1951, Henrietta Lacks went to Johns Hopkins Hospital in Baltimore with severe abdominal pain. She was diagnosed with aggressive adenocarcinoma of the cervix and started radiation treatment. During one of her subsequent treatments, two cervical biopsies were taken from Lacks. It was from these two biopsies that researchers were able to establish the first human cell line—HeLa cells. The tissue samples were taken without Lacks’ knowledge, sparking ongoing discussions concerning the rights an individual has over what happens with their cells or genetic material. Lacks’ passed away on October 4th, 1951, unaware that her cells would be cloned, distributed, and sold for profit by the millions.
As the first human cell line, HeLa cells offered the ability to test in experimental repeats—something that could not be done before. It wasn’t until more than two decades later that Lacks’ family discovered the truth when they were contacted and asked for blood samples for further study of the cell line. Organizations and researchers using HeLa cells are now required to give Lacks recognition, but the Lacks family still has not been fully successful in acquiring control of the cell line. Surprisingly, just a little more than three years ago, researchers from the European Molecular Biology Laboratory (EMBL) in Germany published the first HeLa genome sequence without having contacted Lacks’ family. A staggering amount of criticism arose from the public and just hours after its publication, the information was removed and the EMBL issued an apology. HeLa cells have allowed for some of the most notable findings in science including development of a polio vaccine, in vitro fertilization, gene mapping, and breakthroughs in cancer research; however, it is important to remember that an individual’s rights over their own body should be given priority over any potential scientific successes or advances that may arise from it.
STILL IN THE WORKS…
In the past, it was believed that providing too much information would hinder the trust patients had in their physicians. Some also thought that knowing the risks of a proposed procedure would cause patients unnecessary anxiety, which could undermine the efficacy of the treatment or recovery. Views on informed consent have now shifted to place more importance on protecting the autonomy of the patient but this shift has brought some challenges of its own. Procedures for obtaining informed consent have become increasingly long and complex as to include all the details needed and studies have shown that participants often do not fully comprehend what they are signing off on due to difficult terminology and dense descriptions. There is still much to be done in outlining the full responsibilities of physicians/researchers and, most importantly, in developing ways to ensure that patients have a clear understanding prior to agreeing to participate.
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