Informed Consent SERINA HOOVER Informed Consent Terminology- Informed Consent; ▪ A “voluntary agreement given by a patient or a patient's designated responsible proxy (e.g., a parent) for participation in a study, immunization program, treatment regimen, invasive procedure, or other medical or dental undertaking after being informed of the purpose, methods, procedures, benefits, and risks.” https://medical-dictionary.thefreedictionary.com/informed+consent The problem When informed consent is not given nor received, a lack of communication can cause horrific outcomes. Specific examples of such cases where informed consent was not given include; ▪ A case study on hepatitis at WillowBrook state school on Staten Island. ▪ Two cases preformed by the same doctor, Dr. Chester Southam, at Ohio state prison and the Jewish Chronic Disease Hospital in Brooklyn. ▪ The Tuskegee Syphilis Experiments. Importance ▪ Informed consent is important because without it Doctors or Researchers would be able to preform studies or medical procedures on a person, and not tell that person what the possible risks or effects could be. ▪ Patients have the right to know and decide exactly what happens to their body. ▪ Being unaware of such risks may alter one’s decision of participation. Claim Statement Thesis- Even though many studies during the 1950’s lead to key advances in the medical field, preforming such studies without informed consent is unethical. http://media.gettyimages.com/photos/group-of-8young-patients-sit-crammed-into-a-crib-prior-to-receivingpicture-id3041937?s=612x612 WillowBrook ▪ Institution for disabled children ▪ Overcrowding lead to disease ▪ Dr. Krugman began searching for vaccine for hepatitis ▪ He began injecting the children with the disease to study and try to find a cure ▪ The parents were unaware of all information and details ▪ Krugman bribed parents by only allowing children to be admitted to the institute if parents gave consent to their child’s participation in his studies https://willowbrookhs.wikispaces.com/file/view/willowbrook_bw.jpg/501638 220/willowbrook_bw.jpg Dr. Chester Southam Ohio State Prison ▪ Injects 14 patients, as well as healthy inmates, with live cancer cells without their knowledge or consent ▪ 2 inmates died ▪ Others developed tumors Jewish Chronic Disease Hospital ▪ Injects 22 elderly patients with live cancer cells ▪ No consent was given ▪ None of the patients knew anything about being injected with cancer cells Southam was found guilty of deceit and fraud and lost his medical license for 1 year only to return to his work and become president of the American Cancer Society two years later http://www.infiniteunknown.net/wpcontent/uploads/2011/03/In-the-1950s-OhioState-doctors-injected-prisoners-at-the-OhioPenitentiary-with-live-cancer-cells-to-testvaccines..jpg Macon County, Alabama ▪ 1932- Syphilis outbreak begins ▪ Experiment of 399 African American males with syphilis ▪ 201 without syphilis Tuskegee Syphilis Experiments ▪ Bribed for participation ▪ Told they were being treated for “Bad Blood” ▪ Injected with placebo like aspirin ▪ No treatment ever given even when patient disease worsen, doctors just stand by and observe their severities ▪ 1947 penicillin was a found treatment for syphilis, yet none of the participants receive treatment ▪ 1972- 28 died, 100+ passed away from related causes, 40 spouses infected, and 19 babies are born with disease due to their parent’s infection ▪ 40 years experiments went on before public found out and put an end to it http://www.issues4life.org/images/tuskeg eesyphilisstudydoctor1.jpg Overall • DR. KRUGMAN CREATED A VACCINE FOR HEPATITIS FROM WILLOWBROOK EXPERIMENTS, BUT IN ORDER TO OBTAIN HIS RESEARCH HE INJECTED INNOCENT CHILDREN WITH A HORRIBLE DISEASE WITHOUT THE PARENT’S OR THE CHILD’S KNOWLEDGE NOR CONSENT • DR. CHESTER SOUTHAM FORMED CANCER TREATMENTS, AND BROUGHT NEW KNOWLEDGE OF CANCER CELL BEHAVIOR FOR BETTER UNDERSTANDING OF CANCER, BUT DID SO WITHOUT TELLING ANY OF HIS PATIENTS HIS INTENTIONS, OR THAT THEY WOULD BE INJECTED WITH CANCER • TUSKEGEE EXPERIMENTS DID NOT RESULT IN THE PENICILLIN VACCINE, AND IN FACT ONLY HELPED UNDERSTAND THE NATURAL COURSE OF THE DISEASE. IN CONSEQUENCE, MANY PEOPLE DIED AND THEIR DISEASE WORSENED FROM REJECTION OF TREATMENT NOT UNDER THE PATIENTS KNOWLEDGE. WHICH BRINGS ME BACK TO MY ORIGINAL STATEMENTALTHOUGH SOME OF THESE RESEARCH CASES LEAD TO BREAKTHROUGHS IN THE MEDICAL FIELD, IT IS STRONGLY VIEWED AS UNETHICAL FOR THESE STUDIES TO BE PREFORMED WITHOUT A PATIENT’S INFORMED CONSENT. ? ? ? ? ? ?