insight to medicine series irb talk 10.12.16
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Regulations of Human Subject ResearchAssessing Risk and Navigating through IRB ReviewHeather Park-May, IRB AdministratorOctober 12, 2016
Agenda:Discuss Ethical considerations when doing research, and the Belmont ReportGetting started with an idea, question, or identified knowledge gap.Distinguishing Research from QA/QIElements and requirements of a consent form
Add The Reliance agreement with MSU (Briefly)HIPAA considerations for researchCITI Training Using the IRBNet submission platformPI ResponsibilitiesTips for a Smooth IRB Review*
While the focus of this talk is on the IRB piece of the research regulatory pie, keep in mind that there are other things to consider that may apply to your research project such as:
BudgetCoverage AnalysisMaterial Transfer AgreementContracts
Researchers are Change Agents for the Healthcare IndustryResearch is the path to innovation and can empower all caregivers to discover ways to improve the care we provide in a way that is driven by data. Changes made to support our Researchers:
Research Workshop Education ProgramNew streamlined MSU/Sparrow Reliance ProcessResearch Merit Review CommitteeEfforts to centralize research at Sparrow to create a gateway for Sparrow and MSU researchers currently underway
Before I go into the things that went wrong that lead to the invention of the Institutional Review Board for the safety and ethical oversight of research, I would like to share with you a personal story of what happens when research goes right.
15 years ago, my mother in law suffered a widow maker heart attack. As many women do, she presented atypical symptoms. She went through the entire day feeling crummy before deciding to go to the emergency department in the middle of the night. She went into ventricular fibrillation upon arriving in the ED. The amazing team in the ED shocked her heart back into rhythm, and rushed her to the cath lab. After a week in the CICU, she returned home, to make a near full recovery.
Last year, while experiencing sob, Sparrow physicians found an aortic aneurysm that appeared to have had dissected and healed several times. This required an emergency life saving procedure. What was suppose to be a 2 hour long surgery turned into 3, and then 4, and then 5. The clock just kept ticking. As a healthcare professional, you understand all the things that can go wrong, and in many cases, have seen this firsthand. So by the time the family was called into the consultation room, the stress was unbearable. We learned that while the aneurysm was much larger than expected, which required a more invasive procedure, but she was expected to recover well.
She recovered from the procedure, however, the sob remained. She learned that the had end-stage heart failure, and was starting to go into kidney failure because of the stress of 15 years of diuretics puts your kidneys through. She was referred to a cardiologist at U of M to learn about treatment options not available at Sparrow.
The cardiologist at U of M determined that her heart was so fragile, that she may not survive the drive back home after reviewing findings of the cardiac catheterization. She stayed the entire summer of 2015 as an inpatient at U of M hospital. Our options were: 1. An approximate 1 year life expectancy with the current condition of her heart2. A clinical trial to receive an investigational left ventricular assist device to increase the pumping power of her heart as a transitional step to a heart transplant.
Nancy was enrolled in the clinical trial, received the surgery, and returned home about 1 month later. Nancys activity tolerance slowly began to improve, as well as her kidney function tests. She is now losing weight, and very active with her cardiac rehab program, and well on her way to being placed on the heart transplant list.
Because of the endless dedication to finding newer, better treatment options, Nancy has the most cutting edge device keeping her alive, and helping her reach her weight loss goal to ultimately receive a new human heart. Because of the work researchers around the world, and possibly some of the physicians in this very room, Nancy is alive today to spoil her grandchildren, and watch her own children accomplish great things.
I share this story for 2 reasons:To inspire you to continue to search for better ways to deliver the best care to your patients, and not stop at the hoops that the IRB may make you jump through, andTo notify you, if Nancy does have to spend time as a Patient here at Sparrow, do not panic when you check her vitals, and find that she has no pulse.
Human Subjects ProtectionA Shared Responsibility:
1932-1972 Syphilis Study at Tuskegee1939-1945 Nazi Medical War Crimes1944-1974 Cold War Human Radiation Experiments1946- Nuremberg Doctors Trial1947- Nuremberg Code1948- United Nations adopted Universal Declaration 1953- First US Federal Policy for Protection of Human subjects1963- Jewish Chronic Disease Hospital Study1963-1966- Willowbrook Study1974- Federal Protections for Human Subject1979- Publication of the Belmont Report 1980- Publication of FDA Regulations1991- Publication of Common Rule1996- Health Insurance Portability and Accountability Act 1999- Death of Jesse Gelsinger2000- The Office of Human Research Protections Split from NIH. Human Subjects Historical Timeline
Syphilis Study at Tuskegee:Nazi Medical War Crimes: Nazi physicians and scientists conducted many experiments on concentration camps prisoners and other undesirables. Experiments include exposure to extreme conditions (high altitude, ice water) deliberate infliction of wounds or disease; chemical warfare; genetic theories; mass sterilization techniques.Cold War Human Radiation Experiments: The U.S. Government conducted more than 400 experiments to determine the effects of exposure to ionizing radiation on human health or to calibrate instruments designed to detect radiation. Most studies involved minimal risks and most of those involving greater than minimal risks included appropriate informed consent.There were, however, cases where human subjects suffered physical injuries as a result of participating in studies that offered no hope of direct benefit from interventions. Many of these interventions were considered controversial at the time, but were presented to participants as standard practice. Nuremberg Doctors Trial:The physicians who conducted Nazi experiments during WWII were tried separately from other war criminals because of their professional status as physicians and the horrendous and unique nature of their crimes. They were found guilty of crimes against humanity.Nuremberg Code:During the trial at Nuremberg, the judges codified fundamental ethical principles for the conduct of research. The Nuremberg Code set forth ten conditions to be met before research could be deemed ethically permissible. The Nuremberg Code became the first international standard for the conduct of research and introduced the modern era of protection for human research subjects.United Nations Adopted Universal Declaration of Human RightsInspired by atrocities committed during World War II and states the conviction that human rights needed to be preserved at the international level.First U.S. Federal Policy for Protection of Human Subjects:The first U.S. Federal policy for the protection of human subjects was put into place for research conducted at the Clinical Center, NIH. This policy provided a mechanism for prospective review of proposed research by individuals having no direct involvement or intellectual investment in the research. This system is the model for the current IRB system.1963- Jewish Chronic Disease Hospital Study:Studies were conducted at the Jewish Chronic Disease Hospital in New York to learn about the human immune systems response to cancer. Live cancer cells were injected into chronically ill and debilitated patients who were told they were receiving a skin test. The investigators were eventually prosecuted and found guilty of fraud, deceit, and unprofessional conduct.1963-1966- Willowbrook Study:Studies were carried out at the Willowbrook State School for mentally defective persons, to attempt to better understand the transmission of infectious hepatitis and, subsequently, testing the effects of gamma globulin in preventing or ameliorating the disease. Residents of Willowbrook, all of whom were children, were deliberately infected with hepatitis, by ingesting the stools of infected those who were infected with hepatitis or by receiving injections of more-purified virus preparations. The investigators argued that hepatitis infection was inevitable for this population; however, critics found the consent process to be unethical because coercive tactics were used, as admission into Willowbrook was granted only to those children whose parents gave consent to participate.1964- Declaration of Helsinki:The World Medical Association drafted the first international agreement recommending ethical standards for clinical research. Binds physicians to the words The health of my patient will be my first consideration and the international code of medical ethics that declares A physician shall act in the patients best interest when providing medical care. 1974- Federal Protections for Human Subject:After the Syphilis Study at Tuskegee was exposed, the Senate Committee on Labor and Human Resources held hearings on this study and other alleged health care abuses. The outcomes of these hearings were: The enactment of the National Research Act of 1974 requiring the Department of Health, Education, and Welfare to codify its policy for the protection of human subjects into regulations; and The formation of the National Commission for the Protections of Human Subjects of