Ezekial Emanual, Chief of Bioethics NIH Simple idea: justice requires treating everyone, everywhere in exactly the same way Justice requires no such thing.

Slides:



Advertisements
Similar presentations
SLIDE SHOW FOR RADIATION THERAPY DEPT JOHANNESBURG HOSPITAL.
Advertisements

Ask Me Anything American Nurses Training Association.
BIOE 301 Lecture Ten. Summary of Lecture 9 How do vaccines work? Stimulate immunity without causing disease How are vaccines made? Non-infectious vaccines.
The Tenofovir Trial in Cambodia In 2004 a randomized trial by investigators from the United States and Australia was planned to assess the safety and efficacy.
The Duty of Beneficence. Everyday Ethics What people say “Do unto others as you would have them do unto you.”
Definition, pg 225 Introduction to the Practice of Statistics, Sixth Edition © 2009 W.H. Freeman and Company.
Animal Testing By: Daniel Calabrese/Researcher, Jay Palmeri/ Tech Designer, and Amanda Savas/Writing Coordinator and Group Leader.
Alice Walker Quotes. All History is current; all injustice continues on some level, somewhere in the world.
African Health Issues.
What You Need to Know About Tuberculosis (TB). What is Tuberculosis? Tuberculosis is a disease caused by tiny germs that enter your lungs when you breathe.
THE ETHICS OF HUMAN PARTICIPANT RESEARCH Office for Research Protections The Pennsylvania State University.
Extension Article by Dr Tim Kenny
Copyright 2005 Pacific Technology Ventures Ltd  1. What’s my “elevator pitch”? Explain who your customers are, what their problem is, how you solve it,
HIV Clinical Trials Janice Price, M.Ed, RN HIV Clinical Research Program Coordinator Swedish Medical Center Seattle, WA USA.
STANDARD Anything serving as a type or pattern to which other like things must conform (Stedman’s Medical Dictionary) STANDARD OF CARE The level at which.
1954 Salk polio vaccine trials ► Biggest public health experiment ever ► Polio epidemics hit U.S. in 20 th century ► Struck hardest at children ► Responsible.
Myths and Facts About Cancer Clinical Trials. Copyright ENACCT, 2007 It’s a treatment of “last resort!” They treat you like a “guinea pig ” No one benefits.
How Science Works Homeopathy. Structure 1.Choosing Treatments 2.Medical Trials 3.Homeopathy 4.How Science Works 5.Ethics (optional)
Preventing HIV/AIDS There is no way to tell just by looking whether a person is infected with HIV. Because people are unaware that they are HIV-positive,
Writing. Facts Estimates say that between 14 and 70 million animals are used in experiments each year. It’s impossible to know exactly how many animals.
Vaccinations help protect from infectious diseases Vaccination toolkit for schools developed by Public Health England in Collaboration with Wiltshire Council.
Research ethics and how health research is reviewed This presentation has been developed to form part of the lesson ‘Research ethics and how health research.
for pregnant women and new moms
Healthy Aging & Participating in Research. Discoveries from research led to the medicines and treatments we take for granted today: Vaccines to prevent.
BIOMEDICALRESEARCH. What is biomedical research?  Definition: Biomedical research is the broad area of science that looks for ways to prevent and treat.
International Impact of Vaccine Safety Concerns Learning the hard way for 20 years.
Ethical Issues and Treatment Policies. [This document is part of the « Malaria Indicator Survey » toolkit, developed by the RBM-MERG, with contributions.
Idara C.E.. Three ethical principles guides research with human participants. principle of Autonomy 1. The principle of Autonomy requires investigators.
Testing People Scientifically.  Clinical trials are research studies in which people help doctors and researchers find ways to improve health care. Each.
Human guinea pigs? Clinical Trials. Consent and assent Assent is a person’s agreement to participate in research but it is not a legal requirement Children.
Ethical Issues and Treatment Policies. This document is part of the Active Parasite Detection toolkit, developed by the RBM-MERG, with contributions from.
UNICEF and schools have been working together on Day for Change for over 20 years. We ask schools to make a change in their day and ask students, staff.
Getting Better Value in Health Care Public Employers Health Purchasing Committee 5-23 DRAFT.
Pandemics An introduction to. What is a pandemic? A pandemic is the rapid spread of an infectious disease which crosses over many countries and infects.
Animal Rights vs. Animal Welfare. Main Idea… What is the difference between animal rights and animal welfare?
Argumentative Writing. What is Argumentative Writing? Writing used to: change the reader’s point of view request an action by the reader ask the reader.
Tuberculosis What is tuberculosis?.
HIV/AIDS vaccine development Lecture 10. Review of lecture 9 How do vaccines work? Types ofVaccines:
 Two categories of diseases: infectious – caused by microorganisms. Can be transmitted from one to another.  AIDS/HIV, Tuberculosis, flu, SARS, malaria,
HIV/AIDS in Africa By Nathan Sears, Ryan Hofer, Peter Hsu, and Evan.
4. Access to medication & healthcare Learning objectives: - to identify the why many people cannot access medication - to understand how NGOs and the UN.
‘Do the insurance companies and Federal Drug Administration have too much control over the specific medicines patients do and do not receive for their.
Organization of African Unity Pandemic Report. 1. Denial of the Problem For many years, people denied that AIDS was a big problem. Particularly in the.
Introduction to HIV and Ethics Amy Lynn Payne, BA Tete: MSF center for HIV vertical transmission programme.
IMPORTANT DEVELOPMENTS IN THE HISTORY OF AIDS A Timeline of AIDS.
ICORD, Rome Promises and risks of Bayesian analyses in trials of rare diseases Dr Simon Day
Research Issues Can be both sociological and ethical Excesses in the past have made rules and standards necessary Rules are participant oriented and protective.
BDH Discovering Tomorrow’s Healthcare Solutions Today Clinical Research Services, Inc. Basil Halliday, M.Sc. President & CEO BDH Clinical Research Services.
Rationalizing the New Healthcare Paradigm Scientific Agenda vs. Patient Imperatives Scientific Agenda vs. Patient Imperatives.
Euthanasia and Physician Assisted Suicide
Idara C.E.. Three ethical principles guides research with human participants. principle of Autonomy 1. The principle of Autonomy requires investigators.
Human and Animal Research 1. What issues does this raise? 2.
AIDS Acquired Immunodeficiency Syndrome (AIDS) is a disease that is spread through blood and other bodily fluids. It attacks and destroys the immune system,
Brittney Berkley Senior Project Presentation Mr. Clawson AP Literature and Composition Vaccinations for Children.
Matthew 4:18-20 As Jesus was walking beside the Sea of Galilee, he saw two brothers, Simon called Peter and his brother Andrew.
Rene Descartes: “I think; therefore I am.”. 3.3: Data Ethics Statistics Chap 3: Designing Experiments.
JENNIFER WATSON, MA NATIONAL INSTITUTE ON AGING, NIH MAY 19, 2016 Healthy Aging & Participation in Research What Older Adults Should Know.
Global Diseases: HIV/AIDS DR. Amjad Fathi El-Shanti MD,NPH,DR PH University of Palestine 2016.
Lesson #11: Ethics. What are ethics as they pertain to experiments??? O Is it ethical to conduct animal testing? O Is it ethical to distribute placebo.
Why Should You Get Vaccinated?
Argumentative Writing
Choosing representatives and writing our letters
AIDS Acquired Immunodeficiency Syndrome (AIDS) is a disease that is spread through blood and other bodily fluids. It attacks and destroys the immune system,
AIDS Acquired Immunodeficiency Syndrome (AIDS) is a disease that is spread through blood and other bodily fluids. It attacks and destroys the immune system,
RELIGIOUS ATTITUDES TO WORLD POVERTY.
What You Need to Know About Tuberculosis (TB)
Chapter Four Tragedy Begins.
“Seven-minute Safeguarding Staff Meeting”
AIDS Acquired Immunodeficiency Syndrome (AIDS) is a disease that is spread through blood and other bodily fluids. It attacks and destroys the immune system,
Presentation transcript:

Ezekial Emanual, Chief of Bioethics NIH Simple idea: justice requires treating everyone, everywhere in exactly the same way Justice requires no such thing. It simply requires us to treat people fairly. If rules of clinical trials require participants to receive the best care on earth, there would be no clinical trials.

Marcia Angel Medical ethics has no borders What is morally right in America is morally right in Africa, too International rules of medical expt. require: –Volunteers in vaccine trial receive best treatment available, NOT level of care in poor country People are not guinea pigs. Research must hold human welfare above interest of society and science. If you don’t, you’re on a slippery slope where first humans are exploited for worthwhile purposes, then for not so worthwhile purposes.

Peter Lurie Fears scientists will use poor quality of care available in Africa to do what they want You are not permitted to use subjects to collect data just because it is useful to you –That is exploitation and abuse –That is what Tuskegee was Scientists will withhold treatments they know will work in the name of science –Will be greatest injustice in hx of medicine Tests of AZT proved there was a two-tiered standard for health care in the world –One set of rules for rich people, and another for those who are poor

Andrew McMichael Abhors hype Rarely discusses his vaccine work without saying it all might come to nothing First vaccine to target specific viral subtype most prevalent in East Africa Might require frequent booster shots

Sarah Rowland-Jones Infectious disease specialist First vaccine to target specific viral subtype most prevalent in East Africa Might require frequent booster shots

Pontiano Kaleebu We have asked Ugandans to be guinea pigs before. We have not come back to say, “Here is your reward.” Worried that question of whether trials can be done fairly and ethically, will overshadow science –We will give people the best care we can afford. That is fair. –If I could distribute anti-retroviral drugs, I would be thrilled. But, I don’t see how and I don’t see when. And the debate is a bit patronizing. –This is not an issue of individual rights. It is a public health emergency. I never though AIDS would be in my children's futures. I have come to realize that now. And it frightens me.

Edward Mbidde, Uganda Cancer Inst. Last 15 years have best Uganda has seen –We have leadership, support, we are united If we need to go to work and we cannot afford a Mercedes Benz, should we refuse to ride a motorcycle? Or should we get there by the best route we have? Principles matter to us as much to us as they do to Americans. But we have been dying for a long time, and you cannot respond to death with principles.

Seth Berkley You have to ask yourself what on earth the people on this planet are doing In the end only a vaccine will matter There is no incentive for companies to make vaccines Society can’t get it together. These trials cost hundreds of millions of dollars. How do we pay for it?

Don Francis Would be pleased if vaccine worked 1/3 of the time If his vaccine is introduced and proven effective, no other vaccines can be tested against placebo

Ugandan Medical Student Would it be fair for village people to enter trial if those who became infected did not get anti-retroviral drugs? –Indicated missing medical supplies – aspirin, basic antibiotics We do not get the care you get. We never will. But I would line up tomorrow to test anything that might help us in any way. And I am sure the rest of the village would too.

Larry Corey Let’s be realistic for 5 minutes To create a vaccine that works 40% of the time, costs $1,000, and requires that you go to the lab to get a blood test every 6 weeks is crap We need a 90% biologically active product with no side-effects that costs at most $150-$200. We are asking the Third World to take risks that we have never taken ourselves Every other time that we have gone in with a vaccine, we have been able to say, “It works on our people.” Now – I have to say I have no idea if I have schlock or I have gold. But you need it and we need it, so we will have to test it on you.