The Syphilis Study at Tuskegee.Arguably the most notorious example in the United States of the violation of the rights and welfare of human subjects was the long-term study of black males conducted by the United States Public Health Service in Tuskegee, Alabama. This study of the natural history of untreated syphilis was initiated in the 1930s and continued until 1972. The Syphilis Study at Tuskegee involved approximately 600 African-American men: about 400 with syphilis (cases) and about 200 without syphilis (controls). These men were recruited without informed consent and, in fact, were led to believe that some of the procedures done in the interest of research (e.g., spinal taps) were actually “special free treatment.”By 1936, it was apparent that many more infected men than controls had developed complications, and 10 years later, reports indicated that the death rate among those with syphilis was about twice as high as it was among the controls. In the 1940s, penicillin was found to be effective in the treatment of syphilis. The Syphilis Study at Tuskegee continued, however, and the men were neither informed about nor treated with the antibiotic. Nazi Medical War CrimesAlthough not the first example of harmful research on unwilling human subjects, the experiments conducted by Nazi physicians during World War II were unprecedented in their scope and the degree of harm and suffering to which human beings were subjected.“Medical experiments” were performed on thousands of concentration camp prisoners and included deadly studies and tortures such as injecting people with gasoline and live viruses, immersing people in ice water, and forcing people to ingest poisons.In December 1946, the War Crimes Tribunal at Nuremberg indicted 20 physicians and 3 administrators for their willing participation in the systematic torture, mutilation, and killing of prisoners in experiments. The Nuremberg Military Tribunals found that the defendants had:Corrupted the ethics of the medical and scientific professionsRepeatedly and deliberately violated the rights of the subjects The actions of these defendants were condemned as crimes against humanity. Sixteen of the twenty-three physicians/administrators were found guilty and imprisoned, and seven were sentenced to death.
In the August 1947 verdict, the judges included a section called Permissible Medical Experiments. This section became known as the Nuremberg Code and was the first international code of research ethics. The Code provides ten Directives for Human Experimentation Voluntary consent of the human subject is absolutely essentialThe experiment must yield generalizable knowledge that could not be obtained in any other way and is not random and unnecessary in natureAnimal experimentation should precede human experimentationAll unnecessary physical and mental suffering and injury should be avoidedNo experiment should be conducted if there is reason to believe that death or disabling injury will occurThe degree of risk to subjects should never exceed the humanitarian importance of the problemRisks to the subjects should be minimized through proper preparationsExperiments should only be conducted by scientifically qualified investigatorsSubjects should always be at liberty to withdraw from experimentsInvestigators must be ready to end the experiment at any stage if there is cause to believe that continuing the experiment is likely to result in injury, disability or death to the subject
BeneficenceTwo general rules have been articulated as complementary expressions of beneficent actions:Do no harmMaximize possible benefits and minimize possible harmsAn autonomous person is able to:“An individual capable of deliberation about personal goals and of acting under the direction of such deliberation.” Consider the potential harms and benefits of a situationAnalyze how those risks and potential benefits relate to his or her personal goals and valuesTake action based on that analysisPrivacy: the rights of individuals to hold information about themselves free from the knowledge of othersConfidentiality: the assurance that information about identifiable persons will not be disclosed without consent except as allowed by lawJustice requires that individuals and groups be treated fairly and equitably in terms of bearing the burdens and receiving the benefits of research. The principle of justice may arise in decisions about inclusion and exclusion criteria for participation in research and requires investigators to question whether groups are considered for inclusion simply because of their availability, their compromised position, or their vulnerability — rather than for reasons directly related to the problem being studied.
If a similar study of yours exist, why do you need to repeat it?? Maybe the conclusion was not clear & you want to confirm it, extend it, or refute it.
Plagiarism is the use of someone else’s words or ideas as your own without giving appropriate credit or without the person’s consent to use his or her words or ideas without acknowledgment
UQUMRC KAMC Research Bioethics 2012 Updated
Research Ethics SohailBajammal, MBChB, MSc, FRCS(C), PhD(c) Assistant Professor of Orthopaedics, Umm Al-Qura UniversityDirector of CME & Research Administration, King Abdullah Medical City Makkah bajammal
Learning OutcomesBy the end of the lecture, you will be able to:• Identify the importance of research ethics• Anticipate ethical issues in research• Identify the components of informed consent• Know where to ask for help
Dark History• Tuskegee Syphilis Experiment • 1932-1972; Tuskegee, Alabama • Natural history of “untreated” syphilis• Subsequent Nuremberg Trials: – 1946-1949; Nuremberg, Germany – 12 trials, criminals of World War II – The Doctors’ Trial: 23 involved in unethical experimentation on POW
Code of Ethics• Nuremberg Code (1947)• Declaration of Helsinki (1964)
Research Methodology Planning Conducting Publishing
Research Problem Research Question Research Design Data Collection Data AnalysisResearch Dissemination
Ethical Principles of Research Competence Justice Integrity Non-maleficence Dignity Beneficence Researchers ParticipantsResponsibility Autonomy Honesty Privacy Confidentiality
Research Problem• Is it a significant problem that will Responsibility benefit others? Does it worth the public money? Competence• Have you done a thorough literature review to see if other studies exist?• Is it ethical to repeat the study if it Non-maleficence has been done before? – Confirming Beneficence – Extending – Refuting
Research Problem Basic SocialScience Health Problem Legal Economic “Trauma” Clinical Diagnosis Therapy Prognosis
Research Question• Does it expose the participants Non-maleficence to unacceptable risks or invasion of privacy? Beneficence• Clearly identify the purpose of the study to participants
Which is more ethical question?• What is the proportion of Shisha smokers who will develop lung cancer?• What is the proportion of lung cancer patients who are Shisha smokers?
What study needs ethics approval? www.pre.ethics.gc.ca
What study needs ethics approval? www.pre.ethics.gc.ca
If in doubt….. check it out Check with your institutional ethics review board (IRB)
Research Design Research Design• Is your choice of the study design an ethical choice? Non-maleficence – Observational versus Interventional – Benefits/Risks ratio Beneficence• Is it methodologically sound?• Do you have the expertise to do it? Competence – ? Pilot Honesty
Types of Possible Harm• Physical• Psychological Non-maleficence• Social• Economic Beneficence• Legal
Vulnerable Populations• Minors Justice• Minority groups• Mentally incompetent Dignity• Prisoners• Individuals with AIDS Autonomy
Informed Consent• About you & the research: – Who are the researchers & their contact information? – Who is sponsoring? – What is the purpose of the research? Competence Integrity Responsibility Honesty
Informed Consent• About the participants: Justice – How were they selected? Sampling? – Assurance that: • Their participation is voluntary Autonomy • They can withdraw at any time – What are the benefits & risks for them? Non-maleficence – What is the level and type of their involvement? – How will you ensure their Confidentiality confidentiality?
Data Collection• Respect participants & research sites• Respect privacy & confidentiality• MONITOR patient safety
Data Analysis• How will you protect the anonymity of participants?• How will you analyze the data? Do you have the experience?• How long will you keep the data once analyzed? Where & how will you keep it?
Research Dissemination• Authorship: –Who will do what & when? –Authorship order –Conflicts of interests: financial Integrity Honesty
Research Dissemination• Reporting: –Fabrication Integrity –Falsification –Plagiarism: Honesty • Copying without citing • Paraphrasing without citing • Using other’s ideas without citing
Retractions• Wager: – 1988 and 2008: 529 retractions• Woolley: – 1978 to 2008: 463 retractions in English-language literature • 40% due to misconduct in the 80s • 60% due to misconduct in the 2000s Nicola Jones. Nature Medicine. 2009
Summary• Ethical principles of research• Anticipate ethical issues during: – Research problem, question & design – Data collection, analysis, and dissemination• Components of informed consent• Consult IRB: “If in doubt, check it out” bajammal