Keune, Jason D

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Washington University School of MedicineDigital Commons@Becker2012 Ethics Series: What Makes Research Ethical 2012 Conferences2012"What makes research ethical?"Jason D. KeuneWashington University School of Medicine in St. LouisFollow this and additional works at: http://digitalcommons.wustl.edu/hrpoconf_esreseth2012This Presentation is brought to you for free and open access by the 2012 Conferences at Digital Commons@Becker. It has been accepted for inclusionin 2012 Ethics Series: What Makes Research Ethical by an authorized administrator of Digital Commons@Becker. For more information, pleasecontact engeszer@wustl.edu.Recommended CitationKeune, Jason D., ""What makes research ethical?"" (2012). 2012 Ethics Series: What Makes Research Ethical. Paper 2 Human ResearchProtection Office.http://digitalcommons.wustl.edu/hrpoconf_esreseth2012/2Jason D. Keune, MD MBA Chief Resident in General Surgery Washington University School of Medicine August 8, 2012   Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000 May 24-31;283(20):2701-11.  What makes research involving human subjects ethical?  Informed consent is necessary (in most cases) but not sufficient  Other issues: clinical research in developing countries, use of placebos, phase 1 research, protection for communities, involvement of children  A systematic framework is proposed to evaluate clinical studies 1. Social or Scientific Value 2. Scientific Validity 3. Fair Subject Selection 4. Favorable Risk-Benefit Ratio 5. Independent Review 6. Informed Consent 7. Respect for Potential and Enrolled Subjects  To be valuable, research should  evaluate an intervention that could lead to improvements in health or well-being  be a preliminary study to such research  Lead to general knowledge about structure/function of human biological systems  Why?  Responsible use of finite resources  Avoidance of exploitation  Consider comparing the relative value of different clinical research studies   “Scientifically unsound research on human subjects is ipso facto unethical in that it may expose subjects to risks or inconvenience to no purpose.”  International Ethical Guidelines for Biomedical Research involving Human Subjects – CIOMS, 1993.   Research should have a clear scientific objective, be designed using accepted principles, methods and reliable practices, have sufficient power, offer plausible data analysis plan   Must have honest null hypothesis, “clinical equipoise”  Why?  Responsible use of finite resources  Avoidance of exploitation  Scientific goals of the study should be primary basis for determining who will be enrolled  Groups should not be excluded without good reason  Recognize that subject selection can affect the risks and benefits of the study  Groups/individuals who bear the risks of research should be able to enjoy its benefits  Why?  Equals should be treated similarly, benefits/burdens should be distributed evenly   Assessment of potential risks  Risks to individual subjects are identified and minimized  Procedures which are consistent with sound research design  Using procedures already being performed on the subjects for diagnostic/treatment purposes  Potential benefits to individual subjects are enhanced  Should be consistent with the scientific objectives, tests and interventions  Extraneous benefits (e.g. payment, more unrelated health services) should not be weighed against the risks  Risks and benefits to individual subjects are compared   The more likely/serious the potential risks are, the greater the prospective benefits should be  What if no clinical benefit to subjects (e.g. Phase I trial)?  “risk-knowledge calculus”*: when do benefits to society outweigh risks to individuals  No stable framework  Utilitarian approach controversial  *Weijer C. Thinking clearly about research risk: implications of the work of Benjamin Freedman. IRB. 1999 Nov-Dec;21(6):1-5.  Why?  Beneficence  Need to enhance benefits  Need to avoid the exploitation of subjects  Nonmaleficence  Need to reasonably reduce the risks     Minimize the potential impacts of conflicts of interest (e.g. to conduct high-quality research, complete the research expeditiously, protect research subjects, obtain funding, advance career)  Social accountability   Who?  Granting agencies  Local IRBs  Data and safety monitoring board  Purpose:  To ensure that individuals control whether or not they participate  To ensure that individuals participate only when research is consistent with values/interests/preferences.   To provide informed consent:  Must be accurately informed of details  Understand this information and how it relates to their situation  Make a voluntary and uncoerced decision about whether to participate  Non-autonomous persons should be respected  Substituted judgement  Best interests  Respect privacy by managing information in accordance with confidentiality rules  Subjects should be permitted to change their mind and withdraw without penalty  Enrolled subjects should be provided with new information regarding the intervention should it become available  Welfare of subjects should be monitored.   Study subjects should be informed about what was learned from the research 1. Social or Scientific Value 2. Scientific Validity 3. Fair Subject Selection 4. Favorable Risk-Benefit Ratio 5. Independent Review 6. Informed Consent 7. Respect for Potential and Enrolled Subjects  

What makes research ethical?

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What makes research ethical?

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