the ethics of human participant research office for research protections the pennsylvania state...
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THE ETHICS OF HUMAN PARTICIPANT RESEARCHOffice for Research Protections
The Pennsylvania State University
Learning Objectives
• Recognize ethical violations in research
• Understand legal regulations governing research with human participants
• Describe the ethical principles governing research with human participants
• Identify federal protections for research involving human participants
Nazi War Crimes• Sterilization experiments
• Typhus fever
• Vaccine experiments
• Nuremberg Trials
Nuremberg code (1947)• Informed consent is essential
• Research should be based on prior animal work
• The risks should be justified by the anticipated results
• Only qualified scientists must conduct research
• Physical and mental suffering must be avoided
• Research in which death or disabling injury is expected should not be conducted
The Tuskegee Syphilis Study
• 400 African-American men afflicted with Syphilis enrolled
• Intentionally misinformed about medical condition and research
• Treatment never administered
The Willowbrook Study
• Infectious hepatitis study conducted at a New York mental institution
• Children deliberately infected with hepatitis
• Admission to the hospital contingent upon participation in the study
Declaration of Helsinki (1964)
• Minimize risks and maximize benefits
• Obtain informed consent, preferably in writing
• Safeguard personal integrity of participants
• Participants free to withdraw from study
• Research considered to be harmful should be discontinued
The Belmont Principles (1979)• Respect for persons
• Obtain informed consent• Respect the privacy of research subjects
• Beneficence• Use the best possible research design to maximize benefits and
minimize harms• Ensure researchers are able to perform the procedures and handle the
risks• Research without a favorable risk-benefit analysis may not be conducted
• Justice• Select subjects equitably• Avoid exploitation of vulnerable population or a population of
convenience
Jesse Gelsinger Case
• Gene therapy replacement trial for rare enzyme disorder
• Jesse not adequately informed of potential risks
• Investigator found to have substantial stock holdings in sponsoring company
Federal Protections of Human Participants in Research
• Institutional Review Board (IRB)
• Informed consent process
• Institutional assurances
Respect for Persons
• Does the consent process maximize autonomy?
• Does the protocol maximize autonomy?
• What additional protections have been put in place for vulnerable populations?
• Does this study maximally protect subject privacy?
Beneficence
• Is the research design adequate? • Can it be improved?
• What are the risks?• Have they been minimized?
• What are the benefits?• Have they been maximized?
Justice
• Does recruitment for the study target the population that will benefit from the research?
• Does the recruitment unfairly target a population?
• Are the inclusion/exclusion criteria fair?
Risk-Benefit Analysis
• Biomedical Study• PI interested in the effects of exercise on cardiovascular
health and hormone levels
• Jogging on a treadmill for 20 minutes
• Blood samples taken
• Participants connected to cardiovascular equipment to monitor heart rate and other indicators
Risk-Benefit Analysis
• Social Science Study• PI interested in the effects of past experiences on
students’ emotional health
• Asked to complete a series of mood questionnaires (pre/post test)
• Induce depression
• Debrief and return students to balanced state
