THE ETHICS OF
HUMAN PARTICIPANT
RESEARCH
Office 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
Contact ORP
Office for Research Protections
The 330 Building
Suite 205
865-1775
ORProtections@psu.edu