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