The Ethics of Human Participant Research

1. The Ethics of Human Participant Research Office for Research Protections The Pennsylvania State University

2. 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

3. Nazi War Crimes • Sterilization experiments • Typhus fever • Vaccine experiments • Nuremberg Trials

4. 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

5. The Tuskegee Syphilis Study • 400 African-American men afflicted with Syphilis enrolled • Intentionally misinformed about medical condition and research • Treatment never administered

6. 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

7. 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

8. 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

9. 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

10. Federal Protections of Human Participants in Research • Institutional Review Board (IRB) • Informed consent process • Institutional assurances

11. 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?

12. 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?

13. 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?

14. 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

15. 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

16. Contact ORP Office for Research Protections The 330 Building Suite 205 865-1775 ORProtections@psu.edu