π Understanding IRB Failures in Research Ethics
The Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. Its primary purpose is to ensure that all research is conducted ethically and in accordance with federal regulations and institutional policies. Failures in the IRB process can lead to serious ethical breaches, harming participants and undermining the integrity of research. Let's explore some famous cases.
π Objectives
- π― Identify famous cases involving IRB failure.
- π€ Analyze the ethical violations that occurred in each case.
- β
Understand the role and importance of IRBs in protecting human subjects.
- π‘ Learn lessons for ethical research practices to prevent future failures.
π§° Materials
- π Case studies of research misconduct
- ποΈ IRB guidelines and regulations
- π₯οΈ Internet access for research
- π Note-taking materials
π Warm-up Activity (5 minutes)
Briefly discuss what students already know about research ethics and the role of IRBs. Ask students to share any examples of ethical dilemmas they have heard about in research.
π§ͺ Main Instruction
Let's delve into some significant cases where IRB oversight faltered, resulting in ethical lapses and harm to participants:
- π§ Tuskegee Syphilis Study (1932-1972)
- π Background: This study involved observing the natural history of syphilis in African American men in Tuskegee, Alabama.
- π IRB Failure: The men were not informed about their diagnosis and were deliberately denied treatment, even after penicillin became available as a cure.
- βοΈ Ethical Violation: Lack of informed consent, deception, and denial of treatment.
- π Milgram Experiment (1961)
- π Background: Stanley Milgram's experiment examined obedience to authority figures by instructing participants to administer electric shocks to others.
- π IRB Failure: While the study predates formal IRB structures, modern IRBs would scrutinize the intense psychological distress inflicted on participants.
- βοΈ Ethical Violation: Psychological harm, deception, and lack of fully informed consent.
- πΆ Willowbrook State School Study (1963-1966)
- π Background: Children with intellectual disabilities at Willowbrook State School were deliberately infected with hepatitis to study the disease's progression.
- π IRB Failure: Parental consent was obtained, but questions remain about whether it was truly informed and voluntary, given the vulnerable population.
- βοΈ Ethical Violation: Exploitation of a vulnerable population, lack of fully informed consent, and potential harm to participants.
- π» Facebook Emotional Contagion Experiment (2012)
- π Background: Facebook manipulated the news feeds of nearly 700,000 users to study the spread of emotions.
- π IRB Failure: The study was conducted without obtaining informed consent from users, raising concerns about privacy and emotional manipulation.
- βοΈ Ethical Violation: Lack of informed consent, manipulation of emotions, and privacy concerns.
π Lessons for Ethical Research
- π Informed Consent: Always obtain voluntary, informed consent from participants, ensuring they understand the risks and benefits of the study.
- π‘οΈ Vulnerable Populations: Exercise extra caution when working with vulnerable populations, such as children, prisoners, or individuals with cognitive impairments.
- βοΈ Risk-Benefit Assessment: Conduct a thorough risk-benefit assessment to ensure that the potential benefits of the research outweigh the risks to participants.
- ποΈ Transparency: Be transparent about the study's purpose, methods, and potential conflicts of interest.
- π€ Debriefing: Provide participants with a debriefing after the study, explaining the true nature of the research and addressing any concerns.
- π IRB Review: Ensure that all research protocols are reviewed and approved by an IRB before implementation.
π Assessment
Discuss the importance of ethical guidelines and IRB oversight in research. Have students write a short essay on how the lessons learned from these cases can be applied to future research endeavors.