Answer 1 of these questions with explanation and details. Cite sources. One page.
- What are two historical research studies that were found to be unethical?
- How do law and ethics affect research?
- What is the purpose and function of an institutional review board?
The Purpose and Function of an Institutional Review Board (IRB)
Research involving human subjects has a complex history marred by unethical practices. To safeguard the rights and well-being of individuals participating in research, Institutional Review Boards (IRBs) were established. An IRB is a critical component of ethical oversight in research institutions, tasked with evaluating, approving, and monitoring studies involving human subjects.
Purpose:
The primary purpose of an IRB is to ensure the protection of human subjects involved in research. It assesses proposed studies to verify that they meet ethical guidelines, respect participants’ autonomy, and minimize risks while maximizing potential benefits.
Function:
- Ethical Evaluation: IRBs scrutinize research protocols to ensure they comply with ethical standards set forth by regulations like the Belmont Report in the United States, which highlights principles of respect for persons, beneficence, and justice.
- Risk Assessment: IRBs evaluate potential risks to participants, including physical, psychological, social, and legal risks, ensuring that the benefits of the research outweigh these potential harms.
- Informed Consent: Ensuring that participants provide informed consent is a crucial aspect of IRB function. They review consent forms to ensure they are comprehensive, understandable, and clearly outline the risks and benefits of participation.
- Continual Monitoring: IRBs oversee ongoing studies to ensure that researchers adhere to approved protocols and that any unexpected risks or adverse events are addressed promptly.
- Educational Role: IRBs educate researchers on ethical considerations, guidelines, and best practices, fostering a culture of ethical research conduct within institutions.
- Legal Compliance: IRBs ensure that research complies with not only ethical standards but also relevant laws and regulations governing research involving human subjects.
Ethical considerations are paramount due to historical research studies that breached ethical norms, such as the Tuskegee Syphilis Study and the Milgram Experiment. The Tuskegee Study, conducted between 1932 and 1972, withheld treatment for syphilis from African American men without their informed consent, leading to lasting distrust in medical research among marginalized communities.
The Milgram Experiment, conducted in the 1960s, raised ethical concerns due to the psychological distress inflicted on participants by deceiving them about the nature of the study and the potential harm caused by the administered electric shocks.
In conclusion, IRBs play a crucial role in upholding ethical standards in research, aiming to prevent the recurrence of unethical practices witnessed in historical studies. Their oversight ensures that research involving human subjects respects individual rights, minimizes risks, and maximizes the benefits of scientific inquiry.
Sources:
- The Belmont Report – National Institutes of Health
- “Ethical Issues in Social Science Research” by Tom L. Beauchamp