Institutional review board (IRB)

Definition

An institutional review board (IRB) is a committee that reviews and approves research involving human subjects to ensure ethical standards are met. Its main role is to protect the rights and welfare of participants by overseeing the research process, evaluating the potential risks and benefits, and ensuring informed consent is obtained. This oversight is crucial in clinical trials, particularly in fields like plasma oncology where innovative therapies are being tested.

5 Must Know Facts For Your Next Test

1. IRBs are mandated by federal regulations to review all research involving human subjects conducted or supported by institutions receiving federal funding.
2. The composition of an IRB typically includes a diverse group of members, such as scientists, non-scientists, and community representatives, to ensure a range of perspectives.
3. IRBs can approve, modify, or disapprove research proposals based on their ethical considerations, particularly concerning participant risks versus benefits.
4. In plasma oncology, IRBs play a vital role in assessing the safety of experimental treatments involving plasma-derived therapies and their potential effects on patients.
5. Researchers must submit progress reports to the IRB at regular intervals to ensure ongoing compliance with ethical standards throughout the study.

Review Questions

• How does an institutional review board (IRB) contribute to ensuring ethical practices in clinical trials?
  • An institutional review board (IRB) contributes significantly to ethical practices in clinical trials by reviewing research proposals to evaluate the potential risks and benefits for participants. They ensure that participants are fully informed about the study and provide informed consent before taking part. By overseeing the entire research process and requiring regular updates from researchers, IRBs help maintain high ethical standards and protect participant welfare.
• Discuss the role of informed consent in the IRB approval process for clinical trials involving plasma oncology.
  • Informed consent is a critical component of the IRB approval process for clinical trials involving plasma oncology. The IRB evaluates whether participants receive clear and comprehensive information about the experimental treatments, potential risks, and expected benefits before agreeing to participate. This ensures that individuals are making informed choices about their involvement in potentially risky studies, reflecting the IRB's commitment to protecting participant rights and welfare.
• Evaluate the implications of an IRB's decisions on the advancement of research in plasma oncology.
  • The decisions made by an IRB can have profound implications on advancing research in plasma oncology. If an IRB disapproves a study due to ethical concerns, it can delay or halt potentially groundbreaking therapies from reaching patients. Conversely, if a study is approved, it may facilitate the development of innovative treatments that could significantly improve patient outcomes. Thus, the IRB acts as both a safeguard for participants and a gatekeeper for research progress in this rapidly evolving field.

Related terms

Informed Consent:

The process by which researchers provide potential participants with comprehensive information about a study, allowing them to make an informed decision about their involvement.

Ethics Review: A formal evaluation conducted by an IRB to assess the ethical implications of a proposed research study, focusing on participant safety and rights.

Clinical Trial Protocol: A detailed plan outlining the objectives, design, methodology, statistical considerations, and organization of a clinical trial, which must be submitted for IRB approval.