Institutional Review Board

Definition

An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects, ensuring that ethical standards are maintained. These boards are essential for protecting the rights and welfare of participants, particularly in fields like biotechnology where the potential for risks and ethical dilemmas is high. By evaluating research proposals, IRBs help balance scientific advancement with the ethical treatment of individuals involved in studies.

5 Must Know Facts For Your Next Test

1. IRBs are mandated by federal regulations in many countries to review research proposals before studies can begin, especially those involving human subjects.
2. The primary goal of an IRB is to ensure that any risks to participants are minimized and that the potential benefits of the research outweigh those risks.
3. Members of an IRB typically include a diverse group of individuals, such as scientists, ethicists, and community representatives, to provide varied perspectives on ethical concerns.
4. IRBs have the authority to approve or disapprove research projects based on their ethical considerations and can require modifications to enhance participant safety.
5. In post-trial access, IRBs play a role in ensuring that participants continue to receive benefits from the research even after its completion, addressing issues related to benefit sharing.

Review Questions

• How does the role of an Institutional Review Board contribute to the ethical conduct of research involving human subjects?
  • An Institutional Review Board plays a crucial role in ensuring the ethical conduct of research by reviewing proposals for studies involving human subjects. By evaluating the potential risks and benefits, IRBs help safeguard the rights and welfare of participants. This oversight is vital in maintaining public trust in research practices, especially in sensitive fields like biotechnology where ethical dilemmas can arise.
• Discuss the implications of post-trial access for participants in research studies, focusing on how IRBs influence this process.
  • Post-trial access refers to the ability of participants to continue receiving benefits or treatments after a study has concluded. Institutional Review Boards influence this process by setting guidelines that ensure participants have fair access to ongoing care or products developed from the research. This aspect is critical for addressing ethical concerns about benefit sharing and ensuring that participants are not left without support once a study ends.
• Evaluate the challenges faced by Institutional Review Boards in balancing scientific innovation with ethical obligations towards human subjects.
  • Institutional Review Boards face significant challenges in balancing the need for scientific innovation with their ethical obligations towards human subjects. On one hand, they must promote advancements in research that could lead to important medical breakthroughs; on the other hand, they must rigorously protect participant rights and welfare. This often requires IRBs to navigate complex ethical dilemmas, such as determining acceptable risk levels and ensuring informed consent is adequately obtained, which can sometimes hinder rapid progress in biotechnology and related fields.

Related terms

Informed Consent: The process by which researchers provide potential participants with clear and comprehensive information about a study, enabling them to make an educated decision about their involvement.

Ethical Guidelines: A set of principles designed to guide researchers in conducting studies ethically, ensuring the well-being and rights of participants are prioritized.

Human Subjects Research: Research that involves collecting data from or about living individuals, requiring careful ethical considerations to protect their rights and welfare.