Institutional Review Boards

Definition

Institutional Review Boards (IRBs) are committees established to review and approve research involving human subjects, ensuring that ethical standards are upheld in biomedical research. They play a critical role in protecting the rights and welfare of participants by reviewing research proposals, informed consent processes, and monitoring ongoing studies. This oversight is essential for maintaining public trust in biomedical research and ensuring compliance with ethical guidelines.

5 Must Know Facts For Your Next Test

1. IRBs consist of a diverse group of members, including scientists, ethicists, and community representatives, to ensure a well-rounded review process.
2. The main responsibilities of an IRB include assessing the risk-to-benefit ratio of a study, ensuring informed consent is adequately obtained, and monitoring compliance with ethical standards throughout the research.
3. IRBs operate under federal regulations in the U.S., primarily guided by the Department of Health and Human Services (HHS) regulations at 45 CFR 46.
4. Studies that involve vulnerable populations, such as children or individuals with cognitive impairments, require additional scrutiny from IRBs to ensure their protection.
5. IRBs have the authority to approve, require modifications to, or disapprove research proposals based on ethical considerations.

Review Questions

• How do Institutional Review Boards contribute to the ethical conduct of biomedical research?
  • Institutional Review Boards contribute to ethical biomedical research by reviewing research proposals to ensure that participants' rights and welfare are protected. They assess the risks versus benefits of studies and ensure informed consent is obtained from participants. By doing so, IRBs help maintain ethical standards and public trust in the research process.
• What are the key responsibilities of an IRB during the review process for a proposed research study?
  • An IRB's key responsibilities include evaluating the risk-to-benefit ratio of proposed studies, ensuring that informed consent processes are clear and comprehensive, monitoring ongoing research for compliance with ethical guidelines, and safeguarding vulnerable populations. These responsibilities help ensure that all aspects of the research align with ethical standards before approval.
• Evaluate the impact of IRBs on research involving vulnerable populations and discuss how their role adapts to address specific challenges these groups face.
  • IRBs play a vital role in overseeing research involving vulnerable populations by implementing additional safeguards tailored to protect these individuals from potential exploitation or harm. Their impact includes requiring researchers to demonstrate how they will minimize risks and maximize benefits specifically for these groups. The presence of diverse IRB members also helps ensure that different perspectives are considered, promoting equitable treatment and respect for all participants. As social norms and regulatory requirements evolve, IRBs continue to adapt their protocols to better address emerging challenges related to vulnerable populations.

Related terms

Informed Consent: The process of providing potential research participants with sufficient information about a study, allowing them to make an educated decision about their involvement.

Ethical Guidelines: A set of principles designed to guide researchers in conducting ethical research, including respect for persons, beneficence, and justice.

Research Protocol: A detailed plan outlining the objectives, design, methodology, and statistical considerations of a research study that must be submitted for IRB approval.