Institutional Review Board (IRB)

Definition

An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects, ensuring that ethical standards are upheld. This board plays a crucial role in the development of research plans and strategies by evaluating the potential risks and benefits, safeguarding participants' rights, and ensuring compliance with regulatory requirements.

5 Must Know Facts For Your Next Test

1. IRBs are mandated by federal regulations in the United States for any research involving human subjects that is federally funded or conducted by institutions that receive federal funding.
2. An IRB consists of members from diverse backgrounds, including scientists, non-scientists, and community members, to ensure a well-rounded perspective in ethical considerations.
3. Research proposals submitted to an IRB undergo a thorough review process that can involve multiple levels of scrutiny, including expedited reviews for minimal risk studies.
4. IRBs have the authority to require modifications to research protocols or even disapprove studies if they do not adequately protect participants’ rights and welfare.
5. Ongoing monitoring is also a key responsibility of IRBs, which includes reviewing any adverse events or unanticipated problems that may arise during the course of the research.

Review Questions

• How does the IRB contribute to developing ethical research plans and strategies?
  • The IRB contributes to developing ethical research plans by evaluating proposals for potential risks to participants, ensuring that informed consent processes are adequate, and assessing whether the benefits of the research outweigh these risks. By requiring modifications or disapproving studies that do not meet ethical standards, IRBs help researchers create protocols that prioritize participant safety and rights. This oversight ultimately fosters trust in the research process among participants and the broader community.
• Discuss the implications of an IRB's approval process on the timelines and outcomes of research projects.
  • The IRB's approval process can significantly affect the timelines and outcomes of research projects. Researchers must allocate sufficient time for submitting proposals and addressing any concerns raised by the IRB. If revisions are necessary or if a study is disapproved, this can delay the start of data collection and affect project budgets. However, this process also enhances the integrity and quality of research outcomes by ensuring ethical considerations are met before beginning any study involving human subjects.
• Evaluate the effectiveness of IRBs in protecting human subjects in research and suggest potential improvements.
  • The effectiveness of IRBs in protecting human subjects largely depends on their ability to conduct thorough reviews and enforce ethical standards consistently. While IRBs have made significant strides in safeguarding participants' rights, there are areas for improvement, such as streamlining the review process to reduce delays without compromising ethical oversight. Additionally, providing ongoing education and training for IRB members can enhance their understanding of contemporary ethical challenges. Engaging with diverse community stakeholders can also help ensure that various perspectives are represented in discussions about participant welfare.

Related terms

Informed Consent: A process by which researchers ensure that participants understand the nature of the research, including any risks and benefits, before agreeing to take part.

Ethics Review: A systematic evaluation of research proposals to ensure they meet ethical standards and protect the welfare of participants.

Compliance: The adherence to laws, regulations, and guidelines that govern research practices, particularly those protecting human subjects.