key term - 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 met and that participants' rights and welfare are protected. The IRB plays a crucial role in upholding ethical principles in public health research by evaluating the risks and benefits of proposed studies, informed consent processes, and the overall integrity of the research methodology.

5 Must Know Facts For Your Next Test

1. IRBs are required by federal regulations for institutions that conduct research involving human subjects, ensuring compliance with ethical standards.
2. The primary functions of an IRB include reviewing research proposals, assessing risks to participants, and ensuring that informed consent is obtained and documented.
3. IRBs consist of members with diverse backgrounds, including scientists, ethicists, and community representatives, to provide a well-rounded perspective on research proposals.
4. There are different levels of review conducted by IRBs, including expedited reviews for low-risk studies and full board reviews for more complex or higher-risk research.
5. IRBs have the authority to approve or disapprove research studies based on their assessment of the ethical considerations involved.

Review Questions

• How does the role of an Institutional Review Board (IRB) contribute to the ethical conduct of public health research?
  • An Institutional Review Board (IRB) is essential in public health research as it ensures that studies involving human subjects adhere to ethical standards. By reviewing research proposals, IRBs assess potential risks to participants and evaluate whether the benefits outweigh these risks. This oversight helps maintain the integrity of research by safeguarding participants' rights and welfare while promoting ethical practices in the scientific community.
• Discuss the key components that an IRB evaluates during the review process of a research proposal.
  • During the review process, an IRB evaluates several key components of a research proposal, including the risk-benefit analysis, the informed consent process, participant selection criteria, and confidentiality measures. The IRB assesses whether the potential benefits of the research justify any risks involved for participants. Additionally, they ensure that informed consent is obtained ethically and that participants’ privacy is protected throughout the study.
• Evaluate how changes in regulatory policies might affect the functioning of Institutional Review Boards (IRBs) and their approach to public health research.
  • Changes in regulatory policies can significantly impact how Institutional Review Boards (IRBs) operate and their approach to public health research. For instance, new guidelines might introduce stricter requirements for informed consent or risk assessment protocols, which could lead IRBs to adopt more rigorous review processes. Conversely, more lenient regulations may encourage faster approvals but could raise concerns about maintaining ethical standards. Ultimately, any shifts in regulations must balance facilitating research advancements with protecting human subjects’ rights and well-being.

Related terms

Informed Consent:

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

Ethics Review: A systematic assessment of the ethical implications of research involving human subjects, typically conducted by an IRB to ensure compliance with ethical guidelines.

Research Protocol: A detailed plan outlining the objectives, design, methodology, statistical considerations, and organization of a research study.