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 upheld throughout the study. The primary role of the IRB is to protect the rights and welfare of participants, assessing potential risks and benefits of the research, while also ensuring compliance with federal regulations. The IRB plays a crucial part in study designs by evaluating whether proposed research methods are ethically sound and in the best interest of participants.

5 Must Know Facts For Your Next Test

1. IRBs must have at least five members with diverse backgrounds to provide a balanced review process, including both scientific and non-scientific expertise.
2. The IRB has the authority to approve or disapprove research proposals based on ethical considerations, even if the research has scientific merit.
3. Federal regulations require that any institution receiving federal funding for research involving human subjects must have an IRB in place.
4. IRBs assess research proposals not only for ethical concerns but also for issues related to participant recruitment, confidentiality, and potential conflicts of interest.
5. The approval process typically involves several steps, including submission of documents by researchers, review meetings, and ongoing monitoring of approved studies.

Review Questions

• What are the primary functions of an Institutional Review Board in the context of human subjects research?
  • The primary functions of an Institutional Review Board (IRB) include reviewing research proposals to ensure ethical standards are maintained and protecting the rights and welfare of participants. The IRB assesses the potential risks and benefits of the proposed research, ensures informed consent processes are appropriate, and verifies compliance with relevant laws and regulations. By fulfilling these functions, the IRB plays a critical role in safeguarding participants' interests during research.
• How does the IRB process contribute to ethical study designs in epidemiology?
  • The IRB process contributes to ethical study designs in epidemiology by ensuring that researchers adhere to established ethical guidelines while conducting studies involving human subjects. This includes evaluating participant recruitment strategies, risk management, and the informed consent process. By critically assessing these aspects, the IRB helps to foster trust between researchers and participants, promoting ethically responsible research that is essential for credible epidemiological findings.
• Evaluate the importance of having a diverse membership within an Institutional Review Board and its impact on decision-making.
  • Having a diverse membership within an Institutional Review Board (IRB) is crucial because it brings various perspectives and expertise to the review process, ultimately enhancing the ethical evaluation of research proposals. A diverse board can better identify potential biases and ethical dilemmas that may arise from different cultural or social contexts. This diversity ensures that decisions made by the IRB reflect a broader understanding of ethical considerations, improving the protection of human subjects while fostering inclusive research practices.

Related terms

Informed Consent:

A process through which researchers ensure that participants understand the nature, risks, and benefits of a study before agreeing to take part.

Human Subjects Research: Research that involves collecting data from or about living individuals, which must be conducted with ethical considerations to protect participants.

Ethical Guidelines: Established principles that dictate how researchers should conduct studies involving human subjects to ensure respect for persons, beneficence, and justice.