How IRBs Protect Human Research Participants

Summary

This video explains the critical role of Institutional Review Boards (IRBs) in protecting research participants involved in federally funded studies. IRBs ensure that research complies with ethical standards and federal regulations, including informed consent and participant safety. Comprising diverse members, including non-scientists, IRBs review research proposals to safeguard the rights and welfare of participants, especially vulnerable groups like children and prisoners. While not all research requires IRB approval, those that do are monitored throughout the study to maintain compliance. For concerns, volunteers can directly contact the IRB for guidance and support.

Takeaways

• 😀 An Institutional Review Board (IRB) is a committee that reviews research studies involving human participants to ensure ethical standards are met.
• 🔍 IRBs are required to review and approve studies before human enrollment, adhering to federal regulations known as the 'Common Rule.'
• 👥 An IRB must consist of at least five members from diverse backgrounds, including at least one member not affiliated with the research institution.
• 🚫 Researchers cannot review their own projects as IRB members, ensuring an independent review process.
• 📝 The IRB's primary role is to verify that potential participants have adequate information to make informed decisions about their participation.
• 📜 The informed consent process is crucial, providing potential volunteers with relevant information about the study, including risks involved.
• 🔒 The IRB ensures that research poses minimal risk to participants and that their privacy and confidentiality are protected.
• ✅ Not all research requires IRB review; for instance, studies using leftover blood samples that are anonymized do not need IRB approval.
• 🏛️ Some research may fall under different regulations, such as those set by the FDA for drug and product testing.
• 📞 Participants can contact the IRB if they have concerns about their protection or the ethical conduct of a study.

Q & A

What is the main role of Institutional Review Boards (IRBs)?

IRBs review research studies involving human participants to ensure that they adhere to ethical standards and regulations designed to protect those participants.

What federal regulations govern IRBs?

IRBs operate under a set of federal regulations known as the 'Common Rule', which outlines the ethical requirements for federally funded research.

Who can be members of an IRB?

An IRB must consist of at least five members from diverse backgrounds, including at least one member who is not affiliated with the institution conducting the research and one who is not a scientist.

What is the informed consent process?

The informed consent process involves researchers providing potential participants with essential information about the study, including risks, so they can make an informed decision about whether to participate.

Do all research studies require IRB review?

No, not all research studies require IRB review. For instance, studies using leftover blood samples where researchers do not know the identity of the samples may be exempt from review due to low privacy risk.

What happens if an IRB does not approve a study?

If an IRB does not approve a study, the researchers must make the necessary changes and resubmit the proposal for review before it can proceed.

How does an IRB ensure participant protection during a study?

IRBs ensure protection by verifying that participants are adequately informed about the study, can understand the information provided, and are free to choose whether or not to participate.

What should a research volunteer do if they have concerns about their protection?

Research volunteers can contact the research team for clarification or raise concerns with the IRB, which is responsible for ensuring that the study meets ethical and federal requirements.

What additional regulations might researchers follow apart from the Common Rule?

Researchers might follow specific regulations set by the Food and Drug Administration (FDA) for studies involving drugs and other products, which also include protections for research participants.

How do IRBs contribute to the overall ethical conduct of research?

IRBs play a critical role in the ethical conduct of research by reviewing study proposals to ensure participant rights and welfare are safeguarded throughout the research process.