Name: How IRBs Protect Human Research Participants
Uploaded: 2018-10-09T15:55:16.000Z
Duration: 12 min 45 s
Description: This video describes what an institutional review board (IRB) is and how IRBs serve to protect people who participate in research. -- U.S. Department of Health and Human Services (HHS) http://www.hhs.gov HHS Privacy Policy http://www.hhs.gov/Privacy.html

How IRBs Protect Human Research Participants

Understanding Institutional Review Boards (IRBs)

What is an IRB?

An Institutional Review Board (IRB) is a committee that reviews research studies to ensure compliance with ethical standards and regulations for research involving human participants.

The IRB evaluates various aspects of proposed studies to protect participants, requiring necessary changes before approval if standards are not met.

Composition of an IRB

An IRB must consist of at least five members from diverse backgrounds to provide varied perspectives on the research.

Membership includes at least one individual not affiliated with the institution conducting the research and one non-scientist, ensuring independent review.

Role and Responsibilities of an IRB

The primary function of an IRB is to verify that potential participants are adequately informed about the study, including risks, and can make voluntary decisions regarding participation.

Informed consent is a critical process where researchers provide essential information to potential volunteers; however, some low-risk studies may not require it.

Ongoing Oversight by the IRB

After approving a study, the IRB continues monitoring to ensure participant protection according to the approved plan throughout the research duration.

While IRBs play a vital role in safeguarding participants, other stakeholders like researchers and institutions also share this responsibility.

When is IRB Review Required?

Not all research requires IRB review; for instance, leftover blood samples used without identifying patient information do not necessitate oversight due to minimal risk involved.

Some studies may follow alternative regulations instead of the Common Rule, such as those set by the FDA for drug development or private funding sources that lack federal regulation.

Addressing Volunteer Concerns

Research volunteers can seek clarification from their study team regarding protections; concerns about participant safety can also be directed towards the respective IRB.