IRB approval refers to the determination made by an Institutional Review Board (IRB) that a research study involving human subjects meets ethical standards and complies with institutional and federal regulations. This approval ensures that the rights and welfare of participants are protected throughout the research process.
IRB approval is primarily used in the context of research involving human subjects in various fields, including education, medicine, and social sciences. Researchers must obtain this approval before initiating their studies to ensure compliance with ethical guidelines and legal requirements. This process often involves submitting research proposals, informed consent forms, and other documentation to the IRB for review.
Here are a couple of examples of abatement:
Example 1: A university researcher studying the effects of a new educational program on student performance submits their research proposal to the IRB. After review, the IRB grants approval, allowing the researcher to proceed with the study.
Example 2: A medical researcher conducting a clinical trial for a new drug must obtain IRB approval to ensure that the trial meets ethical standards and protects the rights of participants. (hypothetical example)
The primary regulation governing IRB approval is found in 34 CFR 97, which outlines the federal policy for the protection of human subjects in research. This regulation mandates that institutions receiving federal funding must have an IRB in place to review and approve research involving human subjects.
Examples of state differences (not exhaustive):
| State | IRB Requirements |
|---|---|
| California | Requires additional state-specific ethical guidelines for IRB review. |
| New York | Mandates that all IRB members receive training on human subjects research. |
| Texas | Allows expedited review processes for certain types of research. |
This is not a complete list. State laws vary and users should consult local rules for specific guidance.
| Term | Definition | Key Differences |
|---|---|---|
| IRB Approval | Approval by an Institutional Review Board for research involving human subjects. | Focuses on ethical review and participant protection. |
| Informed Consent | Process of obtaining voluntary agreement from participants to participate in research. | Informed consent is a component of the IRB approval process. |
| Research Ethics Committee | A committee that reviews research proposals for ethical considerations. | Similar to an IRB but may operate under different regulations or in specific contexts. |
If you are planning to conduct research involving human subjects, follow these steps:
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| Attribute | Details |
|---|---|
| Typical Fees | Varies by institution; some may charge for IRB review. |
| Jurisdiction | Federal and state regulations apply. |
| Possible Penalties | Research may be halted, and institutions may face funding loss. |
The purpose of IRB approval is to ensure that research involving human subjects is conducted ethically and that participants' rights are protected.