Can a study commence within an institution without IRB approval?

Can a study commence within an institution without IRB approval?

• A. Yes, with permission from the department chair.
• B. No, a study cannot commence without IRB approval.
• C. Yes, if it is a retrospective chart review.
• D. Yes, if funded by an internal grant.

Answer: (B)

Before starting any project that involves people or their identifiable data, you need oversight from the IRB. This body reviews the study to protect participants, ensure informed consent where needed, assess risks, and safeguard confidentiality. Because of that protection, a study cannot begin within an institution until the IRB has reviewed and given approval or determined that the project qualifies for an exemption. Departmental permission or internal funding does not replace IRB oversight. Those approvals address different issues (belonging to the department or securing funds) but do not substitute for ensuring that the research meets ethical and regulatory standards for human subjects. There are cases where a study might be eligible for exemption or expedited review, such as certain low-risk analyses like some retrospective chart reviews. Even then, you generally must submit to the IRB to obtain the appropriate exemption determination before you begin collecting data or accessing records, because the status of the project and the permitted activities depend on the IRB’s assessment. In short, without IRB approval or an IRB-determined exemption, you should not start.

Before starting any project that involves people or their identifiable data, you need oversight from the IRB. This body reviews the study to protect participants, ensure informed consent where needed, assess risks, and safeguard confidentiality. Because of that protection, a study cannot begin within an institution until the IRB has reviewed and given approval or determined that the project qualifies for an exemption.

Departmental permission or internal funding does not replace IRB oversight. Those approvals address different issues (belonging to the department or securing funds) but do not substitute for ensuring that the research meets ethical and regulatory standards for human subjects.

There are cases where a study might be eligible for exemption or expedited review, such as certain low-risk analyses like some retrospective chart reviews. Even then, you generally must submit to the IRB to obtain the appropriate exemption determination before you begin collecting data or accessing records, because the status of the project and the permitted activities depend on the IRB’s assessment. In short, without IRB approval or an IRB-determined exemption, you should not start.