If a study collects identifiers and involves risk, it would be subject to which type of IRB review?

If a study collects identifiers and involves risk, it would be subject to which type of IRB review?

• A. Exemption
• B. Expedited
• C. Full Board Review
• D. Not Human Subjects

Answer: (C)

When a study collects identifiers and involves risk to participants, it typically requires a full board review. The level of IRB oversight depends on both the level of risk and whether identifiable information is involved. Exemption applies only to research with very low risk and often no identifiable data (or data that will not identify subjects). Expedited review covers minimal-risk research that fits specific categories, but that option isn’t appropriate when identifiable data are collected and there is real risk to privacy or other harms. Not human subjects would apply only if there’s no interaction with living individuals or no identifiable information at all. So, with identifiable data and any meaningful risk to participants, the study falls into the category that requires the convened IRB to review and discuss before approval. This ensures thorough consideration of protections for privacy, data security, consent, and potential harms.

When a study collects identifiers and involves risk to participants, it typically requires a full board review. The level of IRB oversight depends on both the level of risk and whether identifiable information is involved. Exemption applies only to research with very low risk and often no identifiable data (or data that will not identify subjects). Expedited review covers minimal-risk research that fits specific categories, but that option isn’t appropriate when identifiable data are collected and there is real risk to privacy or other harms. Not human subjects would apply only if there’s no interaction with living individuals or no identifiable information at all.

So, with identifiable data and any meaningful risk to participants, the study falls into the category that requires the convened IRB to review and discuss before approval. This ensures thorough consideration of protections for privacy, data security, consent, and potential harms.