Which scenario illustrates a study that would be eligible for expedited IRB review due to low risk?

Which scenario illustrates a study that would be eligible for expedited IRB review due to low risk?

• A. An anonymous online survey about stress that preserves privacy and has minimal risk.
• B. A clinical trial with invasive procedures and potential serious harms.
• C. A study requiring access to identifiable medical records with potential risk.
• D. A deception-based study with potential psychological harm.

Answer: (A)

This item tests recognizing when a study has only minimal risk and can be reviewed through an expedited IRB process. Minimal risk means the chance and magnitude of harm are not greater than what people commonly encounter day to day or in routine exams or surveys. An anonymous online survey about stress that preserves privacy fits best. Because it is anonymous, there’s no link to identifiable individuals, and participation involves no invasive procedures. The potential risks are mainly the possibility of transient discomfort or concern about questions, which are considered minimal. This combination of low risk and strong privacy protections makes it eligible for expedited IRB review. In contrast, a clinical trial with invasive procedures and potential serious harms goes beyond minimal risk and typically requires full IRB review due to the greater potential for physical harm. A study requiring access to identifiable medical records raises privacy and confidentiality concerns that may necessitate more thorough review to ensure protections are adequate. A deception-based study with potential psychological harm can pose risks that require careful consideration, debriefing plans, and additional safeguards, which also usually demand a more comprehensive review.

This item tests recognizing when a study has only minimal risk and can be reviewed through an expedited IRB process. Minimal risk means the chance and magnitude of harm are not greater than what people commonly encounter day to day or in routine exams or surveys.

An anonymous online survey about stress that preserves privacy fits best. Because it is anonymous, there’s no link to identifiable individuals, and participation involves no invasive procedures. The potential risks are mainly the possibility of transient discomfort or concern about questions, which are considered minimal. This combination of low risk and strong privacy protections makes it eligible for expedited IRB review.

In contrast, a clinical trial with invasive procedures and potential serious harms goes beyond minimal risk and typically requires full IRB review due to the greater potential for physical harm. A study requiring access to identifiable medical records raises privacy and confidentiality concerns that may necessitate more thorough review to ensure protections are adequate. A deception-based study with potential psychological harm can pose risks that require careful consideration, debriefing plans, and additional safeguards, which also usually demand a more comprehensive review.