According to federal regulations, the expedited review process may be used when the study procedures pose
The Correct Answer and Explanation is :
According to federal regulations, the expedited review process may be used when the study procedures pose no more than minimal risk and the research activities fall within specific categories identified as eligible for expedited review.
Understanding Minimal Risk and Expedited Review
“Minimal risk” refers to the probability and magnitude of harm or discomfort anticipated in the research being no greater than those ordinarily encountered in daily life or during routine physical or psychological examinations. When research involves procedures that meet this criterion and align with certain predefined categories, it qualifies for expedited review.
Categories Eligible for Expedited Review
The U.S. Department of Health and Human Services (HHS) outlines specific categories of research that may be eligible for expedited review. These categories include, but are not limited to:
- Clinical Studies: Research involving the collection of blood samples by finger stick, heel stick, ear stick, or venipuncture.
- Behavioral Studies: Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior, provided that the information obtained is recorded in such a manner that human subjects cannot be identified.
- Collection of Biological Specimens: Research involving the collection of biological specimens for research purposes by noninvasive means.
- Data Analysis: Research involving the analysis of existing data, documents, records, pathological specimens, or diagnostic specimens.
These categories are detailed in the HHS regulations at 45 CFR 46.110.
Purpose and Benefits of Expedited Review
The expedited review process aims to streamline the ethical review of research that poses minimal risk to participants. By focusing on studies that meet these criteria, Institutional Review Boards (IRBs) can allocate resources more efficiently, ensuring that more complex studies receive the thorough review they require.
Conclusion
In summary, federal regulations permit the use of the expedited review process for research studies that involve procedures posing no more than minimal risk and fall within specific eligible categories. This approach balances the need for ethical oversight with the practicalities of conducting research, facilitating the advancement of knowledge while safeguarding participant well-being.