OVPRI Human Subject Research Protection Blog

The VCU Human Research Protection Program is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

Federal regulations for the protection of human subjects contain various areas of flexibility, where institutions are allowed to set policy and procedures for certain aspects of the conduct of human research. While many aspects of conducting human research remain the same between institutions, there are certain areas that can vary between institutions. This means investigators moving from one institution to VCU may encounter new or different policies and procedures for human research.

This “New Investigator Tips” blog post series is intended to help investigators who are joining VCU learn about the nuances of VCU’s application of human subjects protections. See the other posts in this series by visiting the “new investigator tips” tag on our blog.

A common question new-to-VCU investigators have is: do I need to submit my exempt research projects to the VCU IRB, given that they are technically exempt from the regulations governing human subjects research?

The answer is, yes, VCU requires research projects that qualify as exempt must still be submitted to the VCU IRB for review and approval.

While it is technically true that “exempt” in this context means “exempt from the regulations,” institutions can, and often do, implement institutional requirements that go above and beyond the regulations. At VCU, one such policy is the requirement to submit exempt research to the IRB for review. This may differ from previous institutions you may have been at.

There are a few reasons why VCU requires exempt research to undergo IRB review. First and foremost, developing and adhering to institutional standards for exempt research is how VCU demonstrates its commitment to the Belmont Principles of Respect for Persons, Beneficence, and Justice, even when the full set of regulations do not apply to a research project due to its exempt status.

Second, VCU’s Human Research Protection Program (HRPP) is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). This accreditor also requires that we have institutional standards for exempt research, including the requirement for exempt research to be submitted to the IRB.

Finally, certain exempt research that falls under exempt categories 2 and 3 may require “Limited IRB Review” under the regulations. These are research projects that collect identifiable, sensitive information. Instead of upgrading these studies to expedited, the regulations allow for these studies to remain exempt, provided the IRB conducts “Limited IRB Review” of these projects. Limited IRB review includes reviewing for basic privacy and confidentiality protections, among other standards, which VCU accomplishes through its processes for reviewing exempt research.

Learn more about exempt research on our review types and requirements webpage. There, you can learn about what types of research qualify for exempt review under the regulations, as well as learning about institutional policies regarding exempt research that are specific to VCU, such as the use of an information sheet when interacting or intervening with participants during exempt research. Even more information on exempt research and VCU’s policies for exempt research can be found in Written Policy and Procedure (WPP) VIII-1. Feel free to schedule a consultation with IRB staff to discuss your project before submitting to the IRB to obtain guidance on VCU’s policies relating to exempt research. 

But what about the difference between Human Subjects Research that is exempt from the regulations, and projects that are Not Human Subjects Research (NHSR)? Learn more about the nuances between “exempt” human subjects research and NHSR in this “Deep Dives” blog post.

Categories IRB Education and Training
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