IRB Mythbusters – New Investigators
The VCU Human Research Protection Program presents IRB Mythbusters — a periodic newsletter clarifying common misconceptions about conducting human research and the IRB!
In this issue, “myths” surrounding starting research as a new investigator at VCU are addressed. Access previous editions of IRB Mythbusters by visiting the “mythbusters” tag on our blog.
If I received IRB approval for my project at my old institution, I don’t need new IRB review at VCU
FACT: IRB review is institution-specific, not project-specific. Just because another institution’s IRB approved a study does not mean that an investigator can continue that research at VCU without obtaining new IRB approval from the VCU IRB. Investigators new to VCU who have ongoing research projects initiated at another institution must arrange to obtain new IRB review for their projects at VCU.
The reason IRB review is institution-specific, rather than project-specific is because the creation of an IRB involves the institution certifying to the federal government that all its employees and agents will comply with applicable regulations. VCU cannot make this guarantee for employees or agents of other institutions, since VCU does not have relationships with or authority over those individuals. This is why special arrangements must be made for research projects that are multi-site. Each study site must be covered by an IRB’s review, either through each site obtaining its own IRB review, or by each site entering into an agreement to allow a single site’s IRB to review for all involved sites. The latter option requires formal agreements and contracts to ensure that the reviewing IRB is able to have adequate oversight over the project at each involved site.
TIP: Plan ahead for how to transfer your research project from your old institution to your new institution. Schedule a consultation with IRB staff to discuss the best way to obtain VCU IRB approval for your ongoing project. If individuals from your old institution will continue to work on the project, you may wish to consult with IRB Reliance staff, specifically, to discuss whether or not those individuals will continue to be “engaged” in the research, and the best way to ensure all study site locations have IRB oversight. IRB Reliance staff can be reached through the link above, or can be emailed at email@example.com.
If I have completed CITI training at my old institution, then I do not need to retake CITI training at VCU
FACT: CITI training is customized by the institution, and therefore VCU may require certain modules that other institutions do not. Because of this, VCU requires all investigators to complete the VCU-specific CITI training course before the IRB will issue approval of a study.
TIP: Credit for CITI modules taken at other institutions within the past 10 years can be transferred to your VCU CITI affiliation, which may reduce the overall number of modules you must complete in the VCU-specific CITI training course. Instructions for how to associate your CITI account with multiple institutions (thereby transferring any credits taken within the past 10 years) can be found here, or on our CITI training website.
Additionally, it is important to understand that all investigators at VCU are required to first complete the VCU-specific BASIC Human Subjects Protections course in CITI. Every 2 years thereafter, investigators may take the VCU-specific REFRESHER Human Subjects Protections course, until three refresher courses have been taken. After three refresher courses, a basic course should be completed again. More information on training requirements and how to add CITI training courses to your account can be found on our CITI training website.
Since “exempt” research is exempt from the regulations, I do not need to submit my exempt research to the VCU IRB
FACT: 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 couple 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.
TIP: 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.