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 conducting research during the COVID-19 pandemic are addressed. Access previous editions of IRB Mythbusters by visiting the “mythbusters” tag on our blog.
All electronic consent (eConsent) platforms are the same. I can use DocuSign, REDCap, or another method to obtain electronic signatures on consent forms.
FACT: Not all eConsent platforms are created equal. Most eConsent platforms, including REDCap, do not have enough identity verification to allow electronic signatures to be legally valid. REDCap eConsent may only be used for exempt research at this time. Minimal risk, nonexempt research can utilize a waiver of documentation of consent, and greater than minimal risk research which is not FDA-regulated may use standard DocuSign. FDA-regulated studies must use the Part 11 DocuSign. DocuSign, in either format, is free to use.
It is important to note that DocuSign (both standard and Part 11) may not be used to collect assent signatures. In these cases (expedited and full board studies), study teams must indicate that they will use a verbal assent process in their IRB submission. Study teams must also indicate that a verbal assent process will be used when requesting a waiver of documentation of consent to conduct nonexempt, minimal risk research involving children, when parental permission and assent are obtained remotely.
TIP: The VCU HRPP offers guidance on eConsent methods. This document compares REDCap and DocuSign. This guidance document and this template can assist investigators conducting exempt studies, specifically. And finally, this document compares different methods eConsent and describes common research scenarios that utilize eConsent. These guidance documents can all be found in the “Informed Consent” section of the HRPP’s policies and guidance page. For studies that need to use Part 11 DocuSign (FDA-regulated studies), more information can be found in this blog post. To access standard DocuSign, visit this IT webpage.
If using a waiver of documentation of consent, it is still advisable to document in the study records that consent was obtained, and how consent was conveyed to the study team. Tools for documenting how consent was communicated can be found in the HRPP’s study conduct toolkit (see bottom of page).
When I implement the University’s required baseline COVID-19 risk-mitigation procedures for my study, I need to submit an amendment to the IRB.
FACT: The IRB does not need to approve changes made to a research protocol to address the baseline VCU Phased Return to Research Plan – the basic health and safety requirements outlined by the University and VCU Health (e.g. wearing a mask, physical distancing, etc.) for on-campus activities. The IRB also does not require review and approval of an amendment to direct participants to view the IRB’s video for participants about returning to campus.
However, any procedures which go above and beyond these requirements must be submitted in an amendment to the IRB.
Examples of changes that would need to be submitted to the IRB in an amendment include, but are not limited to:
As always, exempt research has more flexibility for what does and does not need to be submitted in amendments. A list of the types of changes that require approval for exempt studies can be found in the “Conditions of Approval” section in your approval letter from the IRB, or in section 2.1 of IRB WPP X-1.
TIP: If you’re not sure whether you need to amend your research study or not, contact the IRB Coordinator assigned to your study. If you do need to amend your study with temporary COVID changes, you should use the Contingency Protocol process developed by the HRPP. You can learn more about the Contingency Protocol process by seeing this blog post. If you need to amend your study to make permanent changes (changes that may or may not address COVID-19, but which you plan to implement permanently), you should use the usual amendment process, outlined beginning on page 10 of the RAMS-IRB for Researchers Guide.
If I secure IRB approval, then I am approved to carry out my research during COVID-19.
FACT: Securing IRB approval does not necessarily mean your research may proceed during COVID-19. There may be other institutional requirements or approvals needed in addition to IRB approval. Given the continually fluctuating situation of COVID-19, the institution needs to be able to adapt and pivot quickly in order to protect VCU employees, students, and members of our community. So, while IRB approval is a necessary step in carrying out your research, the institution can and does implement additional requirements to achieve this protective aim.
The human subjects research regulations stipulate that, while IRB approval is required to conduct human research, institutional officials have the final say on whether a research project that has been IRB-approved may proceed (conversely, research that has not been IRB-approved may not be approved by institutional officials).
TIP: Keep an eye on the OVPRI’s Return to Research website. This page will have the most up-to-date information about VCU’s Phased Return to Research plan, and contains guidance for research operational areas, such as IRB, IACUC, Sponsored Programs, and more. In particular, this guidance document outlines investigator responsibilities to the IRB in the time of COVID-19.