The VCU Human Research Protection Program (HRPP) would like to inform the VCU research community regarding some updates made to our Written Policies and Procedures (WPPs). Below are each of the WPPs that were updated, with a brief summary of the changes. Researchers can continue to access all WPPs through our Policies and Guidance page.
WPP VII-4: Continuing Review
In section 2.8, it was clarified that study expiration may be considered as a reason to enforce continuing review for expedited studies.
In section 2.9, it was clarified that failure to submit a Status Update will result in study expiration, and continuing review will be required to bring the study back to a current state.
WPP XI-5: Enrolling Research Subjects with Limited English Proficiency (LEP)
In section 3.1.2, guidance was added for documenting the presence of a witness when the short form consent process is utilized with a remote interpreter (an interpreter who is not physically present, i.e.: CyraCom and MARTTI) and the interpreter is also serving as a witness.
WPP XIV-1: Prisoners as Research Participants (Special Protections)
In section 2.9, it was clarified that all research at VCU involving prisoners, regardless of funding source, must fit into one of the allowable prisoner research categories in Subpart C of 45 CFR 46. However, certain requirements relating to Secretarial consultation or OHRP certification only pertain to research conducted or supported by HHS.
Also in section 2.9, clarifications were added to the requirements for utilizing Epidemiological Research Waiver.
WPP XVII-2: Subject Recruitment and Compensation
A minor edit was made to correct a link in the references section.
Any questions regarding these updates can be directed to ORSP@vcu.edu