The Human Subjects Office has continued to work with the Office of the Vice President for Research and the Human Research Protection Program (HRPP) Committees to implement continuous quality improvement enhancements to streamline the IRB submission process. That process has continued unabated even as we all contend with the significant impact on the research enterprise caused by the COVID-19 outbreak. We are excited to summarize two changes to the HRPP/IRB review processes to better serve the needs of our research community and the Human Research Protection Program.
Pharmacy & Therapeutics (P&T) Investigational Drug Service (IDS) upgrades
P&T IDS have identified three primary questions that are routinely asked when reviewing IRB applications for research studies involving investigational drug(s). Those questions are:
- Who is supplying the drug?
- Who is dispensing the drug? AND
- Where will the drug be stored?
Starting Wednesday evening (4/8), these questions will be part of the investigational drug questions asked in section V.8 of the eResearch (HawkIRB) application. These new questions will appear on all draft and new project submissions. We hope the addition of these questions will help to reduce the number of clarifications required as part of the IDS review and approval process and expedite decisions.
Changes to the VA Privacy Officer and VA Information Security Officer Checklists
The VA has separated the VA Privacy Officer (PO) and Information Security Officer (ISO) Checklists into two separate checklists for those researchers submitting IRB-01 applications. The location of the checklists within the IRB application have not changed. You can locate both checklists in the “Other Review Attachments” category accessible from the Project Index. Each checklist pulls basic demographic information from the IRB application into the checklist on your behalf. Those data points include:
- PI name
- Study title
- PI contact information (email & phone)
- Type of submission (new project, modification, continuing review)
The requirements for the use of the checklist remain unchanged. The VA ISO and VA PO will continue to review these checklists and issue their approval in the same manner as they have in the past.
If you have any questions or need additional information regarding these enhancements, please contact the Human Subjects Office at either firstname.lastname@example.org or (319)335-6564. We are here to assist you.
COVID-19 Related updates
The Office of the Vice President for Research (OVPR) and the Human Subjects Office (HSO) have prepared web pages to keep faculty, staff, and students up to date on matters related to COVID-19. For FAQs and the latest information, visit the pages regularly.