From the Director
The Human Subjects Office has been working over the last year to implement much of the feedback we have received from the Human Research Protection Program (HRPP) survey and focus groups. We are excited to announce the next wave of changes occurring to the IRB submission and review process to better serve the needs of our research community and the Human Research Protection Program. These bulk of these changes will be launching late evening on Tuesday, October 9, 2018. We have more updates planned over the next six months, so stay tuned to the IRB Connection announcements. The current changes going into effect include:
Changes to the timing of IRB approval and Pharmacy & Therapeutics Investigational Drug Service approval
Effective immediately, the Pharmacy and Therapeutics (P&T) Investigational Drug Service (IDS) approval timing in conjunction with IRB approval has changed. P&T IDS approval will now be required prior to release of the IRB application to begin the research. This change is as a result of feedback from our research community via the focus group and surveys conducted on behalf of the Human Research Protections Program (HRPP) taskforce. With these new changes, IRB approval can be granted if P&T IDS approval is pending. Note, P&T approval requirements remain unchanged. P&T review is required prior to IRB approval. The P&T IDS change will apply for all applicable IRB-01 and Western IRB (WIRB) new and pending IRB applications. All other external IRB submissions processes will remain unchanged. Those submissions will require HRPP committee approvals prior to external IRB submission, review, and approval. To review a revised HRPP Review Flowchart for the committee review and approval processes.
Changes to question V.22 that may impact research submissions
The National Cancer Institute (NCI) has additional reporting requirements for human subjects research involving cancer. Enrollment information for studies that do not use Holden Comprehensive Cancer Center (HCCC) resources may still need to be reported to the NCI via the Cancer Center. For this reason, HCCC has revised question V.22 of the HawkIRB application to better identify cancer studies. All HawkIRB applications that currently indicate “No” to Section V.22 will be required to answer the newly worded question at the time of the next modification submission. All HawkIRB applications for studies that involve the treatment, detection, supportive care, prevention, or observation of cancer should respond “Yes” to Section V.22 of the application. The Protocol Review and Monitoring Committee (PRMC) administrative staff will then screen the application to determine and communicate applicable reporting requirements to the research team.
New Automated UI Health Care Clinical (UIHC) Trials and Research Website recruitment tool
The eResearch (HawkIRB) application will have an added recruitment feature available for all IRB applications required to document a subject’s research participation in EPIC. This feature will be available beginning with all IRB-01 submissions that have research related activities that meets the medical record registration requirements under the University of Iowa Health Care (UIHC) policy IM-MR-06.21 titled “Documentation of patient participation as a subject in a research protocol or use of an investigational medication, study medication, investigational device, or biologic.” All IRB-01 research submissions meeting this criterion (selecting option 3 under question ROC.1) will have an additional question (ROC.7) appear at the next modification submission asking if the research team would like to opt in advertising their research study on the new, soon to be launched, UIHC Clinical Trials and Research Website. Other external IRBs available under I.1 will have this feature available at a later date. The new UIHC Clinical Trials and Research website will replace the existing UIHC subject recruitment website and will be fully automated. Research teams interested in utilizing this service, need to simply indicate a few minor items in HawkIRB and the rest is taken care of for you! If ROC.7 is selected “yes,” the following additional changes will be required:
- Select “website” under VII.D.1
- In the free text field, add “UIHC Clinical Trials and Research Website.” No URL is required for this selection
- Update VII.D.29 to reflect, when available, the UIHC Clinical Trials and Research Website will have this research study available as a listed research study for potential research subjects to find out more information and express interest in participating.
Once the modification is approved with this selection, there is a webservice set up via HawkIRB to a UIHC IT team to provide relevant IRB approved information for prepopulating the UIHC Clinical Trials and Research Website. If the study is listed on the ClinicalTrials.gov page, additional information is also pulled from the registered study information. For a listing of what information is used, review the data map used to populate the recruitment website. If you are not interested in this recruitment service, simply select “no” to the ROC.7 question and no further action is required. A UIHC announcement will be made once this new tool goes live.