September 6, 2022
For the Record- September 6th, 2022: Lapsed IRB Approval Policy, NIH and CT.gov, HUD Updates
In this Issue:
- Complete the Zipline Support Survey
- Lapsed IRB Approval Policy
- NIH Issues Individual Investigator Notice of Noncompliance with ClinicalTrials.gov Results Reporting
- Opportunity to Partner with ITHS to Promote Health Equity in Remote Research
- Updates to Humanitarian Use Device (HUD) and Expanded Access Materials
- Zipline Updates
Complete the Zipline Support Survey
Help HSD Improve Zipline Resources
HSD needs your help to improve Zipline resources! Please complete a short survey to provide feedback on what current Zipline resources you use most and what future Zipline resources you’d be most likely to use. The survey contains 6 questions and should take less than 5 minutes to complete. After completing the survey, you have the option to enter a drawing to receive a coffee gift card as a thank you for your participation.
Lapsed IRB Approval Policy
Implemented September 1, 2022
HSD’s policy on research with lapsed IRB approval has been revised to provide more robust follow-up of studies once IRB approval has expired with an emphasis on studies that involve more risk.
Tracking IRB approval periods and preventing a lapse in approval is ultimately the researcher’s responsibility. You can find the expiration date in approval letters and in the upper left-hand corner of the main study workspace in Zipline.
To assist researchers, the HSD Zipline system sends automated courtesy reminders at 8 weeks and 4 weeks prior to the expiration of IRB approval, and a notice when IRB approval has expired.
HSD has defined a category of studies that cannot be closed without the submission of a status report confirming that all human research activities ceased when IRB approval expired. These include FDA regulated studies, more than minimal risk research, and studies initially reviewed by the full board (excluding studies that are now in data analysis).
- Within 30 days an email reminder will be sent to the research team outside of the Zipline system.
- At 60 days an email reminder will be sent to the research team and the department head. HSD will also stop accepting new applications and study modifications from the PI of the lapsed study.
- At 90 days the study will be in continuing noncompliance and the IRB will be asked to consider corrective action which may include termination of the study and reporting to relevant federal agencies, study sponsors and collaborators.
For all other studies, HSD will administratively close the Zipline application if no continuing review application or study closure request is received within 90 days after the expiration of IRB approval. A new Zipline application will be required to continue the research.
For more information, see section 5.4 of SOP IRB Review.
If you have questions or concerns, please contact us at email@example.com.
NIH Issues Individual Investigator Notice of Noncompliance with ClinicalTrials.gov Results Reporting
Know What To Do
The UW recently received a Notice of Noncompliance issued by the National Institutes of Health (NIH) to an individual researcher for failure to comply with the requirements for submission of clinical trial results to ClinicalTrials.gov as set forth in the NIH Grants Policy Statement (Section 4.1.3, December 2021).
This comes after a recent report issued by the U.S. Department of Health and Human Services Office of Inspector General found that NIH did not ensure that all clinical trial results were reported in accordance with federal requirements. The findings are likely to spur NIH to issue more notices to researchers who fail to report results and potentially take enforcement actions such as withholding funds for existing grants and/or awards of new funding to the researcher and/or institution.
For UW research, identification of a clinical trial that requires registration and results reporting on ClinicalTrials.gov is made by HSD and communicated to the researcher via Zipline. Researchers who are identified as the Responsible Party for an applicable clinical trial should ensure they understand the reporting requirements and timelines for submission. Information regarding this can be found on the HSD website.
UW researchers who receive a NIH notice of noncompliance should contact HSD at firstname.lastname@example.org as soon as possible for guidance.
Opportunity to Partner with ITHS to Promote Health Equity in Remote Research
The Institute of Translational Health Sciences (ITHS) Integrating Special Populations (ISP) program is seeking clinical trial study teams to partner with them in a project to increase engagement of underrepresented children and older adults in research. ISP plans to develop and disseminate a set of best practices for remote research engagement to ensure that children and older adults from diverse communities have equitable access to research as more studies shift to remote and/or hybrid engagement. To accomplish this, they are inviting study teams with active clinical trials that utilize at least some remote engagement methods (e.g., for participant recruitment or study activities) to take part in qualitative interviews about their experience and to help identify research participants to interview about their remote research engagement.
To learn more about how your study can collaborate with ISP, contact the study’s research coordinator: email@example.com
Updates to Humanitarian Use Device (HUD) and Expanded Access Materials
Fred Hutch Clinicians Should Submit Emergency Use Notifications Through HSD
HSD’s HUD and Expanded Access materials have been updated as part of our ongoing efforts to convert Word-based guidance into webpages. These revised materials can be found under the Guidance section of the website.
- The Word-based SOP Humanitarian Use Device has been converted into the webpage Humanitarian Use Device Guidance. There have been some minor revisions to content and organization of the information.
- There are some minor revisions to the webpage listing UW-approved clinical use HUDs and it has a new web link.
- The Word-based SOP Expanded Access has been converted into the webpage Expanded Access Guidance.
- The Single Patient Emergency or Compassionate Use webpage has a new web link but can still be accessed using the red button on our homepage.
- The Emergency and Compassionate Use forms have been converted from PDF to Word and formatted to match our other application forms.
NEW – Fred Hutch clinicians should submit their Emergency Use drug and device notifications through HSD. Our forms are being updated to include FHCC-specific information.
Implemented August 29, 2022
Minor changes were made to Zipline the evening of August 29, 2022. Read on to learn how this update answers some frequently asked questions.
- What is the difference between a PI Proxy and a Primary Contact? A PI Proxy is the only role that can submit on behalf of the PI, while a Primary Contact Links to the Zipline Online Help Library have been added to Zipline in strategic locations to help users understand the differences.
- I’m a student or resident, how do I comply with the additional requirements?
- IRB 101 Tutorial. All students and residents must upload their completion certificate to Zipline. Additional instructions have been added to Zipline to help guide users with this process.
- Ancillary Review. This means “Faculty Advisor Review” in Zipline. Links to the Zipline Online Help Library have been added to Zipline in strategic locations to help users understand how to obtain and document the review of their faculty advisor.
- Why am I getting a weird error message when I try to log in? A recent security upgrade to Zipline revealed that former UW students and employees that were previously able to log in to Zipline could no longer do so. A check has been added that sends these users to a more helpful login failure page.
List of all changes. The Release Notes describing all changes to Zipline are posted to the Zipline Release Notes page.