Senior Contracts Specialist, Team Lead,

Program Coordinator,

The post Current OSP Employment Opportunities appeared first on UW Research.

SAGE releases that require system downtime will take place after business hours, typically at 5:30 p.m. PT. A banner will be posted in SAGE whenever the system will be unavailable. We appreciate your patience.

SAGE Support: Please contact sagehelp@uw.edu if you experience an issue in SAGE. If you have contacted SAGE support about an issue, our agents will respond to your message as soon as possible and let you know once the issue has been resolved.

Updated June 5, 2024

Features Now Available

PI Escalation Remediated on eGC1

• Status: Released 4/11/2024 – When PI Escalation is selected on an eGC1 Certify & Route page, the reviewer for the Cost Center Receiving Funding is now able to approve the eGC1 on the PI’s behalf in their absence.

Award Section Updates

ASR and MOD Character Limit Increase for Return Comments

• Status: Released 4/11/2024 – When reviewers return ASRs or MODs to campus, they now may enter up to 1,000 characters when adding comments for return reasons.

Award Email Notification Content Updates

• Status: Released 4/11/2024 – Notification formats for ADVs, ASRs, and MODs have been updated to provide clarity on when action is needed and by whom.

Various Fixes to Sync of Data between SAGE and Workday

• Status: Released 4/11/2024 – The sync of data between SAGE and Workday was updated to capture a more complete set of awards from Workday, and missing PIs and awards.

SAGE Budget Updates & Fixes

Budget Navigation & Snapshot Help Text Updates

• Status: Released 4/11/2024 – Within SAGE Budget, the left navigation menu text of an open budget has been updated from “History” to “Snapshots & History.” Once selected, additional help text clarifies the use of snapshots for Award Modifications.

Improved Performance on Large, Complex Budgets

• Status: Released 4/11/2024 – Technical improvements have been made to decrease the time it takes to load and save large, complex SAGE budgets, improving SAGE stability by reducing timeouts experienced by users.

Fix: Worksheet Custom F&A Saving Issue

• Status: Released 4/11/2024 – Users were at times experiencing long wait times when saving custom F&A settings. This issue has been resolved.

Performance Improvements

Subawards

• Status: Released 4/11/2024 – Subaward performance improvements have been implemented to decrease the processing time required to open and submit subawards.

Applications Tasklist

• Status: Released 3/18/2024 – The SAGE Central Applications Tasklist has been updated to improve performance and add to the SAGE stabilization efforts.

Miscellaneous Improvements

Preliminary Benefit Rates Updated

• Status: Released on 3/18/2024 – The new preliminary benefit rates are now available in SAGE Budget for use in proposal and award budgeting

SAGE to Workday Integration: SAGE Budget to Workday Award Plan

• Status: Released 2/29/2024 – To assist GCA with workflow and backlog reduction, the SAGE Budget data associated with an Award Setup Request now integrates to Workday Award Plans. This saves GCA time spent manually entering these details.

New Features Coming Soon

New features and infrastructure improvements are coming to SAGE throughout 2024. Updates will be shared here and at MRAM on how the SAGE team is addressing four main priorities:

• Improving OSP and GCA’s workflow to reduce backlogs. Targets include:
  • Integration of Award Setup Requests when an award already exists in Advanced Spend status
  • Automating OSP Assignments for eGC1 and award requests
  • Advance Request remediation to capture Workday required fields
  • Integration of initial Advance Requests to Workday for new award setup
  • Modification request enhancements and improvements targeted at reduction in returns
• Address high-priority support, maintenance, and remaining Finance Transformation remediation

Prioritized Issues

Personnel Lookup Search in Tasklists is not working yet; however, PI Name Search is working

• Workaround: Please contact sagehelp@uw.edu if you need any urgent data pulls for personnel until this is resolved.

Fixed Issues

For a full list of issues fixed since UW Finance Transformation, visit the SAGE Release Calendar.

Questions?

• For questions about SAGE, please contact sagehelp@uw.edu.
• For questions on award terms and conditions, budget extensions, award changes, subawards, and other sponsor-related questions, reach out to the Office of Sponsored Programs (OSP) at osp@uw.edu.
• For questions on award information in Workday or financial terms and conditions, contact Grant & Contract Accounting (GCA) at gcahelp@uw.edu.
• For full technical release notes, view the SAGE Release Calendar.

The post SAGE Features & Prioritized Issues appeared first on UW Research.

• • OHRP/FDA draft guidance, “Key Information and Facilitating Understanding in Informed Consent”
  • Zipline Downtime
  • Zipline Website Redesign
  • Human Subjects Protections Training for Community Partners
  • HSD Administrative Fee Increase for Industry Clinical Trials

OHRP/FDA draft guidance, “Key Information and Facilitating Understanding in Informed Consent”

New Draft Federal Guidance and Associated Edits to UW IRB Resources

The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) recently issued  on how to comply with the Revised Common Rule requirement that consent information “begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.”

The draft federal guidance is generally in agreement with existing published UW IRB resources. We have made some minor edits to our  ���Ի��� to incorporate some of the recommendations in the draft guidance.

These edits primarily include formatting changes to the Key Information section of the template and additional instructions for researchers who are conducting investigational drug and device studies.

Key Information

The Key Information should be unique for each study because it is intended to be the information that is most likely to assist the specific participant population with making an enrollment decision.

Researchers are responsible for identifying the Key Information for their studies and may benefit from reading publications about participant preferences and/or consulting with disease-focused non-profit groups, patient interest groups, or other researchers with experience with the study population.

Presenting Key Information

The Key Information requirement applies to the consent process as a whole which means there is flexibility in how the presentation of Key Information is structured so long as it is provided first and is organized and presented in a way that facilitates comprehension for the prospective participants.

Generally, information that is fully described in the Key Information section does not need to be repeated later in the process or form. Though there may be some limited situations when intentional repetition of information could improve comprehension or clarify complex concepts (e.g., certain risks, alternatives, uncertainty about direct benefits). Even when there is repetition, information should be briefly mentioned in the Key Information with a note that complete information can be found later in the form (e.g., provide a hyperlink or page number reference).

The UW IRB provides two optional templates for researchers.

• This template has a distinct Key Information section at the beginning of the form. It should be used for complicated, higher risk studies that require the consent form to be more than 2,000 words in order to explain that complexity. The separate Key Information section helps prospective participants focus up-front on the information that is most likely to influence their decision. The rest of the form fills in additional details and provides other information that may be of interest and/or is regulatorily required.
• This template is for simpler studies, studies with few procedures, minimal risks, and/or that require 2,000 words or less to explain. The UW IRB considers these shorter forms to be concise and focused enough that they don’t require a distinct Key Information section.

If you have questions about the guidance or changes to UW IRB resources, contact .

Zipline Downtime

June 25, 2024

Zipline will be unavailable while we make some minor updates to the e-IRB system the evening of June 25, 2024, from 5 pm until 8 pm Pacific Time. Please remember to save your work and log off before this time.

Zipline changes. Most of the changes will not be noticeable to researchers, but we have made several updates based on user feedback including:

• The Modifications Required to Secure Approval letter for follow-on submissions will now automatically include the parent study number, for faster study identification.
• The Continuing Review notification email will now contain a direct link to the Status Report form, enabling researchers to quickly locate and download the form.
• As part of the Zipline Help Library redesign: the Zipline Help Center will be streamlined to direct users to the main Help Library page; unnecessary help bubbles will be removed from the Workspace and SmartForms; all affected URLs will be updated.

If you have any questions, please contact .

Zipline Website Redesign

Launching June 25, 2024

The Human Subjects Division is excited to announce a new design for our Zipline landing page and associated help materials launching on June 25. The goal of this project is to improve site navigation by providing clear pathways to the most needed information for all types of researchers, from students working with the IRB for the first time to experienced study staff. Our Zipline landing pages and Zipline Help Library will be under construction on June 25 and it may be more difficult to find materials that day as we make updates. Contact  if you have any questions or need assistance.

Changes will include:

• Streamlined Zipline landing page featuring quick access to the most used resources
• Updated process overview pages designed to give new and infrequent users a high level overview of common actions such as applying for review
• Flattened structure in the Zipline Help Library with curated information to make it easier to find step by step instructions for common tasks such as updating the study team in Zipline
• Updated Zipline FAQs to address the most common questions about using Zipline

Thank you to all the members of our campus community who participated in interviews and provided in-depth feedback about our draft designs. Your insights helped to ensure that our final design is better suited to the needs of the UW research community.

Human Subjects Protections Training for Community Partners

New Offering

The Human Subjects Division is offering a new human subjects protections training option specifically for community partners.

CIRTification: Community Involvement in Research Training is designed by the University of Illinois Chicago Center for Clinical and Translational Science (UIC CCTS) especially for community partners who are involved in activities such as recruiting research participants, obtaining informed consent, or collecting data. This training is not for UW researchers who need to satisfy the NIH training requirement. They should take training offered through the .

Visit the to learn more about this new human subjects protections training, including how to register. Contact with any questions.

HSD Administrative Fee Increase for Industry Clinical Trials

Reminder

Effective July 1, 2024, HSD’s administrative fee will be increasing from $1933.70 to $2060.06. This one-time fee only applies to industry-sponsored-and-initiated clinical trials reviewed by a non-UW IRB where the contract was negotiated by UW’s Office of Sponsored Programs (OSP). This fee is charged because this type of research has an indirect cost rate that does not cover HSD’s costs for performing necessary administrative and regulatory oversight activities. The rate increase reflects updated costs for HSD to perform these activities. It is common for universities and research institutes to charge these fees for industry research.

Applicable external authorization requests submitted in Zipline on or after the effective date will have the new rate applied.

Contact if you have any questions.

The post For the Record- June 4, 2024: Key Information Draft OHRP/FDA Guidance, Zipline Updates, New Human Subjects Training appeared first on UW Research.

As of Monday 5/20/2024, the Office of Sponsored Programs has 846 subaward actions in OSP. Typically, a high volume for these action types is around 350. See OSP Volume: Awards, Modifications, and Subawards.

Please review these updates & reminders to ensure the fastest possible processing of your subaward action.

Updates & Reminders

• Review foundational steps required before a subaward can be requested in SAGE along with the follow-up steps required to establish a subaward in the UW systems.
• Requesting an Advance award does not help you get a subaward set up sooner.
• The related Award Setup or Modification Requests (ASR or MOD) in SAGE must be Processed before you submit a Subaward Request in SAGE.
• Confirm your subaward requests in the SAGE Subaward Module include all required documentation and are accurate.
  • If this is a new subaward request or a modification where the scope of work changes, attach a scope of work to the subaward request (SA).
  • If this is a new subaward request or a subaward modification that includes funding changes, attach the subrecipient’s categorical budget (not a SAGE Budget) to the SA.
  • The total on the attached budget should match the figure in the “Request Amount” field in the SA.
• Include Workday GR# for subaward and ASR or MOD number related to the subaward in “Special Terms or Instructions For OSP” field. This is not required, but including this is very helpful.
  • If OSP cannot determine the ASR/MOD and/or GR#, they will need to return the SA for clarification.

What if I need to escalate a subaward request?

Review guidance and instructions for Urgent Subaward Requests.

Resources

• Outgoing Subaward Set Up
  • First Steps
  • Next Steps to Establish a Subaward
• Urgent OSP Requests: Award Setup, Modifications, and Subawards
• OSP Volume: Award Setup Requests, Modification Requests, Subawards
• CORE course materials: Subaward Fundamentals
• CORE course materials: Subawards in SAGE

This announcement was sent to all active principal investigators and the MRAM mailing list.

The post Update: Setting up Outgoing Subawards appeared first on UW Research.

Proposers must:

• Seek guidance from the potentially impacted Tribal Nation on activities that require review and prior approval from that Tribal Nation’s authorized designee.
• Submit a written request to the relevant Tribal Nation (based on their guidance), for approval to carry out the proposed activity that requires their review and approval.
• Complete the checkbox for “Potential Impacts on Tribal Nations” on the Cover Sheet. Note, lead organizations are responsible for this on collaborative proposals & proposals with subawards considered a single unified project.
• Upload one of the following into “Other supplementary documents” of Research.gov:
  • a copy of the written request to the relevant Tribal Nation to carry out any proposed activity/activities that may require prior approval from them
  • written confirmation from the Tribal Nation(s) that review and approval is not required
  • a copy of relevant Tribal Nation approval

Review , Seeking and Obtaining Tribal Nation Approval for Proposals that May Impact Tribal Resources or Interests.

The post NSF: Proposals impacting Tribal Nation Resources & Interests appeared first on UW Research.

• Offline Saturday, May 18, 2024 at 12:01 AM ET
• Back Online Tuesday, May 21, 2024 at 6:00 AM ET

During this maintenance window, depending on the system used to prepare and submit proposals, users can expect disruptions in creating new applications, updating existing applications, checking for errors, submitting applications, and getting status updates.

All sponsors and systems that rely on Grants.gov may be impacted. This includes the NIH, NSF, Dept. of Defense, Dept. of Education, USAID, AHRQ, and others. Proposal submission systems impacted include Grants.Gov Workspace, ASSIST, Research.gov, and the UW’s Grant Runner feature in SAGE.

The post Upcoming Grants.gov Downtime: Plan Ahead for Proposal Impacts appeared first on UW Research.

Jump to Sections:

• Award Setup Requests
• Modifications
• Comments & History
• SAGE Budget Worksheets
• Returns and Holds
• Resources and Links

Award Setup Requests

If you (campus or PI) receive the Notice of Award (NoA), whether or not OSP is included, you should create the Award Setup Request (ASR) in SAGE as soon as possible.

If you’ve received an ASR from OSP, refer to our FAQ: What do I do when I receive an Award Setup Request created by OSP? Note: OSP only creates an ASR when the PI and/or campus are not included on the Notice of Award.

•  Supporting Attachments:
  • Award documentation and any sponsor correspondence that accompany award document
  • Documentation when there is a sponsor deadline for accepting an award
  • Compliance documentation (IRB/IACUC)
• Comments & History:
  • Include sponsor contact information
  • Provide more information about your request such as an explanation that may help reviewers understand what you are requesting

Review more on:

• How to get an Award Setup at the UW.
• What do I do when I receive an Award Setup Request OSP has created? 
  

Award Modifications

Use the Modification Request (OSP/GCA) for all changes that require sponsor approval, an authorized official signature, or review from the Office of Sponsored Programs (OSP).

For both GCA only and OSP/GCA requests that do not already have a required form (e.g. Extension, Change of PI, etc) use as a guide for required information before routing.

• Select at least one modification category, and all that apply
  • For example, Funding & Budget Change, Schedule Change, Other Changes, etc.

• Comments: indicate what type of changes you are asking for in the comments field, add any other relevant information that will help OSP or GCA complete your request
  • For example, for Modifications that require a SAGE Budget  and include a link to that snapshot in the comments field of the Modification
• Confirm you have updated any relevant fields and attachments needed to complete your request
• Include links to SAGE Budget Snapshot URLs when Modification request that includes funding changes
  • How to Make a SAGE Budget Snapshot
  •  Include the Workday Grant ID (GR######)
• Complete and attach relevant forms, such as Extension or Change of PI, or sponsor

Review more details on:

• Submitting Modifications to OSP/GCA
• How do I know which Modification Request Type to choose? 

Comments & History

Use the Comments & History section to provide additional details and explanations for your request. Appropriate comments can help ensure OSP and GCA have a clearer understanding of your request and may help reduce returns.

For example:

• Provide sponsor contact information when request needs to be sent to the sponsor by an Authorized Organization Representative (AOR), at the UW this is OSP
• Include comments on relevant compliance information

Be aware of character limits in the comment fields:

• Comments allow for 1000 characters
• Returns and resubmitted items:
  • When GCA returns an item, 300 character limit
  • When campus resubmits an item, 300 character limit

OSP and GCA will also use the Comments & History to provide you with information. Review the Comments & History section for more information on why an item was returned or why it may have a hold.

Returns & Holds

• Review the Comments & History section for information about why a request was returned or is on hold.
• Address reasons an item was returned before sending it back to OSP or GCA.
• Use the returned items list that to stay on top of returned ASRs and MODs.

SAGE Budget Worksheets

• Principal Investigator: Enter a named Principal Investigator for each SAGE Budget worksheet, even if they are not supported by the award.
  • This populates Workday Principal Investigator (Grant) field.

• Cost Center Receiving Funding: Enter the Cost Center Receiving Funding on the Award Setup Request and all worksheets.
• Worksheet Security Grant Hierarchy: Enter the security hierarchy into the Worksheet Security Grant Hierarchy field for all budget worksheets.
• Sponsored Program Activity (SPA) Type: Ensure the SPA type on budget worksheets matches the Award Setup Request SPA type, unless there’s a legitimate reason for them to be different (e.g. sponsored program award includes multiple SPA types).

• Worksheet Periods: SAGE Budget worksheet periods should match, or be within, the Award Setup Request Current Period Start Date and the Current Period End Date.
• Award Lines: Create and include separate worksheets for anything that needs to be on a separate award line in Workday, including subawards, equipment fabrication, or multiple F&A rates.
• Primary Worksheet Name: Change the name your SAGE Budget Worksheet from “Primary Worksheet” to have a meaningful Grant Name in Workday.
• Include links to SAGE Budget Snapshot URLs for Award Modification requests that includes funding changes.
  •  Include the Workday Grant ID (GR######) in the comments.
• Review SAGE Budget Resources.

Resources and Links

• Setup Financials – includes Award Setup Workflow, How to get an award setup at the UW, and more…
  • I received an ASR created by OSP – now what? 
• Grant & Contract Accounting
• Manage Award Changes – includes guidance for Award Modification Requests and required information for each request type
• Grant and Contract Accounting –
• OSP Urgent Requests – Award Setup, Modifications, and Subawards
• SAGE Budget Resources
• SAGE Awards and Modifications Resources
• SAGE Office Hours – a great place to get help on your questions or challenges using SAGE

The post Tips for Success – Award Setup and Modifications Requests in SAGE appeared first on UW Research.

The post May 2024 Edition of Horizons Newsletter is Online appeared first on UW Research.

• • Protecting Research Participant Data in Workday
  • WA State Diversity in Clinical Trials Bill
  • HSD Administrative Fee Increase for Industry Clinical Trials
  • Advance Consultation about the UW as a Single IRB

Protecting Research Participant Data in Workday

UW Finance Safeguards and Additional Measures For Researchers

UW Finance recently  about how study participant payment data placed in Workday is protected from unauthorized access and disclosure. With the transition to Workday the process for paying research participants via check or Zelle was centralized under the Workday Miscellaneous Payment business process. UW Finance implemented the following safeguards to prevent potential violations:

• Limited Access: Access to research participant payment information is available through certain Workday reports. Only authorized personnel have access to reporting data in Workday. Access is restricted to individuals who need it to perform their job duties related to financial transacting on behalf of the UW.
• Data Storage/ Migration: Research participant payment information is not migrated to the University’s enterprise data warehouse (EDW). Participant names are contained solely in the Workday system.
• User Training: UW is working towards a central learning management tool. This will facilitate annual training on proper handling of sensitive data, security best practices, and procedures for reporting any potential breaches or security incidents.
• Audit Trails: The audit trail mechanisms within Workday track and monitor access to reports. This data allows UW to review and analyze user activity logs to detect any unauthorized access or suspicious behavior.

There are additional measures that researchers can take to ensure personal information in Workday is minimized, such as:

• Use Non-Identifying Titles for Grant Worktags: When creating the “short title” for research projects or grants in Workday, avoid using titles that that include a study acronym that is searchable on the web or has the condition under study (e.g., GR12346 HIV Study). This prevents the research participant name from being associated with any information that would reveal something personal about them (e.g., they have HIV because they are in an HIV study).
• Include Information in Consent Forms: If a particular study population may have concerns that their financial information is accessible to others outside the study team, you can provide additional disclosure information as part of the consent process. Sample language may be found in .

If you have any questions, contact UW Finance at .

WA State Diversity in Clinical Trials Bill

Update

In our , we introduced the new WA State Diversity in Clinical Trials bill () and its requirements.

The UW intends to apply the bill requirements to all prospective UW research that meets the and where UW employees or agents are responsible for or engaged in recruitment and consent activities. This means that all new UW clinical trials submitted to the IRB on or after the UW policy effective date (TBD, summer 2025) should seek to improve enrollment of underrepresented groups applicable to their target study population. The target study population must be based on epidemiology/pathophysiology of the disease and/or the population that the intervention is intended to treat. Some exclusions will apply but must be justified by science, medicine, ethics, and safety. Phase 1, pilot, and feasibility studies, for example, may meet these criteria. This policy would:

• Apply regardless of where the interventions occur.
• Apply to studies relying on an external non-UW IRB for review.
• Be a condition of the UW agreeing to review on behalf of non-UW institutions and individuals.

The work towards implementation of the bill is under way and is being overseen by the UW Medicine Office of Healthcare Equity and led by a Strategic Leadership Committee comprised of interested parties and subject matter experts. There are also five working groups supporting various aspects of the bill:

HSD Administrative Fee Increase for Industry Clinical Trials

Update

Effective July 1, 2024, HSD’s administrative fee will be increasing from $1933.70 to $2060.06. This one-time fee only applies to industry-sponsored-and-initiated clinical trials reviewed by a non-UW IRB where the contract was negotiated by UW’s Office of Sponsored Programs (OSP). This fee is charged because this type of research has an indirect cost rate that does not cover HSD’s costs for performing necessary administrative and regulatory oversight activities. The rate increase reflects updated costs for HSD to perform these activities. It is common for universities and research institutes to charge these fees for industry research.

Applicable external authorization requests submitted in Zipline on or after the effective date will have the new rate applied.

Contact if you have any questions.

Advance Consultation about the UW as a Single IRB

Reminder

Serving as the Single IRB for a multi-site trial or multi-institutional collaborative research requires a significant commitment of limited HSD and UW IRB resources. Therefore, HSD must be consulted in advance of a funding application if a researcher wants to use the UW as the Single IRB for a study. continues to be that it cannot guarantee UW IRB review of any multi-institutional research for which it has not been consulted in advance of any commitment to funding agencies or other institutions. Contact us at if you would like to set up a consultation.

The post For the Record- May 7, 2024: Protecting Participant Data in Workday, WA State DCT Bill, More appeared first on UW Research.

See NIH

Retroactive adjustments or supplementation of stipends for an award made prior to October 1, 2023 are not permitted.

If an award was issued on or after October 1, 2023, but before the new stipend levels were released, NIH will revise the award to adjust the funding to new levels.

Appointments to institutional training grants must be amended to reflect the FY24 levels after the award is adjusted. This is done by amending appointments through in eRA Commons.

The post NIH Announces NRSA Stipend Levels appeared first on UW Research.