ORA Announcements

ORA Virtual Office Hours – November 9th at 11:00 am

Please join ORA for our first monthly drop-in virtual Office Hours on Thursday, November 9th at 11:00 am. We will briefly discuss the Fibi go-live, new Data Use Agreement request form, and changes to the NIH Subawards Policy before opening the floor for your questions.Representatives from Contracts, Grants, and Subawards teams will join a panel to answer general questions.

Registration is not required, simply click the Zoom link here on November 9th at 11:00am.

If you would like to submit questions for the Q&A ahead of time, please send them to jatlass1@jhmi.edu or ora@jhmi.edu with “Office Hours Q&A” in the email subject. We look forward to hearing from you!

Fibi Updates – Go-Live is October 23rd!

Fibi, the software that will replace JHU’s current proposal preparation, routing, approval and reporting platform (Coeus), will go-live on October 23, 2023. Please visit the ORIS WEBSITE to familiarize yourself with Fibi, practice in the testing environment, and review training material options and opportunities.

September 27, 2023 – NIH Notice #NOT-OD-23-185 – Prior Approval Requests for Revisions to an Approved Data Management and Sharing (DMS) Plan Must be Submitted Using the Prior Approval Module

This NIH notice clarifies the process for submitting DMS revisions requests and requires these requests to be submitted via the eRA Commons Prior Approval module. Additional information on the submission process can be found in NOT-OD-23-185 here. Please work with your ORA Grants Associate to submit a prior approval request.

September 19, 2023 – An Update on the NIH Foreign Subaward/Consortium Policy – Effective 1/1/2024

NIH has issued its Final Updated Policy Guidance for Subaward/Consortium Written Agreements:  https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-182.html

The Policy goes into effect on January 1, 2024 and updates Section 15.2 of the NIH Grants Policy Statement to include the following clarifications:

15.2 ADMINISTRATIVE AND OTHER REQUIREMENTS

The following highlights several areas within the consortium relationship that the recipient needs to address with consortium organizations receiving subawards under a grant to ensure compliance with NIH requirements. The requirement for a written agreement addressing these and other areas is specified in this section.  NIH will not support any agreement that does not meet the minimum requirements outlined in the written agreement section below (15.2.1). NIH reserves the right to request copies of the written agreement and relevant supporting documentation as needed, as part of its oversight responsibilities. Failure to provide requested documentation may lead to remedies for noncompliance and potential enforcement actions (see 8.5, Specific award conditions and remedies for noncompliance).

NIH expects recipients to ask potential subrecipients, at the application stage, to submit language in their letters of support indicating their awareness of these requirements and the subrecipient’s willingness to abide by all requirements should an award be issued.

Note that most of these requirements only apply to a recipient’s consortium relationships with sub-recipients. When the relationship is with a vendor that is providing routine goods and services within normal business operations that are ancillary to the operation of the research program, the public policy requirements listed below do not apply. The vendor must also be providing similar goods and services to many different purchasers and provide them in a competitive environment.

15.2.1 Written Agreement

The recipient must enter into a formal written agreement, signed, and agreed to by both parties, with each consortium participant/subrecipient that addresses the negotiated arrangements for meeting the scientific, administrative, financial, and reporting requirements of the grant, including those necessary to ensure compliance with all applicable Federal regulations and policies and facilitate an efficient collaborative venture. If a subrecipient is unwilling to accept the requirements outlined in this section, by signing a written agreement, then an agreement cannot be issued. At a minimum, this agreement must include the following:

Note: All current requirements remain in place, with the addition of:

• For foreign subrecipients, a provision requiring the foreign subrecipient to provide access to copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report, to the primary recipient with a frequency of no less than once per year, in alignment with the timing requirements for Research Performance Progress Report submission. Such access may be entirely electronic.

The NIH has provided FAQ’s on the Policy which are found here:  https://grants.nih.gov/faqs#/subawards.htm?anchor=4304

September 6, 2023 – Postdoctoral Fellows Can Serve as PI on Select Proposals

As of September 6, 2023, the Office of Research Administration will accept and submit applications for sponsored projects where Postdoctoral Researchers serve in the role of Principal Investigator where the following criteria are met:

January 25, 2023 – JHU Data Services Data Management and Sharing Plan webinars

WRITING YOUR NIH DATA MANAGEMENT AND SHARING PLAN
Date: Wednesday, January 25, 2023
Time:12:00pm – 1:00pm
Registration link: https://jhu.libcal.com/event/10151186

WRITING DATA MANAGEMENT PLANS WITH DMPTOOL
Date: Wednesday, January 25, 2023
Time: 1:30pm – 2:30pm
Registration link: https://jhu.libcal.com/event/10151128

January 10 & 19, 2023 – ORA Q&A Sessions with Data Services & Welch Library

ORA hosted two joint NIH Data Management and Sharing Policy webinars with Data Services and Welch Library to discuss the new NIH policy and review available resources for Data Management and Sharing Plan drafting and budgeting. The webinar recording can be viewed here and the presentation slides can be downloaded here.

Additional resources referenced in the webinar include the Data Services flyer, as well as The Welch Library’s Data Management & Sharing Planning Guide.

Visit the JHU webpage on the new NIH Data Management and Sharing Policy for additional resource links.

December 14, 2022 – JHURA Brown Bag Data Management and Sharing Policy webinar

A recording of the December 14th JHURA Brown Bag session on the DMS Policy with presenters from JHURA, ORA, General Counsel, and the Office of Emerging Technology is also available in MyLearning here. Slides from this joint presentation can be found here.

December 2022 – New NIH Policy: Data Management & Sharing Requirement for NIH applications effective January 25, 2023

All NIH applications due on or after January 25, 2023 that will result in the generation of scientific data will be required to include a Data Management and Sharing Plan. Under this new Data Management and Sharing (DMS) policy, NIH expects that investigators and institutions:

• Plan and budget for the managing and sharing of data
• Submit a DMS plan for review when applying for funding
• Comply with the approved DMS plan

Additional information about planning & budgeting, submission & review, and implementation can be found on the NIH Data Management and Sharing Policy website.

The JHU Data Services website is an excellent internal resource for further guidance on research data management and sharing:

• Data Services overview
• Workshops and online trainings
• Data-related resources
• Data Management Plan (DMP) Tool guidance to assist faculty in composing their plan
• DMPTool website for Data Management Plan building