ORA Virtual Office Hours

This session was cancelled. Please join us in April: https://jhjhm.zoom.us/webinar/register/WN_G5x_vondTVaCz_T4lmdiWQ

This was an open Q&A session that continued the discussion on NIH Common Forms and NIH’s extended grace period. There were no presentations slides for this session.

Panelist included:

• Tom Burns, Associate Vice Provost for Research Compliance
• Sharel Brown, Associate Director of Grants
• Haleigh LaChance, Assistant Director of RA Training

Links referenced during the session included:

• NIH Common Forms FAQs for Biosketches and Other Support
• SOM Malign Foreign Talent Recruitment Program (MFTRP) template (not needed if using NIH Common Forms Other Support)
• JHU resources and training videos on Common Forms and SciENcv can be found on the Research Administration Training Program page
• Please reach out directly to the NCBI helpdesk via their website here or via email ([email protected]) for system issues with SciENcv
• SciENcv delegation FAQs can also be found here.

This session focused on the implementation of the new NIH Common Forms – required for all NIH submissions (proposals, JIT, RPPR, and prior approval request) due on and after January 25, 2026. NIH’s announcement on this change can be found here: NOT-OD-26-018. The NIH Common Forms for Biosketches and Other Support page has also been updated with additional information.

The recording of the presentation portion of the session can be viewed here. The presentation slides can also be downloaded here. Please note that there was a typo in the slides that has been corrected: in-kind contributions are reportable if they are greater than or equal to $5,000 and involve committed effort.

We had close to 500 attendees for this session and received over 100 questions – a new ORA record! Thank you for your enthusiastic engagement and please bear with us as we assemble the extensive list of FAQs from the Q&A. Once completed, you will be able to find them here.

For system issues with SciENcv, please reach out directly to the NCBI helpdesk via their website here or via email ([email protected]).

SciENcv delegation FAQs can be found here. 

The December session was cancelled. Please join us in the new year!

This was an open Q&A session with ORA staff. No slides were presented.

December Office Hours will be cancelled, but please join us in January (registration link here).

This session focused on the changing federal policies and processes for foreign sites and foreign supplements, with panelists from the Grants and Outgoing Subawards teams.

The presentation slides can be downloaded here.

The presentation recording can be viewed here.

A list of FAQs from this session can be downloaded here.

This was an open Q&A session. No slides were presented. Thank you for bringing your questions!

In this session we discussed the change in submission method for SOM Data Use Agreements from Qualtrics to Fibi Service Request, followed by a Fibi demo by Angel Gasior from ORIS.

A copy of the recording can be viewed here and the short slide deck can be downloaded here. Helpful links referenced include the Request a Data Use Agreement page on the ORA website, as well as the Fibi DUA Service Request Snapshot Guide on the ORIS website.

Register for our next session on September 11th here: https://jhjhm.zoom.us/webinar/register/WN_E9U5DGnaQiuzU8fuI4F5dw

The July 10th Office Hours session was cancelled. Please join us in August for an overview of changes to the SOM Data Use Agreement (DUA) submission process.

In this session, Nancy Shin and Beth Whipple from the JH Welch Medical Library discussed updates to the NIH Public Access Policy that will go into effect on July 1, 2025.

The presentation recording can be viewed here and the slides are available for download here.

Addition resources discussed during this session included:

2024 NIH Public Policy Access Notice (NOT-OD-25-047): https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-047.html 

Welch Medical Library Guide about the NIH Public Access Policy: https://browse.welch.jhmi.edu/nih-public-access

Welch Library classes (including this session): https://welch.jhmi.libcal.com/calendar/welch-classes?cid=15168&t=d&d=0000-00-00&cal=15168&inc=0

Submitting papers through the NIHMS: Methods C and D best practices: https://sharing.nih.gov/public-access-policy/reporting-publications-to-nih/submitting-papers-through-the-nihms-methods-c-and-d-best-practices 

Method D Publishers List (2008 policy version) – please note the 2024 list is still pending: https://sharing.nih.gov/public-access-policy/submitting-to-pubmed-central/method-d-publishers 

In this session, Valerie Smothers, Director of the JHM Office of the Data Trust, presented a overview of the Data Trust.

The session recording can be viewed here and slides can be downloaded here.

Register for the June 12th session here: https://jhjhm.zoom.us/webinar/register/WN_-UJ1UhbLRFmqF77OirGNhg

The April 10th Office Hours session was cancelled. Please join us in May for an overview from the SOM Data Trust.

This was an open Q&A session with senior members of ORA. No slides were presented.

Helpful links referenced during this session:
* Prior Office Hours session on Updates on the NIH Common Forms for May 25th, 2025. Slides and recording from this November session can be found here: https://ora.jhmi.edu/training-resources/ora-office-hours/#1736198305362-03bc7420-4020 We anticipate more information from NIH in late March and will update faculty and staff when we receive more information.

* Prior Office Hours session on Demystifying ORA Processes. Slides and recording from this November session can be found here: https://ora.jhmi.edu/training-resources/ora-office-hours/#1723148428357-5183a67c-e56c

* Information about Outgoing Subawards can be found on the ORA website here: https://ora.jhmi.edu/outgoing-subawards/ For specific questions about an in-process subaward, please contact the Subawards team at: [email protected].

This session included a discussion of publication restrictions from ORA Contracts Assistant Director Mike Harmon, as well as an overview of the Classified/Restricted Work Review Committee from JHU’s Facility Security Officer, Khaleena Anderson.

A recording of the presentation can be viewed here and presentation slides can be downloaded here.

This session focused on an overview of NIH’s Forms-I that are in effect for proposals due on and after January 25, 2025.

The presentation recording can be viewed here and presentation slides can be downloaded here.

The link to new NIH Sponsor guidance for Fellowship applications that is referenced at the end of the recording can be found here and is crucial for fellowship applicants and their faculty sponsor(s) to review to ensure that the required application criteria for new fellowship research plans are being met.

To register for our next session on February 13th, please click here.

Due to the winter holiday season, ORA will not hold an office hours session in December. Please join us in January for the next session.

This session reviewed the latest information about NIH’s implementation of the new Common Forms for Biosketches and Other Support documents that will be required for proposals due on or after May 25, 2025. The presentation covered policy information, online resources, preparation suggestions, and visuals from SciENcv.

A copy of the recording can be viewed here and the presentation slides can be downloaded here.

Additional sessions about this topic will be held in 2025 as we learn more and once NIH has finalized their version of the Common Forms.

This was an open Q&A session. No presentation was included, so there was no recording or slides.

This session discussed the differences between Research Agreements vs. Service Agreements and compared institutional vs. private Consulting Agreements.

A recording of the session can be viewed here and a copy of the presentation slides can be downloaded here.

To register for our next session on October 10th, please register here.

This session focused on navigating the various sections of the ORA website to find information related to proposals, awards, agreements, outgoing subawards, compliance information, and training resources.

A recording of the session can be viewed here (there were no slides for this session).

This session focused on demystifying who we are, what we do, and addressed the question, “what happens after I submit my grant/contract/outgoing subaward, etc. to ORA?” We covered the four ORA teams, team responsibilities, ORA processes, and how to find the ORA contacts assigned to your department.

A recording of the session can be viewed here and a copy of the presentation slides can be downloaded here.

For questions about commercially funded clinical research/clinical trials, please consult the Clinical Research Contracting (CRC) session from May 9th.

This session focused on a JHM Institutional Review Board (IRB) overview, presented by Megan Singleton, Associate Dean for Human Research Protection and Director of the Human Research Protection Program (HRPP). More information about the JHM IRB can be found on their website here.

A recording of the session can be viewed here and a copy of the presentation slides can be downloaded here.

Additional links referenced during the Q&A included:

• Request an IRB consult: https://jhmi.co1.qualtrics.com/jfe/form/SV_eGbJ1cbenceOVQa
• Case Report Publication Guidance: IRB Review and HIPAA Compliance: https://www.hopkinsmedicine.org/institutional-review-board/guidelines-policies/guidelines/case-report
• Organization Policy on Single Case Reports and Case Series: https://www.hopkinsmedicine.org/institutional-review-board/guidelines-policies/organization-policies/102-3
• Requesting a Reliance Agreement: https://www.hopkinsmedicine.org/institutional-review-board/about/agreements#requesting-reliance-agreement

This session focused on a Clinical Research Contracting (CRC) office overview, presented by Mont Brownlee, Executive Director of CRC. CRC is responsible for the review, negotiation, and signature of all commercially sponsored clinical research and all Confidentiality/Non-Disclosure Agreements (CDA/NDA) for the School of Medicine.

A recording of the presentation can be viewed here and a copy of the presentation slides can be downloaded here.

This session briefly covered research security updates, the new NIH resubmission markup policy, and a refresher on Data Use Agreement and Materials Transfer Agreement routing.

A recording of the presentation portion is available to view here and a copy of the slides can also be downloaded here.

In this session we covered the elements of Just-in-Time submissions for grants.

A recording of the presentation is available to view here and a copy of the slides can also be downloaded here.

Additional resources mentioned during the session include sample automated and formal JIT email requests, and a JIT acronyms list.

As there were a number of Other Support-related questions during the Q&A, we have included a list of available JHU Other Support resources below:

• How to run an Other Support report query in Fibi
• NIH Biosketch & Other Support Quick Guide
• Changes to NIH Other Support & Signature Requirement Q&A Slides
• University-wide Other Support page
• JHU-Specific FAQs
• NIH Other Support FAQs
• DocuSign video tutorial
• DocuSign instructions
• To request a Research Admin DocuSign account (for Other Support purposes only), please email your request to [email protected]

In this session we covered agreement types, Fibi routing, and how to submit various proposal, award, and agreement types to our office.

A recording of the presentation is available to view here and a copy of the slides can also be downloaded.

Fibi resources referenced in the session include the ORIS website and ORA Fibi training page (includes the Coeus to Fibi cheat sheet).

A copy of the DUA presentation slides shared during this session can be found here.