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Research Week in Review

In the Office of the Vice Provost for Research & Scholarship, over 250 professionals guide faculty, staff, and learners through the entire Research Lifecycle, from project conception and grant submission to sharing results with the world and creating commercial opportunities

To submit an announcement to the Week in Review, email vprs@miami.edu or to have your event appear in the Research Events Round Up newsletter promote your event.

 

Spotlight

Now Available!

New Adobe e-Signature Process for FDA-Regulated Research

The Adobe Self-Sign Digital ID electronic signature process has been validated and is considered compliant with FDA’s 21 CFR Part 11 regulation.

Who should use this e-signature process?

Researchers conducting FDA-regulated studies under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application must in the absence of wet signatures, apply e-signatures using a 21 CFR Part 11 compliant system.

For FDA-regulated studies: If you need to e-sign a research document to be maintained as part of your study records, and the document cannot be signed within Complion, Velos, or other Part 11 compliant system, then you must e-sign the document using the Adobe Self-Sign Digital ID e-signature process. For example, if you need to add a note to file to your records, and this note cannot be signed within Complion, you must e-sign using the Adobe Self-Sign Digital ID e-signature process.   

Training and More Information:

  • Join us for a live demonstration on May 4th at noon. Register in advance for the Zoom session.  
  • An online module entitled, Adobe Self Sign Digital ID Electronic Signature, has been developed and is available in ULearn. Search keyword: digital id.
  • View Frequently Asked Questions here.

Read more.

 

Announcements & Reminders

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The Office of the Vice Provost + Scholarship (OVPRS) is now on social media! Connect with OVPRS on Twitter, Instagram and Facebook for the latest updates.

A Message from Jean Feldman, Head Policy Office, National Science Foundation

FAQs on NSF Proposal Preparation & Award Administration

NSF has issued revised Frequently Asked Questions (FAQs) On Proposal Preparation and Award Administration Related to the NSF Proposal & Award Policies & Procedures Guide (PAPPG) (NSF 23-1). Any questions should be directed to the Policy Office in the Division of Institution and Award Support at policy@nsf.gov.

A Message from Jean Feldman, Head Policy Office, National Science Foundation

NSF Opens Comments for PAPPG

The National Science Foundation (NSF) published a notice today in the Federal Register announcing the availability of the “For comment” draft of the Proposal & Award Policies & Procedures Guide (PAPPG) (NSF 24-1). The Foundation is accepting comments from the external community until cob June 12, 2023.  The draft PAPPG is available on the Policy Office website.

To facilitate review, revised text has been highlighted in yellow throughout the document and explanatory comments have been included in the margins, where appropriate. 

Any questions should be directed to the Policy Office at policy@nsf.gov.

Coming Soon

New IACUC System

We are thrilled to share that the University of Miami is implementing the Huron IACUC module to manage animal research protocols!

We understand that transitioning to a new system can be overwhelming, which is why we've created a list of FAQs that can be found at www.miami.edu/iacuc to address any concerns you may have. 

We want you to know that we are here to support you every step of the way, as we are committed to advancing scientific research in an ethical and responsible manner.

So please remember, you are not alone!

Read more.

IBISResearch - IRB

Enrollment Tracking for Protocols with a Billing Component

IBISResearch – IRB is a human subjects research protocol review system at the University of Miami. This system includes questions that ascertain the scope of work that the protocol entails, including the billing/costs related to a study. The new enrollment tracking policy requires that studies who answer “Yes” to the question below, report participant accruals in Velos (refer to the Enrollment Tracking Decision Tree).

Does this study include procedures, lab tests, or medical interventions of any kind that might generate a charge through UHealth or a commercial laboratory, no matter the source of reimbursement?  YES or NO

The question above is crucial to ensuring proper research billing practices, which can have significant implications for the University. Here are additional details to help ensure you answer this question correctly within the IRB system.

Now Available!

Corporate and Foundation Grant Opportunity Database

The Office of Corporate and Foundation Relations is excited to announce a new resource for faculty, physician-scientists, researchers, and graduate students seeking philanthropic grants to support research or outreach projects.

The Corporate and Foundation Grant Opportunity Database presents over 1,000 grant opportunities – which are searchable by keyword, sponsor, career level, grant amount, deadline, and more.

Visit this useful new tool on the Office of the Vice Provost for Research and Scholarship website to identify potential grant opportunities, and then contact the Corporate and Foundation Relations team to collaborate on your grant proposal.

We are here to help!

Important NIH Notices

NIH Notices

  • eRA Information: Select Withdrawn NIH Applications Will Display a Grant Number Appended with a "D" in eRA Commons Effective April 26 - A new process to go into effect tomorrow, April 26, 2023, will tag a resubmission or renewal application that is withdrawn prior to review with a ‘D’ in the grant number. The tag will only appear when a subsequent version is submitted.

    This will allow NIH staff to assign the original grant number of the withdrawn application to the subsequent version and preserve information related to the withdrawn application in the eRA Commons.

    Applicants will see the withdrawn application listed on the Status Information screen (also called Grant Folder) with a D% (D1, D2, D3) at the end of the grant number.  An example is 1R01CA12345-01D1. The Status will state ‘Application withdrawn.’

  • Reminder: NIH Policy for Data Management and Sharing Plan Effective January 25, 2023. The National Institutes of Health issued a notice (NOT-OD-23-053) to remind the community of the effective date of the NIH Policy for Data Management and Sharing (DMS Policy) and summarize available key resources.

    As noted in the Final NIH Policy for Data Management and Sharing (NOT-OD-21-013), the effective date of the DMS Policy was January 25, 2023 for competing grant applications submitted to NIH on or after January 25, 2023 and subsequent receipt dates; proposals for contracts  submitted to NIH on or after January 25, 2023; NIH Intramural Research Projects conducted on or after January 25, 2023; and other funding agreements (e.g., Other Transactions)  executed on or after January 25, 2023, unless otherwise stipulated by NIH.

    The DMS Policy applies to all NIH research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data. Note that the DMS Policy does not apply to research and other activities that do not generate scientific data, for example: research training, fellowships, infrastructure development, and non-research activities. See Research Covered Under the Data Management & Sharing Policy for more details. 

  • Forms-H Coming for January 23, 2023 Due Dates. 
    Applicants applying to NIH funding opportunities with due dates on or after January 25, 2023 must use updated application forms and instructions identified with a Competition ID of “FORMS-H” (NOT-OD-22-195). The primary change to the updated application forms is the addition of an “Other Plan(s)” attachment on the PHS 398 Research Plan and PHS 398 Career Development Supplemental forms as part of the implementation of the 2023 NIH Data Management and Sharing Policy. Applicants must attach the required Data Management and Sharing Plan in this new field in FORMS-H applications (NOT-OD-22-189).
  • Notice for the NIGMS Grant Writing Webinar Series for Institutions Building Research and Research Training Capacity The National Institute of General Medical Sciences (NIGMS) will host an informational webinar series for faculty and sponsored programs/research development personnel from institutions building research and research training capacity. During the webinars, suggestions will be shared for navigating the process of seeking NIH funding. Attendees will learn considerations for determining research idea and grant writing readiness, selecting opportunities to apply for, effectively writing a grant application, and seeking appropriate feedback. Registration is required to attend.
  • Do you have questions about the National Institutes of Health (NIH) Inclusion Plans?  In Part 1 of this NIH All About Grants podcast mini-series, NIH's Inclusion Policy Officer, Dawn Corbett, discusses how to consider inclusion plans when putting together your application (MP3 / Transcript). Part 2 of the podcast covers inclusion plans during peer-review and post-award (MP3 / Transcript). NIH's All About Grants episodes can also be heard on iTunes and Spotify. Read the article in the Extramural Nexus.
  • Updated Requirements for NIH Notification of Removal or Disciplinary Action Involving Program Directors/Princial Investigators or other Senior/Key Personnel. Section 239 now requires that, “[t]he Director of the National Institutes of Health shall hereafter require institutions that receive funds through a grant or cooperative agreement during fiscal year 2022 and in future years to notify the Director when individuals identified as a principal investigator or as key personnel in an NIH notice of award are removed from their position or are otherwise disciplined due to concerns about harassment, bullying, retaliation, or hostile working conditions.” Therefore, effective 60 days from the publication of this Notice, NIH recipient institutions are required to notify NIH when individuals identified as PD/PI or other Senior/Key personnel in an NIH notice of award are removed from their position or are otherwise disciplined by the recipient institution due to concerns about harassment, bullying, retaliation or hostile working conditions. Notification must be provided by the Authorized Organization Representative within 30 days of the removal or disciplinary action and must be submitted to NIH through a dedicated web form.
  • NIH NIAID Technology Transfer Fellowship ProgramFellows will be mentored by professionals that work side-by-side with with world-renowned NIAID and Centers for Disease Control and Prevention (CDC) scientists and will be part of the team that helps transfer innovations from the lab to commercial products (including vaccines, therapeutics, and diagnostics) that benefit global public health.
  • Childcare Funding Available for Pre/Post Docs Full-time appointed predoctoral  and postdoctoral NIH-NRSA supported trainees are eligible to  receive $2,500 per budget period for childcare costs provided by a  licensed childcare provider. For households where both parents are eligible full-time predoctoral or postdoctoral NRSA trainees, each parent is eligible to receive $2,500.
  • Guidance on Salary Limitation for Grants and Cooperative Agreements  This Notice provides information regarding the salary limitation for NIH grant and cooperative agreement awards and extramural research and development contract awards.Since 1990, Congress has legislatively mandated a limitation on direct salary for individuals under NIH grant and cooperative agreement awards (referred to here as a grant). The mandate appears in the Consolidated Appropriations Act, 2023 (Public Law 117-328), signed into law on December 29, 2022, which provides authority for NIH to incur obligations for Fiscal Year 2023. The Consolidated Appropriations Act, 2023 restricts the amount of direct salary to Executive Level II of the Federal Executive pay scale. The Office of Personnel Management recently released new salary levels for the Executive Pay Scale. Effective January 1, 2023, the salary limitation for Executive Level II is $212,100.

 

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