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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

With the constant evolution of technology, there has been a significant increase in the availability and usage of artificial intelligence (AI) software. AI tools, such as ChatGPT, will help shape the future, but they can also pose potential risk if used inappropriately. ChatGPT is a chatbot driven by AI that was created to mimic human conversation and collects information to train, improve and enhance the platform’s performance.

ChatGPT is not HIPAA compliant, and the University does not permit its use with any patient data. We are in the process of developing a policy to ensure appropriate use within the University setting. OpenAI, the company behind ChatGPT, also warns against inputting confidential data into the platform, which could constitute a public disclosure and lead to a loss in our ability to protect University information, including intellectual property.

We will continue to monitor the changing AI landscape and share updates as needed. If you have any questions or have a specific use case for this tool you would like to discuss, please contact UHealth Compliance or the Office of the Vice Provost for Research and Scholarship.

 

Announcements & Reminders

FY 2023 Opens July 10, 2023

Effort Reminder

The effort certification period for the second half of fiscal year (FY) 2023 will be open July 10, 2023.

This certification is required by the Federal Government and must be completed within 60 days. Therefore, the deadline will be September 8, 2023.

Please note that this means that PAAs for both biweekly and monthly payroll must be received no later than June 26, 2023 to ensure they will be loaded in ECC for the beginning of the effort period.

Unless there is an approved exception from ORA, effort must be certified timely. Please send exception requests prior to the end of the certification period to Gloria Gari at ggari@miami.edu.

Late exceptions will not be granted. Compensation not certified will be removed from the sponsored account and moved on a non-sponsored account.

Training for ECC will be offered on the following dates:

  • June 21, 2023 10:00 AM – 12:00 Noon
  • June 23, 2023 1:30 PM – 3:30PM
  • June 28, 2023 10:00 AM – 12:00 Noon
  • June 30, 2023 1:30 PM – 3:30 PM
  • July 19, 2023 10:00 AM – 12:00 Noon
  • July 21, 2023 1:30 – 3:30 PM
  • July 24, 2023 10:00 AM – 12:00 Noon

For more information, visit https://www.ora.miami.edu/compliance/effort-reporting/index.html. If you have any questions, please contact the ECC Administrative Office at ecrt.admin@miami.edu or call (305) 284-4054.

Clinical Research Management & Support Office Study Intake Form

Did you know that CRMSO has a Study Intake Form? The CRMSO study intake form is a valuable resource for investigators. This form can be used to prepare a high-level and comprehensive study concept that can also be presented to funding sponsors at the time of the proposal. 

The data collected from this form allows the CRMSO team to develop a preliminary approach to manage the project and identify the necessary resources to implement the study.

The Study Intake form can be found at this link: CRMSO Study Intake Form.

As of May 22, 2023

New HSRO Contact Email

Effective on 5/22/2023, the HSROletterrequest@miami.edu is available for the following requests:

  • Preparatory to Research Exception (HIPAA E)
  • Completed GDS Certification Form
  • COC for Non-NIH Funded Studies
  • Not Human Subject Research (NHSR)

For existing unaddressed requests, please re-direct to the new email address.

For future requests, please email the new address.

For general questions about submission and procedures, please visit the HSRO Contact Page to locate the relevant contact

As of March 20, 2023

Updates to Enrollment Tracking Policy Using Institutionally Supported Platforms: Velos or REDCap

Updates have been made to the Enrollment Tracking Using REDCap policy, which was communicated previously to the UM community, based on important dialogue with human subject researchers from across UM. Below is a summary of these updates.

  1. Protocols that have an IRB Exempt determination under one of the following exemption categories are excluded from the Enrollment Tracking Using REDCap policy.
  2. Cancer-related protocols that meet the REDCap criteria will be required to report accruals data for each participant within 5 days of consent. The REDCap Participant-Level Tracking Template was designed to meet NCI reporting requirements.
  3. If a non-cancer protocol meets the REDCap criteria, study teams will continue to be required to report aggregate accruals data for participants, including race, ethnicity, biological sex, and age. It is the responsibility of UM faculty and research personnel to report their accruals on either a quarterly or an annual basis, depending on the type of research project.
    • For research projects requiring informed consent, the REDCap Aggregate Accruals of Study Participants Template must be used to report quarterly accruals.
    • For research projects with an informed consent exemption or that are IRB-exempt (with the exception of excluded categories), the REDCap Aggregate Accruals of Study Participants Template must be used to report annual accruals

Workflow for Studies Requiring REDCap

As of Monday, March 20, 2023, when an IRB protocol is approved, a notification will be sent to the Principal Investigator, PI Proxies, Primary Contact, and Research Coordinators/Assistants of protocols identified as needing to use REDCap to report participant accruals. The notification will include a link to a new REDCap Accruals Reporting project with the Aggregate Accruals of Study Participants Template or the REDCap Participant-Level Tracking Template, depending on the type of protocol. If you already have a project in REDCap, a new project will be automatically created specifically for accruals reporting. This will prevent disruptions to your existing REDCap project(s).

For protocols requiring periodic aggregate accruals reporting, reminder notifications will be sent when data is due. Protocols requiring informed consent will receive quarterly reminder notifications starting three months after IRB approval. Protocols with an informed consent exemption or that are IRB-exempt (with the exception of excluded categories) will receive annual reminder notifications starting one year after IRB approval. These reminder notifications will continue until the protocol is closed.   

Additional Resources

Anyone needing additional support can:

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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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