Third-Party Requests for University Information Frequently Asked Questions Document

There are instances when faculty and staff are approached, either in person or through document requests such as warrants or subpoenas, by law enforcement agencies, other investigative agencies, the media, or outside legal counsel regarding University-related matters. The attached fact sheet contains information to help faculty and staff handle these encounters appropriately and to comply with applicable laws, such as privacy laws, including but not limited to, the Family Educational Rights and Privacy Act (“FERPA”) and the Health Insurance Portability and Accountability Act (“HIPAA”).  Please see the attached Word file “Government Agent FAQ” or click here for more information.

 

Final NIH Policy for Data Management and Sharing Plan - REQUIRED

This is a reminder that this policy became effective January 25, 2023 for all NIH applications, unless specified otherwise in the RFA.
Please go to https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html for the Final Policy Announcement and guidelines.
Please see the DMS Plan Format document attached.

 

Resources Available to Researchers for Preparing NIH Data Management and Sharing Plans

OU IT has provided some resources and guidance on research data storage and costs. Please refer to the documents below that are attached.

• Research Data Infographics (PDF)
• Research Matrix (PDF) 

 

IMPORTANT NOTE: Please be aware that effective for applications submitted for due dates on or after October 5, 2023, NIH will no longer require the use of the single DMS cost line item. NIH recognizes that DMS costs may be requested in many cost categories. Therefore, in line with NIH standard budget instructions, DMS costs must be requested in the appropriate cost category, e.g., personnel, equipment, supplies, and other expenses, following the instructions for the R&R Budget Form or PHS 398 Modular Budget Form, as applicable. While the single cost line item is no longer required for applications submitted for due dates on or after October 5, 2023, NIH will require applicants to specify estimated DMS cost details within the “Budget Justification” attachment of the R&R Budget Form or “Additional Narrative Justification” attachment of the PHS 398 Modular Budget Form, pursuant to the instructions. For more information, please see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-161.html. For applications submitted before October 5, 2023, you are still required to include the “Data Management and Sharing Costs” line item under F. Other Direct Costs on the R&R Budget Form.

 

Education Grand Rounds: Leveraging AI as an Educational Tool

Speaker: Jeff Cain, Associate Professor, Director of Office of Teaching Innovation & Scholarship, Vice-Chair, Pharmacy Practice & Science, College of Pharmacy, University of Kentucky
When: August 18th, 2023 from 12:00PM-1:00PM
Join Via Zoom (link only active during event)
Event Details: https://www.ouhsc.edu/facdev/Calendar/details/education-grand-rounds-84

 

Biosafety Administrator Association (BSAA) Webinar: Transgenic Animals, Regulatory Expectations (Click her to Register) – This virtual webinar is scheduled for Wednesday, September 6, 2023, from 3:00-4:30 PM Eastern Time.  For program details follow this link.

 

Biosafety Administrator Association (BSAA) Webinar: Biosafety Compliance Programs, “It takes a Village” (Click here to Register) – This is a virtual webinar scheduled for Wednesday, September 27, 2023, at 3:00 – 4:30 PM Eastern Time Zone. For program details follow this link.

 

2023 OSCTR Pilot Grants Program

Description: The Oklahoma Clinical and Translational Science Institute (OCTSI) and Oklahoma Shared Clinical and Translational Resources (OSCTR) is soliciting applications for its Clinical and Translational Research Pilot (CTRP) Grants Program. The purpose of the program is to provide funding for clinical and translational pilot projects from investigators of the OSCTR member institutions and preference is given to investigators who qualify as NIH New or Early Stage Investigators, or to investigators who are transitioning to clinical and translational research. The program seeks to support proposals designed to generate preliminary data that will result in improved health and/or health outcomes for citizens of Oklahoma and other IDeA states and enhance the competitiveness of the investigator for future extramural funding. The program also seeks to fund innovative concepts, approaches, and methodologies that bring fresh new ideas to solving the health issues of those living in Oklahoma and collaborating IDeA states. Projects that focus on the medically underserved and on health concerns prevalent within Oklahoma and our OSCTR partners will be a priority. Only projects which meet the NIH definition of clinical and/or translational research will be accepted.
The forms, instructions, and submission link can be found at:  http://osctr.ouhsc.edu/pilots2023. Deadline: Friday, September 15, 2023 at 5:00 PM CDT. If you have any technical questions about the grant submission process or grant eligibility please contact the OSCTR Research Navigator Service at osctr@ouhsc.edu or call 405-271-3480.

 

Once-a-year NIH SBIR Contract Solicitation from NIH (PHS-2024-1)

Any OUHSC researcher interested in commercializing their research should look at this once-a-year solicitation.  It relates to one of the following specific areas listed below. The once-a-year NIH SBIR Contract Solicitation will soon be coming out and from prior experience of other investigators it is often the single easiest SBIR award mechanism to get a fundable score. This is not the normal, more academic NIH SBIR, the contract proposals don’t go through the Center for Scientific Review (CSR).  The awards directly fund what NIH program managers want to fund. So if, you are interested in launching a startup, securing SBIR funding, and there is a topic in the list below that matches your area of interest, this could be a great opportunity. If any faculty are interested they can contact John Hanak (jhanak@ou.edu), the Chief Innovation and Corporate officer that oversees these activities on the OUHSC, OU-Norman, and OU-Tulsa campuses. He will be able to get you in touch with the OK Catalyst team and they will help you through the process.  

THE FOLLOWING RESEARCH TOPICS ARE ANTICIPATED TO BE INCLUDED IN SBIR CONTRACT SOLICITATION PHS-2024-1
NATIONAL INSTITUTES OF HEALTH (NIH)
NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES (NCATS):
Topic 024 - Small Manufacturing Systems to Produce Research Grade Pharmaceutical Intermediates
NATIONAL CANCER INSTITUTE (NCI):
Topic 455 - Point-of-Care Detection of Prostate Specific Antigen
Topic 456 - Rapid and Affordable Point-of-Care HPV Diagnostics for Cervical Cancer Control
Topic 457 - Technologies for Detecting Tumor-Derived Cell Clusters
Topic 458 - Microbiome-Based Tests for Cancer Research, Diagnosis, Prognosis and/or Patient Management
Topic 459 - Automated Software for Point-of-Care Testing to Identify Cancer-Associated Malnutrition
Topic 460 - Evaluation Datasets as Medical Device Development Tools for Testing Cancer Technologies
Topic 461 - Ultra-Fast Dose Rate (FLASH) Radiation Detectors and Safety Systems for Cancer Treatment
Topic 462 - Organ-on-Chip for Preclinical and Translational Radiobiological Studies
Topic 463 - Translation of Novel Cancer-specific Imaging Agents and Techniques to Mediate Successful Image-guided Cancer Interventions
Topic 464 - Cloud-Based Multimodal Data Analysis Software for the Cancer Research Data Commons
Topic 465 - Cancer Prevention and Treatment Clinical Trials Tools for Recruitment and Retention of Diverse Populations
NATIONAL INSTITUTE ON AGING (NIA): 
Topic 010 - Technology to facilitate characterization of the exosome in under –resourced populations for AD/ADRD Studies
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID):
Topic 124 - Development of Next-Generation Devices and Materials-Based Platforms for the Administration of HIV-1 Broadly Neutralizing Antibodies
Topic 125 - Development of Long-Acting Treatments for HCV Cure
Topic 126 - Rapid Diagnostic Assays for Self-Monitoring of Acute or Rebound HIV-1 Infection
Topic 127 - Multiplexed Patient Administered Diagnostics for Hepatitis B, Hepatitis C, and HIV
Topic 128 - Adjuvant Development for Vaccines for Infectious and Immune-Mediated Diseases
Topic 129 - Reagents for Immunologic Analysis of Non-mammalian and Underrepresented Mammalian Models
Topic 130 - Adjuvant Discovery and Down-Selection for Vaccines against Infectious and Immune-Mediated Diseases
Topic 131 - Development of Bacteriophage for Treatment of Mycobacterial Infections
Topic 132 - Novel Diagnostic Biomarker Discovery and Validation for Malaria and Select Neglected Tropical Diseases (NTDs)
Topic 133 - Development of a Serological Test for Herpes Simplex Types 1 and 2 Infections
Topic 134 - Alternatives to Benzathine Penicillin for Treatment of Syphilis
Topic 135 - Software or Web Services to Automate Metadata Enrichment and Standardization for Data on Infectious and Immune – Mediated Diseases
Topic 136 - Software or Web Services to Re-Represent Existing Scientific Data and Knowledge into a Knowledge Graph Format
NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI):
Topic 115 - Clinical Instrument for Para-Hydrogen (pH2) Based Signal Amplification by Reversible Exchange (SABRE) for Hyperpolarizing 13C-Pyruvate and Other Probes for MRI Imaging
NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH):
Topic 001 - Point-of-Care HIV Viral Load and Drug Adherence Assays
Topic 002 - Development of novel In-vitro and In-vivo Models to support NeuroHIV Research

 

Office of Technology Commercialization presents the following opportunity for researchers to engage with industry (click here for more information, or email otc@ou.edu or gina-mcmillen@ouhsc.edu).  

• Bicycle Therapeutics is seeking proposals to enhance understanding how their novel compound library, which are constrained bicycle peptides, interact with OX40 in disease, including but not limited to cancer and immune-inflammation.  Initial priority is proposals focused on in vitro biology with potential to expand to in vivo.  Also interested in research that reveals new insights to understand their MOA.  Submission completion of the application form, with a non-confidential overview of your proposal. (deadline 09/01). 
• A global personal care company is looking for biodegradable molecules with antimicrobial properties for use in cosmetic formulas.  Molecules should target/disrupt bacterial membranes by any modality and ideally have a broad antimicrobial activity.  Solubility in water, ethanol and DMSO acceptable with water preferred and no/low skin penetration.  Submission entails a one-page 200-300 word non-confidential brief.  (deadline 09/08). 
• Novus International is seeking novel opportunities and ideas in inhibition of methanogenesis in ruminants.  Approaches of interest include antibodies and lytic enzymes; research involving either natural or synthetic compounds considered. Submission entails a one-page 200-300 word non-confidential brief.  (deadline 09/22). 

NOTE: If the project is selected to move forward with a full application, it will need to be routed through SoonerTrack II.

 

• NIDCR Notice of Participation in PAR-23-182 "Accelerating Behavioral and Social Science Through Ontology Development and Use: Research Network Projects (U01 Clinical Trial Not Allowed)"
  (NOT-DE-23-015)
• Notice of Pre-Application Webinar for the Investigator-Initiated Research in Genomics and Health Equity: RFA-HG-23-017 (R01 Clinical Trial Optional) and RFA-HG-23-018 (R21 Clinical Trial Optional)
  (NOT-HG-23-049)
• Notice of Availability: Proposed Amendments to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
  (NOT-OD-23-162)
• Notice of Change to Application Due Date and Instruction in Section IV in RFA-DA-24-007, "Avenir Award Program for Chemistry and Pharmacology of Substance Use Disorders (DP1- Clinical Trial Not Allowed)"
  (NOT-DA-23-032)
• Notice of NICHD Participation in PAR-23-122: "Research With Activities Related to Diversity (ReWARD) (R01 Clinical Trial Optional)"
  (NOT-HD-23-024)
• Notice of Changes to RFA-HL-24-010 "The Blood and Marrow Transplant Clinical Trials Network - Core Clinical Centers (UG1 Clinical Trial Optional)"
  (NOT-HL-23-101)
• Notice of Change to RFA-HL-24-011 "The Blood and Marrow Transplant Clinical Trials Network - Data Coordinating Center (U24 Clinical Trial Not Allowed)"
  (NOT-HL-23-105)
• Notice of Early Termination of PAR-21-057 "Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)"
  (NOT-NS-23-103)
• Notice of Early Termination of PAR-21-059 "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)"
  (NOT-NS-23-104)
• Notice of Change to Award Budget for RFA-NS-21-029, "HEAL Initiative: Planning Studies for Initial Analgesic Development [Small Molecules and Biologics] (R61 Clinical Trial Not Allowed)
  (NOT-NS-23-105)
• Notice of Correction to Other Submission Requirements and Information in PAR-22-181 "Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional)"
  (NOT-NS-23-106)
• Notice of Special Interest (NOSI): Promoting implementation research to address HIV-associated comorbidities and risk factors within well-established cohorts (R01 Clinical Trial Optional)
  (NOT-HL-23-102)

NOTE: When only one application is allowed per Institution according to the sponsor instructions, a one-page letter of intent summarizing the proposed project should be submitted to the Vice President for Research at least two months prior to the application deadline (unless otherwise noted).  The letters of intent will be reviewed and a single application will be chosen for submission from the University.

 

• NIH Brain Development Cohorts (NBDC) Biospecimen Access (X01 Clinical Trial Not Allowed)
  (PAR-23-229)
  Application Receipt Date(s): Multiple dates, see announcement.
• NCI Research Specialist (Laboratory-based Scientist) Award (R50 Clinical Trial Not Allowed)
  (PAR-23-242)
  Application Receipt Date(s): November 03, 2025
• NCI Research Specialist (Core-based Scientist) Award (R50 Clinical Trial Not Allowed)
  (PAR-23-243)
  Application Receipt Date(s): November 03, 2025
• Personal Health Informatics for Delivering Actionable Insights to Individuals (R01 Clinical Trial Optional)
  (PAR-23-245)
  Application Receipt Date(s): November 05, 2026
• Alcohol Treatment, Pharmacotherapy, and Recovery Research (R34 Clinical Trial required)
  (PAR-23-249)
  Application Receipt Date(s): September 07, 2026
• Alcohol Treatment, Pharmacotherapy, and Recovery Research (R01 Clinical Trial Required)
  (PAR-23-250)
  Application Receipt Date(s): September 07, 2026
• Alcohol Health Services Research (R01 Clinical Trial Optional)
  (PAR-23-251)
  Application Receipt Date(s): September 07, 2026
• Alcohol Health Services Research (R34 Clinical Trial Optional)
  (PAR-23-252)
  Application Receipt Date(s): September 07, 2026
• Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R34 Clinical Trial Required)
  (PAR-23-256)
  Application Receipt Date(s): Multiple dates, see announcement.
• Academic-Industrial Partnerships (AIP) to Translate and Validate In Vivo Imaging Systems (R01 Clinical Trial Optional)
  (PAR-23-259)
  Application Receipt Date(s): January 07, 2027
• Assay development and screening for discovery of chemical probes, drugs or immunomodulators (R01 Clinical Trial Not Allowed)
  (PAR-23-264)
  Application Receipt Date(s): September 07, 2026
• Understanding Expectancies in Cancer Symptom Management (R01 Clinical Trial Required)
  (PAR-23-273)
  Application Receipt Date(s): May 07, 2026
• Behavioral and Social Research on the Role of Immigration on Life Course Health and Aging, including AD/ADRD?(R01 Clinical Trial Not Allowed)
  (RFA-AG-24-028)
  Application Receipt Date(s): November 03, 2023
• Behavioral and Social Research on the Role of Immigration on Life Course Health and Aging, including AD/ADRD?(R21 Clinical Trial Not Allowed)
  (RFA-AG-24-029)
  Application Receipt Date(s): November 03, 2023
• Neural and Non-Neural Mechanisms Underlying Gait as a Preclinical Marker for Alzheimers Disease and Alzheimers Disease-Related Dementias (R01 Clinical Trial Optional)
  (RFA-AG-24-041)
  Application Receipt Date(s): November 03, 2023
• Elucidating Variability of Physiologic and Functional Responses to Exercise Training in Older Adults (R01 Clinical Trial Required)
  (RFA-AG-24-045)
  Application Receipt Date(s): November 03, 2023
• Community-Engaged Health Equity Research in Neuroscience Initiative (R01 CT Not Allowed)
  (RFA-NS-24-006)
  Application Receipt Date(s): February 02, 2024
• Community-Engaged Health Equity Research in Neuroscience Initiative (R34 CT Not Allowed)
  (RFA-NS-24-007)
  Application Receipt Date(s): Multiple dates, see announcement.
• HEAL Initiative: Understanding Individual Differences in Human Pain Conditions (R01 - Clinical Trial Optional)
  (RFA-NS-24-021)
  Application Receipt Date(s): Multiple dates, see announcement.

 

New ARPA-H Program to Fund Novel Technologies for More Precise Cancer Tumor Removal

ARPA-H’s new Precision Surgical Interventions (PSI) program aims to deliver groundbreaking tools to enable surgeons to successfully remove cancer from patients through a single operation by better identifying and differentiating between healthy and cancer tissue. Through a Broad Agency Announcement (BAA) for the PSI program, ARPA-H will solicit proposals for strategies to improve visibility of cancer and other critical anatomical structures during surgery.
“With the Precision Surgical Interventions program, we're seeking to fundamentally change how surgery is done. Imagine if surgeries fixed problems flawlessly, the first time,” said Ileana Hancu, Ph.D., ARPA-H PSI Program Manager. "Cancer is one disease we're addressing, but the potential benefits of the tools developed could extend across many types of surgery, for many diseases and populations."
Read the news announcement and learn more about PSI on its program page.

 

The National Cancer Institute (NCI): Informatics Technology for Cancer Research (ITCR)

Description: The ITCR program has funding opportunities aimed at successive stages of informatics technology development, including:

• Innovative Algorithm Development,
• Prototyping and Hardening,
• Advanced Development and Enhancement, and
• Sustainment of Tools.

Next receipt date is November 17, 2023.
Contact Dr. Juli Klemm with questions at juli.klemm@nih.gov.

 

The National Cancer Institute (NCI): Innovative Molecular Analysis Technologies (IMAT)

Description: The IMAT program has funding opportunities to support the development of technologies suitable for the molecular and cellular targeting or analysis of cancers and their host environment in support of basic, clinical, and epidemiological research:

• Early-stage innovative molecular and cellular analysis technologies
• Advanced development and validation of emerging technologies

IMAT also supports the development of novel technologies for sample collection, processing, and preservation:

• Early-stage innovative biospecimen science technologies
• Advanced development & validation of biospecimen science technologies

Incorporate new technologies into your ongoing research.
NCI offers supplemental funding for current NCI grantees to incorporate new technologies developed through the IMAT program into their ongoing research. Applications should offer to accelerate the research and may increase the scope of the projects in addition to promoting collaborations and independent validation of these technologies. Check out the list of IMAT projects to find new technologies that could advance your research!
Next receipt date is September 1, 2023.
Contact Dr. Kelly Crotty or Dr. Tony Dickherber with questions at kelly.crotty@nih.gov or anthony.dickherber@nih.gov.

 

NOT-CA-22-083: NCI has issued a Notice of Special Interest to support the development of technologies and informatics tools specifically for metabolomics and lipidomics research in cancer.

NOT-CA-23-037: NCI has issued a Notice of Special Interest to support the development of technologies and informatics tools specifically for research in cancer control and population sciences.

 

Advanced Research Projects Agency for Health (ARPA-H) Open Broad Agency Announcement (BAA)

Description: The mission of ARPA-H is to accelerate better health outcomes for everyone by supporting the development of high-impact solutions to society's most challenging health problems. Awardees will develop groundbreaking new ways to tackle health-related challenges through highpotential, high-impact biomedical and health research. With a scope spanning the molecular to the societal, ARPA-H seeks proposals that aim to rapidly achieve better health outcomes across patient populations, communities, diseases, and health conditions, including in support of the Cancer Moonshot. Proposals are expected to use innovative approaches to enable revolutionary advances in science, technology, or systems.
Abstract deadline: March 14, 2024
Link to Full Announcement: https://sam.gov/opp/caf109b75a0449418ead3630cef1915e/view#general

 

OCAST Oklahoma Applied Research Support (OARS)

Description: CAST awards funding of up to $500,000 to companies leading innovation projects that have the potential to create economic impact in Oklahoma. Projects must have an end user application within the targeted industries identified in the 2021-2026 Science and Innovation Strategic Plan, which includes biotechnology; aerospace, autonomous systems and defense; and energy diversification.
Applications Deadline: September 6, 2023
Link to Full Announcement: https://oklahoma.gov/ocast/programs/oklahoma-applied-research-support.html

 

Cystic Fibrosis Foundation (CFF) Request for Information (RFI): Soliciting Interest and Input for Biospecimen Collection in Support of New Methodologies to Detect Bacteria in the Lung

Description: The CFF is soliciting interest and input for potential biospecimen collection and processing within the PROMISE observational clinical study to support ancillary studies developing novel approaches or technology capable of detecting and identifying bacteria present in the lungs of people with cystic fibrosis (PwCF).
Link to Full Announcement: https://www.surveymonkey.com/r/C6S6R9D

 

Melanoma Research Alliance (MRA) 2023-2024 Request for Proposals

Description: The Melanoma Research Alliance (MRA) is pleased to announce a Request for Proposals (RFP) for pre-clinical, translational, and early clinical research with the potential to produce unusually high impact, near-term advancements in melanoma prevention, detection, diagnosis, and treatment.
Proposals will be accepted for Team Science Awards, Team Science Academic-Industry Partnership Awards, Young Investigator Awards, Dermatology Career Development Awards (new for 2023-2024), and Pilot Awards. Special opportunities are also available in acral melanoma, melanoma brain metastases, dermatology technologies, immunotherapy, radiation oncology, uveal melanoma, and UK or Israel based researchers. We intend to support at least $11.5 million in new funding through this RFP.
Applications Deadline:

• September 20, 2023: Letters of Intent (LOI) for Team Science Awards due
• October 20, 2023: Eligibility Checklist for Young Investigator & Dermatology Career Development Award applicants due
• November 3, 2023: Proposals for individual investigator awards due
• January 4, 2024: Invited Team Science Award full proposals due

Link to Full Announcement: https://www.curemelanoma.org/research/request-for-proposals/mra-general-rfp