#18 in OB-GYN NIH Research Funding
$5,017,347 in NIH Funding in 2021
*Source: Blue Ridge Institute for Medical ResearchCU Obstetrics and Gynecology Research
A tradition of producing effective, high-impact research that will improve the health of our population and future generations.
CU Women’s Reproductive Health Research (WRHR) Career Development Program
Applications due January 15, 2022
The history of research in the Department of Obstetrics and Gynecology at the University of Colorado School of Medicine is rich and diverse. Seminal, historic achievements in Maternal-Fetal Medicine, Gynecologic Oncology and Reproductive Endocrinology have emanated from this institution, including but not limited to:
- The first Maternal-Fetal Medicine fellowship training program in the world (E. Stewart Taylor and Fred Battaglia).
- The advent of Obstetrical and Gynecologic Ultrasound (Kenneth Gottesfeld).
- The first use of urinary estrogen as a marker of fetal well-being (Rudolph Anker, Paul Bruns, and George Betz).
- The first studies on fetal physiology at altitude (Edward Makowski and Lorna Moore).
- Maternal and gynecological infectious diseases (Ron Gibbs and Jamie McGregor).
- The role of estrogen and progesterone receptor in endometrial cancer onset and progression (Kimberly Leslie).
Our basic sciences investigators and clinical researchers are fully committed to extending this tradition of research excellence. To this end, we have established research programs in all of the major subdivision of OB-GYN and some non-traditional areas, such as mammary gland biology. We have developed full-spectrum bench-to-bedside research programs in most of these areas, and have been participants in numerous clinical trials, both NIH and industry-sponsored.
We have partnered with the community to engage our patients, through the Center for Women’s Health Research and through division-based community initiatives, and we have maintained old and created new collaborative research efforts that reach into geriatrics, metabolism and endocrinology, biochemistry, molecular biology, and –omics technology. In addition to these traditional scientific efforts, we collaborate intensely with each other, and self-evaluate on a regular basis to maintain the most effective research teams possible.
About the Administrative Research Core (ARC)
ARC is a full-service research support team serving all University of Colorado School of Medicine Deptartment of OB-GYN Faculty Researchers and Trainees. The team strives to provide expertise and resources with a high level of customer service.
- We administer the regulatory and financial components of the OB-GYN research portfolio.
- We facilitate communication with the different offices in the University as well as reaching out to other institutions and sponsors.
- We provide guidance to the Department on Federal, State, Sponsor, and University policies.
- We train research teams on University systems.
Greta Devol
PreAward Coordinator
Assists with Federal and Foundation proposal submissions; Works with principle investigators on post-submission requests including JITs and progress reports; Routes all incoming money with few exceptions.
Phone: (303) 724-0279
Jillian Kneppe
Regulatory and Finance Coordinator
Regulatory submissions; prepares budgets for industry sponsors and oversees contract negotiations; ensures compliance for clinical study subject compensation programs.
Phone: (303) 724-3859
Erin LoCoco, BA, MA
Grants and Contracts Coordinator
Provides post award administration for federal and foundation grants and contracts; maintains financial projections and reconciliation of projects; prepares and routes budgets for complex grant proposals.
Phone: (303) 724-9765
Naila Naushad, MBBS
Regulatory Manager
Oversees regulatory management for clinical research.
Phone: (303) 724-3053
Bergonias Sessou
Research Services Regulatory Entry Coordinator
Assists with all the regulatory processes and submissions.
Phone: (303) 724-9765
This information is brought to you by the Department of OB-GYN Administrative Research Core (ARC). Please direct any questions to obgynARC@cuanschutz.edu.
Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship
PA-21-051
(Parent F31)
Due: 08/08/2023
Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship
PA-21-048
(Parent F32)
Due: 08/08/2023
NIH Research Project Grant
PA-20-185
(Parent R01 Clinical Trial Not Allowed)
Due Dates: 06/05/2023 (New) or 07/05/2023 (Resubmission, Renewal, Revision)
NIH Small Research Project Grant
PA-20-200
(Parent R03 Clinical Trial Not Allowed)
Due Dates: 06/16/2023 (New) or 07/16/2023 (Resubmission, Renewal, Revision)
NIH Exploratory/Developmental Research Project Grant
PA-20-195
(Parent R21 Clinical Trial Not Allowed)
Due Dates: 06/16/2023 (New) or 07/16/2023 (Resubmission, Renewal, Revision)
This information is brought to you by the Department of OB-GYN Administrative Research Core (ARC). Please direct any questions to obgynARC@cuanschutz.edu.
April 2023 Announcements
NIH Salary Cap (NOT-OD-23-056)
Effective January 1, 2023, the salary limitation for Executive Level II is $212,100. 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.
For Full Text: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-056.html
NRSA Stipends (NOT-OD-23-076)
This Notice supersedes NOT-OD-22-132 and establishes stipend levels for fiscal year (FY) 2023 Kirschstein-NRSA awards for undergraduate, predoctoral, and postdoctoral trainees and fellows…The Training Related Expenses and Institutional Allowances for predoctoral and postdoctoral trainees and fellows reflect a moderate increase. The Tuition and Fees for all educational levels remain unchanged from the prior budget year. See NIH Funding Strategies for guidance on current NIH Fiscal Operations.
For Full Text: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-076.html
Updates to Funding Opportunity Terminology (NOT-OD-23-109)
Effective immediately, NIH will use the term notice of funding opportunity (NOFO) to refer to formal announcements of the availability of Federal funding through a financial assistance program. Previously, such announcements were referred to as funding opportunity announcements (FOAs).
For Full Text: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-109.html
E-Consent in Epic
E-Consent can be delivered to the patient via MyHealthConnection. This option can be added through HSR portal for studies.
Not available for projects that:
- Require witness signature or LAR
- Contain embedded lines for initials and additional questions
- Are under FDA purview
Please reach out to uch-researchadmin@uchealth.org for further details.
Available RECRUIT Tools
Focused Recruitment Messages: Patients receive recruitment messages containing information about a research study through My Health Connection (MHC).
Research Preference Profile: Patients use MHC to indicate their research interests by providing their preferences for the types of research studies they want to learn more about. Patients can update or change their preferences over time.
Recruitment Lists: Potential recruitment contact lists are provided to study teams.
“I'm Interested” Button: Displays a virtual flyer to potential eligible patients in MHC and allows them to indicate interest in a specific study.
E-consent: Patients use MHC to electronically receive informed consent forms to review and sign to participate in a research study.
Criteria for RECRUIT Tools Use
- May only be used for prospectively enrolling studies.
- QA/QI projects will not use RECRUIT.
- Retrospective data requests or analysis will not be fulfilled by RECRUIT and will be routed to Health Data Compass.
- Study must intend to enroll for at least one year.
- Study PI must be a CU Medicine provider, University Faculty, UCHealthMG (UCHealth Medical Group) provider, or UCHealth Employee.
- Local accrual goal must be greater than five participants.
- Requires “Open to Accrual” status in OnCore.
- Requires potential participants to have an active My Health Connection account.
Please reach out to uch-researchadmin@uchealth.org for these tools as this will require DPX approval.
Gift Card Program Training - CU: Custodian Responsibilities
OGC is happy to announce that a new training course has been launched in Skillsoft for custodians of gift cards, petty cash, and change fund programs. The online Skillsoft training CU: Custodian Responsibilities - Gift Cards, Petty Cash, and Change Funds (U00224) is available for all CU employees wanting to learn more about the rules and guidelines for managing compliant programs as well locating and referencing relevant resources.
Beginning May 1, 2023, this course will be required for all NEW custodians of a gift card, petty cash fund, or change fund program. Completion of the training will be required prior to being approved to oversee one of these programs. While this requirement is only for new CU Denver/CU Anschutz custodians, we encourage anyone overseeing one of these programs to take the Skillsoft course to re-familiarize themselves with university and campus requirements and best practices.
Questions on this course may be directed to pcgc@ucdenver.edu.
Gift Card Program Training - CU: Custodian Responsibilities
The Office of University Controller will be launching a new Gift Card Authorization form in May 2023. The current excel format will be replaced with an electronic form, including dynamic fields and automated routing. More details on training resources, campus support, and an official 'go live' date will be released in the coming weeks.
Announcements Archive
January 2023 Announcements
Gift Card Policy: Reminders for Gift Card Custodians
W-9 Collection: The custodian will collect a W-9 from participants receiving over $100 during the calendar year. The W-9s will be maintained in a secure location. The custodian will track payments to ensure a W-9 is collected from all participants who will exceed $100 in a calendar year. This information will be reported to the Procurement Service Center at the end of the calendar year using the 1099MISC spreadsheet following the instructions provided by the Finance Office.
E-mail or electronic distribution: When gift cards are distributed electronically (by email or other electronic means) and are not physically present in the OB-GYN offices, the custodian will track the appropriate information related to gift cards being purchased and distributed. The custodian will contact PCGC@ucdenver.edu if there are questions about the information that needs to be tracked when gift cards do not meet the standard criteria outlined in the Audit Log provided.
This information can be found in the Internal Controls Policy.
More information can be found at: www.cuanschutz.edu/offices/finance-office/policies-guidelines/guidelines/gift-cards
Requests for Other Support Documentation
As a reminder, the ARC team can help with the digital signatures now required by NIH for any request for Other Support through Docusign.
Pfizer Announces Positive Top-Line Data of Phase 3 Global Maternal Immunization Trial for its Bivalent Respiratory Syncytial Virus (RSV) Vaccine Candidate
The Perinatal Research Core participated in the MATISSE Phase 3 Clinical Trial and the results have been recently published by Pfizer. The full news article can be found here.
NIH Data Sharing Management and Data Management Plan Survey
With this survey, the CRIO Council aims to understand the spectrum of data assets and researcher needs regarding data storage and analytics across the Anschutz Medical Campus community (including Anschutzs hospital partners). RIO Research Data Needs Survey (qualtrics.com)
From the Department of OB-GYN Scientific Editor
Happy New Year! As you gear up for 2023, the Department of Obstetrics and Gynecology Scientific Editing Services are here to support you in your scientific writing endeavors.
- Upcoming Manuscript Writing Workshop: April 5-May 10
Watch your email for more details coming soon. - Scientific editing can be utilized at any stage of the writing process - from pre-writing support to well-developed drafts to resubmissions. Depending on your project and timeline, scientific editing can also occur at multiple draft stages.
- Even if you do not have a specific draft ready for review, feel free to reach out ahead of time to discuss your project and timeline. Especially for grants or projects with tight deadlines, the sooner we discuss your project needs, the more likely we can arrange a timeline to meet your due dates.
- Please contact me with questions, ideas, or to discuss your writing project.
More information about the Department of Obstetrics and Gynecology Scientific Editing Services can be found here: medschool.cuanschutz.edu/ob-gyn/scientific-editing.
October 2022 Announcements
Clinical Trials Design and Performance Trainings
Federal requirements for education in the protection of human research participants are met according to Colorado Multiple Institutional Review Board (COMIRB) policy for all affiliated/local principal investigators, co-investigators, and research coordinators listed on human research protocols by successfully completing the CITI course in human subject protections and the Conflict of Interest (COI) prior to submitting a protocol. Courses for Training and Education for Developing a Clinical Trial can be found here: Clinical Trials Design and Performance Trainings | CCTSI (cuanschutz.edu)
NIH Data Management and Sharing Policy
Beginning in January 2023, the Final NIH Policy for Data Management and Sharing (NOT-OD-21-013) will require researchers to include a data management and sharing (DMS) plan in funding applications. Information on how CU Anschutz is planning on addressing this new policy, including a free database of DMP templates for the Anschutz Research Community, can be found on the University Research website.
COI Disclosure Period
The next Conflict of Interest (COI) collection period is coming to an end and COI Disclosures will be due by Monday, October 31st, 2022.
As a reminder, a COI Disclosure must be filed by faculty, officers, staff with fiscal roles, staff who negotiate on behalf of the university, and individuals who are engaged in research.
Questions? Click here to visit the COI webpage for more information on the University of Colorado Denver | Anschutz Medical Campus Conflict of Interest Policy or contact the COI staff at COI@ucdenver.edu.
Standard Proposal Routing Deadlines
Routings for applications where the final grant submission is performed by CU Denver Grants and Contracts (Authorized Organizational Representative submission) must be received for review by Grants and Contracts PreAward by the end of the 12th business day prior to the submission deadline for OGC PreAward Approval.
The final electronic version, ready for submission, must be in InfoEd eRA for Grants and Contracts by 4:00pm on the 4th business day prior to the submission deadline date. Notification must be sent to eapp.xenia@ucdenver.edu when application is ready for submission. If the application is submitted by a method other than InfoEd eRA, then the notification must include the application file or the application must be ready in the applicable sponsor portal.
Routings where the final grant submission is performed by the PI/Department must be received for review by Grants and Contracts PreAward five (5) full business days prior to the submission deadline.
CURE Panel
Next submission deadline is November 28, 2022. This is an opportunity for a review panel consisting of 5 members from the Division of Reproductive Science, Dept OB-GYN and Division of Neonatology, Department of Pediatrics to review grant proposals to be submitted to major funding agencies.
The Lorna Grindlay Moore, PhD Faculty Launch Award
We are pleased to announce the Call for Proposals for the Lorna Grindlay Moore, PhD Faculty Launch Award! The Due date for Letter of Intent is January 20, 2023. Due date for applications: March 24, 2023. Please visit the following link for additional information: medschool.cuanschutz.edu/ob-gyn/lorna-moore-fund
ARC Happenings
NCURA Presentation: We submitted a proposal to present at an upcoming National Council of University Research Administrators “NCURA” conference and were accepted with our presentation title “Yours, Mine, and Ours: A Case Study on the Sharing of Administrative Duties Over the Lifetime of a Funded Clinical Study.” The presentation will be part of the NCURA Region VI/VII Meeting to take place October 30 - November 2, 2022 in Tucson, Arizona. We are excited to represent the University of Colorado and the Department of OB-GYN!
Position Updates: We will have a new Regulatory Entry Coordinator joining us starting November 1st! Our position for Grants and Contracts Coordinator is listed in CU Careers and still accepting applications.
AMC Workplace Development Core: We will be participating as a mentor team in the 2023 Research Administration Program (RAP). RAP is looking for undergraduates, graduates, and professionals who are hoping to change careers to join our paid research administration internship program. This year's program will take place with a hybrid model from January 19th, 2023 - May 4th, 2023, at the University of Colorado AMC. Please find additional information about eligibility and the application process here. Applications are due no later than Sunday, October 30th, 2022, by midnight MST.
July 2022 Announcements
2022 Lorna Grindlay Moore, PhD Faculty Launch Awardee Announcement
It is our pleasure to announce that the 2022 Lorna Grindlay Moore, PhD, Faculty Launch Fund award goes to Michelle Fullard, MD, MSCE! Her research project titled “Improving Shared Decision-Making for Women with Parkinson's Disease” was ranked highest among this year's applicants. We are excited to see the fruits from Dr. Fullard's research! Congratulations Michelle, well deserved!
CURE Deadline
Next submission deadline is August 1, 2022 for Cycle 2. The submission deadline for cycle 3 is November 28, 2022 This is an opportunity for a review panel consisting of 5 members from the Division of Reproductive Science, Dept OB-GYN and Division of Neonatology, Department of Pediatrics to review grant proposals to be submitted to major funding agencies.
For more information: CURE Review Panel
COI Disclosure Period
The next Conflict of Interest (COI) collection period begins on Wednesday, August 10, 2022 and COI Disclosures will be due by the end of October 2021.
As a reminder, a COI Disclosure must be filed by faculty, officers, staff with fiscal roles, staff who negotiate on behalf of the university, and individuals who are engaged in research.
Questions? Click here to visit the COI webpage for more information on the University of Colorado Denver | Anschutz Medical Campus Conflict of Interest Policy or contact the COI staff at COI@ucdenver.edu.
ORCID Campaign
ORCID stands for Open Researcher and Contributor ID, and is a global, not-for-profit organization that has the goal of uniquely identifying all who participate in research, scholarship, and innovation such that their contributions across disciplines, borders, and time can be documented. Funding agencies, including NIH, and publishers are increasingly requiring ORCIDs for submission.
The overarching goal of this ORCID campaign is to garner Anschutz community ORCID adoption and perform integrations such that the primary content required for grant and manuscript submissions can be used to maintain other local campus profiles, as well as to publicly promote individuals and campus research and expertise. The ORCID tool is very easy to use and can ingest content about you.
The first step to use ORCID at Anschutz is to sign up for your InfoEd profile and share your ORCID ID at your InfoEd profile. When logged into your InfoEd profile, you will find an ORCID button that will redirect you to your ORCID login. After performing your ORCID login, your ORCID ID will be saved at your InfoEd profile. If you don't yet have an ORCID account, you will be able to create one through the InfoEd ORCID integration.
The Research Informatics Office will be tracking campus use of ORCID and will provide updates on adoption as the project proceeds. You can track ORCID adoption across the Anschutz through the dashboards presented on their website.
Standard Proposal Routing Deadlines
Routings for applications where the final grant submission is performed by CU Denver Grants and Contracts (Authorized Organizational Representative submission) must be received for review by Grants and Contracts PreAward by the end of the 12th business day prior to the submission deadline for OGC PreAward Approval.
The final electronic version, ready for submission, must be in InfoEd eRA for Grants and Contracts by 4:00pm on the 4th business day prior to the submission deadline date. Notification must be sent to eapp.xenia@ucdenver.edu when application is ready for submission. If the application is submitted by a method other than InfoEd eRA, then the notification must include the application file or the application must be ready in the applicable sponsor portal.
Routings where the final grant submission is performed by the PI/Department must be received for review by Grants and Contracts PreAward five (5) full business days prior to the submission deadline.
ARC Happenings
ARC Retreat: In late April, we set aside half a day to brainstorm and outline plans for upcoming presentations. During this time, we worked on a fun crossword puzzle activity to activate our minds and as a teambuilding exercise.
2022 ARC Team Retreat: Zejian Liu, Jillian Ellermann, Greta Devol, Naila Naushad, Pamela Alvarez
Research Retreat Poster: Our team was pleased to participate in this year's Research Retreat Poster Session by adding our own case study describing the separation of duties and workflow of our administrative duties. Our poster is now displayed on the wall outside of the ARC Team office in RC2.
2022 Research Retreat: Pamela Alvarez, Jillian Ellermann, Naila Naushad, Greta Devol
NCURA Presentation: We submitted a proposal to present at an upcoming National Council of University Research Administrators “NCURA” conference and were accepted with our presentation title “Yours, Mine, and Ours: A Case Study on the Sharing of Administrative Duties Over the Lifetime of a Funded Clinical Study.” The presentation will be part of the NCURA Region VI/VII Meeting to take place October 30 - November 2, 2022 in Tucson, Arizona. We are excited to represent the University of Colorado and the Department of OB-GYN!
April 2022 Announcements
Standard Proposal Routing Deadlines
Routings for applications where the final grant submission is performed by CU Denver Grants and Contracts (Authorized Organizational Representative submission) must be received for review by Grants and Contracts PreAward by the end of the 12th business day prior to the submission deadline for OGC PreAward Approval.
The final electronic version, ready for submission, must be in InfoEd eRA for Grants and Contracts by 4:00pm on the 4th business day prior to the submission deadline date. Notification must be sent to eapp.xenia@ucdenver.edu when application is ready for submission. If the application is submitted by a method other than InfoEd eRA, then the notification must include the application file or the application must be ready in the applicable sponsor portal.
Routings where the final grant submission is performed by the PI/Department must be received for review by Grants and Contracts PreAward five (5) full business days prior to the submission deadline.
NIH Salary Cap
The Consolidated Appropriations Act, 2021, restricts the amount of direct salary to Executive Level II of the Federal Executive pay scale. The Office of Personnel Management released new salary levels for the Executive Pay Scale and effective January 2, 2022, the salary limitation for Executive Level II is $203,700.
For Full Text: NOT-OD-22-076: Guidance on Salary Limitation for Grants and Cooperative Agreements (nih.gov)
NIH NRSA Stipends, Tuition/Fees and Other Budgetary Levels
This Notice establishes stipend levels for fiscal year (FY) 2022 Kirschstein-NRSA awards for undergraduate, predoctoral, and postdoctoral trainees and fellows, as shown in the full text. The Training Related Expenses and Institutional Allowances for predoctoral and postdoctoral trainees and fellows reflect a moderate increase and the Tuition and Fees for all educational levels remain unchanged from the prior budget year. This Notice reflects the Consolidated Appropriations Act, 2022 (H.R. 2471, Public Law No: 117-103), signed into law on March 15, 2022.
Research Retreat 2022
Research Retreat season is upon us! If you would like to attend, please register at the link below.
The Retreat will begin at 8:00 am on Wednesday May 18th. We will have three Keynote Speakers as well as the Alumna WRHR Scholar Presentation. We will conclude with poster prizes and refreshments beginning at 4:00 pm. Please join us at the Inn at Hudson Gardens in Littleton, CO!
Staff members, if you are interested in volunteering on the day of the Retreat, please fill out this brief survey.
January 2022 Announcements
Standard Proposal Routing Deadlines
SPIN
Sponsored Programs Information Network (SPIN) is a fund search database provided as part of the University’s subscription to the InfoEd Electronic Research Administration (ERA) Suite. On any given day, it has about 40,000 funding opportunities, representing 10,000 sponsors. It can be accessed through the InfoEd ERA Portal (era.cu.edu) where it is the last item in the navigation pane.
SPIN offers three search modes as outlined below. You may also choose ready-to-run searches such as Impending Deadlines and New/Modified Opportunities from the SEARCH menu.
- BASIC SEARCH – This is the default mode. It operates much like Google where you set up your search strategy and terms. See the “Help Menu – Basic Search Help” for examples of useful search strategies.
- KEYWORD SEARCH – This search mode allows access to the SPIN Keyword Thesaurus, arranged by category. Clicking “Select Keywords” (above the box) brings up a category list of search terms in a separate screen in which you drill down to view available keywords. Explorer tab allows you to select keywords via checkbox; your selected keywords appear to the right. There are no limits on the number of keywords selected. Use the Searcher tab to quickly locate terms in the SPIN Keyword Thesaurus. Once you have made your selections, click on “Save Selections and Continue” up at the top right of the screen. Your selected keywords will appear in a box at the top of your screen. Click on the “Locate Funding” button to the right of this box and potential funding sources appear in table format. SAVE YOUR SEARCH at this time.
- ADVANCED SEARCH – This search mode provides more user control. The initial field comes up with Full Program as the default but is a drop-down menu. To add additional criteria, click the Add New button. Selecting distinct fields creates AND queries while selecting the same field multiple times creates OR queries.
In addition to your search results, you may use your saved searches to create automatic notifications of future funding opportunities using InfoEd’s funding alert service, SMARTS. Set up your SMARTS configuration when you save your search or go into the Funding Alerts tab after your search is saved. Your choices are to receive SMARTS notifications daily or weekly and in HTML or text format.
Forms G
Effective January 25, 2022, NIH will require the use of Forms G. Below is a summary of the changes that will be taking effect with the full NIH Notices linked at the bottom.
Biosketch changes:
- Section B ‘Positions and Honors’ has been renamed ‘Positions, Scientific Appointments, and Honors’.
- For the non-Fellowship Biosketch, Section D. has been removed.
- For the Fellowship Biosketch, Section D has been updated to remove ‘Research Support.’
- As applicable, all applicants may include details on ongoing and completed research projects from the past three years that they want to draw attention to within the personal statement, Section A.
Other Support Changes:
- Signature block added, for Program Director/Principal Investigator or Other Senior/Key Personnel to certify the accuracy of the information submitted. Each PD/PI or senior/key personnel must electronically sign their respective Other Support form as a PDF prior to submission.
Expanding Requirement for eRA Commons Ids to All Senior/Key Personnel:
- eRA Commons ID must be included for all Senior/Key Personnel on an application
- As a reminder, individuals needing scientific roles should only have one eRA Commons ID for the life of their research career. Check for an existing account prior to creating a new one. Affiliations to institutions can be changed as PIs move institutions.
Childcare Costs for NRSA Individual Fellow:
- NRSA childcare costs apply to full-time NIH-NRSA supported fellowship positions.
- Each fellow is eligible to receive $2,500 per budget period for costs for childcare provided by a licensed childcare provider.
- For households where both parents are NRSA fellows, each parent is eligible to receive $2,500.
- Applicants and recipients may request the NRSA childcare costs as part of new applications, continuation applications, or as an admin supplement request.
For Full Text:
- NOT-OD-21-110: Implementation of Changes to the Biographical Sketch and Other Support Format Page (nih.gov)
- NOT-OD-21-109: Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel (nih.gov)
- NOT-OD-21-074: Announcement of Childcare Costs for Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellows (nih.gov)
New UCHealth MCA Fee
UCHealth is implementing a new Medicare Coverage Analysis (MCA) fee policy effective February 1, 2022. Existing studies will be exempted from the initial and amendment fees. Qualifying future studies will be charged accordingly. Full statement below:
“Effective February 1, 2022, UCHealth will assess a $1,700 fee per initial MCA and a $600 fee per amendment MCA for all new industry-sponsored projects in which costs are billed to Medicare or other third-party payers as part of the IRB approved protocol. The MCA fee will NOT be assessed for federally funded or investigator-initiated (IIT) projects, including IIT projects with industry support. All projects submitted to the HSR Portal prior to February 1, 2022, will be exempted (grandfathered) from this fee for initial and amendments.
Any industry-sponsored project submitted after February 1, 2022 to the Human Subjects Research Portal that contains billable services at UCHealth will have this fee assessed.”
If you have questions, please visit the MCA Fee FAQs or contact UCHealth’s Research Administration at UCH-ResearchAdmin@uchealth.org.
November 2021 Announcements
CURE Panel
Next submission deadline is November 29, 2021. This is an opportunity for a review panel consisting of 5 members from the Division of Reproductive Science, Dept OB-GYN and Division of Neonatology, Department of Pediatrics to review grant proposals to be submitted to major funding agencies.
For more information: CURE Review Panel
Proposal Form
ARC is currently piloting a new pre proposal form that will be sent to PIs once they have discussed their intention to submit a proposal with the ARC PreAward Coordinator, Greta Devol. We welcome any feedback on this form and the proposal submission process.
ePERS Tutorial
Have you received an email about your ePER? An ePER is an Electronic Personal Effort Report. Individuals who work on sponsored projects are required to certify their effort on those projects per Uniform Guidance. If this applies to you, you will receive emails after the end of each term (Spring, Summer, and Fall) asking you to complete the certification within 120 days. The subject line will read “Your ePER Requires Certification” and you will receive periodic reminder emails until the certification is complete. The instructions on how to find if you have outstanding ePERs and how to complete the process are linked here. If you have any questions, please contact Pamela.AlvarezMoran@CUAnschutz.edu.
FDA Notice of Noncompliance
- On August 31, 2021, FDA issued a Notice of Noncompliance to an individual investigator for failing to submit required results data ClinicalTrials.gov.https://www.fda.gov/media/151965/download
- This is the first time the Agency has warned an individual investigator, rather than a drug maker.
- This is the first time FDA has brought enforcement action related to a trial sponsored by an academic institution.
- The Notice describes and refutes two common arguments from the Responsible Party/PI: 1) that the results should not be required to be submitted because they are already available in the published manuscript, and 2) that the investigator is busy and short staffed due to the COVID-19 pandemic and does not have time to comply.
Requirements for Human Subjects Researchers
As a reminder, there are three requirements to be approved as an investigator or research personnel on a study that uses identifiable data or specimens from humans. Please find the most updated list of HSR trainings required here.
New Staff Announcement
Heather Aldrich, PhD
Scientific Editor
heather.aldrich@cuanschutz.edu
Heather Aldrich, PhD, is excited to join the Department of Obstetrics and Gynecology as the new Scientific Editor. Passionate about science and writing, Dr. Aldrich has experience combining these interests in academic and industry settings. She has worked on campus for several years in a variety of roles for the College of Nursing and Colorado School of Public Health, including her previous role as an Assistant Research Professor. Dr. Aldrich has collaborated with research teams covering a diverse range of topics and methodology – from laboratories, to agricultural fields, to clinical and community settings. She has undergraduate degrees in Technical Journalism/Specialized Communication as well as Nutrition and Food Science. Dr. Aldrich’s graduate degrees are in Food Science and Human Nutrition. When not at work, she enjoys cooking, gardening, sewing, and discovering other creative projects with her husband and two children.
July 2021 Announcements
Limited Submission Portal
OGC recently launched their Limited Submission Portal under the direction of Amy Gannon, associate vice chancellor for financial services and controller; and Lori Sussel, PhD, associate vice chancellor for basic science research. This is the new mechanism
to submit an application if you would like to be considered for limited submission funding opportunities.
For up-to-date information regarding all Limited Submission Funding Opportunities and to submit your application please visit: Limited Submission Funding Opportunities (cuanschutz.edu)
NIH: Notice of Pre-Application Webinar for "Radiation Oncology-Biology Integration Network (ROBIN) Centers: RFA-CA-21-040
The National Cancer Institute (NCI) will hold a public pre-application webinar for "Radiation Oncology-Biology Integration Network (ROBIN) Centers (U54 Clinical Trial Required).
For Full Text: NOT-CA-21-093
NIH: Required Use of Two-Factor Authentication Using Login.Gov for eRA's External Modules in 2021
In April 2020, eRA launched the availability of login.gov for its external modules for optional use. Login.gov is a shared service authentication provider managed by General Services Administration (GSA). With one login.gov account, users can sign into
multiple government agency systems while taking advantage of login.gov’s two-factor authentication capabilities that ensure the security of their personal information.
By September 15, 2021, all external users will be required to use login.gov when logging into eRA systems. All users of eRA Commons, Commons Mobile and ASSIST are encouraged to begin the switchover now, before the mandatory deadline.
For Full Text: NOT-OD-21-040
NIH: Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021
In an effort to support strong collaboration between Federal research agencies, NIH has made every effort to align the Biographical Sketch (Biosketch), Other Support format page and Application Form Instructions with the guidance issued by the Office of Science and Technology Policy Joint Committee on the Research Environment.
As a result, this Guide Notice informs the extramural community that NIH has updated its application forms and instructions to support the need for applicants and recipients to provide full transparency and disclosure of all research activities, foreign and domestic.
The updated forms and instructions will be required for use for applications and Research Performance Progress Reports (RPPR) submitted for due dates on or after May 25, 2021.
For Full Text: NNOT-OD-21-073
Clinical Research
Resources for Clinical Researchers including:
- CCTSI Early Life Exposures Program (ELEP)
- Obstetrics Research Team
Researcher Toolkit
Resources for Laboratory Researchers including:
- Research Faculty and PRA Onboarding
- Regulatory Processes Maps
- Regulatory Submission Process Guide
- Statistical Support Guide
Laboratory Research
Resources for Laboratory Researchers including:
- Lab Faculty and Staff Onboarding
- Campus Resources for Lab Research
- Vendors and Campus Supply Centers
- Guide to Shared Lab Equipment and Spaces
Funding Opportunities
Resources for various internal and external research funding including:
- Grant Development Support
- Resident Research Funding
- OB-GYN Department Funding
- External Funding
- Women's Reproductive Health Research (WRHR) Career Development Program
Jayne Martin Carli, PhD is awarded an NIH K99/R00 Pathway to Independence Award
Jayne Martin Carli, PhD, Post-doctoral Fellow in the McManaman-Monks Lab recently received an NIH K99/R00 Pathway to Independence Award on her continued study of human milk-derived cells to interrogate lactation insufficiency in the context of obesity and/or insulin resistance.
Theresa Powell, PhD is awarded an NICHD R01
Theresa Powell, PhD is a professor in Pediatrics’ Neonatology Section as well as the Division of Reproductive Sciences in OB-GYN. She recently was awarded an NICHD R01 in July 2022 for 5 years. Title: Novel Roles for Phospholipids in Regulating Placental Function and in the Delivery of DHA to the Fetal Brain.
WRHR Award Recipients for over 20 years
The Department of OB-GYN has held a Women’s Reproductive Health Research Career Development Award since 1999.Forward Looking Research
The department focuses on cutting edge translational research with the objective to develop novel interventions in women’s reproductive health.
Thomas Jansson, MD, PhD
Florence Crozier Cobb Endowed ProfessorChief, Division of Reproductive Sciences
Vice Chair of Research, Department of Obstetrics and Gynecology
T. Rajendra Kumar, PhD
Professor and Edgar L., Patricia M. Makowski and Family Endowed ChairAssociate Vice Chair of Research
Jeanelle Sheeder, MSPH, PhD
ProfessorAssociate Vice Chair of Clinical Research
Looking to Participate in OB-GYN Research?
Check out all of our currently recruiting clinical studies in the CU Anschutz Research Studies database!
Thomas Jansson, MD, PhD
Florence Crozier Cobb Endowed ProfessorChief, Division of Reproductive Sciences
Vice Chair of Research, Department of Obstetrics and Gynecology
T. Rajendra Kumar, PhD
Professor and Edgar L., Patricia M. Makowski and Family Endowed ChairAssociate Vice Chair of Research
Jeanelle Sheeder, MSPH, PhD
ProfessorAssociate Vice Chair of Clinical Research