The Columbia University Human Research Protection Office invites you to attend our upcoming "IRB 101" seminar. The intent of this session is to provide basic information about the history of human subjects protection, regulatory requirements, submission tips, and Rascal updates as they relate to the Human Research Protection Program and Institutional Review Board (IRB) review at Columbia.
May 9, 2019 from 12:00 - 4:00 p.m. Click here for the presentation slide deck.
NIH & AHRQ issued announcements that their salary caps increased from $189,600 to $192,300. See NIH Guidance NOT-OD-19-099 and AHRQ Guidance NOT-HS-19-013. The effective date of this increase is January 6th, 2019.
In summary, this is how the $192,300 salary cap can be applied:
- Proposals: NIH and AHRQ proposal budgets may be submitted using the new cap.
- Active Awards: Can rebudget funds to allow for increase in rates. It is a good time to verify all salary allocations, and adjust salary distributions as appropriate.
If you have any questions, please feel free to reach out to your SPA Project Officer.
More Department of Defense (DoD) Funding Opportunities have been released since I sent the original announcement on February 28th, 2019. There are opportunities for postdocs all the way through the full professor level. Pre-applications are required for most programs. Take a look at the following recently released announcements:
- Alcohol and Substance Abuse Disorders Research Program (ASADRP)
- Autism Research Program (ARP)
- Lung Cancer Research Program (LCRP)
- Military Burn Research Program (MBRP)
- Neurofibromatosis Research Program (NFRP)
- Ovarian Cancer Research Program (OCRP)
- Parkinson's Research Program (PRP)
- Peer Reviewed Cancer Research Program (PRCRP)
You may wish to subscribe to individual CDMRP programs so you may receive information about opportunities as soon as they are available specific to your area of interest:
As a reminder, we have a subscription to Pivot for you to search for all types of funding opportunities. For more information about Pivot, along with quick start guides, go to Find Funding using Pivot.
The Opioid Crisis and the Need for Research
As you may know, the US is facing a crisis with opioid abuse, with over 47,000 deaths in 2017. In response, many federal agencies are providing funding opportunities to research that addresses this crisis. The opportunities are broad in scope and inclusive of many scientific disciplines.
Columbia’s Response to the Opioid Crisis
The Irving Institute for Clinical and Translational Research is dedicated to addressing this national crisis, and strongly supports multi-disciplinary research and new collaborations to examine all aspects of the problem. The Irving Institute is facilitating working groups and meetings where investigators of all scientific areas can connect and collaborate on new research projects. Harold Pincus, MD, and Jennifer Humensky, PhD, are leading this initiative. If you'd like to learn more about participating in the working groups or get on the email list, email Jennifer.Humensky@nyspi.columbia.edu.
NIH's HEAL initiative has numerous funding opportunities. For more information and to subscribe to its listserv, visit NIH Heal Initiative Funding Opportunities. In addition, the Irving Institute’s dedicated webpage on the opioid crisis contains a link to additional federal and non-federal opportunities, updated in real-time, using Pivot, the funding opportunity database.
TOPIC: Investigational New Devices
Thursday, March 21, 2019 from 3:30-4:30 pm in the Hammer Science Center LL203
- Regulatory context for clinical investigations
- When an IDE is required
- Sponsor-Investigator Responsibilities
- Application process to FDA
- IRB Submission and Requirements
NIH continues to update the Fellowship Parent Funding Opportunity Announcements (FOAs) with information on participating NIH Institutes and Centers (ICs). See the latest list of updates in the March 8th version of their Weekly Guide:
There have been corrections made with regards to NIAID, NIBIB, and NEI. Therefore, it is possible you saw that an IC was not participating in a fellowship, but now they are!
The important thing to note is if you are not sure, or have other questions, review the Table of IC-Specific Information provided in each Parent FOA, and contact the Scientific Program Contact. All Parent FOAs are located at https://grants.nih.gov/grants/guide/parent_announcements.htm.
I wanted to draw your attention to the NIH Center for Scientific Review’s Early Career Reviewer (ECR) Program. If eligible, it is an opportunity to improve your grant proposal writing skills by experiencing first-hand how grant applications are evaluated. You will also network with accomplished researchers, and learn how applications are reviewed and scored.
To qualify for the ECR program, you must:
- Have at least 2 years’ experience as a full-time faculty member or researcher in a similar role. Post-doctoral fellows are not eligible.
- Show evidence of an active, independent research program. Examples include publications, presentations, institutional research support, patents, acting as supervisor of student projects.
- Have at least 2 recent senior-authored research publications in peer-reviewed journals in the last 2 years. In press publications are considered and author position can be as single author, corresponding author, or first or last author.
- Have not served on a CSR study section in a role other than mail reviewer. (Mail reviews do not include participation in the meeting.) Review service at other agencies or at other NIH institutes/centers are not disqualifiers.
- Current funding is not required. (Anyone who has received an R01 award is over-qualified and could be considered as a temporary reviewer.)
For more information: https://public.csr.nih.gov/ForReviewers/BecomeAReviewer/ECR
Pre-recorded Webinars on Funding Opportunities:
The Congressionally Directed Medical Research Programs (CDMRP) of the Department of Defense (DoD) invites the research community to view a webinar series on funding opportunities in both research and career development. The second webinar, which was posted today, walks through three categories of hypothesis-driven, high risk/high gain funding opportunities - Initial Concept Awards, Early Idea Awards, and Established Idea Awards. The key features associated with these categories include innovation, impact, and research strategy and feasibility. In addition, the relevant peer and programmatic review criteria will be reviewed. Find the webinars here: https://cdmrp.army.mil/pubs/Webinars/webinar_series
Currently Available CDMRP FY 19 Funding Opportunities
There are opportunities for postdocs all the way through the full professor level. Pre-applications are required for most programs. See the Synopsis and Eligibility Criteria for each area below, which contains all deadlines.
Peer Reviewed Medical Research Program (PRMRP)
* This program offers very broad topic areas in many areas of biomedical research. See FY19 Topic Areas.
Breast Cancer Research Program (BCRP):
Tuberous Sclerosis Complex Research Program (TSCRP)
Amyotrophic Lateral Sclerosis Research Program (ALSRP)
Combat Casualty Care Research Program (JPC-6)
More funding opportunities will be released soon. You may wish to subscribe to individual CDMRP programs so you may receive information about opportunities as soon as they are available specific to your area of interest:
Reminder: If interested in finding other types of funding opportunities, don’t forget to create a Pivot account (the funding opportunity database), using your Columbia email address. Pivot Quick Start Guide.
We are writing to inform you that on March 1st, 2019, Pivot is moving to https://pivot.proquest.com and the current Pivot URL, pivot.cos.com will be discontinued. Traffic to cos.com will not automatically redirect to the new URL. Please update your bookmarks, hyperlinks and other materials to the new URL. All other functionality in Pivot will remain the same, including your account and any searches you have saved. Should you have any questions about Pivot or the URL change, please feel free to reach out to Ricardo Andrade at firstname.lastname@example.org or Stephanie Scott at email@example.com.
The following announcement came directly from the NSF Policy Office on 2/15/2019. It is copied and pasted below.
Due to the recent lapse in appropriations, implementation of the revised NSF Proposal & Award Policies & Procedures Guide (PAPPG), (NSF 19-1) was postponed. We are pleased to announce that the revised PAPPG will now be effective for proposals submitted, or due, on or after February 25, 2019. Significant changes include:
- Addition of Research.gov as an option for proposal preparation and submission, and proposal file updates;
- Revision of eligibility standards for unaffiliated individuals;
- Specification that conference proposals over $50,000 and all equipment proposals must include the Collaborators and Other Affiliations information in the proposal submission;
- Revision of resubmission guidelines for NSF programs that accept proposals at any time;
- Implementation of NSF’s policy on sexual harassment and other forms of harassment, or sexual assault;
- Specification that proposers are required to have a policy or code-of-conduct that addresses sexual harassment, other forms of harassment, and sexual assault, and that includes clear and accessible means of reporting violations of the policy or code-of-conduct. This policy or code-of-conduct must be disseminated to conference participants prior to attendance at the conference as well as made available at the conference itself;
- Emphasis on the importance of training faculty in the responsible and ethical conduct of research;
- Incorporation of existing patent policy into the PAPPG. This policy was previously implemented by regulation at 45 CFR 650; and
- Numerous clarifications and other changes throughout the document;
You are encouraged to review the by-chapter summary of changes provided in the Introduction section of the PAPPG.
To learn about the changes in the revised PAPPG (NSF 19-1), please view the latest NSF Proposal & Award Policy Update webinar.
While this version of the PAPPG becomes effective on February 25, 2019, in the interim, the guidelines contained in the current PAPPG (NSF 18-1) continue to apply. We will ensure that the current version of the PAPPG remains on the NSF website, with a notation to proposers that specifies when the new PAPPG (including a link to the new Guide) will become effective.
Associated award terms and conditions (including RTC NSF Agency Specific Requirements, GC-1, and FL-26) will also be effective for proposals submitted or due, on or after, February 25, 2019. Cooperative Agreement Conditions (CA-FATC) and CA-FATC Modifications and Supplemental terms and conditions are effective for new awards and funding actions to existing awards beginning on February 12, 2019.
If you have any questions regarding these changes, please contact the DIAS/Policy Office at firstname.lastname@example.org.
The National Science Foundation
NIH just posted in the Extramural Nexus this morning a reminder to applicants of the new Inclusion Across the Lifespan Policy. It requires grant applicants to address the age-appropriate inclusion or exclusion of individuals in Section 2.4 of the Study Record in the PHS Human Subjects and Clinical Trial Information Form.
As a reminder, this policy, and all other policy changes impacting NIH proposal preparation for 2019 can be found on our website at New NIH FOAs and Application Changes for 2019. We’ll continue to update this page with additional resources and materials as they become available.
As always, if you have any questions please feel free to reach out to your SPA Project Officer.
The Resumption of Operations at NSF page on the NSF website has been updated with important information, including identification of new deadline dates for specific solicitations and Dear Colleague Letters. Please review the website carefully, and you may need to go to the NSF Program Officials for clarifications.
As many of you are aware, a continuing resolution was signed by the President, which keeps the government operating through February 15th. NSF created a webpage, Resumption of Operations at NSF, containing guidance for proposers and awardees. It contains a list of solicitations and Dear Colleague Letters (DCLs) that will have new proposal deadline dates. These revised deadlines will be released by February 1st on this webpage.
NSF is experiencing a backlog of activities resulting from the shutdown. NSF’s Resumption of Operations at NSF webpage will continue to be updated with new information. It is important to refer to this webpage for the most up to date information relating to NSF proposals and awards.
SPA will continue to provide updates as we receive them. Please feel free to contact your SPA Project Officer should you have any questions.
A number of new and re-issued NIH Parent Funding Opportunity Announcements (FOAs), as well as policy changes impacting proposal preparation, are going into effect in the coming weeks. To assist researchers and administrators with the transition, we created a new webpage as a ‘one-stop-shop’ to provide summaries and guidance. We’ll continue to update and include more resources to this webpage as we receive more information.
Please see New NIH FOAs and Application Changes for 2019.
In addition, you can use the attached one-pager to distribute during department faculty and staff meetings to facilitate discussion of the changes.
As always, please feel free to ask any questions to your assigned SPA Project Officer.
January 07, 2019
As of this time, the partial government shutdown continues and it is uncertain when it will be resolved. This announcement serves to provide guidance on the management of sponsored projects funded by those federal agencies impacted by the shutdown. This includes NASA, NSF, Commerce (including NIST and NOAA), FDA, EPA, the U.S. Geological Survey and the National Endowments for the Arts and Humanities.
None of HHS (including NIH, CDC, CMS, HRSA, SAMHSA and AHRQ), DOD, VA, DOE and the DE is impacted by the shutdown.
Contact with federal agency staff by phone, email, fax, USPS mail, FedEx or UPS will not be possible during the funding lapse. Please do not contact furloughed federal employees, including program officers, until operations resume.
Grants.gov will continue to operate during the shutdown. All federal agency proposal deadlines remain in effect. While proposals can be submitted, they will not be processed until normal agency operations resume. Help desk support for agency-specific proposal development systems, such as NSF FastLane, will not be available to provide technical assistance.
Peer Review/Panel Council Meetings
All panels scheduled to take place during the shutdown will be cancelled. Affected meetings will likely be rescheduled at a later date.
Awardees may continue performance under their awards during a lapse in appropriations, to the extent funds are available, and if the period of performance of the grant or cooperative agreement has not expired. However, federal agencies are not obligated to reimburse expenditures for amounts in excess of total funds authorized per the terms of awarded grants or cooperative agreements.
Notices of Awards
No new notices of awards (NoAs) or non-competing awards will be released during the funding lapse. Pending NoAs will be released once operations resume.
Please continue to submit progress reports per required deadlines. However, they will not be processed by federal agency staff until operations resume.
No Cost Extensions
A no cost extension (NCE) request for most federal awards can be processed through SPA if it is a first time request, and if the NoA does not indicate that it requires agency prior approval. Contact your SPA Project Officer for guidance. If the federal agency requires prior approval for the NCE, the request can be submitted to the agency via your SPA Project Officer; however, it cannot be reviewed or processed by agency staff until operations resume. Unused funds remaining beyond the award end date cannot be obligated for expenses until the federal agency approves the NCE request.
Other Prior Approval Requests
Requests can be submitted to a federal agency via your SPA Project Officer. Such requests cannot be reviewed or processed by agency staff until operations resume.
Contractors will be notified if work on contracts can continue. No new contracts will be issued during the shutdown. SPA will contact the PI immediately if we receive notice of a Stop Work Order. Should you receive a Stop Work Order directly, or other communication regarding a federal contract, notify your SPA Project Officer immediately.
SPA will continue to provide updates as we receive them. Please feel free to contact your SPA Project Officer should you have any questions.
For more specific information for specific agencies:
Dept. of Commerce (includes NIST and NOAA): Shutdown Due to Lapse of Congressional Appropriations
Office of Management and Budget: Other Agency Contingency Plans
Rudi Odeh-Ramadan, PharmD
Vice President for Research Administration