Announcements

The Human Research Protection Office September 2024 Newsletter #10

Dear Principal Investigators,

As we gear up for the fall semester, I want to highlight the importance of planning for not only new proposals, experiments and papers, but also the continuity of your research in the event of an emergency. 

Columbia’s research enterprise is one of our greatest assets.  Over the past four years, we have experienced a pandemic, weather emergencies including hurricanes and floods, a relatively small earthquake, and civil unrest. Any such events have the potential to disrupt Columbia research. For this reason, we have developed a dedicated research continuity website. This website is intended to be a “one-stop-shop” for researchers across the University, applicable to any emergency and updated in real time.  

In the event that campus access is restricted for research, we will update the research continuity website to detail the restrictions and access criteria applicable to research. Research deans at the school level will continue to be responsible for approving access for researchers and research visitors in their schools. As EVPR, my team and I meet regularly with the research deans and will continue to coordinate and serve as a point of contact with the University’s senior leadership.

The website highlights the importance of plans to back up critical data, ensure protection for other unique research assets, and identify key personnel who may require physical access to campus. It includes a definition of “essential personnel” for research, incorporating the concepts of “life-critical” processes required to preserve the life of a research asset, and “time-critical” processes required to meet a deadline or avoid a major disruption to a research program.

Finally, we are piloting the use of Environmental Health and Safety’s Laboratory Information Online Network (LION) database to streamline the access approval process. The pilot is currently for wet labs on the Morningside campus only. For these labs, principal investigators or their designee(s) as assigned in LION should log into LION and update their laboratory personnel roster as soon as possible. These rosters will serve as the basis for research deans to coordinate access for specific individuals.  Please note, wet laboratory personnel must be current with applicable Laboratory Safety Training (TC2150, TC4951 or TC0950) in order to be eligible to access campus during periods of significant restriction. If you have questions about this process, please visit the EH&S FAQs or contact [email protected].

We will continue to build out the research continuity website and welcome your suggestions for content. In the meantime, please feel free to forward this email to your teams, and we look forward to a safe and productive fall.

Jeannette M. Wing

Executive Vice President for Research, Columbia University

The Human Research Protection Office August 2024 Newsletter #9

Dear Principal Investigator & Laboratory Safety Manager:

In the event of an emergency, the University is committed to providing appropriate laboratory access to essential research personnel (faculty, staff, students), including during potential access restriction periods. We have identified the laboratory personnel rosters in Environmental Health & Safety’s (EH&S) Laboratory Information Online Network (LION) system as an efficient mechanism to facilitate campus access for research continuity purposes. Accordingly, all Principal Investigators (PIs) - or their designees as assigned by them as Laboratory Safety Manager(s) in LION - are requested to log in to LION within the next week and update their laboratory personnel roster.

Please be aware that laboratory personnel must be current with applicable Laboratory Safety Training (TC2150, TC4951 or TC0950) to be eligible for campus access as essential personnel. This training ensures that research personnel are prepared and can perform their essential functions safely, particularly during periods of modified campus operation. The LION enables PIs to monitor the training status of their personnel so that they are eligible for access.

Depending on the nature of the emergency and potential access restriction, campus may be open to all researchers, or only to some. The relevant vice dean for research will have access to the LION rosters of each PI’s personnel in their school, as a starting place in case access restrictions for researchers are needed. As we continue to enhance the LION system, PIs may be required to designate access categories in LION. This step requires updates by the software vendor, and we will be in touch as soon as any such updates are completed. 

As a starting point, it is crucial that all laboratory rosters are up to date by August 21, 2024, in preparation for the start of the fall semester. Further, rosters should be periodically reviewed to add new personnel and remove those that have left. Rosters can be updated by logging into LION and following the stepwise instructions beginning on p.3.

Finally, we know that campus access may also be essential to research continuity for researchers who do not have wet labs and do not use LION. We are working with the vice deans for research of relevant schools to ensure that these researchers are also included in the planning process.

Please reach out to EH&S or email [email protected] with any questions about roster updates, and we wish you a productive start to the fall semester.

Kathleen Crowley

Vice President, Environmental Health and Safety

Helen Kim

Vice President for Research Operations and Policy (VPROP)

Naomi Schrag

Vice President for Research Compliance, Training and Policy

We have published new FAQs to provide additional guidance on NIH's Final Updated Policy Guidance for Subaward/Consortium Written Agreements (NOT-OD-23-182). These FAQs are now available on our website at Columbia FAQs on NIH Foreign Subawards.

Key highlights from the new FAQs include:

• Proposal Stage Requirements: Information on what PIs need to discuss with proposed foreign subrecipients, including the necessity for access to all lab notebooks, data, and documentation supporting research outcomes.
• Electronic Platforms: Guidance on using Columbia-supported electronic platforms for sharing and storing research documentation.
• Human Subjects: Specific language for informed consent forms to ensure compliance with NIH requirements for sharing research records with Columbia.
• RPPRs (Research Performance Progress Reports): Responsibilities for PIs, including a new certification requirement in Rascal Proposal Tracking (PT) for non-competing continuations that they have access to all necessary documentation from subrecipients and identify the electronic platform used for this purpose.

We encourage you to review the FAQs and familiarize yourself with these requirements to ensure compliance with NIH policies. Should you have any questions or need further assistance, please reach out to your SPA Project Officer.

A new webpage is available dedicated to providing guidance for the Columbia research community with respect to the review and execution of “non-traditional agreements,” e.g. sponsored project activities that extend beyond the performance of research, education, and public service. Guidelines for facilitating non-traditional projects have been added to the site. See the new Non-traditional Agreements webpage for more information.

Dear Principal Investigators and Senior and Key Personnel,

Please see important information below concerning a new certification requirement for individuals applying for Department of Defense (DoD) funding; background relevant to all researchers; and a refresher regarding comprehensively sanctioned countries and regions.

New Mandatory Certification for PIs and Senior/Key Persons Applying for DoD Funding

Starting on August 9, 2024, a new certification in Rascal will be required for all principal investigators and senior/key persons submitting proposals to the DoD. The certification takes only a minute or two to complete. Investigators will be certifying that they are not participating in malign foreign talent recruitment programs (Malign FTRPs), in compliance with U.S. law. After August 9, DoD proposals may not be finalized in Rascal or submitted to DoD until all senior and key persons have completed the new certification.

The definition of Malign FTRP is complex. If you are not certain whether an engagement meets the definition, please contact [email protected] for a consultation. More information is also available on the University’s research security webpage.

Background on Malign FTRP Certification Requirement

As we have communicated previously, the CHIPS & Science Act of 2022 (“CHIPS Act”) and Columbia policy prohibit federally funded senior and key persons from participating in any Malign FTRPs.  By definition, Malign FTRPs must involve China, Iran, North Korea, or Russia (which the CHIPS Act has defined as “Foreign Countries of Concern”), or entities in those countries, and must meet certain other criteria.  Researchers who participate in Malign FTRPs are not eligible to serve as senior/key persons on federally funded projects.

The CHIPS Act requires researchers participating in federally funded projects to certify that they are not participating in Malign FTRPs.  Funding agencies are implementing this requirement on a rolling basis. For example, NSF has implemented it through SciENcv as of May 2024; NIH has stated it will implement SciENcv in May 2025. DoD, however, has not yet implemented a certification mechanism. For this reason, the separate Rascal certification is required for individuals applying for DoD funding.

Comprehensively Sanctioned Countries and Regions
Finally, we also take this opportunity to remind all researchers that in addition to the Malign FTRP restrictions for Foreign Countries of Concern listed above, the U.S. government also has comprehensive sanctions against the following countries and regions:

• Cuba
• Iran
• North Korea 
• Russia*
• Syria 
• Ukraine (the Crimea, Donetsk (DNR) and Luhansk (LNR) regions)

Any researcher planning a project that involves a comprehensively sanctioned country or region should contact [email protected] as soon as possible for guidance.

Thank you for your attention to these important topics.

Naomi Schrag, JD

Vice President for Research Compliance, Training, and Policy

William Berger

Assistant Vice President, Sponsored Projects Administration

NIH recently announced they have increased the childcare cost support from $2,500 to $3,000 per budget period, effective for federal fiscal year 2024 (FY2024, 10/1/2023 – 9/30/2024). This change, detailed in NOT-OD-24-116, applies to all eligible NIH NRSA training and fellowship awards. Awards issued prior to this notice will be retroactively adjusted.

NOTE: Childcare costs for AHRQ NRSA training and fellowship awards will remain at $2,500 per budget period at this time.

Key Points for NIH NRSA training and fellowship awards:

• Effective Date: FY2024
• Retroactive Adjustment: Applicable FY2024 awards issued before the notice (NOT-OD-24-116) will be revised to reflect the increase.
• Identifying FY2024 Awards: the Notice of Award (NOA) will reflect if it is issued under FY2024, with the childcare costs awarded.

Our website and childcare costs reimbursement form have been updated to reflect these changes. For more information, visit NIH/AHRQ Childcare Costs. Questions can be directed to the Research Policy and Indirect Cost Group at [email protected].

Dear Principal Investigators and Senior/Key Personnel:

We write to remind you of significant changes to Current and Pending (Other) Support and Biosketch disclosures that will take effect beginning May 20, 2024 for the National Science Foundation, and later this year for Department of Defense, National Institutes of Health and other federal funders.  See this Research Security Update hand-out with more information. The key details are below:

1. New Certification: No participation in malign foreign talent recruitment programs (MFTRPs)

The CHIPS & Science Act of 2022 (“CHIPS Act”) prohibits federally-funded senior and key persons from participating in any MFTRPs.  By definition, MFTRPs must involve China, Iran, North Korea, or Russia, or entities in those countries, and must meet certain other criteria.  Researchers who participate in MFTRPs are not eligible to serve as senior/key persons on federally funded projects. 

The definition of MFTRP is complex. If you are not certain whether an engagement meets the definition, please contact [email protected] for a consultation.

As of May 20, 2024, NSF will require senior/key persons to certify on their Current and Pending Support and Biosketch disclosures that they are not currently participating in an MFTRP.  Researchers must use SciENcv to complete these disclosures. The SciENcv forms will automatically include the certification for completion.

The Department of Defense MFTRP certification requirement will take effect in August 2024, but the mechanism has not yet been announced.  Because the mechanism is unclear, we are developing a stand-alone institutional certification for Department of Defense funded individuals.  More about this stand-alone certification will be forthcoming.

NIH’s MFTRP certification requirement will take effect in January 2025.

False representations regarding this MFTRP certification may be subject to prosecution and liability pursuant to, but not limited to, 18 U.S.C. §§.287, 1001, 1031 and 31 U.S.C. §§ 3729-3733 and 3802.

Anyone with questions regarding MFTRPs should feel free to contact the Office of Research Compliance and Training at [email protected].

2. Disclosure of Consulting Required in Current and Pending (Other) Support

New, federal-wide Current and Pending (Other) Support disclosure forms require disclosure of consulting activities under the proposals and active projects section of the form when any of the following scenarios apply:

• The consulting activity will require the senior/key person to perform research as part of the consulting activity;
• The consulting activity does not involve performing research, but is related to the senior/key person’s research portfolio and may have the ability to impact funding, alter time or effort commitments, or otherwise impact scientific integrity; or
• The consulting entity has provided a contract that requires the senior/key person to conceal or withhold confidential financial or other ties between the senior/key person and the entity, irrespective of the duration of the engagement.

3. Disclosure of Start-up Companies Based on Non-Organizational Intellectual Property in Current and Pending (Other) Support

The new Current and Pending (Other) Support forms require senior and key persons to disclose any start-up companies if they are based on non-organizational intellectual property. This would include, for example, start-up companies based on intellectual property relinquished by Columbia University or never owned by Columbia University.

4. Biographical Sketch:  3-Year Look-back for Professional Appointments

The new, federal-wide biographical sketch requires disclosure of all academic and institutional appointments in reverse chronological order. It also requires disclosure of all domestic and foreign professional appointments and positions for a period of three years prior to the date the applicant submits the funding application.  Examples of professional appointments could include service as a grant reviewer or on the board of an academic society or journal.

Over the past several years, Current and Pending (Other) Support and Biosketch disclosures have taken on additional importance, as you know, and funding agencies are scrutinizing them closely.  Please treat them with the greatest seriousness, ensure they are current, accurate, and complete, and if you have questions, please do not hesitate to contact your SPA project officer or the Office of Research Compliance and Training. More information is also available on the University’s Research Security webpage and on the federal-wide common disclosure webpage.

Thank you.

Naomi Schrag                                                             William Berger

VP for Research Compliance, Training and Policy    AVP for Sponsored Projects Administration

As part of our commitment to keeping our research community informed and prepared, we would like to remind you of significant upcoming changes to the National Science Foundation's (NSF) Proposal & Award Policies & Procedures Guide (PAPPG), NSF 24-1, which will be effective for proposals submitted or due on or after May 20, 2024.

Key updates include:

• Enhanced Guidelines for Foreign Collaborations: Proposals involving foreign collaborators must now include detailed justifications, clarifying the necessity and benefits of international collaboration.

• Use of Generative AI: If used in proposal preparation, the extent and manner of AI involvement must be disclosed.

• Synergistic Activities: Now required as a separate attachment for each senior/key person.

• Mentoring Plan Requirements: Expanded to include all supported postdoctoral researchers and graduate students.

• Individual Development Plans (IDPs): IDPs will be required for each NSF award that provides substantial support (at least one person month) to postdoctoral scholars and graduate students. The IDPs must be updated annually.

• Tribal Nations Impact: Proposals affecting Tribal Nations require prior written approval, with new documentation requirements.

• Implementation of the Common Forms(Biographical Sketches and Current and Pending (Other) Support Forms), containing a new certification on Malign Foreign Talent Recruitment Programs (MFTRPs).*
  • Additional resources to assist you with the Common Forms are available on our website at NSF Researcher Disclosure Requirements.

*Note that a subsequent announcement is forthcoming concerning Current and Pending (Other) Support and Biosketch Disclosures.

To assist you in navigating these changes, we have prepared a detailed summary document that outlines revisions and new requirements introduced in PAPPG 24-1.

• Word version (with headers collapsed): Summary of NSF PAPPG 24-1 Changes
• PDF version (headers expanded) Summary of NSF PAPPG 24-1 Changes

We strongly encourage all PIs and administrators to review this summary. Should you have any questions, please contact your SPA Project Officer.

Dear Members of the Research Community,

As you saw in earlier messages this morning, there are significant ongoing protest activities on the Morningside campus, with campus closed to all but essential personnel. This means that research continues but we are implementing a short-term reduction in on-campus researcher presence on the Morningside campus. Only researchers needed to ensure all laboratory equipment and materials are secure or to preserve key research assets should be physically present on Morningside campus. If you can work remotely now, you do not need to read the rest of this email.

“Essential” research activities are those that:

• preserve ongoing projects (tissue preservation, animal care, etc.),
• protect instrumentation and other key research assets (climate control, supervised shut-downs)
• receive and process pending arrivals of critical research assets

Public Safety has already locked Columbia buildings. If you think your laboratory or research assets require your attention to ensure safety or preservation, please reach out to:

• SEAS – Garud Iyengar, Senior Vice Dean for Research and Academic Affairs
• Natural Sciences – Robert Mawhinney, Dean of Science
• Other – your dean

The relevant deans for research for affected schools are providing requests to restore access to Public Safety.  They will let you know if your request is granted and when access has been restored. 

Thank you for your cooperation with this evolving situation and we will be in touch with any relevant updates for the research community.

Jeannette M. Wing

Executive Vice President for Research

The National Institutes of Health (NIH) has announced updated stipend levels for recipients of the National Research Service Award (NRSA) for Fiscal Year (FY) 2024. See NOT-OD-24-104. These new stipend levels are effective with all Kirschstein-NRSA awards made on or after October 1, 2023.

Key Updates Include:

• Predoctoral Trainees: Stipends will increase by 4%.
• Postdoctoral Scholars: Stipends will increase by 8%.
• Childcare Subsidy: The annual childcare subsidy for eligible participants will rise from $2,500 to $3,000.
• Institutional Allowance (for fellowships)/Training Related Expenses (for training grants): Increase to $4,750 for predocs, and $12,400 for postdocs.

These adjustments are based on recommendations from a December 2023 working group to the NIH Advisory Committee to the Director.

Further Information and Resources:

• Read NIH’s Press Release.
• Detailed information can be found in the NIH Guide Notice.
• See the recent blog post by NIH Deputy Director for Extramural Research, Dr. Michael Lauer.

For any questions, please do not hesitate to reach out to your SPA Project Officer.

The Human Research Protection Office April 2024 Newsletter #8

The Human Research Protection Office March 2024 Newsletter #7

Dear members of the Columbia research community,

Columbia University is deeply committed to integrity in scholarly research. We write to remind you of key resources and policy to support your research endeavors. If you conduct research or support people who do, please be sure to read the information below.

New On-Line Training: Handling Digital Scientific Images

Columbia has launched a new, on-line training on proper handling of digital scientific images.  Module 1, Handling Digital Scientific Images Dos & Don’ts (TC7150), covers ethical image handling practices, acceptable versus unacceptable modifications, and the management of digital images to maintain traceability and compliance. Module 2, From the Benign to Research Misconduct: Case Studies and Strategies for Detection (TC7151), addresses detection of improper image manipulations, the classification of these alterations, and emerging challenges. There is a brief quiz at the end of Module 2.

Proper handling of scientific images is a critical component of research integrity. We encourage anyone who works with scientific images, at any career stage, to take the new training. Principal investigators should set an example for their teams by taking the training now. The training will be assigned to all postdocs and associate research scientists at CUIMC and relevant other departments on the Morningside and Manhattanville campuses in Rascal and will appear in the My Training To-Do list. We strongly recommend that these individuals complete the training within the next 90 days.  Departments will be provided completion reports for follow-up.

Resources to Support Data Management, Rigor and Reproducibility

The University’s Research and Data Integrity (ReaDI) Program, overseen by the Office of Research Compliance and Training, links to extensive resources to support researchers at all career stages. We highlight some of the many resources below:

• Catalog of Columbia-supported Data Repositories, including cost (if any) 
• LabArchives Electronic Research Notebook, provided at no cost to Columbia researchers
• Columbia Data Platform, a cloud-based research data solution including a low-cost option to “cold store” big data
• Checklists for keeping a lab notebook and for team member departures 
• Tutorials on Good Laboratory Notebook Practices, Best Practices for Data Management When Using Instrumentation, and Guidelines on the Organization of Samples
• Reproducibility Resources by Topic
• Data Management at Columbia

Research Misconduct

The University’s Institutional Policy on Research Misconduct ensures that allegations of research misconduct (i.e., fabrication, falsification, or plagiarism) are handled with care and rigor and in accordance with funder requirements. The Policy requires fact-driven analysis by experts in the scientific field at issue, and contains numerous protections for all involved, including confidentiality and a presumption of innocence. More information is available on the Research Compliance and Training website. We also note that the University’s Compliance Hotline is a resource for individuals who have concerns.

Thank you and we wish you a productive spring.

Katrina Armstrong, CEO, CUIMC

Dennis Mitchell, Interim Provost

Jeannette M. Wing, Executive Vice President for Research