Announcements

New Information Concerning E-Signatures for NIH Other Support/Town Hall Part II tomorrow

As a reminder, effective January 25, 2022, PIs and other senior/key personnel must electronically sign the NIH Other Support form to certify the accuracy of the information provided, and adhere to Columbia University’s Electronic Signature Policy. A typed name is not an electronic signature and is not acceptable. Certification cannot be delegated to administrators or other staff. NIH will not accept wet signatures, or pictures of wet signatures. 

The University recommends using DocuSign to electronically sign the Other Support forms. DocuSign is cloud-based and automatically retains the originally signed documents. Both faculty and administrators can use DocuSign. 

CUIT is in the process of creating DocuSign accounts for PIs who have current active or pending NIH grants. Administrators who support faculty in creating and organizing Other Support forms and wish to have access to DocuSign will need to request an account. Please complete this Qualtrics form as soon as possible in order for CUIT to create an account. We only need the person’s name and UNI, and one person can complete forms for multiple individuals.   

DocuSign training will be offered next week by CUIT and SPA, and will be recorded if you are unable to attend. A quick desktop reference guide and instructional video resources will also be forthcoming. Please register for the trainings by using a Columbia-affiliated email address here:

In addition, we’d like to remind you about tomorrow’s NIH Town Hall – Part II. During the town hall, we will cover the latest changes to the NIH application forms (FORMS-G), the new eRA Commons ID requirements, and leave time for open Q&A on anything concerning the biosketches and Other Support forms. To register: 

Please feel free to send me any questions at [email protected]

As a reminder, effective January 25, 2022, PIs and other senior/key personnel must electronically sign the NIH Other Support form to certify the accuracy of the information provided, and adhere to Columbia University’s Electronic Signature Policy. A typed name is not an electronic signature and is not acceptable. Certification cannot be delegated to administrators or other staff. NIH will not accept wet signatures, or pictures of wet signatures. 

The University recommends using DocuSign to electronically sign the Other Support forms. DocuSign is cloud-based and automatically retains the originally signed documents. Both faculty and administrators can use DocuSign. 

CUIT is in the process of creating DocuSign accounts for PIs who have current active or pending NIH grants. Administrators who support faculty in creating and organizing Other Support forms and wish to have access to DocuSign will need to request an account. Please complete this Qualtrics form as soon as possible in order for CUIT to create an account. We only need the person’s name and UNI, and one person can complete forms for multiple individuals.   

DocuSign training will be offered next week by CUIT and SPA, and will be recorded if you are unable to attend. A quick desktop reference guide and instructional video resources will also be forthcoming. Please register for the trainings by using a Columbia-affiliated email address here:

In addition, we’d like to remind you about tomorrow’s NIH Town Hall – Part II. During the town hall, we will cover the latest changes to the NIH application forms (FORMS-G), the new eRA Commons ID requirements, and leave time for open Q&A on anything concerning the biosketches and Other Support forms. To register: 

Please feel free to send me any questions at [email protected]

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Archived Announcements

Dear NIH Researchers,

As previously announced, as of January 25, 2022, NIH will require new Biographical Sketches and Other Support format pages containing substantial changes. The updated forms and instructions are required for use in applications and Research Performance Progress Reports (RPPRs) due on or after January 25, 2022.

IMPORTANT: the revised Other Support form requires three new action items for all PIs and senior/key persons:

  • Sign Electronically:  The PI and other senior/key personnel must electronically sign the Other Support form to certify the accuracy of the information provided, and adhere to Columbia University’s Electronic Signature Policy. A typed name is not an electronic signature and is not acceptable.  Acceptable methods for obtaining electronic signature are DocuSign, and a departmentally licensed version of Adobe.
    • PIs and Departments must retain the “original” electronic signatures, prior to the conversion to PDF format, and prior to submission to Sponsored Projects Administration (SPA).
  • Include Non-U.S. Supporting Documentation in JIT/RPPR Other Support Packet: With the electronically signed Other Support forms, PIs and senior/key persons must include copies of contracts/agreements specific to any non-U.S. appointments and/or employment for any non-U.S. activities and resources that are reported in Other Support. If the contracts/agreements are not in English, recipients must provide translated copies.  These materials must be provided to SPA as part of the JIT/RPPR Other Support packet.
  • Upload Non-U.S. Supporting Documentation to Rascal:  A new Rascal module has been launched to allow PIs and senior/key personnel to upload their supporting documentation for a limited, parallel compliance review by the Office of Research Compliance and Training (ORCT).  Documentation need only be uploaded one time in the life of the agreement, but amendments and modifications must be uploaded.  This upload is separate from the submission to SPA noted above. 

We strongly recommend that individuals who have non-U.S. agreements related to Other Support upload the documentation to Rascal now, so that ORCT can review before submission to NIH.

To learn more about the changes to the Biosketches and Other Support forms, complying with the electronic signature mandate, and the new Rascal module for supporting documentation, sign up for an upcoming webinar:

Schedule (click on the hyperlinks below to register, using a Columbia-affiliated email address. Other email addresses will be rejected):

We will continue to provide updates as we get closer to January 25, 2022. We are also happy to discuss these updates at upcoming faculty or administrator meeting as scheduling permits. For questions about these webinars and speaking engagements, please reach out to Stephanie Scott at [email protected]. For more information, see our NIH Researcher Disclosure Requirements webpage, and our supplemental FAQs.

Sincerely,

Naomi J. Schrag, JD

Vice President for Research Compliance, Training & Policy

Office of Research Compliance & Training

 

William Berger

Executive Director

Sponsored Projects Administration

Last week, the NIH implemented new system validations for Research Performance Progress Reports (RPPR) for clinical trial registration and results reporting. RPPRs that have associated clinical trials that are non-compliant with these requirements will receive errors preventing submission of the RPPR. See NOT-OD-22-008 for more details.

As a reminder, failure to register or report results data for an Applicable Clinical Trial (ACT) as per FDAAA 801 and the Final Rule or the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information can result in immediate suspension or termination of funding, monetary civil penalties of up to $10,000 per day of non-compliance, criminal or civil prosecution, and/or a permanent notice of non-compliance publicly posted on the ClinicalTrials.gov record for a study.

Of note, the FDA issued its first Notice of Noncompliance to an individual investigator conducting a trial sponsored by an academic institution. The Principal Investigator (PI) failed to submit required results data to ClinicalTrials.gov.  As a result of this noncompliance, the ClinicalTrials.gov record for the study will be permanently marked with and searchable by the “FDAAA 801 Violations” field, even though results were posted a day after the Notice was issued.

The requirements for registration and results reporting are as follows:

  • Applicable studies must be registered no later than 21 days after enrollment of the 1st participant (i.e., date of when the 1st participant signs a study consent form).
  • Results information for applicable studies must be submitted to ClinicalTrials.gov no later than one year after primary completion date (with limited exceptions) for the primary outcome measure, and one year after the study completion date for all other outcome measures, including safety data.

If you require assistance with ClinicalTrials.gov registration or results reporting, please contact the University’s system administrators at [email protected].

We will be hosting webinars on the NIH Biosketches and Other Support format pages to provide you with the latest information and guidance. The new format pages will be required for proposals, Just-In-Time (JIT) and the Research Performance Progress Reports (RPPRs) for due dates on or after January 25, 2022. In addition, electronic signatures and the collection of supporting documentation, where applicable, will take effect January 25, 2022 for Other Support. The University will be implementing new procedures in order to meet these requirements.

NIH is continuing to provide clarifications and guidance on these new requirements. For this reason, we may have additional information as we get closer to the January 25, 2022 effective date, and you may wish to register for multiple sessions to stay current on the latest information.

Schedule (click on the hyperlinks below to register, using a Columbia-affiliated email address.Other email addresses will be rejected):

If you have any questions about these webinars, feel free to contact me at [email protected].

With the NIH application due dates approaching in late September and early October, we wanted to take this opportunity to remind the research community of the latest required researcher disclosure requirements in proposals:

Biographical Sketch (“Biosketch”) –

  • The newest Biosketch format is preferred immediately and required to be used for applications and Research Performance Progress Reports (RPPRs) submitted on or after January 25, 2022 (NOT-OD-21-073 and NOT-OD-21-110).
  • The Positions, Scientific Appointments and Honors section of the Biosketch must include, in reverse chronological order, all current positions and scientific appointments both domestic and foreign, including affiliations with foreign entities or governments. This includes titled academic, professional, or institutional appointments whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).
  • Regardless of whether you use the old or new formats, only current positions and scientific appointments are required in the Biosketch. Applicants may choose to include past appointments that they wish to highlight.
  • The Personal Statement may now include including ongoing and completed research projects from the past three years that you want to draw attention to (previously captured under Section D. Research Support).
  • Biosketches can be created using SciENcv, or using NIH’s blank format page in Word.
  • If you forgot to include an item in the Biosketch after submission, contact your SPA Project Officer as soon as possible.
  • Refer to NIH’s Biosketch FAQs, Columbia’s supplementary FAQs, and contact your SPA Project Officer should you have any questions.

Disclosing a Foreign Component

  • If any significant scientific element or segment of your project will be performed outside the United States, either by you or by a researcher employed by a foreign organization, whether or not grant funds will be expended, your project has a “foreign component” that requires disclosure and prior approval by NIH.  See NIH’s full definition of Foreign Component.
  • You must answer Field 6 of the Research and Related (R&R) Other Project Information form to indicate whether your project involves activities outside the U.S. or partnerships with international collaborators.
  • If you indicate “Yes” to Field 6, you must include a "Foreign Justification" attachment in Field 12, Other Attachments.
  • If a project develops a foreign component during the course of the project, prior approval must be obtained. Contact your SPA Project Officer in this situation.
  • See NIH’s Foreign Component FAQs.

We will be hosting several webinars in the coming months to provide the latest information on Biosketches and Other Support. Stay tuned for a subsequent announcement.

As always, all questions should be directed to your SPA Project Officer.

Sponsored Projects Administration (SPA) invites you to our next Research Administration Forum. The Forum is an interactive opportunity for you to hear the latest policy updates from central Columbia offices, and ask questions concerning the sponsored project lifecycle.

We are excited to introduce you to Dr. Jeannette M. Wing, the newly appointed Executive Vice President for Research, who will kick off our meeting. Jeannette will speak briefly about her background, and strategic ideas in her new role as EVPR.

Also included on the agenda will be the latest updates concerning NSF and NIH. A more detailed agenda will be issued as we get closer to the event. Registration is now open!

Date: Wednesday, October 13th, 2021

Time: 11:00 am  - 12:30 pm EDT

RegisterHERE.

Feel free to ask me any questions about this event at [email protected].

The NIH Loan Repayment Program (LRP) is now accepting applications throughNovember 18, 2021. Awardees can receive up to $100,000 of qualified educational debt repayment with a two-year contract. This includes most undergraduate, graduate, and medical school loans. Loan repayment benefits are in addition to the institutional salary received for research. LRP awards are based on an applicant's potential to build and sustain a research career.

It is important to review the LRP eligibility criteria, and reach out to the LRP Information Center or LRP Liaison directly if you have any questions about eligibility or the various LRP Extramural Programs.

New This Year - ASSIST:

The NIH LRP application is now part of the Application Submission System & Interface for Submission Tracking (ASSIST) system. To access ASSIST an eRA commons ID is required. You will not be able to start or submit an LRP application without an eRA commons ID. If you do not have an eRA commons ID, contact [email protected].

Read the LRP Application Guide in its entirety, and watch the 11-minute LRP application video, prior to starting the application. Note you will not need to create a Rascal Proposal Tracking Sheet. Although applications are now submitted through ASSIST, the process itself is the same as prior cycles: the applicant creates and submits the application online and adds the appropriate Institutional Business Official (IBO) in the system using the IBO’s eRA Commons ID. William Berger is the IBO for both Columbia University’s Morningside and Irving Medical Center campuses. Contact him directly at [email protected] to obtain the appropriate NIH eRA Commons ID.

PLEASE NOTE: For NYSPI/RFMH please contact Simone Roberts ([email protected]) and Steve Valdez ([email protected]) for NYSPI/RFMH specific instructions.

New Extramural LRP Subcategory

There is a new subcategory for the Extramural LRP called Research in Emerging Areas Critical to Human Health (REACH). The REACH subcategory is designed for investigators pursuing major opportunities or gaps in emerging high-priority research areas, as defined by NIH Institutes and Centers. REACH will provide new LRP funding opportunities for those applicants who do not meet research eligibility requirements for any of the existing Extramural LRP subcategories. Please review the REACH Priority Statements list for information on each IC-specified area that is considered an emerging and/or a gap area. We strongly encourage applicants to discuss their career interests with an NIH Institute or Center scientific liaison before applying to REACH.

Checklist for applying:

For general questions, reach out to NIH LRP at (866) 849-4047 or [email protected].

NIH recently released new clarifications for the Other Support format pages and Biographical Sketches. Key clarifications include:

  • Signatures are not required on the Other Support format pages until January 25, 2022, regardless of whether you use the old or new formats.
  • Completed support from the last three years is no longer required in Other Support. Only include active and pending projects.
  • Awardees must report significant changes in Other Support in RPPRs, such as a change in status of previously reported current or pending projects, or access to a new resource/in-kind contribution.
  • Only unique, high-value materials and data received within the past three years, that are still in use, must be included as in-kind contributions in Other Support.
  • Only current positions and scientific appointments are required in the Biosketch. Applicants may choose to include past appointments that they wish to highlight.
  • Consulting agreements must be included in Other Support only when the PD/PI or other senior/key personnel will be conducting research as part of the consulting activities. Non-research consulting activities are not Other Support.
    • Include estimates for the amount paid, rather than time and effort reflected in calendar months, for consulting that is disclosed in Other Support.
  • Rather than simply updating a previously submitted Other Support form, we strongly recommend that you create a new form from scratch, to ensure that you are able to implement all changes.

To assist you further, we created additional FAQs based on questions collected from researchers and administrators at Columbia University. They are meant to supplement NIH's FAQs. In addition, we will be hosting monthly webinars to walk you through the forms. Stay tuned for a separate communication with the webinar schedule.

All questions should be directed to your SPA Project Officer. Below is a listing of applicable resources:

NIH’s FAQs and Instructions:

Columbia resources:

The National Institutes of Health (NIH) released six separate program announcements for the 2022 application cycle of the NIH Loan Repayment Program (LRP).  The LRP may repay up to $50,000 of qualified student loan debt per year to outstanding health professionals who commit at least two years to conduct biomedical, behavioral, social, or clinical research, and who agree to engage in such research for an average of at least 20 hours per week based on a 40-hour work week. This includes most undergraduate, graduate, and medical school loans. Loan repayment benefits are in addition to the institutional salary received for research. LRP awards are based on an applicant's potential to build and sustain a research career.

NEW – the application process is different this year! All applications must be submitted through the Application Submission System & Interface for Submission Tracking (ASSIST), and not the LRP website. We will provide more explicit instructions on how to apply through ASSIST as it becomes available. ASSIST will begin accepting applications on September 1st, 2021 through November 18, 2021, 8pm EST.

Potential applicants should carefully read the general eligibility requirements, plus the eligibility requirements and application instructions under each funding announcement. Questions concerning eligibility should be discussed with NIH staff. Find the appropriate contact at the Contact and Engage page.

The six program announcements are:

  • NOT-OD-21-139 – LRP for Clinical Researchers (LRP-CR)
  • NOT-OD-21-140 – LRP for Pediatric Research (LRP-PR)
  • NOT-OD-21-141 – LRP for Health Disparities Research (LRP-HDR)
  • NOT-OD-21-142 – Clinical Research LRP for Individuals from Disadvantaged Backgrounds (LRP-IDB)
  • NOT-OD-21-143 – LRP for Contraception and Infertility Research (LRP-CIR)
  • NOT-OD-21-144 – LRP for Research in Emerging Areas Critical to Human Health (LRP-REACH) - NEW

Please note: Recipients of Ruth L. Kirschstein National Research Service Award (NRSA) support from an individual postdoctoral fellowship (F32) or an institutional research training grant (T32) will be eligible for loan repayment during the second year of NRSA support if a formal extension of the NRSA service payback is granted (see NIH Training Payback).  Concurrent fulfillment of LRP and NRSA service obligations is prohibited. You must request a deferral of NRSA payback service prior to acceptance into the LRP. A deferral form can be obtained by contacting the LRP Help Line at 866-849-4047.  It is important to note, though, that NRSA recipients may continue to receive their stipends from the NRSA.

All general questions should be directed to the LRP Information Center at (866) 849-4047 or [email protected].

The following FAQs related to the NIH Other Support format pages were collected from researchers and administrators at Columbia University. See https://research.columbia.edu/FAQs_NIH_OtherSupport. They are meant to supplement NIH's FAQs. Please refer to NIH’s websites for additional information and guidance on this topic:

Should you have any questions, please feel free to reach out to your SPA Project Officer.

The following announcement was issued by NSF on 6/23/2021. Questions should be sent to your SPA Project Officer.


Dear Colleagues:

We are pleased to announce that a revised version of the NSF Proposal & Award Policies & Procedures Guide (PAPPG) (NSF 22-1) has been issued.

The new PAPPG will be effective for proposals submitted or due on or after October 4, 2021. Significant changes include:

  • A new section covering requests for reasonable and accessibility accommodations regarding the proposal process or requests for accessibility accommodations to access NSF’s electronic systems, websites and other digital content;
  • A table entitled, NSF Pre-award and Post-award Disclosures Relating to the Biographical Sketch and Current and Pending Support. This table identifies where pre- and post-award current and pending support disclosure information must be provided. Proposers and awardees may begin using this table immediately;
  • Increasing the page limit for the biographical sketch from two to three pages;
  • Updates to the current and pending support section of NSF proposals to require that information on objectives and overlap with other projects is provided to help NSF and reviewers assess overlap/duplication;
  • Adding planning proposals and Career-Life Balance supplemental funding requests as new proposal types;
  • Updates to travel proposals will require that AORs certify that prior to the proposer’s participation in the meeting for which NSF travel support is being requested, the proposer will assure that the meeting organizer has a written policy or code-of-conduct addressing harassment.

You are encouraged to review the by-chapter summary of changes provided in the Introduction section of the PAPPG.

NSF plans to conduct a webinar covering these changes. Visit the NSF policy outreach website to sign up for notifications about this and other outreach events.

While this version of the PAPPG becomes effective on October 4, 2021, in the interim, the guidelines contained in the current PAPPG (NSF 20-1) continue to apply. 

If you have any questions regarding these changes, please contact the DIAS/Policy Office at [email protected].

Regards,

Jean Feldman
Head, Policy Office
Division of Institution and Award Support
Office of Budget, Finance & Award Management

The slides from today’s town hall on the revised NIH other support format pages are available here (included in the NIH Researcher Disclosure Requirements webpage).

Key takeaways:

  • You may continue to use the current biosketch and other support format pages, however, the new formats will be required for applications, JIT requests, and RPPRs due on or after 1/25/2022.
  • Regardless of which format you use, applicants and recipients remain responsible for disclosing all research endeavors.
  • Other Support: As a reminder (see NIH announcement NOT-OD-19-114, July 10, 2019), regardless of the format used, you must ensure to include: completed projects (past three years); consulting that involves the conduct of research; and in-kind contributions.

We will continue to schedule future town halls and develop tools to assist you. For immediate questions, please contact your SPA Project Officer.

The slides from today’s town hall on the revised NIH biographical sketches and other support format pages are available here (included in the NIH Researcher Disclosure Requirements webpage). For those of you who attended previous town halls, minor revisions were made to the slides to reflect the latest information from NIH, issued after last week’s May 5 town hall. This latest slide deck should be used regardless of which session you may have attended in the past.

Key takeaways:

  • You may continue to use the current biosketch and other support format pages, however, the new formats will be required for applications, JIT requests, and RPPRs due on or after 1/25/2022.
  • Regardless of which format you use, applicants and recipients remain responsible for disclosing all research endeavors.
  • Other Support: As a reminder (see NIH announcement NOT-OD-19-114, July 10, 2019), regardless of the format used, you must ensure to include: completed projects (past three years); consulting that involves the conduct of research; and in-kind contributions.

Another town hall focusing on the NIH Other Support format pages is scheduled for Wednesday, May 19, 11:00 am – 12:30 pm (can register using a Columbia-affiliated email address). We will continue to schedule future town halls and develop tools to assist you. For immediate questions, please contact your SPA Project Officer.

Tomorrow we’ll be resuming our town halls on the new NIH biosketches and other support format pages. We will provide the latest information and guidance.

We added another session to cover both the biosketches and other support forms on Monday, May 10, from 10am – 11:30am (see schedule below). This will be a shortened version covering both topics. In addition, we will have pre-recorded videos available later in the month.

You can register for any of the sessions below using a Columbia-affiliated email address. If you have immediate questions about the forms, please contact your SPA Project Officer. You can send policy-related questions to me prior to the webinars, and to assist us in the creation of FAQs.

Webinars

Changes to the NIH Biosketch

Wednesday, May 5, 11:00 am – 12:00 pm

NIH Other Support Format Pages

Wednesday, May 5, 12:30 pm – 2:00 pm

NEW – both Biosketch and Other Support

Monday, May 10, 10:00 am – 11:30 am

NIH Other Support Format Pages

Wednesday, May 19, 11:00 am – 12:30 pm

Resources:

NIH has issued a follow-up notice to NOT-OD-21-073 on the upcoming changes to the biographical sketch and other support format pages. Per the new announcement NOT-OD-21-110, “NIH expects* applicants and recipients to use the updated biosketch and other support format for applications, Just-in-Time (JIT) Reports, and Research Performance Progress Reports (RPPRs) as of May 25, 2021. NIH will require* the use of the updated format pages for the previously mentioned submissions for anything on and after January 25, 2022.”
*emphasis added.

In addition, NIH states:

“Please note, applicants and recipients remain responsible for disclosing all research endeavors regardless of the version of the forms used. Therefore, if applicants and recipients choose not to use the updated format pages before they are required, applicants and recipients must still capture all the necessary information.”

As of this most recent Notice, NIH has not specified a limited lookback period for disclosures under Section B of the biographical sketch, “Positions, Scientific Appointments and Honors. As we have previously advised, for biographical sketches being submitted with NIH institutional training grants due May 25, if you are pressed for space, we encourage you to prioritize disclosure of Scientific Appointments held during the last three years, both domestic and foreign, including any affiliations with foreign entities or governments.  A scientific appointment can include participation in study sections, membership in a scientific society, board membership, and some consulting appointments.

All positions, however, should be included. This includes employment history or any kind of institutional appointment, whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).

We will resume our webinars to train on the new biosketches and other support format pages. You can register below using a Columbia-affiliated email address.  Additional webinars are being scheduled now, and we will send a separate email once the schedule is finalized. If you have immediate questions about the forms, please contact your SPA Project Officer. You can send policy-related questions to me at prior to the webinars at [email protected], and to assist us in the creation of FAQs.

Webinars:

Changes to the NIH Biosketch

Wednesday, May 5, 11:00 am – 12:00 pm

NIH Other Support Format Pages

Wednesday, May 5, 12:30 pm – 2:00 pm

NIH Other Support Format Pages

Wednesday, May 19, 11:00 am – 12:30 pm

Resources:

NIH announced the publication of the revised NIH Grants Policy Statement (NIHGPS, rev. April 2021). See:

Per NIH’s announcement, “This revision is applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2020. This revision supersedes, in its entirety, the NIHGPS dated December 2019. Previous versions of the NIHGPS remain applicable as standard terms and conditions of award for all NIH grants and cooperative agreements with budget periods that began prior to October 1, 2020.”

For more information about these changes, see NIH’s full announcement at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-107.html.

As always, contact your SPA Project Officer should you have any NIH policy-related questions.