Announcements

New Research Integrity Resources and Reminders

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:

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

 

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Archived Announcements

Want to learn about the new NIH PHS Human Subjects and Clinical Trials Information Form, now required in FORMS-E? We'll be conducting informal webinars to help you become familiar with the form in preparation for NIH applications due on or after January 25th, 2018.

These sessions are open to both faculty and grants administrators wanting to learn more about the form. It doesn’t matter if you use ASSIST or PD in InfoEd to participate in these calls.

Here are the dates. You can register with your UNI and password within each link, and you’ll receive confirmation via email with the ZOOM webinar link and call-in information:

Once we hit the new year, there will be more training opportunities. When we have those dates set we will let you know!

NIH will make the Project Outcomes Section of all Interim and Final RPPRs submitted on or after October 1, 2017 available to the general public via the NIH RePORTER. See notice NOT-OD-18-103.

You should also read Mike Lauer’s Blog, Why Project Outcomes Matter in your Interim and Final RPPR, which provides helpful tips on writing this section for the general public.

Per the notice, this allows recipients of NIH funds “to provide the general public with a concise summary of the cumulative outcomes or findings of the project (analogous to the Project Summary/Abstract section of the competing application) at the end of each competitive segment.”

Extremely important to note:

“The NIH will only publish project outcomes that have been reviewed and approved by NIH staff to ensure the narrative is written for the general public in clear and comprehensible language, without including any proprietary, confidential information or trade secrets. If the description of the project outcomes are found to be unacceptable, recipients will be required upon NIH request to submit revised project outcomes statements using the Additional Material functionality in place for the Final and Interim RPPR (i.e., Final Report Additional Materials (FRAM) for Final RPPR). The Additional Material functionality for both the Final and Interim RPPR have been enhanced in order to capture revised project outcomes in a web form format that will support NIHs ability to make this information publically available. Please note that the web form data entry field pertains only to the entry of Project Outcomes text. Any other additional materials requested, if applicable, should be uploaded as a file attachment. In order to assist recipients, NIH has posted sample descriptions for project outcomes that may assist recipients in submitting acceptable project outcomes. See the Sample Project Outcomes description available at: https://grants.nih.gov/grants/rppr/sample_project_outcomes_RPPR.htm.”

For more information on RPPRs and the Project Outcomes section, see their FAQs. As always, contact your SPA Project Officer with any questions.

The National Institutes of Health (NIH) has started the process of posting Parent Funding Opportunity Announcements (FOAs) with the new FORMS-E packages. This process will continue throughout November. Note that the new Parent FOAs with FORMS-E released at this time have been labeled as either “Clinical Trial Required” or “Clinical Trial Not Allowed.”

Please ensure you proceed as follows:

  1. Determine if your project meets the NIH definition of a clinical trial.
  2. Select the appropriate FOA.
    1. See NIH’s Plan for Clinical Trial Specific Parent R01 and Parent R21 FOAs.
    2. See Clinical Trials: Special Considerations for Career Development, Fellowship, Training, and Research Education Programs.
  3. Ensure you are using FORMS-E for NIH Proposals due on or after January 25, 2018.

Due to the complexity of the FORMS-E, we strongly suggest that you submit your proposals early and encourage submission five business days prior to the NIH deadline.

Additionally, please communicate your plans to submit NIH proposals to your administrator and your SPA Project Officer as soon as possible.

We will continue to provide updates throughout this critical transition. If you have any questions or need additional information please contact your SPA Project Officer.

The following notice came directly from the National Science Foundation (NSF), and is quoted below.

Dear Colleagues:

We are pleased to announce that a revised version of the NSF Proposal & Award Policies & Procedures Guide (PAPPG), (NSF 18-1) has been issued.

A webinar to brief the community on the new PAPPG will be held on December 8 at 2 PM EST. Registration is now available at: https://nsfgrantsconferences.com/pappg-update-webinar/

The new PAPPG will be effective for proposals submitted, or due, on or after January 29, 2018. Significant changes include:

  • Addition of a new eligibility subcategory on international branch campuses of U.S. Institutions of Higher Education;
  • Revision of eligibility standards for foreign organizations;
  • Implementation of the standard Collaborators and Other Affiliations (COA) template that has been in pilot phase since April;
  • Increase in the Budget Justification page limitation from three pages to five pages;
  • Restructuring of coverage on grantee notifications to and requests for approval from NSF, including referral to the Prior Approval Matrix available on the NSF website; 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.

While this version of the PAPPG becomes effective on January 29, 2018, in the interim, the guidelines contained in the current PAPPG (NSF 17-1) 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.

If you have any questions regarding these changes, please contact the Policy Office at (703) 292-8243 or by e-mail [email protected].

Regards,

The National Science Foundation

The National Institutes of Health (NIH) recently released several announcements concerning policy changes impacting studies involving human subjects, in particular those studies meeting the NIH definition of a clinical trial. Some of these changes have been announced previously. The information we’re receiving on these policies is evolving and dynamic.

This communication serves to provide you with the available resources that exist at this time, with emphasis on the definition of a clinical trial, and to identify items for you to consider throughout the sponsored projects lifecycle. Our offices will continue to monitor NIH’s updates, and we’ll communicate them to you.

NIH has several resources to familiarize you with all the policy changes.

NIH Resources

 

Items For You To Consider, or to Take Action Upon, Throughout the Sponsored Projects Lifecycle

Proposal Development Stage:

  • Correctly identify whether your study meets NIH’s definition of a clinical trial during proposal development. Use the decision tree and FAQs included in this link to help you determine if your study meets the criteria. Talk with an NIH Program Official if unsure.
  • All clinical trial applications must be submitted to a Funding Opportunity Announcement (FOA) that allows clinical trials, effective with due dates on or after January 25, 2018. The FOA must explicitly state that it will accept clinical trials. NIH will no longer accept clinical trial applications through existing parent announcements. Applicants should check the online version of the FOA within 8 weeks of the due date to ensure it is still appropriate for their application.
    • Verify by reading Section II. Award Information in the FOA.
    • New FOAs will verify this in the title.
  • We suggest talking to the Program Official listed as a contact on the designated FOA to ensure your project meets the definition of a clinical trial. Get confirmation in writing via email. Reference the name of the individual who confirmed eligibility in the proposal cover letter.
  • Read the FOA very carefully for additional criteria to be included in clinical trial proposals.
  • Consider the NIH Single Institutional Review Board (sIRB) Policy. Applicants will be expected to include a plan for the use of a sIRB in the grant applications and contract proposals they submit to the NIH for due dates on or after January 25, 2018. More information to come concerning Columbia’s implementation of this Policy.
  • Become familiar with the new PHS Human Subjects and Clinical Trials Information Form, required with the new FORMS-E grant application packages due on or after January 25th, 2018.

If Proposal is Awarded:

Several offices under the purview of the Executive Vice President for Research (EVPR) plan to provide you with more detailed guidance on upcoming changes, in particular related to Columbia’s implementation of the sIRB policy. In the interim, the following chart provides the main points of contacts for each area of these policy changes:

This is copied from NIH notice NOT-OD-17-120:

Purpose

The NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research becomes effective for applications with due dates of January 25, 2018 and after. Are you ready? Would you like to learn more about the implementation of the NIH Single IRB Policy, how to write your single IRB plan, and receive guidance on how to effectively request an exception to the policy directly from NIH experts? If so, then make plans to join the experts from NIH Extramural Staff for a webinar on scope and applicability and the NIH Single IRB policy.

This webinar will cover the following topics and more related to the NIH Single IRB policy:

  • Background
  • Implementation process
  • Expectations
  • Process to request exceptions to the policy
  • Responsibilities of the single IRB, local IRB, the investigator, and the institutions in implementing the NIH single IRB policy

NIH Presents: sIRB & the Exceptions Process Webinar
Wednesday, October 18, 2017
2:00pm - 3:30pm ET

Registration Link: https://attendee.gotowebinar.com/register/7756095045402039297
Note: This webinar is limited to 1000 seats and is on a first come basis. We highly recommend group viewing to maximize access.

Who should attend? This webinar is designed for principal investigators, signing officials, research organizations or institutions, and institutional review boards (IRBs).

Presented by:
NIH Extramural Staff

Do you have specific questions or topics you'd like covered? Submit questions in advance to single IRB policy to Petrice Brown-Longenecker, Ph.D. by October 10, 2017. These questions will help in building presentation content and ensure we're providing the answers you need.

Where can you go now for helpful pre-webinar info?

*The recording and transcript will be available 5-7 business days following the event on www.YouTube.com/NIHgrants.

Inquiries

Advance single IRB questions by Oct. 10 to: [email protected].

For registration or GoToMeeting software issues: [email protected]

The following NIH announcement was released yesterday. Please review in its entirety:

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-119.html

The announcement provides you with a summary of the major changes in the upcoming FORMS-E application packages, most notably the new PHS Human Subjects & Clinical Trials Information Form. A video is available to walk you through this form. You can also look at the Annotated Forms-E Set to preview the full set of forms. Subsequent communications will be sent to you regarding the new NIH policies related to clinical trials in order to prepare you for application submissions due on or after January 25th, 2018.

NIH is getting ready to release its new FORMS-E application packages. Yesterday, the instructions for FORMS-E were released online. However, the application packages themselves are not yet available. NIH will be reissuing all their parent announcements with new Funding Opportunity Announcements (FOA) numbers, beginning October 25th, 2017. The process of reissuing FOAs to include FORMS-E packages will happen incrementally throughout October 25th – November 25th. All new application packages will be published at least 60 days ahead of the first due dates.

Applicants must use FORMS-E for due dates on or after January 25th, 2018. Therefore, there will be a period of transition where you must make sure you are using the correct application package based on the due date of the funding opportunity. Below is a chart from NIH which describes when you need to use FORMS-D vs FORMS-E.

NIH just released the following announcement: NOT-OD-17-114

The notice states that between now and October 6th, 2017, they will be updating the text to existing funding opportunity announcements (FOAs) to prepare for application form and policy changes impacting applications for due dates on or after January 25th, 2018. They emphasize “This notice does NOT introduce any new policies. We are simply updating FOA text to align with existing policy.”

They are editing FOA text for all active FOAs, EXCEPT the Parent Announcements (they will be reissued later on with new FOA #s), and the FOAs that will allow applications proposing clinical trials (also to be reissued later on with new FOA #s) for due dates on or after January 25th, 2018.

To view the text changes, by grant type, see:

This notice is just one of several expected related to the rollout of the new FORMS-E packages. The reissuing of the Parent Announcements and FOAs allowing for clinical trials will happen in phases. There will be a period of transition between October and November. We will keep you posted of all these developments.

I remind the research and grants administrators of our upcoming Research Administration Forums, taking place on October 19th, where we will review these forms and policy changes in person.

Expect further communications from our office related to applications proposing clinical trials soon. As always, feel free to reach out to your assigned SPA Project Officer with questions.

NIH will be hosting a webinar on the three types of Research Performance Progress Reports (RPPRs). Registration is required.

It is intended for PIs, grants administrators, and SPA.

Naomi Schrag, Vice President for Research Compliance, Training, and Policy, and G. Michael Purdy, Executive Vice President for Research, authored an article entitled, "Step up for quality research," Science, 11 Aug 2017, pp. 531.

"In response to calls for change from within and outside the scientific community, funding agencies, journals, and professional societies are developing new requirements to promote reproducibility and integrity in research..." Continue reading...

We wanted to pass along this proposal applicant training/workshop opportunity, taking place in Arlington, Virginia from September 10th – September 12th. It’s an opportunity to meet with the Patient-Centered Outcomes Research Institute (PCORI) staff and learn about their funding opportunities and application process. It is open for both researchers and administrators.

See https://www.pcori.org/events/2017/getting-know-pcori-application-closeout-september-2017 for all the details, agenda, and registration information.

Per NIH Notice NOT-OD-17-098: “This Notice alerts the scientific research community of plans to eliminate Appendix materials related to clinical trials for applications submitted to the NIH, AHRQ, or NIOSH for due dates on or after January 25, 2018. Clinical trial-related materials will be specified and required in the new PHS Human Subjects and Clinical Trials Information Form and no longer allowed in the Appendix unless specifically stated as required in the funding opportunity announcement (FOA). This Notice clarifies the types of Appendix materials allowable after this date.”

Also note, “Applications submitted for due dates on or after January 25, 2018 will be withdrawn as noncompliant if they are submitted with Appendix materials that are not specified in this Notice or specified in the individual FOA as allowed or required."

See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-098.html for the full announcement and a listing of the only allowable Appendix materials.

This coincides with the required use of FORMS-E, to be released later this fall. You can preview the new form set, including a walk-through video of the new PHS Human Subjects and Clinical Trials Information Form, at https://grants.nih.gov/grants/how-to-apply-application-guide/resources/annotated-form-sets.htm.

We will provide further updates as I receive them prior to the release of the new form set.

NIH just released an announcement that for federal fiscal year FY 2017 (October 1, 2016 - September 30, 2017), awards for predoctoral trainees and fellows will be adjusted for the new stipend level of $23,844, up from $23,376 from FY16. Training Related Expenses and Institutional Allowances for predocs remain unchanged at $4,200. All FY 2017 awards previously issued using FY 2016 stipend levels will be adjusted by NIH with revised NOAs with the new stipend level.

Please see NOT-OD-17-084 for the full details of this announcement.

The FY 2017 stipend levels for postdoctoral trainees and fellows was issued on December 15, 2016:NOT-OD-17-003.

Please let me, or your SPA Project Officer, know if you have any questions.

-------------------------------------------------------

Stephanie F. Scott, MS, CRA

Communications and Outreach Director

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-074.html

NIH released a reminder announcement today about the importance of accurate and timely progress reports, and financial reports. The notice reminds award recipients of the due dates. Please take a moment to review the link above.

NIH and AHRQ just announced that they will issue new “FORMS-E” grant application forms and instructions for grant applications due on or after January 25th, 2018.