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.
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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.”
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:
- Determine if your project meets the NIH definition of a clinical trial.
- Select the appropriate FOA.
- 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.
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 firstname.lastname@example.org.
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.
- Training Resources: includes summary presentations, videos, FAQs, and upcoming webinars.
- Clinical Trial Requirements for Grants and Contracts: includes the details of all the policy changes, including a decision tree for determining if your study is a clinical trial.
- Case Studies: examples of studies to help you decide if your study meets the definition of a clinical trial. This list is constantly being updated.
- Continuing to Clarify the NIH Definition of a Clinical Trial – blog from Dr. Mike Lauer, NIH's Deputy Director for Extramural Research.
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:
- All investigators and clinical research staff who work on NIH-funded clinical trials (funded in whole or in part) must complete Good Clinical Practice (GCP) Trainingevery three years. Register for training in Rascal, and view these instructions.
- All NIH-funded clinical trials initiated and awarded on or after January 18, 2017 must register and submit results in ClinicalTrials.gov. Seek assistance with registration from the Clinical Trials Office (CTO). The timeline for registering an applicable clinical trial in ClinicalTrials.gov is not later than 21 calendar days after the enrollment of the first participant. However, please refer to the Summary Table of HHS/NIH Initiatives and ICMJE Guidelines to Enhance Availability of Clinical Trial Information for more information about timelines.
- Submit summary results to ClinicalTrials.gov no later than one year after primary completion date.
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:
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:
- Implementation process
- 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).
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?
- NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
- Office of Science Policy (OSP)
- FAQs on implementation and cost
*The recording and transcript will be available 5-7 business days following the event on www.YouTube.com/NIHgrants.
Advance single IRB questions by Oct. 10 to: Petrice.Brown@nih.gov.
For registration or GoToMeeting software issues: OERwebinars@mail.nih.gov
The following NIH announcement was released yesterday. Please review in its entirety:
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.
The National Institutes of Health (NIH) will be hosting a webinar on the Loan Repayment Program (LRP). This is a technical assistance webinar for applicants to become familiar with the application submission process. You must register for this webinar in order to participate. Please do pass this information to anyone interesting in learning more about the LRP.
Date and Time: Wednesday, September 27, 2017 3:00 pm, EST
For more information about the LRP, see our website at https://research.columbia.edu/content/nih-loan-repayment-program-lrp.
See NIH’s website at https://www.lrp.nih.gov/.
The deadline for applications is November 15th, 2017!
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.
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.
The National Institutes of Health (NIH) released five separate program announcements for the 2018 application cycle of the NIH Loan Repayment Program (LRP). The LRP may repay up to $35,000 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.
The five program announcements are:
- NOT-OD-17-077 – LRP for Clinical Researchers (LRP-CR)
- NOT-OD-17-078 – LRP for Pediatric Research (LRP-PR)
- NOT-OD-17-079 – LRP for Contraception and Infertility Research (LRP-CIR)
- NOT-OD-17-080 – LRP for Health Disparities Research (LRP-HDR)
- NOT-OD-17-081 – LRP for Individuals from Disadvantaged Backgrounds (LRP-IDB)
The NIH will begin accepting applications on September 1, 2017. Applications are limited to one per year. The deadline for applications is November 15th, 2017, 8pm EST. Potential applicants should carefully read the general eligibility requirements, plus the requirements under each funding announcement. Questions concerning eligibility should be discussed with NIH staff. Find the appropriate contact at the Contact and Engage page.
Applications are submitted via the LRP website at https://www.lrp.nih.gov/apply. The system will not accept applications until September 1st. For applicants paid through Columbia University, Columbia University should be listed as their institution. William Berger is the Institutional Approver at Columbia for LRP at email@example.com.
Applicants who are paid through Research Foundation for Mental Hygiene, Inc. (RFMH) are to enter RFMH as their institution (NOT Columbia or NYSPI). Please contact Simone Roberts (firstname.lastname@example.org) for information on the Institutional Approver.
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 applications must be completed and submitted online at https://www.lrp.nih.gov/.
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
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.