Announcements

Human Subjects and Clinical Trials: A Summary of Policies Impacting NIH-Funded Studies

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:

October 10, 2017

Human Subjects and Clinical Trials: A Summary of Policies Impacting NIH-Funded Studies

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.

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Archived Announcements

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.

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:

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 wb2174@columbia.edu.

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 (simone.roberts@nyspi.columbia.edu) 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.

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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.

The Department of Defense (DoD) recently released Fiscal Year 2017 (FY17) funding opportunities managed by the office of Congressionally Directed Medical Research Programs (CDMRP).

Please refer to the Electronic Informed Consent guidance when needed.

Please see the IRB meeting schedules for IRB CUMC 1-5 and Morningside for 2017.

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.

On Friday, March 17th, NIH issued interim guidance on the use of a new NIH salary cap, to increase from $185,100 to $187,000. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-049.html. The effective date of this increase is January 8th, 2017.

NSF updated its FAQs on its Public Access Policy.

Refer to Public Access to Results of NSF-funded Research for full details about the policy.

NIH announced their plans for the implementation of the Interim-RPPR.