NASA Adopts New Policy for No-Cost Extensions

NASA has significantly changed the process for submitting no-cost extension requests under grants and cooperative agreements. These new rules are in effect now and are being enforced:

• Requests must be submitted within a 20-day time window, no earlier than 30 days and no later than 10 days prior to the last day of the period of performance.
• An annual progress report must be attached. The NASA Shared Services Center’s on-line no-cost extension request web form will not allow the request to be submitted without the report. The submitter must also certify that the progress report is current and that the request is being sent within the last 30 days of the period of performance.

The web form still offers a standard rationale for use with a first no-cost extension request, and a window for entering a longer explanation for needing a second or third request.

These new requirements, and the fact that they are electronically enforced, mean that it will be essential for investigators and administrators to monitor the remaining balances of their NASA awards carefully.

Images in NIH Applications and Formatting Guidance

Reminder: Images in National Institutes of Health applications can only be used in the Research Strategy section.

NIH provides guidance on the Format Attachments page that is linked through the SF 424.

• Digital images of material such as electron micrographs or gels must only be included within the page limits of the Research Strategy. The maximum size of images to be included should be approximately 1200 X 1500 pixels using 256 colors. Figures must be readable as printed on an 8.5” x 11” page at normal scale.
• Investigators must use image compression such as JPEG or PNG. Do not include figures or photographs as separate attachments either as an Appendix or elsewhere in the application.

See the Format Attachments page for other important formatting information.

NSF Newsletter for August/September 2017

The National Science Foundation has published the August/September 2017 issue of the NSF Proposal & Award Policy Newsletter.

Contents:

• PAPPG – Proposed Significant Changes
• The Newly Revised Common Rule for the Protection of Human Subjects
• Faculty Salary Policy – The Two Month Rule
• Collaborators and Other Affiliations Pilot – FAQs
• Project Reporting Policies and Reminders
• Upcoming Outreach
• NSF is Moving!

NIH Human Subjects: New Policies and Forms Required January 25, 2018

Michael S. Lauer, MD, Deputy Director for Extramural Research, National Institutes of Health, sent the following message to NIH grant applicants/awardees, contractors, researchers and research administrators.

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If you are conducting NIH-funded research that involves human subjects, or are considering applying to NIH for support of such research, we want to call your attention to important changes that may affect how you:

• select the right NIH funding opportunity announcement
• write the research strategy and human subjects sections of your application
• comply with appropriate policies and regulations

First, familiarize yourself with the new PHS Human Subject and Clinical Trial Information form.
For application due dates of January 25, 2018, and beyond, you will be required to use an updated application forms package (FORMS-E), which includes the new human subject and clinical trial form. This form requests human subject and clinical trials information at the study level using discrete form fields, which is a change from current practice. Contract proposals will also require this information. Learn about the new form here.

Second, take a moment to answer these four questions about your current or proposed research:

1. Does the study involve human participants?
2. Are the participants prospectively assigned to an intervention?
3. Is the study designed to evaluate the effect of the intervention on the participants?
4. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is yes, then your proposed research meets the NIH definition of a clinical trial. Clarified and broadened in 2014, the definition encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. NIH expanded the clinical trial definition in response to widespread calls from diverse stakeholders for improved reporting of research milestones and outcomes, and for assuring maximal transparency.

Need help determining whether your study would be considered by NIH to be a clinical trial? See our webpage on the definition that includes case studies, FAQs and other resources that can help. Still unsure?  Contact your NIH program official or the scientific point of contact listed on the funding opportunity announcement to which you are applying.

Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials.
NIH made a number of policy changes to improve the stewardship of clinical trials across the life cycle of the trial. We encourage you to familiarize yourself with all that is changing, including:

• the requirement to apply to an FOA that specifically allows for the submission of clinical trial applications for due dates beginning January 25, 2018.
• Good Clinical Practice training expectations for NIH staff, grantees, and contractors that went into effect January 2017.
• updated peer review criteria that will be included in FOAs for clinical trial applications and solicitations for due dates on/after January 25, 2018.
• new Human Subject Information form requirements for clinical trials that will be included in updated application forms (FORMS-E) for due dates on/after January 25, 2018, and contract solicitations published as of January 25, 2018.
• use of a single IRB for non-exempt, multi-site clinical trials for application due dates on/after January 25, 2018.
• expanded ClinicalTrials.gov registration and reporting to include all NIH supported clinical trials.

Improving the design, efficiency, and transparency of clinical trials is important because it:

• respects our ethical obligation to participants to maximize the use of the knowledge from the trials in which they participate
• facilitates design of clinical trials while reducing unnecessary duplication
• promotes broad, timely, and responsible dissemination of research information and results
• fosters responsible stewardship of the public’s investment in biomedical research

We have developed a new Clinical Trial Requirements for NIH Grantees and Contractors web page to bring together all the information you need to know.  Please review this information carefully.  Your attention to detail will be critical to ensuring successful funding of your clinical trial awards.

We will be putting out a series of reminder policy notices, training opportunities, and other resources in the NIH Guide to Grants and Contracts, in the NIH Extramural Nexus, and on my blog.

The success of clinical trials relies on the public trust in scientific rigor and ethical oversight.  We all play a critical role in this process. We are most grateful to you for your help and support.

Grants.gov is Changing: Be Prepared

Grants.gov is changing!

The Grants.gov application package and the forms currently in use will be phased out after December 2017, and will be replaced by Grants.gov Workspace—a new way to create a federal grant application.

Federal agencies that previously required organizations and individuals to use Grants.gov to apply for federal funds in the past will require applications to be submitted via Workspace after the New Year.

Note: After the New Year, proposals to NSF still may be submitted using FastLane. NIH proposals still must be submitted via ASSIST. NASA proposals will continue to be submitted using NSPIRES.

What do PIs need to do now?

All that Principal Investgators (PIs) need to do now is register as an “Organization Applicant.”

To do this, the PI will need Berkeley’s DUNS number: 124726725. (Do not enter any dashes between numbers.) After registering, the PI should give their username to the campus Research Administrator (RA) who will be helping the PI with future Grants.gov applications in Workspace.

What do RAs need to do now?

Before an RA can help a PI with a future Grants.gov application in Workspace, the RA must obtain a “Manage Workspace Role.” To do this, the RA will need to register in Workspace as an Organization Applicant as described above, and SPO will need to approve the RA’s “Manage Workspace Role.”

All campus RAs planning to be involved in proposal development after the New Year should register in Workspace by September 15, 2017. SPO will approve the “Manage Workspace Role” for all campus RAs that have registered by this date.