August 16, 2017

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.

August 15, 2017

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!

August 14, 2017

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.

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.

August 11, 2017

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.

July 27, 2017

What SPO Requires: PHS FCOI

Proposals submitted to and awards funded by Public Health Service (PHS) sponsors (and sponsors that have adopted PHS financial conflict of interest (FCOI) regulations) must follow specific campus procedures to ensure UC Berkeley conforms to the PHS FCOI requirements.

Due to improvements brought about by the campus’ End-to-End (E2E) review of research administration services, these campus requirements recently have been streamlined, and the PHS FCOI Guide for CSS/Department Research Administrators and Principal Investigators on the SPO website has been updated to reflect these improvements.

Notable changes include:
  • Elimination of the need to submit a Form 5 for each subrecipient investigator at the proposal stage. Required information is now supplied by the subrecipient’s authorized official via the current Subrecipient Commitment Form.
  • Retirement of the PI Certification Form at the proposal stage and throughout the life of the award. The information on the PI Certification Form is now included in the Principal Investigator and Co-Investigator Certification provided on the PI and Co-PI approval screen in Phoebe Proposal Development.
Please note: Each time a PI/Co-PI approve a proposal in Phoebe that is being submitted to a PHS sponsor or a sponsor that has adopted PHS FCOI requirements, the PI and Co-PI are certifying and agreeing to the following:
  • All required PHS Financial Disclosures have been submitted to the Sponsored Projects Office (SPO).
  • I will submit a PHS disclosure form for all existing investigators annually and for any new UC Berkeley investigator I add to this project in the future before the investigator joins the project.
  • I will not use project funds to support any UC Berkeley investigator who makes a positive disclosure until the UC Berkeley Conflict of Interest (COI) Committee reviews and approves this disclosure.
  • I will not allow any UC Berkeley investigator to participate in this project until the investigator provides me with a certificate of completion of PHS-compliant training dated within the last four years.
  • I will maintain a file containing up to date certificates of PHS-compliant training for all UC Berkeley investigators for as long as each investigator is involved in the project and to make this information available to the UC Berkeley’s COI Coordinator upon request. PIs and Co-PIs always should make sure that have provided all required disclosures to SPO and that they understand these requirements before approving the proposal.

July 20, 2017

Reminder: Use of ASSIST for NIH Applications Required Now

Earlier this year, the Sponsored Projects Office and Campus Shared Services Research Administration agreed that all National Institutes of Health applications due after July 1, 2017 would be submitted using the NIH Application Submission System and Interface for Submission Tracking (ASSIST) instead of the Grants.gov system.

ASSIST allows for the identification of errors that could undermine the success of the application before submission to SPO.

This is a reminder that all NIH applications developed by Berkeley principal investigators now must be processed via ASSIST not Grants.gov.

Note: NIH proposals already in process as a Grants.gov application do not need to be modified.  However, after August 1, 2017, SPO will not accept any NIH application that was not processed using ASSIST.

July 11, 2017

Subrecipient Commitment Form for FDP Institutions

UC Berkeley is participating in a pilot program established by the Federal Demonstration Partnership (FDP) to test the efficacy and efficiency of using online organization profiles in lieu of subrecipient commitment forms to obtain information needed by pass-through entities when they are issuing subawards.

As a participant in this pilot program, UC Berkeley has agreed to use a modified subrecipient commitment form for subrecipients that are also participating in the FDP pilot.

To find out if a potential subrecipient is participating in the FDP pilot, Research Administrators should consult the master list of Participating Organizations on the FDP website and search for a specific institution.

Please note: Cohort 3 listed below has just been added to the list of participating institutions in the FDP pilot. Research Administrators still may submit the standard Subrecipient Commitment Form for any Cohort 3 institution that is “in progress” during this transition phase.

Cohort 3 (Added to the FDP Pilot July 7, 2017)
  • Ball State University (ERI)
  • Boston University (Charles River Campus)
  • Boston University (Medical Campus)
  • Bucknell University (ERI)
  • Charles Drew University of Medicine and Science (ERI)
  • Florida Atlantic University
  • Georgia Southern University Research and Service Foundation, Inc. (ERI)
  • Governors State University (ERI)
  • Loyola University, Chicago (ERI)
  • Michigan State University
  • Rensselaer Polytechnic Institute (RPI)
  • Saint Louis University
  • Southern Illinois University Edwardsville (ERI)
  • Texas A&M Engineering Experiment Station (TEES)
  • Texas A&M University
  • Tufts Medical Center, Inc.
  • University of Arizona
  • University of California, San Diego
  • University of California, Santa Cruz
  • University of Connecticut
  • University of New Mexico
  • University of Oklahoma
  • University of Pennsylvania
  • University of South Florida
  • University of Southern California
  • University of Texas at Arlington
  • University of Texas Health Sciences Center, Houston
  • University of Virginia
  • Virginia Commonwealth University
  • West Virginia University
  • West Virginia University Research Corporation
  • Wright State University

August 18, 2016 Research Advocate: New Process for Some Subrecipients: UCB Participating in FDP Pilot

June 12, 2017

NSF Websites Unavailable June 30-July 4

The National Science Foundation is moving its Data Center IT servers to the new NSF headquarters in Alexandria, Virginia, from June 30 at 8:00 PM EDT through July 4 at 6:00 PM EDT, to prepare for NSF staff relocation in August 2017.

The NSF website, FastLane, and Research.gov will be unavailable from Friday, June 30 at 8:00 PM EDT until Tuesday, July 4 at 6:00 PM EDT. During this outage period, there will be no access to these websites, proposals cannot be submitted in FastLane, and project reports and cash requests cannot be submitted in Research.gov. However, previously saved information and uploaded documents in FastLane and Research.gov, including in-process proposals and reports, will be accessible after the Data Center move.

For more information, see NSF Important Notice No. 139, National Science Foundation Headquarters Moving to Alexandria, Virginia.

June 08, 2017

NIH’s New Next Generation Researchers Initiative

The National Institutes of Health has launched the Next Generation Researchers Initiative to bolster support for early-stage and mid-career investigators to address longstanding challenges faced by researchers trying to embark upon and sustain independent research careers.

NIH will take a multi-pronged approach to increase the number of NIH-funded early-stage and mid-career investigators and stabilize the career trajectory of scientists by:
  • Further extending the payline for early stage investigators, with an aim of funding most applications that score in the top 25 percent
  • Providing additional support for mid-career investigators with ≤ 10 years as a principal investigator
    • Extending the payline for those about to lose all NIH funding
    • Identifying “rising stars” who are seeking support for their second RPG, but just missed the payline
NIH will also place greater emphasis on current NIH funding programs aimed at early-stage and mid-career investigators, such as:
  • NIH Common Fund’s New Innovator Awards
  • National Institute of General Medicine Sciences Maximizing Investigators’ Research Award (MIRA)
  • National Institute of Dental and Craniofacial Research Sustaining Outstanding Achievement in Research (SOAR) awards
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases Supplements to Advance Research (STAR) from Projects to Programs
  • Other special awards from specific institutes

June 02, 2017

NIH, AHRQ, and NIOSH: Updated Policies on Post-Submission Materials

The National Institutes of Health, Agency for Healthcare Research and Quality, and National Institute for Occupational Safety and Health have updated their policies for post-submission materials for applications submitted for due dates on or after September 25, 2017.

Post-submission materials are those submitted after submission of the grant application but prior to initial peer review. They are not intended to correct oversights or errors discovered after submission of the application, but rather allow applicants the opportunity to respond to unforeseen events.  

New: For grant applications submitted for due dates on or after September 25, 2017, citations of issued patents will be accepted as post-submission materials.

For additional information on allowable and non-allowable post-submission materials see Additional Change to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials NOT-OD-17-066.

May 26, 2017

New NSF Proposal and Award Newsletter

The Policy Office in the Division of Institution and Award Support at the National Science Foundation has released the second quarterly NSF Proposal & Award Policy Newsletter. This issue contains information and guidance on how NSF views participant support costs.

May 02, 2017

NIH Plans to Implement a Grant Support Index Limit

National Institutes of Health Director Francis S. Collins has issued an important notice, New NIH Approach to Grant Funding Aimed at Optimizing Stewardship of Taxpayer Dollars.

In this notice, Dr. Collins describes a new tool that NIH plans to implement—the Grant Support Index (GSI)—to ensure that the NIH supports a diversity of biomedical problems, rather than concentrating resources in a smaller number of labs. NIH’s goal is to free up about 1,600 new awards to broaden the pool of investigators conducting NIH research and improve the stability of the enterprise.

The plan is that each principal investigator (PI) that submits an application to NIH will be assigned a GSI value based on the type, complexity, and size of the PI’s current NIH awards. PIs that have GSIs over 21 (the equivalent of 3 single-PI R01 awards) will be expected to include a plan in their applications for how they would adjust their existing grant load to be within the GSI limits if their application is awarded. (Note: A GSI limit is not specified by Dr. Collins.)

Rationale for the use of the GSI from Dr. Collins:
  • The distribution of NIH grant funding is highly skewed, with 10 percent of NIH-funded investigators receiving over 40 percent of NIH funding. Analyses conducted by both NIH and others has shown that incremental research output gradually diminishes as the amount of support per investigator increases.
  • The more principal investigators must manage in terms of additional projects, personnel, and grant applications, the less additional time they have to dedicate to their research.
  • There are reasons to believe that supporting more researchers working on a diversity of biomedical problems, rather than concentrating resources in a smaller number of labs, might maximize the number of important discoveries.
This will not affect current funding and is expected to free up approximately $500-$650 million in funding for 1500-1600 new awards. The GSI could potentially be implemented for applications being accepted in September 2017.

Over the next few months, NIH will be seeking feedback from the scientific community on how best to implement the GSI limit. Dr. Collins indicates that there are still many details of the policy that need to be worked out. Look for more on this topic from NIH Deputy Director for Extramural Research Dr. Michael Lauer through his Open Mike Blog.

April 20, 2017

Advantages of Using an Updated Subrecipient Commitment Form (4/2017)

The Sponsored Projects Office has posted a new Subrecipient Commitment Form for Non-FDP Pilot Institutions (4/2017).

Advantages of using the new form:

If the subrecipient institution has answered the relevant conflict of interest (COI) question in section 5 of the Subrecipient Commitment Form for Non-FDP Pilot Institutions (4/2017), it will not be necessary to provide SPO with a PHS Financial Disclosure (Form 5) or the NSF Financial Disclosure Form for any subrecipient investigator at the proposal stage.

Please note that it also is not necessary to provide SPO with a PHS Financial Disclosure (Form 5) or the NSF Financial Disclosure Form for any subrecipient investigator at the proposal stage if the subrecipient is participating in the FDP Expanded Clearinghouse Pilot. See the list of participating institutions.

Institutions participating in the FDP pilot program are required to complete the FDP Pilot Subrecipient Project Information Form (8/2016).

April 10, 2017

New Requirement for NSF FastLane Submissions

The National Science Foundation has issued the following important message. More details are available on Collaborator and Other Affliations Information on the NSF website.


Dear Colleagues:

On April 24, 2017, the National Science Foundation (NSF) will initiate a new requirement for all FastLane proposal submissions. This requirement does not apply to NSF Grants.gov submissions.

The new requirement requires the use of a spreadsheet template for identifying Collaborators and Other Affiliations information for Principal Investigators (PIs), co-PIs, and other senior project personnel identified on proposals.

Effective April 24, 2017, NSF will require the submission of a spreadsheet template to identify collaborators and other affiliations. Please note that the spreadsheet template:
  • Has been developed to be fillable. However, the content and format requirements must not be altered by submitters.
  • Must be saved in .xlsx or .xls formats and directly uploaded into FastLane as a Collaborators and Other Affiliations Single Copy Document.
  • Will be converted by FastLane from an .xlsx or .xls file to a PDF file.
  • Has been tested in Microsoft Excel, Google Sheets, and LibreOffice.
  • Will enable preservation of searchable text that otherwise would be lost. Must be uploaded in .xlsx or .xls formats only. Uploading a Collaborators and Other Affiliations Single Copy Document in any other format may delay the timely processing and review of your proposal.
  • Will be directly linked in FastLane.
The template and associated instructions may also be accessed directly at: https://www.nsf.gov/bfa/dias/policy/coa.jsp.

NSF believes that in addition to the merit review process benefits, the Collaborators and Other Affiliations template will reduce administrative burden and improve efficiencies by providing submitters with a compliant and reusable format to maintain this information for use in subsequent proposal submissions to NSF.

March 23, 2017

Research Administrators’ June RAC Forum Poster Session

As of June 14, 2017, the Research Administration and Compliance (RAC) Forum will be renamed the Research Administration Community (RAC) Forum to reflect the reality of the cooperative nature of research administration on the Berkeley campus. To launch this new enterprise, the June 14th RAC Forum at the Alumni House will be a Poster Session Event “Promoting a Culture of Collaboration.”

This event will provide research administrators across campus with an opportunity to display posters illustrating a process, policy, or job aid that they believe has improved (or has the potential to improve) the effectiveness or efficiency of research administration on the UC Berkeley campus.

Each of the following “research administration communities” are invited to display posters at this event: CSS RA, Department RA, SPO, CGA, and IAO. For information on how to create and display a poster at the June 14th RAC Forum, go to the June 2017 RAC Forum folder in UC Berkeley Box.

In this folder applicants will find an overview of the poster event and instructions. This folder also includes blank poster templates that can be used/adapted to create a 36" x 48" poster. Applicants should read the poster instructions first as well as the tips for creating a visually interesting poster.

The applicant/s that submit the best poster (as judged by RAC Forum attendees) will be treated to a luncheon at the Women’s Faculty Club over the summer months.