July 15, 2016

Reminder on PHS Regulation to Disclose New Significant Financial Interests in 30 Days

A reminder from the Conflict of Interest Coordinator:

The Public Health Service (including National Institutes of Health) regulations require that when new Significant Financial Interests are acquired or discovered by an Investigator, they must be disclosed within thirty (30) days of that acquisition or discovery. When this is not done in a timely manner, the institution is not in compliance with the regulations and must perform a mandated special retrospective review which causes delays in the ability of the Committee to approve ongoing projects. This is an onerous process and falls on the faculty Conflict of Interest Committee and the COI office to handle.

Please direct any questions to Jyl Baldwin, COI Coordinator, at jbaldwin@berkeley.edu or researchcoi@berkeley.edu.

Compliance Information Form for Research Gifts No Longer Required

Effective immediately, the Compliance Information Form for Research Gifts has been discontinued and is no longer required with the Form 700-U (Principal Investigator Statement of Financial Interests) when research gifts are received. The form has been removed from the COI and SPO websites. Please direct any questions to Jyl Baldwin, COI Coordinator, at jbaldwin@berkeley.edu or researchcoi@berkeley.edu.

July 01, 2016

NSF FastLane: New Automated Proposal Submission Compliance Checks

The National Science Foundation has issued a notice that effective July 25, 2016, all proposals will be subject to a new series of automated compliance validation checks to ensure proposals comply with requirements outlined in Chapter II.C.2. of the Proposal and Award Policies and Procedures Guide (PAPPG).

The new set of automated compliance checks will trigger warning or error messages depending on the funding opportunity type for each of the following rules:
  • Biographical Sketch(es) and Current and Pending Support files are required for each Senior Personnel associated with a proposal.
  • Biographical Sketch(es) can only be uploaded as a file, must not exceed two pages and can no longer be entered as text.
Proposers should be aware that if a proposal was previously submitted successfully with only one Biographical Sketch and/or Current & Pending Support file (rather than individual files for each senior personnel), a Proposal File Update performed on such proposals will be prevented from submission if it does not comply with the new compliance checks.

Proposers submitting through Grants.gov should be aware that Grants.gov will allow a proposal to be submitted, even if it does not comply with these proposal preparation requirements. Should NSF receive a proposal from Grants.gov that is not compliant, it may be returned without review.

For additional information see:

FastLane Advisory: Attention Proposers: New Automated Proposal Submission Compliance Checks Coming to FastLane
Research.gov: Attention Proposers: New Automated Proposal Submission Compliance Checks Coming to FastLane

NIH SF424 and R&R Forms: Continue to Use Despite Expiration Dates

The National Institutes of Health has published OMB Approval for SF424 R&R Forms Used Federal-wide Underway - Continue to Use Current Forms Until Further Notice (NOT-OD-16-120) in the NIH Guide. From the notice:
NIH and AHRQ grant application form packages include both agency-specific forms (typically labeled PHS) and federal-wide forms (typically labeled Research & Related or R&R). Although our agency-specific forms were recently approved for use through October 31, 2018 (FORMS-D, NOT-OD-16-004), the forms used federal-wide are on different clearance cycles and have recently expired or will expire soon.
Applicants and grantees should continue to use the application form packages (FORMS-D) posted with our funding opportunity announcements despite the expiration dates noted on each form.
Grants.gov is working with the Office of Management and Budget (OMB) on the federal-wide form clearance and expects OMB approval for proposed form changes later this summer.

June 29, 2016

Second Part of Report on Federal Research Regulations Issued

The National Academies of Sciences, Engineering, and Medicine has released Part 2 of the report Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century.

The report, issued on June 29, 2016 by the Committee on Federal Research Regulations and Reporting Requirements, contains the full contents of Part 1, first released in September 2015 as a separate publication.

The report “reviews the federal regulatory framework for research institutions as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. It identifies specific actions Congress, the White House, federal agencies, and research institutions should take to reduce regulatory burden.

June 30, 2016 update: The Council on Governmental Relations (COGR), Association of American Universities (AAU), and Association of Public and Land-grant Universities (APLU) have released a joint statement on the report, related to shared concerns regarding the recent Common Rule Notice of Proposed Rulemaking (NPRM) for the treatment of human subjects in research. COGR plans to issue a full analysis in the coming weeks.

September 23, 2015 Research Advocate: New Report on Regulation of Federally Funded Research

June 24, 2016

NSF Award Terms and Conditions Revised

The National Science Foundation Policy Office in the Division of Institution and Award Support has announced that the NSF Award Terms and Conditions have been revised to implement the requirements stipulated in Appendix XII to Part 200 of 2 CFR § 200 (Uniform Guidance) regarding the Federal Awardee Performance and Integrity Information System (FAPIIS), as well as other clarifications to the conditions.

The revised Terms and Conditions will apply to all new NSF awards and funding amendments to existing NSF awards issued on or after July 1, 2016.

Revisions have been made to the following:
  • Grant General Conditions (GC-1);
  • Cooperative Agreement Conditions:
    • Cooperative Agreement Financial and Administrative Terms and Conditions (CA-FATC),
    • Cooperative Agreement Supplemental Financial and Administrative Terms and Conditions for Managers of Large Facilities,
    • Cooperative Agreement Supplemental Financial and Administrative Terms and Conditions for Managers of Federally Funded Research and Development Centers (FFRDCS);
  • Special Conditions:
    • International Research Terms and Conditions,
    • Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Phase I Grant General Conditions,
    • Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Phase II Grant General Conditions, and
    • Administration of NSF Conference or Group Travel Grant Special Conditions (FL 26).

June 17, 2016

PIs Can Now Request Early Review of NIH COI Disclosures

The current process for review of complete positive financial disclosures for new National Institutes of Health proposals by the Conflict of Interest (COI) Committee has been to conduct that review at the time a Just-In-Time (JIT) request arrives from NIH. As JIT is generally some indication that the project may be funded, review at this juncture alleviated some of the burden on the COI Committee for review of all NIH positive disclosures at the proposal stage, when a significant percentage of those proposals are not funded. For funders that do not have an equivalent JIT process (e.g., NSF) review of complete disclosures has always been conducted right after the proposal is submitted. However, beginning on June 20, the COI Committee will conduct early review for new NIH projects with complete positive financial disclosures, at the request of the Principal Investigator. Any request for early review should be sent to researchcoi@berkeley.edu.

June 15, 2016

New COI Review and Approval Process

On June 1, the COI Committee began a new review and approval process for all complete non-substantive PHS (specifically including those which are unchanged or unrelated) and NSF financial disclosures, and for State 700-U disclosures that meet certain specified expedited review criteria. All such disclosures are now reviewed and approved on a rolling weekly basis, leaving the monthly COI Committee meeting for deliberation of more complex and/or complicated cases.

This new process will allow the Sponsored Projects Office to set-up many awards more quickly, and Donor and Gift Services to more quickly make gift funds available.

Approval letters will be issued via email from the COI office every Monday or Tuesday. In all cases, the COI office will copy the CSS RA identified with the individual who filed the disclosure, unless another contact is identified.

Please address any questions to COI Coordinator Jyl Baldwin at jbaldwin@berkeley.edu or researchcoi.berkeley.edu.

June 10, 2016

NIH Fellowship Application Problem

Today, June 10, 2016, the National Institutes of Health informed the research community that there is a temporary issue with the application form packages associated with the fellowship funding opportunity announcements listed in the NIH Guide Notice Form Correction Made for All NIH Fellowship Opportunities (NOT-OD-16-106).

The application forms packages posted with these opportunities on June 3, 2016 included an incorrect version of the PHS Fellowship Supplemental Form. This posting error was corrected the evening of June 7, 2016.

Anyone who started a grant application for any of these opportunities prior to June 8, 2016 must return to the funding opportunity announcement and begin again.

The ASSIST system recognized the posting issue and prevented users from initiating an application with the incorrect form package. If you attempted to initiate an application prior to June 8 and received an error, you can now safely initiate your application.

May 18, 2016

NSF Requests Comments on Large Facilities Manual Draft

On May 9th, the National Science Foundation published a Federal Register notice announcing the availability of a “For comment” draft of the NSF Large Facilities Manual (LFM). NSF is accepting comments on the LFM  and the accompanying Large Facilities Financial Data Collection Tool by July 8, 2016.

For more information, see the Federal Register notice, Comment Request: National Science Foundation Proposal—Large Facilities Manual, and the draft LFM on the NSF website.

April 28, 2016

Grants.gov and Adobe Reader DC Compatibility Workaround

According to a Grants.gov Blog post, Grants.gov Adobe Reader DC Compatibility Issue Workaround, a recent version of Adobe Reader DC (version 2015.010.20060) is compatible with Grants.gov.

Grants.gov applicants may continue to use Adobe Reader version 9 through 11 and, now, Adobe Reader DC version 2015.010.20060 or later. Versions of Adobe Reader DC prior to version 2015.010.20060 are still incompatible with Grants.gov.

Applicants who would like to use Adobe Reader DC must download the application package from Grants.gov again and use Adobe Reader DC Version 2015.010.20060 or later. Then after installing Adobe Reader DC, uncheck the “Show online storage when saving files” option. For more detailed instructions, see the Grants.gov Adobe Software Compatibility page.

January 25, 2016 Research Advocate: Grants.gov and Adobe Reader DC Compatibility Issue

April 14, 2016

Mobile Health Apps Interactive Tool

Researchers—if you are creating and testing an app in a human subjects research project, there is regulatory guidance on mobile apps that you should know about. See the Mobile Health Apps Interactive Tool from the U.S. Federal Trade Commission for more information.

March 28, 2016

New Streamlined Subrecipient Commitment Form

The Sponsored Projects Office has issued a revised Subrecipient Commitment Form. The form has been streamlined and reduced in length from five to three pages. SPO has also provided new instructions to make it easier for subrecipients around the world to understand and complete the form.

SPO encourages the campus to begin using the new form as soon as possible for the benefit of our subrecipient organizations. If an older version of the form has already been submitted to SPO, there is no need to submit the new form. However, the new form will be required for proposals submitted after April 15, 2016.

March 23, 2016

New Partnership to Help Fund Unfunded NIH Proposals

Dr. Michael Lauer, the NIH Deputy Director for Extramural Research, published A Pilot Partnership to Find Private Support for Unfunded Applications in his Open Mike blog at NIH.

Excerpted from the March 23, 2016 blog post:
The Online Partnership to Accelerate Research (OnPAR) program, operated by Leidos Life Sciences, will act as a matchmaker between unfunded NIH applicants and private research funders. OnPAR’s growing list of private funders currently includes the Juvenile Diabetes Research Foundation, National Alopecia Areata Foundation, Children’s Tumor Foundation, Adenoid Cystic Carcinoma Research Foundation, Breast Cancer Research Foundation, Melanoma Research Alliance, and Parent Project Muscular Dystrophy. We anticipate that more private funders and federal research agencies will be added to this program in the future.

To begin the process, NIH program officers will inform select applicants about potential funding opportunities via the OnPAR pilot. Select applicants include those who have a) have undergone Council review within the past year, b) have scored well (i.e., within the 30th percentile or promising non-percentiled applications), c) were unfunded and d) have research proposals that fall under the missions of the participating private funders. Applicants, at their discretion, can decide whether to submit materials to OnPAR for consideration of private funding.
More information is available in a March 23 Science Translational Medicine article, Funding unfunded NIH research application.

March 01, 2016

Getting Ready for Revised Forms from NIH: FORMS-D

The National Institutes of Health has been developing updated application forms, identified as FORMS-D, that must be used for all applications submitted for due dates on or after May 25, 2016. NIH intends to have the new forms available by March 25. NIH Guide notice NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (NOT-OD-16-004) provides information on planned changes to the forms.

To prepare for the change, NIH is developing resources for applicants, including a “completely revamped application guide that is much easier to use and understand.” NIH Extramural News Gearing Up for FORMS-D gives a brief summary. For more details, see NIH eSubmission Items of Interest – February 29, 2016. This covers topics such as FORMS-D application changes, timing, impact on continuous submission, impact on administrative requests, and identifying which form version was used for an application.

March 23, 2016 update: Reminder: NIH & AHRQ Grant Application Changes for Due Dates On or After May 25, 2016 (NOT-OD-16-081)
March 28, 2016 update: Restructured and Streamlined Application Guides and Supplemental Instructions Available for Applications Due Dates On or After May 25, 2016 (NOT-OD-16-084)