Human Research Protection: Three-Year Approval for Qualifying Minimal Risk Research

The Committee for Protection of Human Subjects (CPHS), in collaboration with the Office for the Protection of Human Subjects (OPHS) and the Vice Chancellor for Research, has announced the following change in policy. UC Berkeley will join UC Davis and UC San Francisco in utilizing flexibility available under our Federalwide Assurance (FWA) regarding certain study approval periods. Specifically, effective June 1, 2013, CPHS will begin issuing three (3) year approvals for research that qualifies for this extended approval period. To qualify, the research must:

1. involve no more than minimal risk to participants (as defined by 45 CFR 46.102);
2. not be supported by federal funds; and
3. not be subject to federal oversight.

For more detailed information, e.g., about what to do if federal funding is received after initial approval, how to apply for Continuing Review of currently approved research, or what kind of studies are not eligible for this extended approval period, see Three-Year Approval FAQs.

The CPHS/OPHS decided to make this change after an in-depth analysis of the type of research conducted at UCB and what, if any, funding supports that research. We found that for many years, a large majority of the research conducted by UCB investigators has been determined to be no greater than minimal risk to the subjects (participants) of that research. Likewise, approximately two-thirds of the human research protocols reviewed by CPHS are not federally funded or subject to federal oversight (e.g., FDA). Therefore, CPHS/ OPHS felt that we could and should assist our investigators by using the flexibility in the terms of our FWA to grant three-year instead of one-year approval periods where appropriate. Of course, this will not change the ethical standards by which a protocol is evaluated. We hope that investigators will appreciate this reduction of their administrative burden, while we continue to work together to ensure the welfare of the people who participate as subjects in research.

New NIH Electronic Forms (FORMS-C) for Applications Due on or after September 25

National Institutes of Health applications due on or after September 25 will use a new electronic forms package, FORMS-C.

For due dates on or after September 25, 2013, most applicants will be required to use FORMS-C packages, with exceptions below. The requirement includes electronic applications submitted under the continuous submission policy, administrative supplement requests (Type 3), change of organization requests (Type 6) and change of grantee/training institution requests (Type 7). Multiproject applications that are transitioning to electronic submission beginning with the September 25, 2013 due date will also use FORMS-C packages.

NIH Funding Opportunity Announcements (FOAs) published between now and July that have submission due dates on or after September 25, 2013, will be posted without application packages. Beginning in July, the updated forms will be incorporated into new and existing FOAs.

Exceptions

• Individual Research Career Development Award Programs (Ks), Institutional Training and Career Development Programs (Ts and Ds), and Individual National Research Service Awards (Fs) applicants will use FORMS-C packages for due dates on or after January 25, 2014.
• Small Business programs (SBIR/STTR) applicants will transition to FORMS-C packages later in 2014.

For details, see NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013 (NOT-OD-13-074).

For multiproject applications, see NIH Announces an Adjustment to Transition Timeline for Electronic Submission of Multi-Project Applications (NOT-OD-13-075).

Updates in Fund Advance Form and Procedures for Sponsored Projects

A fund advance provides a principal investigator (PI) who is awaiting his/her award with a project fund that can be charged for a limited amount of allowable pre-award costs necessary to start up the project. This same fund can then be used for all subsequent project charges when the award is finalized, thus eliminating the possibility of inappropriate cost transfers. The Sponsored Projects Office (SPO)  is responsible for processing fund advance requests for UC Berkeley PIs and departments.

Guidelines and restrictions for Fund Advance Request processing and the UCB Fund Advance Request Form can be found on the SPO web site.

Recent updates and clarifications have been made to the fund advance request guidelines and form.

• The Type “A” fund advance is appropriate for new and competing continuation awards from U.S. federal sponsors made directly to UC Berkeley. A Type “A” is not appropriate for the non-competing segments of U.S. federal awards made to UC Berkeley. The Type “A” also is not appropriate for subagreements to UC Berkeley under U.S. federal awards awarded to other entities.
• The Type "B" fund advance is appropriate when departments/units wish to proactively identify a backup fund to charge if the award is not received as anticipated. As in the past, the authorized financial administrator of the backup fund must certify that this fund has sufficient unrestricted funds to cover the advance.
• The Type “A” fund advance period continues to be limited to 90 calendar days. Type “B” and “C” fund advance period extensions may be processed by SPO with chair/dean/director approval as long as no other restrictions apply.
• A signed certification from the chair/dean/director is now included at the bottom of every fund advance form indicating that the approver understands that any deficit that results from any type of fund advance continues to be the responsibility of the PI’s department/unit and will, as in the past, be cleared according to the campus policy on deficit reduction.

All previous restrictions and requirements for processing a fund advance at UC Berkeley still apply.

NIH Publishes Fiscal Policy for FY 2013

The National Institutes of Health has issued NIH Fiscal Policy for Grant Awards – FY 2013 (NOT-OD-13-064), that provides guidance for the remainder of fiscal year 2013 (through September 30, 2013).

Sally Rockey, NIH Deputy Director for Extramural Research, published a Rock Talk blog post, Funding Operations for FY2013, that summarizes the new notice.

Key points from the Rock Talk post:

• NIH will continue many of the same policies established in FY 2012, including National Research Service Awards (NRSA) stipend levels, salary limits, and other legislative mandates in effect for FY 2012.
• Some non-competing continuation awards were already made at reduced levels (as described in an earlier blog post.) These reductions may be partially restored, but NIH institutes and centers (ICs) likely will be required to issue all non-competing awards at levels below the FY 2013 commitment indicated on the notice of grant award.
• NIH will make fewer competing awards.
• The policy set forth in FY 2012, which discontinued inflationary increases for future year commitments, remains in place, but adjustments for special needs will be considered.
• NIH will continue the targeted support of new investigators, aiming for a success rate on new (type 1) R01 equivalent grants comparable to that of established investigators.

In related news, NIH Director Francis Collins is using Twitter to ask “how the #sequester is affecting your biomedical research right now,” using hashtag #NIHSequesterImpact.

More information on sequestration is available on the SPO web site: Impact of Federal Budget Sequestration on Sponsored Projects.

NIH Reminds Grantees to Use RPPR for Progress Reports for Awards with Start Dates on or after July 1, 2013

The National Institutes of Health has issued a reminder to grantees that “they are required to use the eRA Research Performance Progress Report (RPPR) Commons Module for submitting Streamlined Noncompeting Award Process (SNAP) and Fellowship progress reports for awards with start dates on or after July 1, 2013 (i.e., due dates on or after May 15, 2013, for SNAP awards and May 1, 2013, for Fellowships).”

Progress reports submitted in another format for SNAP and fellowships will not be processed by the NIH and will require resubmission in the RPPR format.

If a progress report for a fellowship has been submitted on paper, the grantee must resubmit the progress report using the RPPR format.

If a progress report for a SNAP grant has been initiated as an eSNAP, the grantee must contact the NIH eRA Help Desk to change the progress report format to the RPPR. It may take eRA up to two business days to reset the progress report so the grantee can start a progress report in the appropriate format.

Resources

• NIH Reminds Grantee Institutions of the Requirement to Use the Research Performance Progress Report (RPPR) for All SNAP and Fellowship Progress Reports for Awards with Start Dates On or After July 1, 2013 (NOT-OD-13-061)
• NIH Requires Use of RPPR for All SNAP and Fellowship Progress Reports, and Expands RPPR Functionality (NOT-OD-13-035)
• Research Performance Progress Report (RPPR)

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December 4 Research Advocate: NIH RPPR Requirement Coming in Spring 2013

Obama Announces BRAIN Initiative

On April 2, President Obama announced a new BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative designed to revolutionize our understanding of the human brain, to be funded with approximately $100 million in the President’s Fiscal Year 2014 Budget.

Beginning in fiscal year 2014, the National Institutes of Health, the Defense Advanced Research Projects Agency, and the National Science Foundation will support approximately $100 million in “research to accelerate the development and application of new technologies that will enable researchers to produce dynamic pictures of the brain that show how individual brain cells and complex neural circuits interact at the speed of thought.” Federal agencies will partner with companies, foundations, and other private institutions, such as the Allen Institute, the Howard Hughes Medical Institute, the Kavli Foundation, and the Salk Institute for Biological Studies.

Resources

• White House Fact Sheet: BRAIN Initiative
• White House Blog: BRAIN Initiative Challenges Researchers to Unlock Mysteries of Human Mind
• NIH: Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative
• NIH Director’s Blog
• National Science Foundation Participates in White House Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative
• DARPA: Better Understanding of Human Brain Supports National Security
• UC Berkeley News: Campus poised to join Obama’s BRAIN initiative

National Science Board Seeks Faculty Input on Administrative Workload Associated with Federal Awards

In 2005 and 2012, the Federal Demonstration Partnership (FDP) conducted faculty burden surveys that indicate that administrative burdens associated with federal research funding consume roughly 42 percent of an awardee’s available research time.

The National Science Board (NSB), which establishes the policies of the National Science Foundation and recommends and encourages the pursuit of national policies for the promotion of research and education in science and engineering, recently established a Task Force on Administrative Burdens charged with examining faculty administrative workload as it relates to federally sponsored research.

The NSB Task Force has released a Request for Information (RFI) seeking recommendations from principal investigators for reducing the administrative workload associated with their federal awards. Responses to the RFI will be accepted through May 24, 2013.

In addition, the Task Force will be conducting three Roundtable Discussions to elicit feedback directly from faculty and administrators. To attend any of the discussions, please send email to Administrative-Reform-Inquiries@nsf.gov.

• April 16, 2013, Stanford University, Palo Alto, CA, 4:00 PM, Location TBD
• April 30, 2013, Tufts University, Boston, MA, 11:30 AM, Winthrop Street Function Hall
• May 1, 2013, Georgia Tech, Atlanta, GA, 1:30 PM, Georgia Tech Global Learning Center

PHS Financial Disclosure: $5K De Minimus Travel Disclosure

Late last year, the National Institutes of Health issued updated guidance and subsequently updated a Frequently Asked Question with respect to the ability of institutions to apply a $5,000 de minimus for disclosure of sponsored or reimbursed travel under the new (2011) PHS financial disclosure regulations.

The UC Office of the President has now issued guidance memo 13-03 to the UC policy, which confirms that campuses may choose to apply the $5,000 de minimus to the disclosure of sponsored or reimbursed travel by investigators.

The UC Berkeley COI Office has updated the financial disclosure forms, instructions and accompanying guidance on the COI Committee web site to reflect this guidance. Effective immediately, when completing PHS Financial Disclosure Form 1, Form 2, and Form 4, only travel in excess of $5,000 per entity per 12-month period should be disclosed. Questions regarding this new guidance should be directed to COI Coordinator Jyl Baldwin at jbaldwin@berkeley.edu or 642-8110.

Federal Budget Sequestration: NIH, NSF Issue Notices

The federal budget sequestration process was included in the Budget Control Act of 2011, which increased the debt limit, cut $1 trillion in discretionary appropriations through lower annual spending caps over nine years, and directed a committee to identify an additional $1.2 trillion in cuts to federal programs over fiscal years 2013-2021. This committee failed to reach an agreement, triggering sequestration to carry out the additional $1.2 trillion in cuts. The budget sequestration, set to begin in January 2013, was delayed until March 1, 2013 by Congressional passage of the American Taxpayer Relief Act of 2012.

Federal agencies have begun to issue notices related to the potential impact of sequestration on grants and contracts.

Note: For updated information, see Impact of Federal Budget Sequestration on Sponsored Projects on the Sponsored Projects Office web site.

National Institutes of Health

The National Institutes of Health published NIH Operation Plan in the Event of a Sequestration (NOT-OD-13-043) on February 21, 2013. This notice states the following.

“The NIH continues to operate under a Continuing Resolution as described in NOT-OD-13-002, and therefore all non-competing continuation awards are currently being funded at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level). Final levels of FY 2013 funding may be reduced by a sequestration. Despite the potential for reduced funding, the NIH remains committed to our mission to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability.

Should a sequestration occur, NIH likely will reduce the final FY 2013 funding levels of non-competing continuation grants and expects to make fewer competing awards to allow the agency to meet the available budget allocation. Although each NIH Institute and Center (IC) will assess allocations within their portfolio to maximize the scientific impact, non-competing continuation awards that have already been made may be restored above the current level as described in NOT-OD-13-002 but likely will not reach the full FY 2013 commitment level described in the Notice of Award. Finally, in the event of a sequestration, NIH ICs will announce their respective approaches to meeting the new budget level.”

National Science Foundation

The National Science Foundation issued Important Notice No. 133: Impact of FY 2013 Sequestration Order on NSF Awards on February 27, 2013. This notice to presidents of universities and colleges and heads of other NSF awardee institutions includes the following statement.

“At NSF, the major impact of sequestration will be seen in reductions to the number of new research grants and cooperative agreements awarded in FY 2013. We anticipate that the total number of new research grants will be reduced by approximately 1,000.

In keeping with the first core principle listed above, and to assure continuity and minimize disruption of scientific research, all continuing grant increments in FY 2013 will be awarded, as scheduled, and there will be no impact on existing NSF standard grants. The same intent applies to annual increments for cooperative agreements, though overall funding constraints may require reductions to certain major investments. These will be handled on a case-by-case basis.

It is also important to advise you that the Foundation is currently operating under a Continuing Resolution (CR) that will expire on March 27, 2013. Once NSF has appropriations in place beyond March 27th, we will revise this notice as necessary.”

Resources

• UCOP Federal Government Relations: University of California Fact Sheet: Impacts of Sequestration on the University of California
• American Association for the Advancement of Science (AAAS) Sequestration Resources
• Congressional Budget Office (CBO) Sequestration Reports
• Association of American Universities (AAU)

NSF Workshop at UC Davis on April 25

The National Science Foundation and UC Davis will be holding a one-day workshop on Thursday, April 25, 2013, from 7:30 am to 4:30 pm at the UC Davis Conference Center.

This NSF Day workshop is primarily designed for researchers and educators less experienced in proposing to the NSF; however, more experienced proposers and NSF grantees may well find the workshop useful and informative. The workshop will provide an overview of NSF, its mission, priorities, and budget. It will cover the NSF proposal and merit review process and NSF programs that cut across disciplines. Additionally, representatives from the seven NSF directorates and the Office of International Science and Engineering and the Office of Integrative Activities will make presentations on their programs and will also be available informally and in breakout sessions for discussions of potential research proposals.

Registration is limited, so please register early. There is a registration fee of $35. See NSF Day at the University of California, Davis for more information.

Federal Public Access Policy Expanding

On February 22, the White House Office of Science and Technology Policy (OSTP) announced a new policy to expand the federal public access policy.

OSTP Director John Holdren has “directed Federal agencies with more than $100M in R&D expenditures to develop plans to make the published results of federally funded research freely available to the public within one year of publication and requiring researchers to better account for and manage the digital data resulting from federally funded scientific research.” Each agency will have six months to submit a draft plan to OSTP.

The National Institutes of Health has had a public access policy in place since 2008. Direct Holdren stated, “while this new policy call does not insist that every agency copy the NIH approach exactly, it does ensure that similar policies will appear across government.”

The National Science Foundation issued a same-day response to the new policy, stating that NSF and other federal partners have a “commitment to expand public access to the results of its funded research” and that “NSF has already laid out a tentative timeline for consultation, planning, systems development, and changes to its policies, which will be fine-tuned over the coming months.”

Resources

• OSTP Blog: Expanding Public Access to the Results of Federally Funded Research
• OSTP Policy Memorandum: Increasing Access to the Results of Federally Funded Scientific Research
• Dr. Holdren’s response to the We the People petition
• NSF Press Release: National Science Foundation Collaborates with Federal Partners to Plan for Comprehensive Public Access to Research Results
• NIH Public Access Policy

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February 14 Research Advocate: NIH Public Access Policy Applies to Awards with July 1 Start Dates

Proposal Information: Change in Congressional District, State Assembly District

In January 2013, the U. S. Congressional District for the Berkeley campus changed from the 9th to 13th District, and the California State Assembly District changed from the 14th to the 15th.

Please use the following information for all future proposals:

U.S. Congressional District: 13th
State Assembly District: 15th
State Senate District: 9th

For more information, see:

• SPO Standard Institutional Information for Proposals
• Alameda County Redistricting
• U.S. House of Representatives - Find Your Representative
• Find your California Representative
• State of California 15th Assembly District Map

Participant Support Costs in NSF REUs

The National Science Foundation has released a revised Research Experiences for Undergraduates (REU) Program Announcement (NSF 13-542). Effective with this REU Program Announcement, NSF no longer permits the recovery of indirect costs on Participant Support Costs in REU awards. NSF states:

“Recovery of indirect costs (F&A) is prohibited on Participant Support Costs in REU Site proposals and REU Supplemental funding requests. This limitation may entail mandatory committed cost sharing by the institution. In such cases, it constitutes an exception to NSF’s cost sharing policy.”

Reminder from the Sponsored Projects Office:

Until a formal change in NSF policy on this issue is announced, UC Berkeley PIs should act in accordance with the following NSF written guidance and not charge F&A on participant support costs, except under exceptional circumstances with the prior approval of NSF.

“(iv) Generally, indirect costs (F&A) are not allowed on participant support costs. However, an allowance for indirect costs associated with participant support costs may be established or negotiated in advance when circumstances indicate that the grantee could be expected to incur significant expenses in administering participant payments (other than salary or other direct expenses being reimbursed under the award.”

NSF FastLane Begins Automated Proposal Compliance Checking on March 18

Beginning March 18, 2013, the National Science Foundation FastLane system will begin automated compliance checking of all sections of proposals required in the NSF Grant Proposal Guide (GPG). The required sections include: Project Summary; Budget Justification; Project Description; Current and Pending Support; References Cited; Facilities, Equipment and Other Resources; Biographical Sketch(es); Data Management Plan; Budget; Postdoctoral Mentoring Plan (if applicable).

Proposal submission instructions for conferences, symposia, or workshops; international travel grants; or program solicitations may deviate from the GPG instructions. If the submission instructions do not require one of the above sections to be provided, proposers will need to insert text or upload a document in that section of the proposal that states, “Not Applicable.”

Additionally, proposers providing Biographical Sketches and/or Current and Pending Support information for Principal Investigators (PIs), co-PI(s), or Senior Personnel in a single PDF file associated with the PI must insert text or upload a document in that section of the proposal that states, “Not Applicable,” for any co-PI or Senior Personnel, so that FastLane will accept the proposal.

PIs will receive a warning message if any of the GPG-required sections is missing, however, the PI will still be able to submit the proposal to the Sponsored Project Office. If SPO attempts to submit a proposal that is missing any of the GPG-required sections, FastLane will prevent submission to NSF. SPO must obtain all required sections and then submit the proposal in FastLane by the NSF deadline.

Proposals submitted through Grants.gov must include all GPG-required sections or include a document stating that the section is “Not Applicable.”

For additional information, see Automated Compliance Checking of NSF Proposals. NSF is hosting an NSF Proposal Submission and Project Report Update - Webinar on March 8 from 11:30 am to 1:00 pm PST; contact NSF to participate.

NIH Public Access Policy Applies to Awards with July 1 Start Dates

The National Institutes of Health has published Changes to Public Access Policy Compliance Efforts Apply to All Awards with Anticipated Start Dates on or after July 1, 2013 (NOT-OD-13-042):

For non-competing continuation grant awards with a start date of July 1, 2013 or beyond:

1. NIH will delay processing of an award if publications arising from it are not in compliance with the NIH public access policy.
2. Investigators will need to use My NCBI to enter papers onto progress reports.  Papers can be associated electronically using the RPPR, or included in the PHS 2590 using the My NCBI generated PDF report.

For more information, see Upcoming Changes to Public Access Policy Reporting Requirements and Related NIH Efforts to Enhance Compliance (NOT-OD-12-160).

The NIH Rock Talk post, Update on NIH’s Public Access Policy, provides additional details and resources.

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November 20, 2012 Research Advocate: NIH Changing Public Access Policy Reporting Requirements