January 14, 2010

CPHS/OPHS Launch Redesigned Web Site

The Committee for Protection of Human Subjects and Office for the Protection of Human Subjects have a new and improved web site. The site was redesigned using the UC Berkeley campus templates.

The new left menu for the CPHS/OPHS site should make it easier to navigate and find what you need. The site also has some new content and revised guidance and instructions. Some of the new features include a site map, What Needs Review and Types of Review pages, and Where to Start: Decision Tree for new researchers.

Please have a look around the new site, and let OPHS know if you have any questions.

New NSF Requirement for Responsible Conduct of Research Training

Effective January 4, 2010, when submitting new research proposals to the National Science Foundation, UC Berkeley is required to certify that the campus has a plan in place for providing education and training in the Responsible Conduct of Research (RCR) to all students (undergraduate and graduate) and postdoctoral scholars who will be supported by those grants to conduct research.

The Berkeley campus has implemented plans for this new NSF RCR training requirement at http://rac.berkeley.edu/rcr.html.

The Vice Chancellor for Research issued a campus memo through CALmessages on January 13, 2010. The text of the memo is included below.

From: Graham Fleming, Vice Chancellor for Research
To: Deans, Directors, Department Chairs
Subject: New NSF Requirement for Responsible Conduct of Research

On January 4, 2010, the National Science Foundation started requiring that institutions receiving NSF awards have in place plans to provide undergraduates, graduate students, and postdoctoral scholars supported on NSF grants with training in the Responsible Conduct of Research (RCR). This requirement does not apply to existing awards; only those based on proposals submitted after January 4, 2010. While there is no requirement that training plans be submitted with proposals, we must certify that all eligible students and scholars receive some form of training and provide access to these training plans at the agency's request. Institutions are being provided maximum flexibility in creating and implementing RCR programs to meet this new requirement.

At UC Berkeley, we recognize that there are differences between the education and research experiences of the target groups receiving RCR training, and we have designed programs and choices to meet these different needs. Current planned options for UCB undergraduate students, graduate students, and postdoctoral scholars are listed below.

Completion of these activities alone, however, does not guarantee that students and trainees will internalize the essential elements of conducting research responsibly and ethically. The role of the Principal Investigator and other senior faculty in mentoring students and trainees and in providing other opportunities as a basis for didactic discussion (such as readings, workshops, lectures, and courses) cannot be underestimated. I would welcome your ideas about building a more robust campus RCR program.

Graduate Students and Postdoctoral Scholars
The Office of Research Administration and Compliance (RAC) is offering an RCR Curriculum through the Collaborative Institutional Training Initiative (CITI). This online course will form the basis of training in different discipline fields: Biomedical; Social and Behavioral Sciences; Humanities, Physical Sciences; and, Engineering. Students and trainees may go to https://www.citiprogram.org/default.asp to register for the Berkeley course. Individuals who may have taken Berkeley CITI courses for Human or Animal Subjects may use their same user name and password for the RCR coursework.

Undergraduate Students
RAC has also coordinated with UCOP and other UC campuses to develop a handout on major RCR topics. Academic units may choose to provide the handout to all student employees, not just those supported on NSF grants. This handout is available on the RCR web page (http://rac.berkeley.edu/rcr.html) as a PDF document.

Principal Investigators
For NSF proposals submitted after January 4, 2010, Principal Investigators must certify on a per award basis, that all students and post doctoral scholars supported by his or her NSF award have completed RCR training within 60 days of the individual's becoming supported by NSF funding. PIs must provide such certification to RAC by using the Responsible Conduct of Research (RCR) Training Certification Form available at http://rac.berkeley.edu/rcr.html. This document must be submitted to RAC, c/o Rebecca Armstrong - RCR Coordinator, within 90 days of the award being made; and, annually thereafter on the anniversary date of the award for the duration of the project updating any additions of students and postdocs since the last report and certifying that training has occurred as required. This original record will be kept with the SPO award file for the project. PIs should keep a copy for their own records.

January 08, 2010

Keeping Current with NIH: Recent Notices

The National Institutes of Health issued a number of important NIH Guide notices in recent weeks, linked and summarized below.

Availability of Reissued Parent Announcements for Due Dates on or after January 25, 2010
In mid-December NIH issued a notice serving as a progress report on the process of updating and reissuing NIH funding opportunity announcements (FOAs) with due dates on or after January 25, 2010, related to the new shorter NIH forms that must be used for all new or resubmission applications targeting due dates on or after January 25, 2010.

Error-Correction Window Extended for Electronic Applications Intended for Submission Deadlines On and Between January 25 and May 7, 2010
NIH, AHRQ, FDA and CDC are temporarily extending the electronic application error correction window (the time allowed after the submission deadline to correct errors/warnings identified by the eRA system) to five business days for all electronic applications intended for submission deadlines on and between January 25, 2010 and May 7, 2010. The temporary five-day window is being used to accommodate the January 25 transition to new application forms and instructions, part of the implementation of the NIH “Enhancing Peer Review” initiative.

NIH Fiscal Policy for Grant Awards – FY 2010
This Notice provides guidance about the NIH Fiscal Operations Plan for FY 2010 and it implements the FY 2010 enacted Omnibus Appropriation Act that provided NIH with $31.0 billion or 2.3 percent more than FY 2009 funding.

Non-Competing Research Awards: Non-Competing Research Awards: The FY 2010 appropriation as specified in P.L. 111-171 provides NIH a 2 percent inflation allowance to NIH investments in research supported by research grants. Each Institute and Center (IC) will use its own discretion to allocate the adjustment among its non-competing research grants (modular and non-modular) to ensure compliance with the 2 percent inflation allowance provided in its FY 2010 committed level.

Competing Research Awards: Each NIH Institute and Center (IC) will manage its competing portfolio using funds that have not been committed for non-competing awards. Consistent with the FY 2010 appropriation, the FY 2010 average cost of competing grants is allowed to increase by 2 percent over FY 2009 when compared to similar policies.

Ruth L. Kirschstein National Research Service Awards (NRSA): NIH will support a 1 percent increase at all stipend levels.

Salary Limitation on Grants, Cooperative Agreements, and Contracts

Every year since 1990, Congress has legislatively mandated a provision limiting the direct salary that an individual may receive under an NIH grant. For FY 2010, Public Law 111-117: Consolidated Appropriations Act, 2010 restricts the amount of direct salary to Executive Level I of the Federal Executive Pay scale. The Executive Level I annual salary rate was $196,700 for the period January 1 through December 31, 2009. Effective January 1, 2010, the Executive Level I salary level increased to $199,700.

See the NIH Salary Cap Summary page for more information.

Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels Effective for Fiscal Year 2010
This Notice establishes new stipend levels for FY 2010 Kirschstein-NRSA awards for undergraduate, predoctoral and postdoctoral trainees and fellows. The Tuition and Fees, Training Related Expenses for trainees and the Institutional Allowance for individual fellows remain unchanged. The budgetary categories described in the Notice are effective only for Kirschstein-NRSA awards made with FY 2010 funds. All FY 2010 awards issued using FY 2009 stipend levels will be revised to increase the stipend category to the FY 2010 level. Retroactive adjustments or supplementation of stipends or other budgetary categories with Kirschstein-NRSA funds for an award made prior to October 1, 2009 are not permitted.

Notice of Legislative Mandates in Effect for FY2010
Public Law 111-117: Consolidated Appropriations Act, 2010 provides funding to NIH for the fiscal year ending 2010. The intent of this Notice is to provide information on the statutory provisions that limit the use of funds on NIH grant, cooperative agreement, and contract awards for FY2010.

Implementation of the Federal Financial Report (SF-425) - Interim Guidance
The Office of Management and Budget is requiring that the Financial Status Report (FSR or SF-269/SF-269A) and the Federal Cash Transaction Report (FCTR or SF-272/SF-272A) be consolidated into a single form, the Federal Financial Report (FFR or SF-425/SF-425A). The Department of Health and Human Services has submitted the necessary paperwork to OMB to extend approved use of the SF-269 while the Department continues its phased migration to the full use of the FFR.

Effective January 1, 2010, NIH grantees are to report cash transaction data via the Payment Management System (PMS) using the FFR cash transaction data elements. The first quarter fiscal year 2010 report is for the period October 1, 2009 through December 31, 2009, and must be filed within 30 days of the end of the quarter.

Until notified otherwise, NIH grantees should continue to use the eFSR system in the eRA Commons (based on the Financial Status Report SF-269) to report actual expenditures. There are no changes in existing business practices for this reporting requirement at this time.