Research Advocate

RAC Offices to Close During the Annual Campus Winter Break

noreply@blogger.com (Shelley Sprandel) — Fri, 06 Nov 2009 23:12:00 +0000

The Animal Care and Use Committee Office, the Office for the Protection of Human Subjects, the Sponsored Projects Office, and the Research Administration and Compliance Office will be closed during the campus energy curtailment beginning Wednesday, December 23, 2009 through Wednesday, January 6, 2010. Offices will reopen on Thursday, January 7, 2010.

SPO Proposal Submission

SPO will process proposals due in December and January according to the VCR’s five-day proposal submission policy with the following exceptions:

For proposals with deadlines that fall between December 23 and January 8th, the due date to SPO will be no later than Wednesday, December 16, 2009.
For proposals due January 11th-13th, the due date to SPO will be no later than noon on Monday, December 21, 2009.
SPO will not accept proposals after noon on Monday, December 21, 2009.

To assist Berkeley faculty and staff members who need to submit proposals before and/or after the holiday/furlough period SPO will extend its drop box hours from 7 am to 6 pm from December 9th to the 18th. SPO will collect proposals from the drop box each day at 6 pm. These proposals then will be logged in on this date. A SPO Research Analyst also will be available to answer general proposal questions from 7 to 8 am and 5 to 6 pm each day during this same time period. Persons needing assistance from 7 to 8 am and 5 to 6 pm should call the main SPO number: 642-0120.

PIs also are encouraged to inform their SPO Research Analyst if they will be submitting a proposal with a due date just prior to, during, or just after the curtailment period. This will give SPO and the PI an opportunity to discuss the best way to handle the proposal to make sure it is submitted in a timely manner.

ACUC Protocol Submission

Please note that all protocols and protocol revisions must be submitted via email to: ACUC@berkeley.edu by 5 pm on the deadline date.
If you wish to make changes to an approved protocol, you must first contact the ACUC office to obtain a copy of the current approved version of your protocol. Failure to do so may result in your protocol being returned to you.
The deadline for protocol submission for the January 20, 2010 meeting is Monday, November 16, 2009.
The deadline for protocol submission for the February 17, 2010 meeting is January 5, 2010. No exceptions to this deadline will be granted as ACUC staff must process all protocols for the February meeting by end of business on January 6, 2010.

CPHS Protocol Submission

The deadline for protocol submission for the December 4, 2009 CPHS-I meeting is Monday, November 9, 2009.
The deadline for protocol submission for the December 18, 2009 CPHS-II meeting is Monday, November 23, 2009.
There is no CPHS-I meeting in January 2010; the deadline for protocol submission for the February 5, 2010 CPHS-I meeting is Monday, January 11, 2010. Please note that any new protocol to be reviewed at this meeting must be submitted via eProtocol.
The deadline for protocol submission for the January 22, 2010 CPHS-II meeting is Friday, December 18, 2009. (Please note this is an earlier deadline than usual).
Important: if your study is “greater than minimal risk” needing full board review and the approval will expire before January 22, 2010, you must submit your renewal application in time for review at a December 2009 CPHS meeting.
No deliveries will be accepted after noon on December 22, 2009; any documents left in the drop box over the break will not be retrieved and logged until January 7, 2010.
eProtocol Announcement: OPHS anticipates that as of December 18, 2009 investigators will be required to submit ALL NEW PROTOCOLS via eProtocol, therefore no paper-based submissions for new protocols will be accepted after NOON on Friday, December 18, 2009. Please check the CPHS website for updates or changes to this deadline.

In addition, for protocols determined to be exempt prior to July 1, 2009 if an investigator wants to make a modification or revision to his/her protocol then s/he must re-submit the exempt protocol via eProtocol as a “new” project and incorporate the amendment into the protocol application. Please include a reference in the narrative to the original exempt determination CPHS# and append the “old” determination of exemption approval letter to the submission. See the CPHS web site for more detail about eProtocol submissions.

NIH Issues Revised PHS 2590, Implements Policy Changes

noreply@blogger.com (Shelley Sprandel) — Mon, 31 Aug 2009 21:17:00 +0000

The National Institutes of Health has revised “Continuation Progress Report for a DHHS Public Health Service Grant” (PHS 2590, rev. 06/09). The newly revised instructions and forms are available at http://grants.nih.gov/grants/forms.htm. The revised PHS 2590 form will will be accepted immediately for all progress reports and will be required for all annual progress reports due on or after October 1, 2009.

NIH will release corresponding changes to the eSNAP Commons Module on October 9, 2009. For eSNAPs due October 15th, NIH encourages grantees to delay submitting eSNAP reports until after the October 9th enhancements are in production in order to implement use of the revisions for all progress reports submitted for FY 2010 funding. For eSNAPs due by October 15th, NIH encourages grantees to submit them on time; however, an additional grace period to November 1, 2009 is permitted to accommodate these changes.

This revision of the PHS 2590 implements a number of important policy changes, including:

New All Personnel Report: Replacement of the Senior/Key Personnel Report with an All Personnel Report (Form Page 7) that collects information on all personnel who participate in the project for at least one person month or more. The All Personnel Report also implements a new NIH requirement that all individuals with a postdoctoral role with one person month of more of measurable effort must have an eRA Commons user ID (see NIH Guide Notice OD-09-140, New Requirement for eRA Commons User IDs for Individuals in a Postdoctoral Project Role with Measurable Effort on an NIH Annual Progress Report (PHS2590), for details and background on this new requirement).
New Assurance for Institutions Receiving Awards for Training of Graduate Students for Doctoral Degrees: For institutions receiving NIH awards for graduate training through certain Institutional training grants, a new Graduate Student Assurance, required by the NIH Reform Act of 2006 (P.L. 109-482) is now included. In addition, for annual progress reports for Institutional training grants Table 12A is modified to collect data related to the Graduate Student Assurance. More details on this new institutional assurance are described in NIH Guide Notice OD-09-141 , New Reporting and Assurance Requirements for Institutions Receiving Awards for Training of Graduate Students for Doctoral Degrees.
Inclusion of Changes to Innovative Potential: As part of the NIH Enhancing Peer Review Initiative, PD/PIs are asked, if applicable, to address any changes to the innovative potential of the project. This information is now part of the Progress Report Summary, Section B. Studies and Results.
Changes to the Biographical Sketch: Another change associated with the peer review initiative is the addition of a Personal Statement to the biographical sketch. The statement is for the senior/key personnel to address why their experience and qualifications make them particularly well-suited for their role on the project. Instructions for the biographical sketch also encourage applicants to limit the list of publications to no more than 15. Reminder: A new biosketch is only required as part of the progress report for new senior/key personnel since the previous submission.
Human Embryonic Stem Cells (hESCs): A new item is added to the Progress Report Summary, under D. Plans, as Item E. Human Embryonic Stem Cell Line(s) Used, for grantees to note if proposed research involving hESCs is different from that proposed in the previous submission, including use of a different cell line (Form Page 5).

NIH Stem Cell Guidelines to Apply to All Federal Agencies

noreply@blogger.com (Shelley Sprandel) — Thu, 06 Aug 2009 21:18:00 +0000

In a July 30 memorandum to the heads of federal agencies, President Obama directed agencies to adopt the new NIH guidelines governing federally funded research on human stem cells, including human embryonic stem cells.

The memo states:

In order to ensure that all federally funded human stem cell research is conducted according to these same principles and to promote a uniform Federal policy across the executive branch, I hereby direct the heads of executive departments and agencies that support and conduct stem cell research to adopt these Guidelines, to the fullest extent practicable in light of legal authorities and obligations. I also direct those departments and agencies to submit to the Director of the Office of Management and Budget (OMB), within 90 days, proposed additions or revisions to any other guidance, policies, or procedures related to human stem cell research, consistent with Executive Order 13505 and this memorandum.

July 6 Research Advocate article: Final NIH Guidelines for Human Stem Cell Research

Final NIH Guidelines for Human Stem Cell Research

noreply@blogger.com (Shelley Sprandel) — Mon, 06 Jul 2009 19:26:00 +0000

On March 9, President Obama issued Executive Order (EO)13505 Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The EO states that the Secretary of Health and Human Services, through the Director of the National Institues of Health, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law.

On July 6, the NIH published final NIH Guidelines for Human Stem Cell Research, along with the public comments on the draft Guidelines. The Guidelines will be effective on July 7, 2009.

From the July 6 NIH Guide Notice:

The Guidelines will ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law. Internal NIH policies and procedures, consistent with the EO and these Guidelines, will govern the conduct of intramural NIH stem cell research.

The Guidelines prescribe the assurances and supporting documentation that must accompany requests for NIH funding for research using hESCs, and describe research that is not eligible for NIH funding. NIH will provide additional guidance concerning the implementation of the Guidelines and the status of pending applications in future Guide Notices.

Ongoing NIH-supported research involving previously approved hESC lines may continue. No new uses of hESC may be initiated in ongoing funded studies unless reviewed and approved by the NIH.

Update: A July 15 NIH Guide Notice, Status of Applications and Awards under the New NIH Guidelines for Human Stem Cell Research, “provides information about new applications proposing to use hESCs, ongoing NIH research using previously approved hESC lines, and the status of applications previously submitted to NIH proposing to use hESCs, including those that received initial peer review prior to April 17, 2009 when NIH announced that applications that had not already been reviewed would be held pending issuance of the final Guidelines. ”

April 23 Research Advocate article: NIH Issues Implementation Notice and Draft Guidelines for Human Stem Cell Research

NIH Issues Implementation Notice and Draft Guidelines for Human Stem Cell Research

noreply@blogger.com (Shelley Sprandel) — Thu, 23 Apr 2009 17:00:00 +0000

On March 9, 2009, President Barack Obama issued Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells authorizing the Secretary of Health and Human Services, through the Director of the National Institutes of Health, to support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.

The April 17 NIH Guide includes a Notice on Implementation of Executive Order on Removing Barriers to Responsible Scientific Research Involving Human Stem Cells.

This NIH Guide Notice links to Draft National Institutes of Health Guidelines for Human Stem Cell Research. The draft guidelines were published in the April 23 Federal Register; comments must be received by NIH on or before May 26, 2009. NIH plans to issue final Guidelines within the 120 day limit set by the President.

The Notice provides the following implementation guidance:

Ongoing NIH-supported research: Pending issuance of new Guidelines, all ongoing NIH-funded research involving approved uses for human stem cells, including human embryonic stem cells, may continue. However, until the Guidelines are issued in final, no new uses of human embryonic stem cells may be initiated in NIH funded studies unless previously reviewed and approved by the NIH for the ongoing supported research projects. Further, NIH will not consider requests for either administrative supplements or revisions to any grants that include costs for, or involve the study of, human embryonic stem cells until the Guidelines are finalized.
Peer reviewed competing applications: Pending issuance of new Guidelines, any applications previously submitted to the NIH and already reviewed, which propose to use human embryonic stem cells, will be held for funding decisions until the final Guidelines are issued. At that time, highly ranked applications can be modified, as necessary, to comply with the Guidelines, to receive full consideration for funding.
Competing applications pending submission and/or peer review: NIH will accept applications for research proposing to use human embryonic stem cells during the period of Guidelines development, but the review and funding of these applications will be deferred until NIH issues final Guidelines. Such applications should identify illustrative cells for the purposes of the research plan. Once the Guidelines have been issued in final, applicants will have the opportunity to revise their application as necessary to comply with the Guidelines, including utilization of eligible cells. These modified applications will then be peer reviewed and considered for funding.

National Academies Issues Revised Guide to Responsible Conduct in Research

noreply@blogger.com (Shelley Sprandel) — Mon, 06 Apr 2009 21:23:00 +0000

The National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine have released the third edition of On Being a Scientist: A Guide to Responsible Conduct in Research. The book is available free online, or may be purchased as a PDF download or in paperback.

From the online description:

On Being a Scientist was designed to supplement the informal lessons in ethics provided by research supervisors and mentors. The book describes the ethical foundations of scientific practices and some of the personal and professional issues that researchers encounter in their work. It applies to all forms of research--whether in academic, industrial, or governmental settings-and to all scientific disciplines.

On Being a Scientist is aimed primarily at graduate students and beginning researchers, but its lessons apply to all scientists at all stages of their scientific careers.

President Lifts Restrictions on Stem Cell Research

noreply@blogger.com (Shelley Sprandel) — Tue, 10 Mar 2009 00:28:00 +0000

On March 9, 2009, President Barack Obama signed an Executive Order (EO) “Removing Barriers to Responsible Scientific Research Using Human Stem Cells that lifts the ban on federal funding for embryonic stem cell research.

The EO states that:

“The purpose of this order is to remove these limitations on scientific inquiry, to expand NIH support for the exploration of human stem cell research, and in so doing to enhance the contribution of America's scientists to important new discoveries and new therapies for the benefit of humankind.”

The EO directs the National Institues of Health to “review existing NIH guidance and other widely recognized guidelines on human stem cell research, including provisions establishing appropriate safeguards, and issue new NIH guidance” within 120 days.

Also on March 9, the President issued a Presidential Memorandum for the Heads of Executive Departments and Agencies assigning to the Director of the Office of Science and Technology Policy “the responsibility for ensuring the highest level of integrity in all aspects of the executive branch’s involvement with scientific and technological processes.” The OSTP Director, working with heads of of executive departments and agencies, is to develop, within 120 days, recommendations for Presidential action designed to guarantee scientific integrity throughout the executive branch.

SPO Leadership Announcement

noreply@blogger.com (Shelley Sprandel) — Mon, 02 Mar 2009 17:24:00 +0000

Pam Miller is joining us as the new Director of the Sponsored Projects Office on Monday, March 2, 2009.

Pam comes to us from the University of San Francisco where she established their first Office of Sponsored Projects and served as its Director. Prior to joining USF in 2003, Pam was a member of the graduate faculty and a research administrator at Southern Illinois University at Carbondale (1984-2000) and Director of the sponsored projects office at the University of Southern Mississippi (2000-2003). Pam also brings to the office her experience working as a researcher. She received her Masters in Education from Penn State University and received her Ph.D. in Education from Southern Illinois University at Carbondale. She also has published over 25 journal articles and made over 60 professional presentations related to her own research, training, and service interests in the fields of Education and Research Administration, and has received grants totaling over $1.6M from governmental and private agencies, including the U.S. Department of Education and the Jesuit Foundation. Pam is also very active in the research administration field nationally. She has served as the Editor of The Journal of Research Administration from 1995 to 2001 and is currently the President of the Society of Research Administrators International (SRA).

Pam’s telephone number is 642-2925, and her email is plfmiller@berkeley.edu. Please join us in welcoming her to Berkeley and to the Research Administration and Compliance Office.

New AVC for Research Administration and Compliance

noreply@blogger.com (Shelley Sprandel) — Wed, 12 Nov 2008 23:49:00 +0000

The Vice Chancellor for Research Office issued the following news through CALmessages on November 12, 2008.

From: Beth Burnside, Vice Chancellor for Research (Campus-wide)
To: Deans, Directors, Department Chairs, Senior Administrative Officers
Subject: New AVC for Research Administration and Compliance

Deans, Directors, Department Chairs, Senior Administrator Officers:

As many of you may have already heard, Marcia Smith, our AVC for Research Administration and Compliance, has accepted an offer to serve in a broadened role as Associate Vice Chancellor for Research Administration at UCLA. She will be leaving Berkeley early in the new year. During the two and one-half years that she has served at Berkeley, Marcia has provided leadership for contract and grant administration and for compliance in areas of research with animal and human subjects and financial conflict of interest. Although we are sad to see her leave Berkeley, we thank her for all she has accomplished here and wish her the best of luck in her broadened role and responsibilities at UCLA.

I am, at the same time, happy to announce that Pat Schlesinger will be replacing Marcia as the Berkeley campus Assistant Vice Chancellor for Research Administration and Compliance. Pat will take up his new position on December 8, 2008, allowing a short overlap in our AVC appointments so as to ensure a smooth transition.

Pat Schlesinger comes to Berkeley from UCOP, where he has worked for twelve years; first in the Office of General Counsel as Group Leader of the Environmental Law Group, and, more recently, as Director of Research Compliance. Pat brings to the Berkeley campus and our research office an extraordinary depth and breadth of knowledge in the area of Federal and State regulations that impact research institutions and research activities. I have worked with Pat over the last few years on various things and relied on him many times for advice in negotiating the complex world of research regulations. I know he will be a valuable asset to the Berkeley administration and a terrific colleague. I can not be more pleased that he will be joining our team.

Robert M. Price
Associate Vice Chancellor for Research

RAC Offices to Close During the Annual Campus Winter Break

noreply@blogger.com (Shelley Sprandel) — Wed, 29 Oct 2008 22:02:00 +0000

The Office for the Protection of Human Subjects, the Sponsored Projects Office, and the Research Administration and Compliance Office will be closed during the campus energy curtailment beginning Thursday, December 25, 2008 through Friday, January 2, 2009. The Animal Care and Use Committee Office will be closed beginning Wednesday, December 24, 2008 through Friday, January 2, 2009. Offices will reopen on Monday, January 5, 2009.

SPO Proposal Submission

Proposals with deadlines during the campus shutdown should arrive at SPO by Friday, December 12, 2008.
Proposals due at agencies in early January should be at SPO by Monday, December 15, 2008.
No deliveries will be accepted after noon on December 24, 2008; any documents left in the drop box over the break will not be retrieved and logged until January 5, 2009.

ACUC Protocol Submission

The deadline for protocol submission for the January 21, 2009 meeting is Monday, December 8, 2008.
The deadline for protocol submission for the February 18, 2009 meeting is January 12, 2009.
ACUC will be closed on December 24, 2008.

CPHS Protocol Submission

The deadline for protocol submission for the December 5, 2008 CPHS-I meeting is Monday, November 10, 2008.
The deadline for protocol submission for the December 19, 2008 CPHS-II meeting is Monday, November 24, 2008.
There is no CPHS-I meeting in January 2009; the deadline for protocol submission for the February 6, 2009 CPHS-I meeting is Monday, January 12, 2009.
The deadline for protocol submission for the January 16, 2009 CPHS-II meeting is Monday, December 22, 2008.
Important: if your study was given full board review last January and approval will expire before January 16, 2009, you must submit your renewal application in time for review at a December 2008 CPHS meeting.
No deliveries will be accepted after noon on December 24, 2008; any documents left in the drop box over the break will not be retrieved and logged until January 5, 2009.

Keeping Current with NIH: Recent News Highlights

noreply@blogger.com (Shelley Sprandel) — Mon, 06 Oct 2008 22:53:00 +0000

The National Institutes of Health Office of Extramural Research (OER) provides several sources for current news related to grants policy, funding programs, compliance, and electronic research administration.

The NIH Guide, published weekly, is the official publication for research grant policies, guidelines, and funding opportunities. Readers may subscribe to a weekly email listserv of the Table of Contents or an RSS feed of NIH Funding Opportunities.
The NIH Extramural Nexus is a monthly newsletter update from OER.
The OER web page has a News & Events section.
NIH offers a listserv for updates on electronic submission and eRA Commons News.

Some recent important NIH announcements are linked and summarized below.

New NIH Policy on Resubmission (Amended) Applications (October 10 NIH Guide)

Beginning with original new applications and competing renewal applications submitted for the January 25, 2009 due dates and beyond, NIH will accept only a single amendment to the original application. Applicants who fail to receive funding after two submissions (i.e., the original and the single amendment) may resubmit but only if the application is fundamentally revised to qualify as new. A new application is expected to be substantially different in content and scope with more significant differences than are normally encountered in an amended application.

Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments. For these “grandfathered” applications, NIH expects that any second amendment will be submitted no later than January 7, 2011.

Non-Competing Grant Awards under the Current Continuing Resolution

The Department of Health and Human Services continues to operate on a continuing resolution (CR) that currently extends through March 6, 2009. The CR applies the terms of the FY 2008 appropriations for the period covered by the CR. Until the final FY 2009 appropriation is enacted, NIH will issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award (generally up to 90 percent of the previously committed level). This is consistent with NIH practice during the CRs of FY 2006-2008. NIH will consider upward adjustments to these levels after the final appropriation is enacted, but expects institutions to monitor their expenditures carefully during this period. NIH plans to publish additional details at http://grants.nih.gov/grants/financial/index.htm.

UC Berkeley questions regarding adjustments applied to individual grant awards amay be directed to the Grants Management Specialist identified on the Notice of Award.

Encouraging Early Transition to Research Independence: Modifying the NIH New Investigator Policy to Identify Early Stage Investigators

The NIH New Investigator policy been changed to encourage early transition to independence. Under the revised policy, New Investigators within ten years of completing their terminal research degree or within ten years of completing their medical residency will be designated Early Stage Investigators (ESIs). Beginning with traditional R01 applications received for the February 2009 receipt dates, NIH will identify applications from ESIs and New Investigators, and the career stage of the PD/PI will be considered at the time of review and award. NIH will be developing and issuing more complete information, instructions, and Frequently Asked Questions before the February R01 receipt dates.

Reminder Concerning Grantee Compliance with Public Access Policy and Related NIH Monitoring Activities

NIH principal investigators are subject to the terms of the NIH Public Access Policy. The policy, issued in January, requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication and requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication.

NIH published a notice in the September 25 NIH Guide describing NIH Public Access Policy compliance monitoring efforts for fiscal year 2009, along with a reminder about grantee compliance with the policy and the location of citations for papers in applications, proposals and progress reports.

1/18/2008 Research Advocate article: NIH Public Access Policy Now Required

Announcing Transition Schedule for NIH/AHRQ/CDC/NIOSH/FDA to Adobe-based forms for SF424 Research and Related (R&R) Electronic Submissions through Grants.gov

Most electronic submissions to NIH on or after January 1, 2009, must use Grants.gov Adobe application forms. NIH has issued a schedule for the transition to Adobe forms.

Investigators planning to apply to NIH should be aware of that new Funding Opportunity Announcements released after September 1, 2008, will not have Adobe application forms for downloading until December 2008. Applicants will need to check the FOA in December to download the new Adobe application forms. Also, applicants should be aware that Grants.gov requires the use of very specific versions of Adobe Reader, currently 8.1.1, 8.1.2, or 9.0. The Grants.gov web site has a list of compatible versions that is updated when Adobe releases new editions.

For additional information, see the NIH Resources for Adobe Transition web page and the September 29 eRA Commons Items of Interest.

Elias A. Zerhouni to End Tenure as NIH Director

Dr. Elias Zerhouni announced his plans to step down as the director of NIH at the end of October 2008. He plans to pursue writing projects and explore other professional opportunities. Dr. Zerhouni has served as NIH director since May 2002.

RAC Forum Schedule for the Coming Year

noreply@blogger.com (Shelley Sprandel) — Wed, 01 Oct 2008 22:28:00 +0000

Another year of Research Administration and Compliance Forum meetings is underway after a summer break. The monthly RAC Forum is primarily intended for campus administrative staff, but all are welcome. The first meeting was held in September and featured updates from RAC leadership, presentations on subaward business process analysis and the Subrecipient Commitment Form pilot, and an open forum to discuss ideas for topics for future meetings.

Upcoming RAC Forum meetings are scheduled from 10:30 a.m. until noon on the following dates:

October 8, 2008
November 12, 2008
December 10, 2008
January 14, 2009
February 11, 2009
March 11, 2009
April 8, 2009
May 13, 2009
June 10, 2009

Meetings will be held in the Tilden Room, 5th floor, ASUC Martin Luther King Jr. Student Union building. Contact Shelley Sprandel (2-8122, spore@berkeley.edu) to be added to the RAC Forum e-mail list.

Redesigning the Campus Research Subaward Process

noreply@blogger.com (Shelley Sprandel) — Wed, 01 Oct 2008 00:11:00 +0000

Background: Business Process Analysis

The Research Administration and Compliance Office (RAC) was one of several campus groups participating in the business process analysis workshop recently offered by the campus Center for Organization and Workforce Effectiveness (http://administration.berkeley.edu/forms/newsletter/spring-08-about.htm#bpa). The workshop, held from March to May 2008, provided coaching and training for teams actively engaged in improving real campus business processes.

The workshop provided participants with tools and methods to help analyze processes, identify areas for improvement, redesign processes to incorporate improvement ideas, and lay out a framework for ongoing review and improvement of processes.

Assistant Vice Chancellor for Research Marcia Smith selected a team of RAC and Sponsored Projects Office (SPO) staff to participate in the workshop and focus on the research subaward business process. The issuing of subawards under research grants and contracts is an operational challenge for most research institutions and is a process that is growing in volume and complexity.

The RAC business process analysis team was trained to use a set of tools and various approaches to business process redesign, and they applied that training to redesigning the subaward process. As a result of the team's effort, several improvements have already been made to the subaward process and more are on the way.

Subaward Process Improvement: Coeus Data for PIs

One major change is that more complete and current data on subawards and subawardee organizations is now being collected in Berkeley Coeus and can be shared with principal investigators and staff. Based on the new subaward information carried in Coeus, the Notice of Award sent to PIs and administrators now includes more detailed information, including the status of each subaward and guidance for the PI and department about what the status means for them. In addition, Berkeley Coeus Web will soon have a new research subaward report so that PIs and department staff can track subaward status online. The following statuses for subawards have been defined and implemented.

1. Pending: The subaward is known by SPO but a Subaward Request Form has not been submitted by the department.
2. In process: The Subaward Request Form has been received by SPO, and the subaward is being prepared for signature and transmission to the subawardee.
3. Amendment in process: The Subaward Amendment Request Form has been received by SPO and the amendment is in process.
4. Awaiting subawardee response: The subaward/amendment has been sent to the subawardee, but has not yet been returned fully signed.
5. Active: The subaward is fully executed and distributed.
6. Inactive: The subaward’s final expiration date has passed.

In addition to providing more information to PIs and staff, tracking and managing subaward data in Coeus is key to complying with federal regulations, including the Federal Funding Accountability and Transparency Act (FFATA), which will require the campus to provide data about subawards to the federal government for public access (http://www.usaspending.gov/).

Subaward Process Improvement: Subrecipient Commitment Form

SPO will be offering a new tool for campus departments, the Subrecipient Commitment Form. The new form serves as a checklist that will assist faculty and staff in collecting required information from subrecipients. Key information about a subaward project will be in one place, including information about the subawardee organization (debarment, suspension, financial controls, A-133 compliance) and the proposed project (statement of work, budget, indirect costs, fringe benefits, compliance reviews, cost sharing). The form will enhance institutional compliance with federal regulations and UC policy (A-133, FFATA, BUS-43, etc.) and reduce audit exposure.

The Subrecipient Commitment Form is based on commitment forms now in use at many other universities, including other UC campuses. The form is completed by the subawardee’s sponsored projects office and PI, endorsed by the subawardee's authorized institutional representative, and provided at proposal stage with other proposal documents. It will eliminate the need for letters of commitment currently obtained from subawardees at proposal stage. All information requested on the form is already provided at some point in the proposal and award process, often after time-consuming research by the principal investigator, department, and SPO.

Before the new forms are put into use campus-wide in January 2009, SPO has asked several departments to participate in a two-month pilot of the forms and instructions. The pilot will also include an additional form to be used for contracts only, the Fair and Reasonable Cost Analysis/Sole Source Justification Form. This form, to be completed and signed by campus principal investigators, will provide information that is required by UC policy for research subcontracts under contract awards (UCOP Contract & Grant Memo 85-31 and operating guidance for BUS-43).

Feedback from the pilot will be incorporated into the process and procedures. For more information on or to participate in the pilot, contact Patricia Gates (pgates@berkeley.edu or 2-8109).

Members of the RAC subaward process analysis team are Patricia Gates, Jennifer Nadeau, Dan Jacobs, Nancy Han, Alaisha Hellman, Neil Maxwell, and Shelley Sprandel.

Future Plans

RAC is also working on revising additional subaward procedures, guidance, and forms, as well as continuing to make internal process changes to simplify and expedite research subaward processing. Newly learned business process analysis skills will also be applied to other processes used in SPO, Office for the Protection of Human Subjects, Office of the Animal Care and Use Committee, and Conflict of Interest Committee operations in the months to come. Look for more news in the next several months.

NSF Encourages Comments on Cost Sharing

noreply@blogger.com (Shelley Sprandel) — Thu, 04 Sep 2008 22:06:00 +0000

The National Science Board (NSB) Task Force on Cost Sharing is currently examining the National Science Foundation cost-sharing policy. The NSB recently published a notice in the Federal Register soliciting public comment regarding the research communities’ experiences on use of cost sharing in NSF-funded activities. Comments must be received by October 1, 2008.

NSF Director Arden Bement, Jr. has issued a ‘‘Dear Colleague’’ letter strongly encouraging comments from the research community in response to this notice.

NSF’s letter emphasizes that the NSB is ‘‘particularly interested in receiving feedback on the following: (1) the relationship between cost sharing and NSF program goals; (2) the relationship between cost sharing and institutional competitiveness in NSF grant funding; (3) the role of cost sharing in the NSF merit review process; (4) the importance of types, sources, and timing of voluntary cost sharing; (5) effort associated with tracking and reporting cost-shared resources; (6) the relationship between cost sharing and institutional strategic investment; (7) options for ensuring equity in NSF grant funding when cost sharing is either required or volunteered; (8) research resources from state providers; and (9) research resources from industry providers.’’

Emerging Contract and Grant Issues: Federal Focus Areas

noreply@blogger.com (Shelley Sprandel) — Tue, 26 Aug 2008 19:59:00 +0000

Associate Vice Chancellor John Ellis and Assistant Vice Chancellor Marcia Smith sent the following information and guidance to campus administrative staff on August 26, 2008.

This is to bring to your attention three areas that are currently the focus of federal agencies and their audit divisions in their review of colleges and universities.

1. Advancing funds to subrecipients

The federal government only allows for advance funding in rare circumstances when a subrecipient lacks sufficient working capital to perform the work (see Circular A-110, subpart C, 22(f) at http://www.whitehouse.gov/omb/circulars/a110/a110.html#22).

In the rare event that you make an advance to a subrecipient, please ensure the advances are made in accordance with University and federal regulations prior to advancing funds. You should only advance the amount of money needed to cover the short term working capital needs of the subrecipient organization. For example if the subaward is $100k for research work to be performed over a 12 month period, you should not advance the full amount of the subaward. If the subrecipient cannot finance their working capital needs on a month-to-month basis, you might advance $5k or the equivalent of one month’s payroll needs.

If an advance has been made, care needs to be exercised to ensure the work is performed in accordance with the terms of the subaward and documentation is provided by the subrecipient demonstrating the work has been completed. If the subrecipient has not provided documented support for the work performed, you should not advance further funds on this subaward until you are satisfied the subrecipient is performing the agreed upon research and you could prove to the federal government or other parties that the subrecipient has completed the work.

See http://extramuralfundsaccounting.berkeley.edu/POLICY/SubRecipientMonitoring.htm for further guidance on monitoring subrecipients. Please note that most subrecipients can meet their short term working capital needs and can do business on a cost reimbursable basis rather than requiring an advance.

2. Cost transfers

Due to the high incidence rate of late or inadequately documented costs transfers, audit divisions of the federal government are paying special attention to cost transfers across the UC system. To minimize your exposure to disallowance, please ensure you are meeting the requirements of the campus cost transfer policy available at http://generalaccounting.berkeley.edu/costtransferpolicy.pdf.

In previous years, cost transfers that were late or inadequately documented have been disallowed by federal agencies on UC contracts and grants.

3. Sponsors enforcing contractual reporting deadlines

Some federal sponsors have recently refused to pay invoices because reports were not submitted by established deadlines. This applies to all reports including technical, progress, and financial reports. Although past practice has allowed for payment regardless of whether a report was submitted late, some agencies are now strictly enforcing their policy of non-payment for proper charges when we fail to comply with terms and conditions including federal reporting requirements.

**Departments will absorb disallowed or unpaid costs**

In the event that costs are disallowed or not paid by federal funding agencies in any of the areas described above, the administering department or unit will be required to cover these disallowed costs from unrestricted funds. UC Berkeley campus departments have in the past had to cover disallowed costs in these areas.

Please work with your Principal Investigators to ensure that your awards follow proper procedures to minimize your department’s exposure to disallowed expenses. Contact your Extramural Funds Accounting Analyst or Sponsored Project Office Analyst if you have further questions on these topics.

John Ellis
Associate Vice Chancellor-Finance, and Controller

Marcia L. Smith
Assistant Vice Chancellor, Research Administration and Compliance

NIH Publishes Web-based Tutorial on Financial Conflict of Interest Requirements

noreply@blogger.com (Shelley Sprandel) — Sat, 23 Aug 2008 00:24:00 +0000

The National Institutes of Health has announced a web-based tutorial developed to help improve and enhance compliance with federal financial conflict of interest regulations. NIH designed the tutorial for use by “institutional officials responsible for managing NIH-funded grants, cooperative agreements and/or contracts and for individuals who are responsible for the design, conduct or reporting of NIH-supported research.”

The tutorial is available in both Flash and PDF format on the NIH Office of Extramural Research Conflict of Interest web page: http://grants.nih.gov/grants/policy/coi/index.htm.

Review, Approval and Reporting of Requests for Funding from Tobacco Industry Sponsors

noreply@blogger.com (Shelley Sprandel) — Mon, 21 Jul 2008 19:15:00 +0000

Vice Chancellor for Research Burnside issued campus guidance on the new UC policy that require special review, approval, and reporting procedures for all research proposals to be submitted for funding to tobacco industry sponsors. The text of the memo is included below. The Proposal Review Form now includes a checkbox to indicate a tobacco industry sponsor.

Date: 7/15/2008
Sender: Beth Burnside, Vice Chancellor for Research (Campus-wide)
To: Deans, Directors, Department Chairs, Senior Administrative Officers
Subject: Review, Approval and Reporting of Requests for Funding from Tobacco Industry Sponsors

At its meeting last fall, the Board of Regents adopted a new policy to require special review, approval, and reporting procedures for all research proposals to be submitted for funding to tobacco industry sponsors. The Regental Resolution (RE-89) requires each UC campus to put in place procedures to ensure that any proposal to be submitted to "an entity whose principal business is the manufacture and sale of tobacco products, and agencies that are substantially controlled by or acting on behalf of such entities" undergo scientific peer review by the campus and be explicitly approved by the Chancellor before submittal to the tobacco industry sponsor.

RE-89 sets out guidelines for instituting the campus peer review committees and requires that the committees provide a written report of recommendations to the Chancellor. Also, RE-89 requires that the Chancellor provide the researcher, the UC President, and The Regents with a written determination approving or disapproving the request to submit the proposal. No proposal may be submitted to a tobacco company without this review and written approval.

Therefore, any PI who is considering submitting a proposal to a tobacco industry sponsor should contact my office immediately so that we can ensure timely initiation and conduct of the required review and determination process. Principal Investigators must receive a project-specific written determination of approval from the Chancellor before a research proposal can be submitted to a tobacco company.

Finally, RE-89 urges researchers to consider carefully whether or not to accept research funding from the tobacco industry and to exercise the utmost care and vigilance in all research to ensure that no funder is allowed to direct or control the outcome of the research or the dissemination of its results.

The text of RE-89 and the Model Policy on Tobacco industry Funding of Research at the University of California is available at: http://www.ucop.edu/research/policies/documents/review_approval_re89.pdf.

Please contact Marcia Smith, Assistant Vice Chancellor for Research Administration and Compliance at 642-2866 or m_smith@berkeley.edu if you have any questions about the campus procedure, or need assistance in determining whether a specific entity is, or is not considered to meet the definition of the "tobacco industry" for the purpose of the Regental policy.

Beth Burnside
Vice Chancellor for Research

Campus Training Resources: Workshop DVD Library

noreply@blogger.com (Shelley Sprandel) — Fri, 29 Feb 2008 20:30:00 +0000

The Research Administration and Compliance Office has DVDs of the following NCURA workshops and other training material available for campus departments to borrow. To borrow a DVD, contact Alaisha Hellman (3-2836, amhellman@berkeley.edu). RAC is ordering the 2008 NCURA TV DVDs; they will be listed here when available.

NCURA TV Satellite Broadcast Recordings

Conflict of Interest: How to Spot and Manage It (June 2007)
Effort Reporting (March 2007)
Sponsored Program Essentials (January 2007)
Post-award Issues for the Pre-award and Departmental Administrator (January 2006)
Best Practices in Research Compliance: Update on Policies and Regulations and Implementation at Institutions (September 2005)
Principles of Federal Research and Development Contracting (June 2005)

Other DVDs

What Are We Signing Anyway (NCURA Course, December 2005)
Export Control Session (UC IP Managers/C&G Officers Meeting, November 2005)

Berkeley Coeus 4 Upgrade Complete: New Passwords for Coeus Web Accounts

noreply@blogger.com (Shelley Sprandel) — Fri, 18 Jan 2008 21:57:00 +0000

The Research Administration and Compliance Information Systems team (RAC-IS) has successfully finished the upgrade to Berkeley Coeus version 4. All core components of the system (proposals, awards, subcontracts) and all associated infrastructure elements (state of the art development environment, future upgrade capability, Coeus-to-BFS feed, reporting mechanisms) have been upgraded and RAC-IS is now pleased to announce the rollout of the new Coeus Web.

The updated web service runs on new technology and infrastructure. All reports available on the old system are available on the new system. The campus Master Org Tree hierarchy has been implemented to identify organization units associated with proposals and awards. Benefits of the new system include enhanced capabilities for documenting proposal reviews, tracking agreement negotiations, managing subcontracts and subcontractors, and compliance information, among others.

New Coeus Web Passwords

Existing campus users of Coeus Web will need new passwords in order to access the new system.

UPDATE: To sign up to activate your account and receive a new Coeus Web password, to request a new account, or for more information on Berkeley Coeus Web and Coeus version 4, please contact Neil Maxwell (nmaxwell@berkeley.edu, 2-0123).

Please note that accounts established for departments are shared accounts; accounts for faculty are established for the individual faculty member.

More About the Berkeley Coeus 4 Upgrade

The Berkeley Coeus system is the institutional system of record for tracking all Berkeley campus research proposals and awards processed by the Sponsored Projects Office (SPO) and the Industry Alliances Office (IAO). Data captured in Coeus is passed automatically to the Berkeley Financial System (BFS) to establish and modify fund accounts for project spending, and is also used to provide required reports to the UC Office of the President.

The upgrade is a complete technical migration. The client application is now written in Java; upgrades from MIT will be incorporated as they are released, while at the same time preserving Berkeley customizations; the entire system runs on Campus Data Center Web Farm and database infrastructure; and all legacy data has been migrated to the new system.

The upgrade project lays the groundwork for future enhancements in a number of areas, including reporting and campus access to SPO data, conflict of interest disclosure tracking, routing and approval of proposals through the campus, and system-to-system submission of fully electronic proposals. When implemented, the new human and animal subjects protocol systems will be integrated with Coeus.

Berkeley Coeus Upgrade Coming Soon

noreply@blogger.com (Shelley Sprandel) — Tue, 13 Nov 2007 23:08:00 +0000

The Research Administration and Compliance Information Systems team (RAC-IS) is making final preparations to switch to the new, upgraded Berkeley Coeus version 4 in late November. The Berkeley Coeus system is the institutional system of record for tracking all Berkeley campus research proposals and awards processed by the Sponsored Projects Office (SPO) and the Industry Alliances Office (IAO). Data captured in Coeus is passed automatically to the Berkeley Financial System (BFS) to establish and modify fund accounts for project spending.

RAC-IS is working to make the transition to Coeus 4 as transparent and smooth as possible for the campus. However, during the move to the new system, Coeus may be unavailable for one to two days. The interruption in service will affect the Coeus to BFS feed for award set up as well as access to Coeus Web. Campus staff and faculty with possible issues related to award setup during this period may contact Kevin Phung (kphung@berkeley.edu). RAC-IS will provide more details on the move to Coeus 4 during the next several weeks.

The upgrade is a complete technical migration. The client application is now written in Java; upgrades from MIT will be incorporated as they are released, while at the same time preserving Berkeley customizations; the entire system will run on Campus Data Center Web Farm and database infrastructure; and all legacy data will be migrated to the new system. Benefits out of the box include enhanced capabilities for documenting proposal reviews, tracking agreement negotiations, managing subcontracts and subcontractors, and compliance information, among others.

The upgrade project lays the groundwork for future enhancements in a number of areas, including reporting and campus access to SPO data, conflict of interest disclosure tracking, routing and approval of proposals through the campus, and system-to-system submission of fully electronic proposals to the federal Grants.gov system. When implemented, the new human and animal subjects protocol systems will be integrated with Coeus.

RAC Offices to Close During the Annual Campus Winter Break

noreply@blogger.com (Shelley Sprandel) — Thu, 25 Oct 2007 23:10:00 +0000

The Office for the Protection of Human Subjects, Animal Care and Use Committee Office, and the Sponsored Projects Office, along with the Research Administration and Compliance Office, will be closed during the campus energy curtailment beginning Monday, December 24, 2007, through Tuesday, January 1, 2008. The RAC offices will also be closed for the afternoon on Thursday, December 13, 2007.

SPO Proposal Submission

Proposals with deadlines during the campus shutdown should arrive at SPO by Friday, December 7, 2007.
Proposals due at agencies in early January should be at SPO before Friday, December 14, 2007.

ACUC Protocol Submission

The deadline for protocol submission for the December 5, 2007 meeting is Monday, October 22, 2007.
The deadline for protocol submission for the January 23, 2008 meeting is Monday, December 10, 2007.

CPHS Protocol Submission

The deadline for protocol submission for the December 7, 2007 CPHS-I meeting is Monday, November 5, 2007.
The deadline for protocol submission for the December 14, 2007 CPHS-II meeting is Monday, November 12, 2007.
The deadline for protocol submission for the January 4, 2008 CPHS-I meeting is Monday, December 3, 2007.
The deadline for protocol submission for the January 18, 2008 CPHS-II meeting is Monday, December 10, 2007.
Please note that if your study was given full board review last January and approval will expire before January 4, 2008, you must submit your renewal application in time for review at a December 2007 CPHS meeting.

NIH Publishes September Extramural Nexus Newsletter

noreply@blogger.com (Shelley Sprandel) — Mon, 01 Oct 2007 16:47:00 +0000

The National Institutes of Health has published the September edition of NIH Extramual Nexus. The articles, linked below, include interviews, news, and updates from the agency.

For those planning on applying for NIH grants in the near future, a Use of Adobe Forms article explains that NIH will continue to use PureEdge forms at least through March 2008 grant application submission deadlines. A related article, Future Electronic Submission Transitions Still on Hold, states that the transition of NIH Training Grants (T), Career Development Awards (K), and Fellowships (F) to electronic application submission will not occur until Grants.gov can develop the new Adobe forms.

September NIH Extramual Nexus contents:

Work Begins on New Online Protocol Management System

noreply@blogger.com (Shelley Sprandel) — Mon, 06 Aug 2007 23:00:00 +0000

The Research Administration and Compliance Office is very pleased to report that work has begun on the “eProtocol” Project to implement an online protocol management system to support research projects involving human or animal subjects. The system is designed to replace manual, paper-based research protocol processes with a broadly distributed electronic system to simplify protocol submission, processing, and compliance monitoring. The Office of the CIO’s Technology Program Office is providing the services of Jon Conhaim who is representing RAC as project manager of the eProtocol Project.

Over the next months, we will be installing, configuring, testing, and performing a fit/gap analysis on the system. As part of this work, we will be interviewing faculty and OPHS, ACUC, and SPO staff to determine precisely how the system fits with our existing processes and what gaps may exist that will require process or system modifications.

We are excited to initiate this important project with outcomes that will benefit the entire campus.

RAC Forum: Save the Dates!

noreply@blogger.com (Shelley Sprandel) — Fri, 03 Aug 2007 00:47:00 +0000

The Research Administration and Compliance Office has scheduled the monthly RAC Forum meetings for the coming year. This year, we will be holding the RAC Forum on Wednesdays from 10:30 a.m. until noon. All meetings except for April will be held in the Tilden Room, 5th floor, ASUC Martin Luther King Jr. Student Union building. Please save the following dates:

September 12, 2007, 10:30-noon
October 10, 2007, 10:30-noon
November 14, 2007, 10:30-noon
December 12, 2007, 10:30-noon
January 16, 2008, 10:30-noon
February 13, 2008, 10:30-noon
March 12, 2008, 10:30-noon
April 16, 2008, 10:30-noon (location to be determined)
May 14, 2008, 10:30-noon
June 11, 2008, 10:30-noon

We will be sending the agenda for the September meeting soon. You can also check the RAC web site at http://rac.berkeley.edu/racforum.html.

As always, please feel free to contact us if you have ideas or suggestions for topics you'd like to see addressed at the meetings. We'll see you in September!

New Research Advocate Blog

noreply@blogger.com (Shelley Sprandel) — Thu, 31 May 2007 21:00:00 +0000

The Research Administration and Compliance Office is pleased to offer a new model for providing news to the campus: the Research Advocate weblog (or blog).

In the new model, news, information, updates, and other content is published dynamically as articles are written. A key feature is news feed technology. By subscribing to the news feed, you can receive new content automatically delivered to your web browser or RSS/Atom reader without your having to visit the site or check e-mail. RAC will continue to e-mail a notice every month with a table of contents linking to each article online.

Other features:

Seven-day rolling list of new awards received by the campus, updated daily.
Monthly summary of funding program announcements.
Articles are archived for easy browsing of back issues.
Article content is fully searchable.

The Research Advocate blog is published at http://news-rac.berkeley.edu.
For information on how to set up a news feed, see http://rac.berkeley.edu/aboutfeed.html.