December 19, 2007
On December 19, Congress approved the omnibus bill that includes the remaining 11 of the 12 appropriations to fund federal agencies for fiscal year 2008. The bill now goes to President Bush for signature. The federal fiscal year began on October 1.
In November, a separate appropriations bill for Defense Department spending was approved. That bill included a controversial provision to cap overhead on DOD-funded basic research grants and contracts at 35 percent.
For more information and detailed analysis see:
American Association for the Advancement of Science R&D Budget and Policy Program: Congress Wraps Up Another Disappointing Year for Federal R&D Funding
ScienceNOW Daily News article: A Budget Too Small
Association of American Universities: FY 2008 Budget & Appropriations Information
December 13, 2007
OMB published a final request for comments in the December 7 Federal Register on the new Federal Financial Report, including a copy of the proposed form (beginning on the 14th page of the PDF). Comments are due to OMB by January 7, 2008.
The announcement states that the “FFR standardizes reporting information by providing a pool of data elements from which agencies can choose to use for reporting purposes.” Federal agencies will not be not required to collect all of the information included in the FFR. Instead, agencies will identify, before or at the time the award is made, the data elements that recipients must complete, the reporting frequency, the periods covered by each report, report due dates, and where reports are to be submitted.
November 30, 2007
This change will mean that electronic applications will be considered “on-time” if all of the following criteria are met:
- All required registrations must be complete prior to the initial submission.
- Initial successful submission to Grants.gov must have a timestamp on/before 5:00 p.m. local time of the applicant organization on the receipt date.
- Applicants must correct errors and/or warnings within the two business days following the receipt date.
- All application corrections must be in response to a system-identified error/warning; application submissions with additional changes may be refused.
- If final submission is sent after the receipt date, a cover letter attachment must be included identifying the system-identified errors and warnings that have been corrected.
November 20, 2007
Investigators and staff considering upgrading to new Mac or Windows operating systems need to be aware of compatibility issues with PureEdge forms.
- Macintosh - PureEdge Special Edition Mac Viewer does not work with Mac OS X Leopard. To submit Grants.gov PureEdge forms on a Macintosh computer, either stay at OS X 10.4.6, use a virtualization product, install emulator software, or use a Windows terminal service. See Grants.gov “Apply” at Berkeley for more information on PureEdge on the Mac.
- Windows - PureEdge does not work with Microsoft Windows Vista, according to Grants.gov. To submit Grants.gov PureEdge forms, use Windows XP or follow Grants.gov guidance on Microsoft Vista and Office 2007 Compatibility.
November 14, 2007
Co-sponsored by University of California Davis and OHRP
Doubletree Hotel, Sacramento, CA
Friday, February 8, 2008
The Office for Human Research Protections (OHRP) in conjunction with the University of California Davis will be sponsoring a National Research Community Forum entitled, “Thinking Outside the Box: Addressing the Challenges of Human Subject Research in 2008,” on Friday, February 8, 2008, at the Doubletree Hotel in Sacramento California. Co-sponsors for this forum are the Northern California IRB Consortium Forum, the California State University Chancellor's Office, California State University Long Beach, the San Jose State University, and the California State University San Marcos.
This forum will focus on specific applications and interpretations of the regulations entitled, “Protecting Human Subjects” for conducting biomedical and behavioral research that is funded by the Department of Health and Human Services. The program will showcase experts from academia and the federal and state governments who will address unique aspects for balancing the principles of The Belmont Report in conjunction with federal and state laws and ensuring that the protection of human subjects in clinical trials is maximized. Representatives from the OHRP, U.S. Food and Drug Administration, National Institutes of Health, Department of Education, and the Department of Defense will provide federal regulatory updates and clarification of key policy issues.
This forum should be of special interest to those persons currently serving or about to begin serving as a member of an IRB as well as institutional officials and administrators, principal investigators, legal counsel, research staff, patient advocates, research sponsors, public health officials, privacy officials, compliance officers, laypersons and sponsors and contract research professionals.
Visit the UCD web site at http://www.research.ucdavis.edu/ohrpconference or contact Connie Koog at email@example.com.
November 13, 2007
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 (firstname.lastname@example.org). 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.
The objective of the initiative is to establish a uniform format for reporting performance on federally funded research projects. The proposed format is for interim progress reports only. A similar format may be considered for final reports after this RPPR initiative.
Comments are due at NSF by January 8, 2008. The November 9 Federal Register notice and draft report are available at http://www.nsf.gov/bfa/dias/policy/rppr/index.jsp.
October 25, 2007
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.
- 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.
- 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.
October 24, 2007
If you have already submitted a report to DOE containing Protected PII, DOE asks that you contact your DOE contracting officer immediately. Technical reports submitted to the DOE Energy Link System that were marked as publicly releasable “unlimited announcement” will be made public through DOE public web systems.
Public PII versus Protected PII
PII is any information about an individual which can be used to distinguish or trace an individual’s identity. Some information that is considered to be PII is available in public sources such as telephone books, public websites, university listings, etc. This type of information is considered to be Public PII and includes, for example, first and last name, address, work telephone number, email address, home telephone number, and general educational credentials.
In contrast, Protected PII is defined as an individual’s first name or first initial and last name in combination with any one or more of types of information, including, but not limited to, social security number, passport number, credit card numbers, clearances, bank numbers, biometrics, date and place of birth, mother’s maiden name, criminal, medical and financial records, educational transcripts, etc.
October 11, 2007
For an example of what can go wrong, the Sponsored Projects Office had a recent Grants.gov experience in which a SPO staff member was trying to replace a budget on a PureEdge file that was very large because of the number of scanned PDF attachments. Trying to work with this large file caused the SPO computer to hang, which resulted in wiping out all the information in the PureEdge file. Fortunately, SPO had a backup copy of the file. SPO technical staff worked to reduce the size of this file by optimizing the PDF attachments, then the SPO research administrator was able to upload the revised file in time to meet the Grants.gov deadline that afternoon.
For an example of what is considered large, the National Institutes of Health expects an average R01 application to be in the six to 10 megabyte (MB) range with 99 percent of applications falling under 40 MB. NIH provides guidance on file size in the NIH Frequently Asked Questions on electronic submission. One basic tip from NIH is to avoid scanning text documents to produce PDFs. Instead, NIH recommends producing the documents electronically using text or word-processing software and then converting documents to PDF, and making scanned documents the exception rather than the rule when preparing an application.
What You Can Do
• Start Early and Ask for Help
Please start working on your application early, especially if you are using Grants.gov for the first time. If you are new to Grants.gov, preparing applications for electronic submission, or need help with the process, contact SPO staff early.
When scanning documents is necessary, for example when collaboration letters need to be included with the proposal, set the scanner at 150 dpi (dots per inch) instead of a higher resolution. In some cases, an even lower resolution, such as 72 dpi, might work without sacrificing readability.
When preparing images to include in a PDF, reduce the size or resolution in an imaging editing program and use compression such as JPEG to save images. Please note that when experimenting with resolution, make sure the results are suitable before making changes that can't be undone.
• Optimizing PDFs
After creating a PDF, use Acrobat or other software to optimize the file and reduce the file size. Check the help menu or user manual to determine the best method for file reduction. For example, in Acrobat 8 Professional, there are several ways to optimize files: Document -> Reduce File Size, Document -> Optimize Scanned PDF, Save As, and PDF Optimizer. Acrobat 7 also provides tools to reduce PDF file size, as does Acrobat 6.
Computer System Requirements
If you are still having trouble working with files even when reducing size whenever possible, you might need a more powerful computer. Grants.gov provides the minimum requirements for PureEdge, but depending on the file types and applications you work with to create the final PureEdge file, this configuration may be inadequate. Grants.gov states that for PureEdge Viewer to function properly, your computer must meet the following system requirements: Windows 98, ME, NT 4.0, 2000, XP; 500 MHz processor; 128 MB of RAM; 40 MB disk space; Web browser: Internet Explorer 5.01 or higher, Netscape Communicator 4.5 - 4.8, Netscape 6.1, 6.2, or 7. SPO desktop machines have a 2 GHz processor, 1 GB RAM, and an 80-160 GB disk.
IBM has provided Special Edition Mac Viewers for PPC and Intel running Macintosh OS 10.4 or higher that are available for download. If that solution does not work and if you do not have a Windows operating system, you will need to use a Windows Emulation program. SPO provides more information on using Grants.gov with a Macintosh computer.
October 05, 2007
The American Association for the Advancement of Science R&D Budget and Policy Program provides up-to-date information and analysis on the federal budget process, including the status of FY 2008 appropriations, as does the Association of American Universities.
The National Institutes of Health issued guidance on Non-Competing Grant Awards Under the Current Continuing Resolution in the October 5 NIH Guide, stating:
“Until the final FY 2008 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 80% of the previously committed level). This is consistent with our practice during the CRs of FY 2006 & 2007. 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.”
August 20 Research Advocate article: America COMPETES Act to Fund Federal STEM Programs
Deadlines for upcoming programs:
Komen Postdoctoral Fellowships - Full Application
* Deadline to SPO: October 9
* Deadline to Komen Foundation: October 16
Komen Career Catalyst Research - Full Application
* Deadline to SPO: November 1
* Deadline to Komen Foundation: November 8
Komen Investigator Initiated Research - Full Application
* Deadline to SPO: November 1
* Deadline to Komen Foundation: November 8
Komen Promise Grants - Full Application
* Deadline to SPO: November 27
* Deadline to Komen Foundation: December 4
When preparing your Komen application, please indictate Ms. Jyl Baldwin, Assistant Director, as the signing official. The contact information to use in proposal preparation is:
Grants Contract Official: Jyl Baldwin, (510) 642-8117, email@example.com
Alternate Grants Contract Official: This is your SPO contact person on the SPO staff assignment list
Financial Official: Cynthia Kane, (510) 642-1371, firstname.lastname@example.org
Media Contact: Marie Felde, (510) 642-3734, email@example.com
Technology Transfer Official: Carol Mimura, (510) 643-7201, firstname.lastname@example.org
If you have questions, the SPO staff assignments for the Komen foundation and other nonprofit agencies is listed at http://www.spo.berkeley.edu/Staffnonfederal.html.
October 01, 2007
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:
- News From the Director of OER: Creating and Maintaining a Sustainable Scientific Workforce
- In Their Own Words: An Interview with OPASI Director Dr. Alan Krensky
- New Resource for Advancing Innovative Technologies Joins the Commercial Assistance Program
- The NIH System for Enhancing the Science, Safety and Ethics of Recombinant DNA Research
- OER NIH Policy for GWAS Data Sharing Announced
- Powerful Award Trend Resource in the Works
- Eye on PI: NIH Educational Debt Repayment Available to Ph.D. Research Scientists; From Commerce to the Community: New Patent Rules Issued ; Principal Investigator’s eRA Commons Account; Multi PI Update
- Electronic Submission Update: Updated Application Guides Now Available; Future Electronic Submission Transitions Still on Hold; Use of Adobe Forms
- Roadmap Update: NIH Director Announces Recipients of New Innovator Award; NIH Director’s 2007 Pioneer Awardees Announced at Symposium; NIH Interdisciplinary Research Consortia Launched
- NIH Regional Consultation Meetings on Peer Review Available in October
- House and Senate Approve New Bill Extending FDA Authority
- Science in the News
- Guide Notices
September 27, 2007
The Notice highlights the change to the NSF Intellectual Merit Review Criterion to specifically include review of the extent to which a proposal also suggests and explores potentially transformative concepts. The full text of the newly revised Criterion is:
What is the intellectual merit of the proposed activity?
How important is the proposed activity to advancing knowledge and understanding within its own field or across different fields? How well qualified is the proposer (individual or team) to conduct the project? (If appropriate, the reviewer will comment on the quality of prior work.) To what extent does the proposed activity suggest and explore creative, original, or potentially transformative concepts? How well conceived and organized is the proposed activity? Is there sufficient access to resources?
Effective October 1, 2007, the Grant Proposal Guide and new funding opportunities issued after this date will incorporate the change to the Intellectual Merit Criterion. Proposals received after January 5, 2008, will be subject to the revised Merit Review Criterion.
October 1, 2007 Update: NSF Revises PAPPG to Include New Criterion
NSF has published a revised version of the NSF Proposal & Award Policies & Procedures Guide (PAPPG), NSF 08-1. The revisions were made only to the Grant Proposal Guide (GPG); all other parts of the PAPPG remain unchanged. The significant changes made to the GPG include the revision of the intellectual merit review criterion to specifically include language on potentially transformative research, updated guidance on the designated fonts that may be used when preparing an NSF proposal, and the requirement that organizations must be registered in the Central Contractor Registration prior to submitting a proposal to NSF. NSF notes that while the changes are effective for proposals submitted on or after January 5, 2008, proposers are strongly encouraged to begin complying with the guidance as soon as possible.
July 2007 Research Advocate article: NSF Asked to Plan New Transformative Research Initiative
September 21, 2007
The Berkeley campus subscribes to the Community of Science (COS) and IRIS funding opportunities databases; each is accessible on any computer with a berkeley.edu address. COS and IRIS can be used to search or browse program announcements in all areas from federal and regional government sponsors, foundations, and other organizations. The program listings provide full information on each funding opportunity and links to the agency program announcements.
If you are new to using IRIS or COS, the best way to start may be to use the keyword search to select one or more areas of interest, then browse the search results. If the results are too extensive, narrow the search by adding a qualifier or two. The IRIS Help File and COS Instructions are recommended reading for search tips and guidance.
IRIS also provides listings of programs with upcoming deadlines in over twenty subject areas. The lists are divided into two groups: one for all academic levels, and the other for graduate students and undergraduates.
For help using the COS and IRIS databases or for an individual funding search for Berkeley faculty, contact Shelley Sprandel at email@example.com or 2-8122.
Other SPO Resources
The SPO web site has additional resources on funding program information. The funding page provides the following:
- Links to IRIS and COS
- Recently announced federal, UC, nonprofit, and other funding programs, sorted by agency, providing the deadline, a brief summary, and a link to the agency solicitation
- Lists of grant programs in specific categories, with approximate deadlines, program summaries, and links to the program web sites: equipment; travel; young faculty; and postdoctoral research in the biological sciences, social sciences, and humanities
- Funding alert services that provide email notification of new grant programs, including Grants.gov, the Foundation Center, the National Science Foundation, and the National Institutes of Health
- Limited submission programs that limit the number of applications that can come from one institution, with instructions and deadlines for the Berkeley campus
- Lists of links to federal, nonprofit, State of California, and UC funding program web sites
August 21, 2007
Responding to concerns that this trend may be having negative impacts on the academic research community, NSF established the Impact of Proposal and Award Management Mechanisms Working Group (IPAMM) in March 2006. IPAMM was charged to “recommend policies and preferred practices to improve NSF’s program announcement and solicitation processes in ways that achieve appropriate balances between proposal funding rates, award sizes and award duration in the various types of awards that comprise the total NSF portfolio, with the emphasis on individual, investigator-initiated grants.”
NSF published the final report on IPAMM’s study, Impact of Proposal and Award Management Mechanisms, on August 8.
IPAMM Recommendations (from the NSF press release)
1. NSF should require that each of the directorates and research offices develop an overarching strategic framework, incorporating flexible management approaches.
2. Long-term planning for accommodating growth in the communities and infrastructure built by research investments (including both physical infrastructure and human resources) must be incorporated when developing new funding opportunities.
3. The practice of limiting the number of proposals that a principal investigator or institution may submit is appropriate in some situations but should be considered in the context of relevant trade-offs and impacts on the community.
4. Careful consideration should be given to the short-term use of various management practices to increase the number of awards and reduce the need to revise and resubmit highly rated proposals.
5. NSF management should inform the appropriate internal and external communities when implementing new proposal management practices and should monitor their concerns during implementation.
6. NSF should ensure that the community has access to specific and accurate statistical data on funding rates; this will include evaluating the Budget Internet Information System and updating it, as needed.
7. NSF should annually update trend analyses for internal review, and include it in the annual Report on the NSF Merit Review Process to the Board.
August 20, 2007
The Act provides over $40 billion total for fiscal years 2008 to 2010 for STEM programs across federal agencies. Some highlights of the package include:
- $22 billion for the National Science Foundation, putting NSF on a path to double in budget approximately seven years, increasing support for a variety of programs including the Integrative Graduate Education and Research Traineeship (IGERT) program, CAREER grants for young faculty, and a new program of seed grants.
- Nearly $17 billion for Energy Department programs, keeping the Office of Science on a seven-year doubling path, and establishing an Advanced Research Projects Agency (ARPA-E), patterned after DARPA, to support high-risk, high-reward research.
- A new Technology Innovation Program (TIP) at the National Institute of Standards and Technology, replacing the Advanced Technology Program but allowing university participation.
- September 12, 2007 – Chicago
- October 8, 2007 – New York City
- October 25, 2007 – San Francisco
Agenda: NIH Regional Consultation Meetings on Peer Review
|9:00–9:15 ||Meeting context and review of ongoing activities |
Dr. Lawrence Tabak
Director, National Institute of Dental and Craniofacial Research, NIH
Co-Chair of the Working Group of the Advisory Committee to the NIH Director (ACD) on NIH Peer Review
|9:15–9:30 ||Goals for the meeting |
Dr. Keith Yamamoto
Executive Vice Dean, School of Medicine, UCSF
Professor, Cellular/Molecular Pharmacology and Biochemistry/Biophysics, UCSF
Co-Chair of the Working Group of the Advisory Committee to the NIH Director (ACD) on NIH Peer Review
|9:30–10:30 ||Statements/proposals from External Scientific Community offering specific strategies or tactics for enhancing NIH peer review and research support|
|10:45–11:45 ||Open discussion: Response to emerging themes |
As part of our iterative process we welcome feedback about a series of issues/suggestions that have been made thus far- these will be posted on the website in advance of the meeting
Drs. Yamamoto and Tabak, Facilitators
|11:45–12:45 ||Open Discussion |
1) Challenges and opportunities for NIH system of research support
2) Challenges and opportunities for NIH peer review
Drs. Yamamoto and Tabak, Facilitators
|12:45–1:00 ||Closing Remarks|
Drs. Yamamoto and Tabak
August 06, 2007
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.
August 02, 2007
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!
Rates for awards with start dates prior to July 1, 2006 will remain at their current levels for the remaining life of the award, including non-competing budget periods. The new rate schedule applies to new awards (including new competing budget periods) received on or after July 1, 2006. Thus the overhead rate applied to a multi-year on-campus competitive research award received on or after July 1, 2006 will be 52 percent through June 30, 2007, 53 percent from July 1, 2007 through June 30, 2009, and 53.5 percent thereafter.
These rates will be applied automatically by the Controller's Office. For questions concerning how these rates apply to your contracts and grants, contact your representative at the Sponsored Projects Office. For questions on how F&A rates are determined, contact Gregg Carr at firstname.lastname@example.org or 3-7564.
7/1/06 - 6/30/07, 52.0%
7/1/07 - 6/30/09, 53%
7/1/09 - 6/30/11, 53.5%
7/1/06 - 6/30/11, 26.0%
7/1/06 - 6/30/07, 50.0%
7/1/07 - 6/30/09, 56%
7/1/09 - 6/30/11, 56.5%
7/1/06 - 6/30/11, 26.0%
OTHER SPONSORED PROJECTS
7/1/06 - 6/30/07, 30.0%
7/1/07 - 6/30/09, 33%
7/1/09 - 6/30/11, 33.5%
7/1/06 - 6/30/07, 17.0%
7/1/07 - 6/30/11, 19.0%
SPACE SCIENCES LABORATORY
7/1/06 - 6/30/07, 38.0%
7/1/07 - 6/30/11, 29.0%
7/1/06 - 6/30/07, 17.0%
7/1/07 - 6/30/11, 16.6%
*The F&A rate used for most federally sponsored training awards is 8% of total costs.
August 01, 2007
The new OER site includes the following new features and changes:
- New overall look and feel with updated graphics;
- New site features, with content managers, updated header, site navigation, right-side information area and footer;
- New content pages, providing an overview of the NIH grants process and more;
- Many updated web pages, some with significant content changes;
- Some pages removed and other actions taken;
- Links to the redesigned eRA web site.
July 27, 2007
The eRA Commons web-based FSR system allows participants to view information on currently due and late FSRs as well as submit FSRs electronically to the NIH. Additional resources including a user guide and an online demonstration can be found on the eRA Commons Support Page.
July 26, 2007
No definite date was given for when federal agencies would begin using the new Adobe Forms for applications instead of PureEdge, but it appears likely that most if not all agencies will not be using Adobe until September at the earliest. The National Institutes of Health will not be finalizing plans until the new forms have been thoroughly tested, and once plans are finalized NIH will make every effort to give 60 days notice prior to transitioning any program.
As of July 19, all 147 Grants.gov forms had been converted to Adobe Forms. Both individual forms and form “families” are now being tested, with 60 forms in production. Grants.gov plans to have all 147 forms available for agencies to use on September 6.
Applicants need to be aware that currently Grants.gov Adobe Forms are compatible only with Adobe Reader version 7.0.9. Using Adobe Reader 8.0 or 8.1 may cause the application to fail validation after submission and thus be rejected by Grants.gov. Adobe is working on these incompatibility issues, and is targeting a permanent resolution for the September/October timeframe.
- Stakeholder Communications: http://grants.gov/resources/stakeholder_communications.jsp
- Webcast Questions/Comments with guidance on Acrobat compatibility: http://grants.gov/assets/WebcastQ&A071907.pdf
- Grants.gov user guides, updated to include Adobe Forms: http://grants.gov/help/user_guides.jsp.
- FAQ on Adobe and PureEdge : http://grants.gov/help/faq.jsp
- Adobe Statement on Acrobat compatibility issues: http://grants.gov/aboutgrants/technical_alerts.jsp
(revised on 9/12/2007 to include MTDC information)
July 24, 2007
The CPHS follows the P&P in approving, recommending modifications, and in extremely rare cases, suspending or terminating research involving human subjects. UC Berkeley operates within the regulations and guidelines set forth by federal authorities, primarily the Office for Human Research Protections and the Food and Drug Administration, and other bodies such as the International Conference of Harmonisation, all based upon ethical principles elucidated in the Belmont Report. Many of the policies and procedures are derived from these regulations.
The P&P Table of Contents has embedded links to the document sections, making navigation easier. CPHS will post Attachments and Grant-Protocol Review sections soon.
July 16, 2007
Research.gov will be a one-stop web site that will provide a menu of services in a single portal for research institutions and grantees to conduct electronic grants business with federal agencies and to find information about agency policies and upcoming events. The portal will also help federal agencies share grants management best practices as part of the Grants Management Line of Business. The portal is intended to focus on the needs of grantees, provide maximum flexibility to account for differing agency strategies, and allow the best tools to be offered from any research agency.
NSF plans to deploy the portal and initial set of services in fiscal year 2008. Presentations on Research.gov are available at NSF: November 2006 Powerpoint and Spring 2007 NSF Update (starting on page 57). The latter includes a sample image of features and tools the portal might offer.
Services planned for the portal include a tool for grant applicants to check a list of all proposals submitted to Research.gov partner agencies, a tool to submit federal financial reports, a project-reporting tool, and tools to request funds disbursement and payments. The portal would also link to Grants.gov to find grant opportunities and apply for funding, iEdison to report inventions, NSF FastLane, as well as other services and systems.
According to NSF, federal research agencies will sign up to offer services to grantees through these tools, and NSF will recover operations costs through a fee-for-service arrangement. NSF has already successfully conducted an Application Status pilot with the USDA Cooperative State Research, Education, and Extension Service (CSREES), which allows principal investigators to check the status of their USDA CSREES and NSF proposals at one site.
July 12, 2007
Comments are due by
UPDATE: NIH has extended the deadline for comments to September 7, 2007 (August 9 NIH Guide notice).
July 06, 2007
The NSB recently published a report, Enhancing Support of Transformative Research at the National Science Foundation, that recommends that NSF “enhance its ability to identify and fund transformative research” and develop a new Transformative Research Initiative “distinguishable by its potential impact on prevailing paradigms and by the potential to create new fields of science, to develop new technologies and open new frontiers.”
The report states that the “Initiative is meant to be only the first step toward achieving a broader and longer-term capacity for supporting revolutionary ideas within NSF and, more importantly, toward providing the freedom that encourages greater boldness of ideas and aspirations within the research community.”
The NSB has asked NSF to report back with a preliminary plan for the Transformative Research Initiative by the August 2007 Board meeting.
June 29, 2007
In the past, federal holidays were included in the two weekdays allowed for the application viewing window. Beginning with the July 4, 2007 holiday, federal holidays will be excluded from the two weekday application viewing window and all applications will be held for at least two full, non-holiday weekdays (Monday-Friday).
The ten federal holidays are: New Years Day, Birthday of Martin Luther King, Jr., Washington’s Birthday, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day.
June 15, 2007
- Clarify message text and application guide instructions for the most frequent error and warning messages.
- Remove many warning messages (more than 50 percent of the R01 warnings received have been flagged for removal).
- Increase system tolerance for minor inconsistencies in names provided in the application when compared to names included in the eRA Commons profile.
- When possible, change “errors” to “warnings” to allow the submission to proceed.
- Soften the tone of messages and reserve more explicit language or descriptions for cases where delays in application processing are most likely to occur.
- Critically examine errors and warnings that are not required for review and could be addressed prior to award.
June 11, 2007
Defense Instrumentation Programs: DURIP Deadline is August 21; MURI LOIs Due August 6, MURI Proposals Due October 23
The program will provide approximately $40 million in FY 2008 to purchase research equipment that costs $50,000 or more. Individual awards will not exceed $1,000,000. In FY 2007, awards ranged from approximately $50,000 to $950,000, averaging $205,000; very few awards exceeded $500,000. Awards are typically one year in length.
The solicitation is available at http://www.afosr.af.mil/pdfs/afosr_baa_2007_9_2.pdf. The proposal deadline is August 21, 2007. Proposals may be submitted electronically through Grants.gov or in hard copy.
AFOSR, ARO, and ONR are also requesting proposals for the FY 2008 Multidisciplinary University Research Initiative (MURI) program. The MURI program supports basic science and/or engineering research at U.S. institutions of higher education that is of critical importance to national defense. The program is focused on multidisciplinary research efforts that intersect more than one traditional science and engineering discipline to address issues of critical concern to the DoD. The FY 2008 MURI competition is for the 19 topics listed in the Broad Agency Announcement.
Total amount of funding for five years is estimated to be about $207 million. It is anticipated that the maximum award will be $1.5 million per year, with the actual amount contingent on availability of funds, the specific topic, and the scope of the proposed work.
The agency program announcements are posted at Grants.gov: ONR, AFOSR, and ARO. Applicants are encouraged to submit white papers (by email or in hard copy) by August 6, 2007, to minimize the labor and cost associated with the production of full proposals that are unlikely to be selected for funding. The deadline for full proposals deadline is October 23, 2007. Proposals may be submitted electronically through Grants.gov or in hard copy.
May 31, 2007
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.
- 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.
For information on how to set up a news feed, see http://rac.berkeley.edu/aboutfeed.html.
Research Advocate News Feed: RSS | Atom
What are RSS and Atom?
RSS (or Really Simple Syndication) and Atom are two types of web feed formats specified in XML (a generic specification for data formats) and used for Web syndication. RSS and Atom delivers information as an XML file called a feed, web feed, RSS stream, or RSS channel. Feeds provide a way for users to easily receive newly released content.
How to Subscribe
To subscribe to a feed, you will need a feed reader or aggregator. Web browsers, email software, and web-based news sites offer a variety of RSS subscription features. You may already have a feed reader built into software you are already using.
The links below have instructions on how to use some of the more common feed readers:
Browsers: Firefox 2, Internet Explorer 7 (PC only), Opera 9, Safari (Mac only)
Email Software: Mozilla Thunderbird
Portals: Google Reader, MyYahoo
Other Feed Readers: RSS Compendium list, Open Directory Project list
Wikipedia article: Web feed
Once you have set up a feed reader, to subscribe to the news feed, click
Research Advocate RSS feed or Research Advocate Atom feed or go to the Research Advocate blog and click on the links under News Feed on the right column. If you would like a feed only for specific topic areas, you can alternately subscribe to one or more links here:
- Research Advocate News Feed - all topic areas: RSS | Atom
- Research Advocate News Feed - Animal Care and Use (ACUC): RSS | Atom
- Research Advocate News Feed - Conflict of Interest (COI): RSS | Atom
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- Research Advocate News Feed - Sponsored Projects (SPO): RSS | Atom
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May 29, 2007
Memo - Vice Chancellor for Research Office, University of California, Berkeley - February 7, 2006
Sender: Beth Burnside, Vice Chancellor for Research
To: All Academic Titles, Deans, Directors, Department Chairs
Subject: UC Requirement to submit all proposals and to receive all awards for grants and contracts
Since December 1994, it has been University of California policy that all employees who receive any part of their salary through the University, or whose activities use any University resources or facilities, must submit all proposals and receive all awards for extramural support through the appropriate central office, i.e. Sponsored Project Office (SPO) or Industry Alliances Office (IAO). This requirement is necessary to insure that all extramurally funded projects are screened for their compliance with relevant University, state, and federal policies and guidelines, and to insure the appropriate exercise of UCB's fiscal responsibility for all extramural awards.
The purpose of this memorandum is to update and replace the Cerny memorandum of January 3, 1995, implementing the December 15, 1994 UC policy on proposal submission and award acceptance. This policy can be viewed at http://www.spo.berkeley.edu/Policy/grantpolicy.html.
Although this policy remains in effect, there have been an increasing number of cases where faculty have submitted proposals directly to funding sources rather than sending them through SPO or IAO. The authority to implement and carry out the proposal submission policy for the Berkeley campus has been delegated to me as the Vice Chancellor for Research. On behalf of the campus administration, I am writing to strongly reiterate that it is absolutely essential that all UCB faculty and staff comply with UC policy by submitting all grant or contract proposals for extramural funding and accepting all grant or contract awards through SPO or IAO.
Effective immediately, the campus will refuse to accept any grant or contract for extramural funding that has not been appropriately submitted through SPO or IAO. If SPO or IAO receive an award document for a proposal not formally and appropriately submitted through SPO or IAO, the award will be declined. Exceptions may be made only in highly exceptional cases and must be approved in advance and in writing by the Chancellor.
If you have any questions about this memorandum, please contact my office. Thank you, in advance, for protecting Berkeley's research enterprise by helping us make sure that UC, state, and federal requirements are fulfilled.
Vice Chancellor for Research, and
Professor of Cell and Developmental Biology
UCB source - February 7, 2006 memo
Memo - Office of the Chancellor, University of California, Berkeley - January 3, 1995
BERKELEY: OFFICE OF THE CHANCELLOR
January 3, 1995
DEANS, DIRECTORS, DEPARTMENT CHAIRS, ADMINISTRATIVE OFFICERS
SUBJECT: Policy on the Requirement to Submit Proposals and to Receive Awards for Grants and Contracts Through the University
This memorandum transmits the new University of California Policy on the Requirement to Submit Proposals and to Receive Awards for Grants and Contracts through the University. This policy is effective immediately.
This new policy states that all employees who receive any part of their salary through the University, or whose activities use any University resources or facilities, must submit their proposals for extramural support through the appropriate local contracts and grants office. Exceptions to this policy may be granted by the Chancellor in unusual circumstances on a case by case basis. If an exception to policy is made, the name of the University shall not be used by the external party under any circumstances.
The authority to implement and carry out this policy for the Berkeley campus has been delegated to me, as the Vice Chancellor for Research. Implementation will begin immediately and will include all currently funded extramural awards, renewals and continuations of current awards, and all new proposals. All currently funded awards must be transferred to the campus if projects involve any effort, salary recovery, use of University resources or facilities, or name the Berkeley campus as the performance site. These transfers must be in process by February 15, 1995. Exceptions will be considered on a case by case basis; however, there will be no blanket exceptions for an organization or individual. Fellowships made directly to a student, post-doctoral fellow, or faculty member will not be affected by this policy.
Any request for exception should be made in writing to the Vice Chancellor for Research, with a copy of the proposal attached. Requests must be reviewed and approved by the appropriate department chair or unit director. Justifications should include a detailed description of the activities to take place outside normal employment and a clear distinction of the difference between service to the University and service to be provided to the external party.
If you have any questions about this new policy or how to request an exemption, please contact Joyce Freedman, Director of the Sponsored Projects Office, at 642-8110.
Joseph Cerny, Vice Chancellor for Research
Memo - Office of the President, University of California - December 15, 1994
University of California
Office of the President
December 15, 1994
POLICY ON THE REQUIREMENT TO SUBMIT PROPOSALS AND TO RECEIVE AWARDS FOR GRANTS AND CONTRACTS THROUGH THE UNIVERSITY
It is the policy of the University of California that employees who receive any part of their salary through the University, or whose activities use any University resources or facilities, must submit their proposals for extramural support through the appropriate local contracts and grants office. Awards must be made to The Regents of the University of California.
This requirement is necessary to insure that all research and other extramurally funded projects conducted by University employees, or with the use of University resources or facilities, are approved by the appropriate University contract and grant office and comply with relevant University policies and guidelines, including but not limited to those governing:
- integrity in research;
- appropriateness of the activity to the University;
- protection of human and animal subjects and the environment;
- use of University facilities;
- adherence to personnel policies;
- compensation plans;
- intellectual property;
- conflicts of interest;
- recovery of direct and indirect costs;
- liability insurance and indemnification; and
- medical malpractice coverage.
In the case of projects to be conducted by the UniVersity in collaboration with other organizations, the University can be either the prime contractor or a subcontractor. In all cases, all resources required for the conduct of the portion of the work which will be directed by University employees must be included in the award to the University.
Exceptions to the requirement to submit proposals and awards through the University may be granted by Chancellors in unusual circumstances on a case by case basis, after consideration of the policy areas cited above, when it is in the best interest of the University. When an exception is granted, there must be a clear distinction between service to the University and service to the external party; relevant personnel policies shall be followed; the name of the University shall not be used by the external party; and in no case shall the University assume liability for a third party's action without the approval of The Regents as required by the Bylaws and Standing Orders of The Regents.
UCOP source - December 15, 1994 memo
May 17, 2007
On May 23rd, the University of California will launch an online Conflict of Interest Briefing for researchers at all UC locations.
The Briefing, which takes about 30 minutes to complete, is designed to help researchers recognize and deal with conflict of interest situations that may arise during their work. The new Conflict of Interest Briefing was developed by a UC team that included members of the faculty and research staffs from various campuses, headed by the UCOP Office of Research, with a vendor, Workplace Answers. Like the Ethics Briefing, which was rolled out to the campus in April, the Briefing can be taken on any computer with Internet access.
Not all Principal Investigators or those with research responsibilities will be required to take the Briefing. Researchers have been identified as those individuals in the various professorial
and research title series who received more than $1000 in salary from selected extramural funding sources over the past 12 months. On May 23rd, the selected Berkeley researchers will receive an email from email@example.com with a personalized link that will direct
them to the new Conflict of Interest Briefing.
As with the Ethics Briefing, individuals are encouraged to complete the Conflict of Interest Briefing soon after they receive the email notification. The Briefing will remain available to them for their reference throughout the year. Researchers are encouraged to bookmark the link/Briefing so that they may refer to it in the future.
Questions regarding the conflict of interest briefing may be directed to firstname.lastname@example.org.
May 09, 2007
The position will provide the required review and submission of proposals; negotiation of agreements; and all non-financial post-award actions on behalf of the Regents of the University of California and in accordance with federal, state and University regulations and policies. Specifically, as a lead analyst in SPO, the Senior Administrative Analyst is responsible for a wide range of duties including: contract and grant proposal review and submission, negotiation and acceptance of awards, award administration, sponsor relations, professional development, training and mentoring of less experienced staff within SPO and across campus, contract/grant data maintenance, and other related duties as assigned.
The job description is posted at http://www.spo.berkeley.edu/position.html. The position is online on http://jobs.berkeley.edu/ under the “Administration/Management” job category, job requisition is #006438.
May 08, 2007
The National Institutes of Health recently made a variety of changes throughout the eRA Commons system, particularly in the eSNAP function. NIH provides a summary of specific changes in a May 4 NIH Guide announcement. Some key changes are described below.
PIs now have the ability to delegate to any commons-registered individual with an ASST role the ability to view the status of electronically submitted applications. This new menu choice is found in Admin/Account/Delegate Status. Once in the Delegate Status screen, PIs will see a list of all the individuals registered with the ASST role and can manage the ability to “Delegate” and “Remove” delegation for those individuals. Once this delegation has been granted, the individual with the delegated authority will be able to view and access the list of applications associated with the PI. Individuals can have this authority delegated to them by more than one PI. Please note, that the view these delegated individuals now has is equivalent to that of a signing official (SO View) and as such does not include access to confidential information; e.g., summary statements and priority scores. For detailed instructions on how to delegate this authority see eRA Commons Release Notes Version 184.108.40.206.
For electronically submitted applications that involve separately submitted confidential reference letters (e.g., NIH Director’s Pioneer Award), a feature has been added to electronically monitor the submission of these letters. This monitoring feature appears within the Person Profile where a Reference Letter menu choice now appears. This feature lists only data items appropriate for monitoring the submission of reference letters but does not provide access to the actual documents.
Transitioning to the SF424 Research and Related (R&R) introduced a new business practice for measuring effort devoted to a project—person months. Personnel working on projects now indicate effort by indicating the number of calendar, academic, and/or summer months. To keep a consistent business practice in place for all applications and progress reports, eSNAP has been revised to reflect this new effort measure in two areas: 1) PI Effort, found on the Edit Business/Org Info screen; and, 2) effort for all Key Personnel on the Edit Business/Key Personnel screen. Any edits to the Key Personnel section will require that the user convert annual effort to person months for all Key Personnel listed. Frequently Asked Questions for Person Months and a Conversion Calculator Tool are available at http://grants.nih.gov/grants/policy/person_months_faqs.htm.
The PRF issued new application forms for Type AC grants on April 30, 2007 and now requires principal investigators to provide a one-page description of what has been done previously in their area of research and then provide a description of how and why the work in the submitted proposal is “new.” Beginning with proposals submitted for consideration at the Winter 2008 PRF Advisory Board meeting, AC proposals that are deemed as ongoing research will be disqualifed.
April 18, 2007
The webcast included a demonstration of the new platform. The steps for applicants are the same as in the current system, and the forms appear approximately the same. Applicants should not have any trouble learning to use the new forms. The only software required is the free Adobe Reader, version 7.0.9.
The Grants.gov staff will be updating the user guides and FAQs soon, and adding a new section to the Grants.gov web site for updates on the transition.
Grants.gov is hosting an “Adobe Day” webcast on May 3 from 11:00 a.m. until noon. Adobe Day will provide information on using Adobe Reader to complete grant applications, show how the new forms will look and act, and discuss changes between PureEdge and Adobe. Check the Grants.gov “What’s New This Week” in the coming days for more information.
The presentation slides and the webcast are available on the Grants.gov site at http://www.grants.gov/resources/stakeholder_communications.jsp.
April 16, 2007
The document comprises two previously stand-alone policy documents: the NSF Grant Proposal Guide and the Grant Policy Manual. The new Guide has two sections: the Grant Proposal Guide and the Award and Administration Guide. Each section has a summary of significant changes.
One change is NSF specifies the four fonts that may be used when preparing an NSF proposal. The page formatting section also has been revised to state that a standard, single-column format should be used in the body of the proposal.
Another changes eliminates the previous statutory (one percent) cost-sharing requirement. In accordance with prior Congressional requirements, NSF previously required that each grantee share in the cost of research projects resulting from unsolicited proposals. The appropriations providing funds to NSF no longer contain this language.
April 15, 2007
- Detailed definitions have been added to differentiate between Principal Investigator status and Project Director status.
- All references to “Program Director” have been deleted (throughout).
- Statement governing University employment has been revised to reflect current campus appointment procedures (2.-d.).
- Statement added regarding “continuing status” remaining in effect until revoked by the requesting campus department or unit (4.-a.).
- Procedures have been updated to comply with current campus review procedures (5.).
- All references to “co-Principal Investigator” status have been removed to comply with federal agency policies (throughout).
Please direct any questions regarding this revised policy to Laura Mays in the Office of the Vice Chancellor for Research at 642-9689, or email@example.com.
The policy describes how contract and grant funds must be spent for the campus to be in compliance with applicable state and federal law, and other sponsor terms and conditions. Campus policy is dictated by cost principles contained in Office of Management and Budget (OMB) Circular A-21, which governs our grants, contracts and other agreements with the federal government. For federally sponsored projects, including federal flow-through awards, administrative costs may be charged directly to a sponsored project only under certain specified circumstances. The campus policy and associated materials define administrative and technical costs and provide a framework for determining whether various costs qualify as direct charges to sponsored awards.
The staff of the Controller’s, Extramural Funds Accounting, and Sponsored Projects Offices, and those of Financial and Management Analysis are available to assist investigators and staff with questions.
Cost Principles for Contracts & Grants (Sponsored Agreements):
Frequently Asked Questions - Cost Principles for Sponsored Agreements (Contracts and Grants):
Quick Guide on Administrative Costs on Federally Funded Projects:
The Sponsored Projects Office Proposal Review Form (PRF) has been revised to include “major project” administrative costs and use of human stem cells. The revised form also has yes/no checkboxes instead of yes and includes web links to related policy and procedure. The PRF instructions have also been updated. Please begin using the revised PRF immediately. The form is available online at http://www.spo.berkeley.edu/forms/UCForms.html#PRF.
Limited Submission Form Revised
The Limited Submission Cover Sheet has been updated with a new field for other information that might be requested for campus review purposes, depending on agency program requirements. Also, some of the form field names have been changed for clarity. Please use the new form immediately.The form and information on limited submission programs is available at http://www.spo.berkeley.edu/fund/limited.html.
In limited submission programs, the sponsor restricts the number of applications or proposals a campus can submit to the agency. The guidelines for these programs require institutions to screen preproposals or nominations to determine which applications will be submitted for competition. The Cover Sheet is submitted with campus applications.
Non-Federal Team News
The Sponsored Projects Office has made some changes to non-federal team assignments. SPO has recruited Deborah Rutkowski-Howard (formerly in Molecular and Cellular Biology), and Roslyn Kartychak is now serving as Proposal Coordinator for the non-federal team.
The non-federal team has also recently assigned research administrators by department instead of by sponsor. Nonprofits, private foundations, UC-funded programs, foreign agreements, and other state and local government agreements are assigned by department. State of California agencies are the exception — all State agencies will continue to be handled by Betsy Quayle. Another exception is non-federal limited submission programs, which will be handled by Deborah Rutkowski-Howard.
Please refer to the SPO agency assignment list (http://www.spo.berkeley.edu/Staffnonfederal.html) to locate the research administrator assigned to your unit. If you have questions or concerns about this change, please contact Paula Burkhart, Assistant Director, Non-Federal Projects (firstname.lastname@example.org, 2-8110). SPO believes departmental assignments for these sponsors will serve the campus better and is interested in feedback about the rearrangement of responsibilities.
Federal Team News
The SPO federal team now has a department assignment list for NIH and NSF agencies. The list is available at http://www.spo.berkeley.edu/StaffNIHNSF.html. Research administrators are assigned to the most active units. If your department does not have a staff person assigned, you can contact any of the one of the three SPO research administrators for NSF or NIH, or when you submit a proposal it will be assigned to a specific administrator.
New Web Page Lists ERA Links
The SPO web site has a new page that lists federal, UC, and nonfederal funding agencies and the systems each uses for electronic research administration. The page is available at http://www.spo.berkeley.edu/Procedures/eralinks.html.
The Committee for Protection of Human Subjects posted revised forms on March 5, 2007, and is now requiring use of these new forms. Forms are available on the CPHS web site at http://cphs.berkeley.edu/content/forms.htm. Please delete all old versions that you may have downloaded to your local PC.
SPO Proposal Number
The Office for the Protection of Human Subjects must have the SPO Proposal Number on the CPHS Cover Sheet for all funding supporting human subjects research when the funding requests have been submitted through the Sponsored Projects Office. Please make sure you list the SPO Proposal Number in the appropriate box under Part III of the Application Cover Sheet if the funding is pending or even if an award has been made.
The SPO Proposal Number is an eight-digit number beginning with the fiscal year (e.g., 20071234) and is available for Coeus web users immediately after proposals are logged in by SPO. The number is included in the proposal notice that is sent by email to investigators and administrative staff after the proposal has been submitted.
For access to Coeus web site reports, please check with your departmental administrator. For more information about Coeus department accounts, please contact Neil Maxwell or Nancy Han in RAC Information Systems.
Revised Requirements for Continuing Review Submissions
To ease the administrative burden on investigators, CPHS/OPHS has changed the submission requirements for applications for Expedited or Full Committee Continuing Review and Approval. Effective immediately, submission of copies of the current, approved protocol narrative will not be necessary under the following specific conditions:
(1) At the time of renewal submission, NO CHANGES are being proposed to the protocol, including personnel or funding changes. The research that will be conducted in the coming year is exactly as described in the current, active approved protocol on file with CPHS/OPHS; and
(2) The current, approved protocol – which includes any amendments that may have been approved and incorporated in the narrative during the past year – must be written in the CPHS narrative format of September 2005 or the most recent version revised in March 2007.
Also, for studies that are moving into a “data analysis-only” phase, investigators will no longer need to submit consent forms, recruitment materials, or a protocol narrative at the time of continuing review, as long as the only change to the approved protocol is that there is no longer any data collection or subject intervention occurring. If the protocol format has not been updated since September 2005, but the study is moving into a data analysis-only phase now, an updated protocol version will not be required. However, if an investigator wishes to collect additional data and/or recruit new subjects, the protocol narrative in the current version as required at that time must be submitted before the protocol amendment will be reviewed and approved.
Submit Protocols Early
CPHS/OPHS is in the midst of the busiest time of the year as investigators want to get protocols reviewed and approved in time for summer research activities. OPHS strongly advises investigators to submit their projects as soon as possible as all but the full committee protocols are reviewed on a rolling, first-come, first-served basis. Between March and June we are essentially unable to handle “rush” requests due to the huge volume of protocols, so get your protocols in as soon as possible!