SPONSORED PROJECTS

Research Newsletter 2006

January 19 , 2006

This newsletter is written for faculty, postdoctoral researchers, students, and staff who are interested in current research news, as well as conferences and funding opportunities. It is written / compiled by Rosemary Alexander (rosemary.alexander@case.edu), Diane Weitzen (diane.weitzen@case.edu), and Tracy Wilson-Holden (tracy.wilson-holden@case.edu). Editor: Rosemary Alexander

To receive email notifications that new editions of the newsletter have been posted, as well as other occasional important email announcements, subscribe to the Office of Sponsored Projects Administration (OSPA) e-list, ORANews, by emailing Rosemary Alexander.

News Archive: Previous newsletter issues

Sponsored Projects News

Case News

Live Demonstrations at Research ShowCASE 2006 April 5th and 6th, 2006

Research ShowCASE 2006 will include an exciting variety of live demonstrations.  Come and see how SimMan, the life-size simulation test dummy, is used for training at the Case Flight Nurse Academy.  Come and play Planarity, the popular on-line video game inspired by a Case algorithm class.   Take a virtual art museum tour with holographic displays of Stargazer as part of a Cleveland Museum of Art Virtual Worlds project.  The options are many.  Replay for Kids will be on site to collect toys that will be redesigned for kids with disabilities.  FES Center participants will be present, and there will be presentations from the Department of Dance as well.

The fourth annual Research ShowCASE will be held on Wednesday, April 5th and Thursday, April 6th, 2006 at the Case Western Reserve University (Case) Veale Convocation Center. We look forward to a great event that will highlight the quality and quantity of research performed at Case, jumpstart collaboration and drive new opportunities forward. For more information about the event, please visit the Research ShowCASE 2006 website at: http://showcase.case.edu .

Free Sorvall Ultracentrifuge - a give-away!
The Case BL-3 Core Facility of the Center for AIDS Research has an OTD70B Ultracentrifuge from Sorvall to give away. Details below in the Research Equipment Resources section.

Important!!! HUBZone Vendor, Burrows Travel Is No Longer in Business! But Midtown Scientific, Source of Laboratory Supplies & Office Supplies May Substitute To Help Meet HUBZone Quotas
In case you overlooked the notice in the last newsletter, we are repeating it. If you have a federal Small Business Subcontracting Plan, you are likely to have promised to use Burrows Travel to purchase all or part of your travel because they were a HUBZone vendor (Historically Underutilized Business Zone) and we probably had no other HUBZone vendor when you formulated your Plan. Meeting these subcontracting goals is very important because there are penalties for not doing so, monetary and otherwise.

Unfortunately, Burrows Travel, has gone out of business. Burrows was a HUBZone vendor, a rare find for a research contract. BUT -- Midtown Scientific, a small business featured in the last edition of the Research Newsletter, IS a HUBZone vendor. Midtown is also women-owned and minority-owned. Midtown may be able to meet your needs sufficiently to allow you to fill those HUBZone subcontracting goals. In fact, because they provide such a wide variety of laboratory supplies allowing you purchasing choices beyond just travel, they may be able to help you meet those goals even better than Burrows could have. One item, by the way, that they are also able to provide, but which is not mentioned on their flier, is office supplies, which nearly every project needs.

If you find you are not able to meet your subcontracting goals, contact Rosemary Alexander (368-2008) about renegotiating the goals in your Plan with the federal agency, which is entirely possible when there is a reasonable cause.

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Federal News

American Association for the Advancement of Science (AAAS) Report:
Congress Finishes FY 2006 Appropriations, Caps a Disappointing Year for R&D Funding
"On December 30, nearly three months into the fiscal year, President Bush signed the last two FY 2006 appropriations bills into law, bringing the FY 2006 appropriations process to a close. AAAS estimates that the federal R&D portfolio totals $134.8 billion in 2006, a $2.2 billion or 1.7 percent increase. But 97 percent of the increase goes to just two areas: defense weapons development and human space exploration technologies. Funding for all other federal R&D programs collectively will barely increase, and will fall nearly 2 percent after adjusting for inflation. Leaving out large federal investments in development, congressional appropriations for basic and applied research total $57.0 billion, an increase of $1.0 billion or 1.8 percent over 2005. But NASA applied research on human space flight technologies accounts for a majority of the increase, leaving most agency research portfolios with modest increases falling short of inflation, or cuts.

Many flagship federal science agencies have disappointing budgets in 2006: the National Institutes of Health (NIH) budget falls for the first time in 36 years; the National Science Foundation (NSF) wins a small increase but has less in real terms for its research portfolio than in any of the last three years; the Department of Energy (DOE) Office of Science budget declines, and despite big increases in development funding, the Department of Defense (DOD) basic research funding declines.

For several measures of the federal R&D investment, final FY 2006 appropriations represent another year on a downward slope from the highs of a few years ago. For trend after trend, big increases leading up to 2003 flattened out more recently, and now funding is headed down in real terms.

Details of final FY 2006 appropriations of R&D are now available in the FY 2006 appropriations wrap-up, a preview of the forthcoming Congressional Action on R&D in the FY 2006 Budget.

AAAS R&D Funding Updates on final FY 2006 R&D appropriations are also available on the AAAS R&D web site for the 12 top R&D funding agencies.

Full link to the FY 2006 appropriations wrap-up: http://www.aaas.org/spp/rd/upd1205.htm "

Department of Health and Human Services: Call for grant reviewers
HRSA needs new and experienced grant reviewers with expertise in

• Health professions training
• HIV/AIDS
• Maternal and child health
• Organ transplantation
• Primary care for underserved people
• Rural health

Grant reviewers help HRSA select the best programs from competitive groups of applicants. Reviewers are chosen for specific grant programs, based on their knowledge, education and experience. Grant review panels are selected to reflect diversity of ethnicity, gender, experience and geography. If interested, click https://grants.hrsa.gov/webReview/

Free Citrix Server for non-Windows users of Grants.gov
To make Grant.gov compatible with the many platforms used in the applicant community, Citrix and PureEdge were made available for non-Windows grant applicants as of December 20, 2005. All non-Windows users can now download and complete the PureEdge forms, and submit them through the free Citrix server.

Non-Windows users may continue to search and download grant opportunity application packages using their existing web browser. To start using the new Citrix feature for application completion, download Citrix and the PureEdge Client. Non-windows users may also find this PureEdge Support for Non-Windows Users page helpful.

Click here for step-by-step instructions for submission are located on the Grants.gov web
site.

Technical support is available at support@grants.gov or visit Grants.gov at http://grants.gov/MacSupport

Further support for Mac users and other non-Windows users (Linux, Unix, GMU, etc.):
PureEdge Mac support tips and Installation tips.

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NIH

NIH Financial Policy for Grant Awards – FY 2006
Notice: NOT-OD-06-025
National Institutes of Health (NIH)
The NIH appropriation for FY 2006 includes an across-the-board reduction to non-emergency, discretionary programs, which has a direct impact on NIH's budget. The NIH share of this adjustment is approximately $286 million. NIH has established the following financial polices consistent with this appropriation.

• Research Project Grants (RPG) (http://grants.nih.gov/grants/glossary.htm#resproj)
  Non-competing awards for every RPG will be awarded at a level of 97.65% of the amount indicated for the FY2006 budget period in the Notice of Grant Award for the previous budget year. The amounts indicated for future budget periods will also be adjusted by the same factor.
  
  Non-competing awards previously issued in FY 2006 at reduced levels up to 80% of the amount previously indicated, per NOT-OD-06-014, will be revised to provide a restoration of funds to the 97.65% level. Amounts indicated for future budget periods will be adjusted as well.
  
  The amounts provided for competing RPGs will be managed to an average award amount equal to FY 2005 levels. FY 2006 policy includes the provision of a 3% escalation factor in the amounts indicated for future years on competing RPG awards which are not based on modular applications.
  
  
• National Research Service Awards (Fellowships and Training Grants)
  This policy is published in a separate notice as mentioned below. (See notice NOT-OD-06-026)
  
  
• Other Grant Programs
  Other grant programs will be managed in accordance with the policies to be established by each Institute and Center. Questions regarding adjustments applied on individual grant awards may be directed to the Grants Management Specialist identified on the Notice of Award.

Subsequent Notices in the NIH Guide will address Legislative Mandates and Salary Limitations for the FY 2006 Appropriation.

Click here for the full announcement.

NIH Salary Limitation on Grants, Cooperative Agreements, and Contracts
Notice: NOT-HS-06-031
National Institutes of Health (NIH)
Effective January 1, 2006, the AHRQ Executive Level I annual salary rate has been increased from $180,100 to $183,500. Click here to read the notice and full details regarding implementation and limitations.

NIH Makes Major Changes to Its Grant Application Process
The National Institutes of Health (NIH) received its first round of grant applications electronically through the Federal web portal of Grants.gov. Almost 2,000 small business and conference grant applications streamed in electronically to NIH for December receipt dates via Grants.gov, marking a major stride forward in NIH’s ongoing electronic submission efforts.  

December 1, 2005 was the first transition date. All SBIR/STTR applications had to be submitted using the new Standard Form 424 Research and Research Related, SF424 (R&R). Over the next year and a half, NIH will be phasing in use of the electronic SF424 for all competing research grant programs (mechanisms, such as R01, R03, etc.), gradually phasing out use of the paper submission of the PHS 398. Applicants should take careful note of the transition schedule (timeline) to ensure they are using the appropriate mode of application transmission and application form. Click here for a graphic representation of the phased transition timeline. Applications for the transition submission date of a mechanism (even if submitted in advance of the date) and thereafter must use the SF424 (R&R) form and be submitted electronically through Grants.gov. Once a mechanism transitions, the change applies to all subsequent Requests for Applications and Program Announcements. No paper applications will be accepted for transitioned mechanisms.  More info at: NIH Extramural Research Electronic Submission's website.

Rebroadcast of January 11th NIH New Electronic Application Process (SF424) Webcast
For those of you who missed the January 11th webcast, NIH has provided a site at which to view the taped seminars, for both morning and afternoon. So while you may missed the opportunity to ask questions, you can at least view the seminar. To view the rebroadcast, go to http://videocast.nih.gov/PastEvents.asp?c=998 . The title to look for is: NIH's New Electronic Grant Application Process and the SF424 (R+R). The videos for both the morning and afternoon sessions may be viewed. The handouts may also be downloaded from this URL.

Policy Revision of the National Institute of Neurological Disorders and Stroke (NINDS) for Competing Program Project (P01/P50) Grant Application
Notice: NOT-NS-06-004
National Institute of Neurological Disorders and Stroke (NINDS)

The program project grant is an important and valuable mechanism for advancing collaborative science in areas relevant to the NINDS. This Notice announces a policy revision related to NINDS P01 and P50 applications.

Effective with the February 1, 2006 receipt date (October 2006 council), NINDS program project applications will no longer be percentiled. Funding strategies will be based upon scientific and technical merit, Institute priorities, and availability of funds.

The full set of policies and procedures related to NINDS program project grants is available at
http://www.ninds.nih.gov/funding/ppg_guidelines.htm

For program project grant applications, as well as applications requesting $500,000 or more in direct costs (exclusive of any consortium F&A costs) for any year, the applicant must:

1. Contact the NINDS program staff at least 6 weeks before submitting the application
2. Obtain agreement from the NINDS staff that NINDS will accept the application for consideration for awards
3. Include a cover letter with the application identifying the NINDS staff member who agreed to accept assignment of the application. Additional information on this policy is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
   

Restructuring of Ruth L. Kirschstein National Research Service Award Institutional Research Training Grants (T32 and T35) Supported by the National Institute of Environmental Health Sciences
Notice: NOT-ES-06-007
National Institute of Environmental Health Sciences (NIEHS)

The National Institute of Environmental Health Sciences (NIEHS) announced the restructuring and redirection of its Ruth L. Kirschstein National Research Service Award (NRSA) institutional research training programs (T32 and T35).

The restructuring includes:

1. A definition of the scope of the research training to better reflect the areas of research within the mission of the NIEHS
2. A definition of the expected research base for training grant support
3. A requirement of the ratio of predoctoral vs. postdoctoral training slots to be supported in the NIEHS funded NRSA T32 programs
4. A change in eligibility for T35 short-term training programs to comply with current NIH guidelines
5. An enforcement of the standard page limitation for the research training program plan for T32 and T35 grant applications and suggested formats for tabular information.

These changes will be effective for competing NIEHS renewal and new T32 and T35 applications beginning with applications submitted in response to the May 10, 2006 receipt date. Click here to read the full announcement.

Ruth L. Kirschstein National Research Service Award (NRSA) Stipend and Other Budgetary Levels Effective for Fiscal Year 2006
Notice: NOT-OD-06-026
National Institutes of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)
Health Resources Services Administration (HRSA)

The stipend levels for Fiscal Year (FY) 2006 Kirschstein-NRSA awards for undergraduate, predoctoral and postdoctoral trainees and fellows are provided in this announcement, as are the Training Related Expenses for trainees and the Institutional Allowance for individual fellows for FY 2006.

The Budgetary Categories Described in this Notice Are Effective Only for Kirschstein-NRSA Awards Made with FY 2006 Funds. Click here to read the full announcement.

Why Does NIH Need OPASI?
Excerpt from COSSA Washington Update, Vol. 24, Issue 22, December 12, 2005

As reported the December issue of the Case Research Newsletter, OPASI is the newly formed NIH Office of Portfolio Analysis and Strategic Initiatives charged with providing NIH and its constituent centers and institutes "an intellectual home for developing new methods and techniques to manage NIH's large and complex scientific portfolios". As reported in COSSA, according to National Institutes of Health (NIH) Deputy Director Raynard Kington, "...NIH requires a mechanism to coordinate the assessment and management of its overall portfolio.  There is also a need for a transparent, systematic process for coding funding related to specific diseases and conditions, along with the need to provide the ability to assess scientific opportunities within public health needs and integrating them into NIH-wide funding priorities.   He emphasized NIH’s need to continually evaluate the benefits and impact of NIH research investments.  Ultimately, OPASI will allow the NIH “to be nimble, dynamic, and responsive to emerging scientific demands and opportunity,” Kington stated.

Kington explained that a weakness of the NIH structure is the challenge to coordinate funding in areas that cut across and/or between the missions of the ICs.  He cited the area of obesity as an example, noting that it had been identified as a public health challenge at least ten years ago.  Yet, only recently has  NIH developed a coherent trans-agency strategic plan that cut across the missions of the ICs, Kington contended. ...

"He then provided additional detail about OPASI’s three Divisions:  Resource Development and Analysis (DRDA), Strategic Coordination (DSC), and Evaluation and Systemic Assessments (DESA). " He further elaborated on each division's functions. These details are available in the complete article at: COSSA, Vol. 24, Issue 22

More details on OPASI at:

• New NIH Office of Portfolio Analysis (OPASI) to Provide ‘Incubator Space’ for Novel Ideas
  an article by Carla Garnett, NIH Record, Vol LVII, No.25
• NIH Record, Vol. LVII, No.25
• Federal Register Notice, Sept. 28, 2005 (Vol. 70, No.187)

Two Research Centers Join the NIDA Clinical Trials Network (Will Serve Eastern Ohio Population)
The National Institute on Drug Abuse (NIDA), National Institutes of Health, announced January 3rd the establishment of two new Clinical Trials Network (CTN) affiliates, thus enhancing NIDA’s research infrastructure to test drug addiction treatments in real-life settings with diverse patient populations.

" 'Our goal is to improve the quality of drug abuse treatment throughout the nation, using science as the vehicle. Research conducted through the CTN will shorten the time it takes to bring laboratory research findings about drug abuse and addiction to useful implementation in real-life community treatment settings,' says NIDA Director, Dr. Nora D. Volkow. The new nodes are:

• The Texas Node, which comprises the University of Texas Southwestern Medical Center in Dallas and eleven community treatment providers in Dallas-Ft. Worth, Austin, and El Paso; and
  
  
• The Appalachian Tri-State Node, which includes a research group at Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center, in partnership with five community treatment providers in West Virginia, eastern Ohio, and western Pennsylvania . ..." For full text of article, click here.
  
  

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NSF

Ben Franklin Web Portal Brings the Man to the Masses
NSF Press Release 06-006 - excerpt
"In time for the 300th anniversary of Benjamin Franklin's birth, a Web portal (http://ben.clusty.com) based on clustering technology is offering a new method to separate useful Franklin facts from the normal flood of online information. ...

Carnegie Mellon University computer scientist Raul Valdes-Perez and graduate students Chris Palmer and Jerome Pesenti created the underlying clustering algorithms in the early 1990s - with support from the National Science Foundation (NSF) and Pa.'s appropriately named Ben Franklin economic development initiative. The researchers founded Vivísimo and improved upon the technology, furthering the engine's development with NSF Small Business Innovation Research grants.

Since its development, various users have applied the software to both institutional and World-Wide Web searches. Most recently, the U.S. General Services Administration chose Vivísimo's platform for a re-launch of the FirstGov.gov search, the U.S. government's official search gateway for government web pages. ... "

For the complete article, click here.

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NASA

NASA's FY 2006 Budget and Planning Documents
www.nasa.gov/about/budget/index.html

The NASA FY2006 budget and planning documents may be downloaded via the above URL. Per the introductory summary, NASA received a 2.4 percent increase for FY2006 "...to meet established critical priorities and milestones."
The summary further states:
"The FY 2006 budget identifies what is needed to continue transforming America’s civil space
program. It preserves the priorities, milestones, and schedules introduced with the Vision in the FY
2005 budget, and it supports NASA’s continuing organizational and cultural transformation through
new management organizations and a revised budget structure consistent with the
recommendations of the President’s Commission on Implementation of the United States Space
Exploration Policy (Aldridge Commission). The budget for FY 2006 continues to support the Vision
for Space Exploration and is reflected in The New Age of Exploration: NASA’s Direction for 2005
and Beyond, a new document that outlines NASA’s strategic planning efforts and the Agency’s
commitment to implementing and achieving the Vision. The New Age of Exploration also establishes
the new NASA Strategic Objectives that are reflected in the FY 2006 Budget.
The 2006 budget maintains a focus on key exploration priorities and critical milestones informed by
NASA’s science priorities:

• First Step—Space Shuttle return to flight and completion of International Space Station assembly.
• Flagship Program—Project Constellation (maintain 2008 CEV flight demonstration).
• Technology Base—Critical exploration technologies.
• Transforming Technologies—Project Prometheus (flight demonstration in a decade).
• Robotic Precursors—Lunar missions beginning in 2008 and Mars missions added in 2011.
• Shuttle Transition—ISS cargo and crew services via near-term commercial service.
• Scientific Breakthroughs—Exploration of the solar system and the universe (e.g., James Webb Space
• Telescope to be launched in 2011) and the search for Earth-like planets.

The budget also supports critical national needs and revolutionary technologies in aeronautics,
climate change, and education.

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Miscellany

A Useful Internet Tool for Economists - Economics Search Engine (ESE)
The Economics Search Engine, ESE ("ease"), searches the sites listed in Resources for Economists on the Internet (RFE), a guide sponsored by the American Economic Association, and Economics Departments, Institutes and Research Centers in the World (EDIRC). It indexes 300,000 pages on 10,000 economics web sites from around the world, providing contents only in its search results. ESE is driven by the Nutch Search Engine. To access ESE, click http://ese.rfe.org. Bill Goffe at the University of New York at Oswego welcomes questions and comments about ESE.

The Patent Epidemic
Excerpt from Business Week Online, January 9, 2006, Legal Affairs
"It's wasting companies' money and slowing the development of new products. A man 'has a right to use his knife to cut his meat, a fork to hold it; may a patentee take from him the right to combine their use on the same subject?' -- Thomas Jefferson "
"A coalition of businesses, including Microsoft (MSFT ), Cisco Systems (CSCO ), VF, Hallmark Cards, and Fortune Brands (FO ) has jointly filed its own brief in the KSR case asking the Supreme Court to take corrective action. Two dozen intellectual-property law professors have made a similar filing. Massive over patenting, the professors say, 'creates an unnecessary drag on innovation,' forcing companies to redesign their products, pony up license fees for technology that should be free, and even deter some research altogether." For full text of article, click here.

Absurd Patents
While we're on the subject of patents, you may enjoy the following URL, www.patent.freeserve.co.uk/othersites.html, which is a list of absurd and unusual patents, like the wax egg-shaped self-defense device to be carried in one's mouth until attacked; at which time one chews through it, and directs the contents, citric acid, into the eye of one's assailant. (Look under Patent of the Week, "Attack Preventing Device".) Or -- a method of swinging on a swing, side to side by pulling on one chain and then the other. (On the same page & called ------ "Method of Swinging on a Swing") Or -- the "Baby Patting Machine": It mounts on the crib rails and swings a gloved "hand" back and forth in a pendulum motion to pat the baby on the behind, thus inducing it to sleep.

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Compliance News

AAHRPP Site Visit
As many of you are aware, Case Western Reserve University has applied for accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP).  This nearly three-year process will culminate the week of January 23-26 with the AAHRPP site visit.  Researchers, IRB members, and administrators from Case, University Hospitals of Cleveland and MetroHealth will be interviewed by a team from the association.  The team will review our human research protection programs and examine specific research protocols.  We appreciate the cooperation and hard work of all individuals who have been selected for interviews.  Look for results from AAHRPP’s visit in the next few months.

VA Prohibits use of Its IRB Registration Number on Grants Awarded to Case
Federal officials have announced that VA IRBs (Institutional Review Boards) cannot act as the “IRB of Record” for non-VA institutions.  (As a result Case, University Hospitals of Cleveland and The MetroHealth System have removed the Cleveland VAMC IRB from their respective Federalwide Assurances.)  This change will affect researchers who conduct research at the VA where Case is the grantee.  In such cases, the PI must obtain IRB approval from the VA IRB and an additional review from the Case, UHC or MHS IRB, as appropriate, even if the research will not be conducted outside of the Cleveland VAMC. 

In the case where the research will only be conducted at the Cleveland VAMC, the other IRB Administrative Offices have agreed to accept a copy of the VA IRB’s application to lower the administrative burden of these changes.  However, if the research will be conducted at both the VA and UHC or MHS then investigators will need to complete the appropriate application for the non-VA institution as well.

Please note that if investigators are submitting new or continuing applications they need to replace the VA IRB number with the appropriate substitute.  See the Case Humans Subjects Website for current Assurance and IRB Registration numbers.  Questions regarding these changes can be forwarded to Christian LaMantia, Case Office of Research Compliance, at clt@case.edu or 216-368-4513.

Continuing Research Education Credit (CREC) Program Receives National Attention
Case Western Reserve University’s CREC program was highlighted in the January 2006 issue of IRB Advisor as a model program for addressing the continuing education needs of our diverse research community.  Christian LaMantia, Assistant Vice President, Office of Research Compliance, was interviewed about the challenges associated with creating the web-based training program.  The article highlights the successful inclusion of meaningful educational opportunities for biomedical and non-biomedical researchers at various experience levels.

CREC—Are You Up To Date??
As the new semester gets underway, just a reminder that all principal investigators and key personnel are required to be certified in the protection of human subjects.  The Case Western Reserve University Continuing Research Education Credit (CREC) program tracks all affiliated researchers and provides updates of CREC certified individuals to the IRBs.

Initial certification is available only through the online program (CITI) accessed through the Office of Research Compliance website.

Following initial certification, participants are required to obtain 12 continuing education credits every three years.  Many recertification options are available including attending approved seminars on campus, CREC Online (video presentations with quizzes), online courses with quizzes, and attending outside seminars on the protection of human subjects.

The Office of Research Compliance Website provides information on all CREC options at http://ora.ra.cwru.edu/research/orc/crec/index.cfm. 

To check the status of your CREC credits, use your CWRU ID and log onto Spiderweb using the following link https://ora.ra.cwru.edu/spiderweb/.

Upcoming CREC Credit Opportunities, February 2006

The Research Seminar Series for February is offering a variety of choices, including two seminars qualifying for CREC credit.

Look for more CREC seminars and other topics of interest in the upcoming months.  Register for any of these presentations and check out the full Research Seminar calendar at http://ora.ra.cwru.edu/research/orc/education/onlinecalendar.cfm.

ORC Welcomes New Education Administrator
The Case Office of Research Compliance (ORC) is pleased to announce that Tracy Wilson-Holden has joined our staff as the Education Administrator.  Tracy will be managing the Research Seminar Series, the ORC contributions to this newsletter, and the ORC website.  Please feel free to contact her with any human subjects educational questions and concerns, as well as suggestions for future seminar topics.  Tracy can be reached at tracy.wilson-holden@case.edu or 216-368-6131.

IBC Nearing Completion of Online Application Process
The Institutional Biosafety Committee (IBC) is currently at work on a new system that will allow investigators to make online submissions of new recombinant DNA protocols, continuing review updates and terminations of active protocols.  Look for the system to be completed within the next few months.

OHRP Launches New Spanish Website
In an effort to better meet the needs of Spanish-speaking IRB members and investigators, OHRP has instituted a Spanish webpage that includes

1. 45CFR 46, subparts A,B,C and D
2. Instructions for registering an IRB
3. Instructions for IRB updates
4. Terms of the Federalwide Assurance (FWA)
5. Instructions for FWA application
6. Instructions for FWA updates

The site is http://www.hhs.gov/ohrp/espanol/intro.htm

University of Pittsburgh Project Coordinator Debarred for Fabricating Records
A University of Pittsburgh project coordinator has been debarred by the Department of Health and Human Services (HHS) for fabricating data. Jessica Lee Grol will be unable to participate in federally funded research for a period of three years as a result of findings from investigations by the university and the Office of Research Integrity.  She was found to have fabricated patient interview data, data-tracking forms and medical records extraction

IRB Tip of the Month – Reading Level of the Informed Consent Document
According to the Case Western Reserve University IRB Guidebook, informed consent information should be written at a reading level “no higher than 8th grade, or appropriate to the subject population”.  However, a study published in the February 20, 2003 issue of The New England Journal of Medicine found that the average consent form was written at a 10th-grade reading level.  According to The Informatics Review, strategies that increase comprehension include:

• Keeping sentences short (most important for increasing comprehension)
• Avoiding jargon
• Using terminology familiar to your audience
• Using primarily simple, declarative sentences

Research Seminar Series

The Office of Sponsored Projects Administration (OSPA) and the Office of Research Compliance (ORC) offer frequent seminars throughout the year. To view the Research Seminars schedule in full, click here. Below are the upcoming seminars. Many of the seminars require online registration. The announcement will specify. If you have never registered online for the Research Seminars, you must first click here to establish an account for this and future registrations. If you need assistance with the registration process, contact Maureen Dore-Arshenovitz at mxd4@case.edu. Registrations are not confirmed until one week before the event.

January Seminars
February Seminars
March Seminars

Introduction to Proposal Writing - FILLED! Closed to registration.
Thursday, January 26, 2006
Wolstein Auditorium
8:30 am - 12:00 pm
CREC Credits: N/A
Robert A. Lucas, Director of the Institute for Scholarly Activity

Introduction to the New Cancer Center IRB
Friday, February 3, 2006
Wolstein 1413
9:00-10:30 am
CREC Credits: 4
This session will be presented by Mariesa Malinowski, Administrative Director of the Case Cancer IRB. Mariesa will describe the newly established Case Cancer IRB and its relationships among Case Western Reserve University, Cleveland Clinic Foundation, University Hospitals of Cleveland and the Case Comprehensive Cancer Center. Discussions will include key regulatory developments, current operating procedures and the current status of Case Cancer IRB activity. Anyone interested in the process for obtaining Case Cancer IRB review and approval for all cancer related research studies should attend. 4 CREC credits will be awarded to attendees.
Registration is online only. Click here to register.

Effort Reporting
Friday, February 10, 2006
Wolstein 1413
9:00 -10:30 am
CREC Credits: N/A
The compensation and effort reporting practices of recipients of NIH awards are receiving increased national attention. This is a result of several high-profile, multi-million dollar settlements between major research universities and the NIH for alleged effort reporting problems and recent NIH statements clarifying the requirements for including clinical practice compensation as part of the institutional base salary. In light of this trend, Dr. Eric Cottington, Associate Vice President for Research, will present an overview of effort reporting requirements as they pertain to federally sponsored research and discuss Case's planned changes to the current effort reporting system. Since these changes will go into effect in February 2006, your attendance is strongly encouraged.
Registration is online only. Click here to register.

Ask the IRB Administrator
Thursday, February 16, 2006
Biomedical Research Building 105 - Frohring Auditorium
9:00 am -10:30 am
CREC Credits: 4
Policy and procedural changes have been put into place as a result of the accreditation process and newly revised regulatory mandates (i.e. VA IRB status). This seminar will give researchers from PIs to research coordinators to students a chance to ask IRB representatives from Case, University Hospitals of Cleveland, The MetroHealth System, The Louis Stokes Cleveland Department of Veterans Affairs Medical Center, and The Cleveland Clinic about the revised policies. Christian LaMantia, Case Office of Research Compliance, will moderate the panel and will also be there to answer questions about the CREC Program and newly revised Case Human Subject Research Policy. Coffee can be purchased at the BRB Cafeteria next to the auditorium. 4 CREC credits will be awarded to attendees.
Registration is online only. Click here to register.

Grants.gov and the NIH Electronic Submission Process
Friday, February 24, 2006
Biomedical Research Building 105 - Frohring Auditorium
11:30 am – 1:00 pm
Eric Cottington, Case's AVP for Research, will present information concerning grants.gov – the federal gateway for submitting applications electronically – and the NIH electronic submission process for faculty and department administrators involved in grants administration. NIH has recently announced a timeline and phased process for utilizing grants.gov such that all proposals will be submitted electronically to NIH by May 2007. Specific information about this process and the requisite tools will be presented.
Registration is online only. Click here to register.

Data Management: Policies and Practices
Friday, March 10, 2006
Biomedical Research Building 105 - Frohring Auditorium
9:00 AM - 10:30 AM
CREC Credits: N/A   
Dr. Eric Cottington, Associate Vice President for Research, will address issues related to the management of research data. Several case studies will be used to address the following questions: What is research data? Why is research data management important? How should research data be managed? Who owns the research data? How is data management affected by collaborative research and peer review issues? What resources are available to assist with research data management?
Registration is online only. Click here to register.

Mission Possible: Setting Up a Research Database
Friday, March 24, 2006
Biomedical Research Building 105 - Frohring Auditorium
CREC Credits: 4
This seminar will explore how to submit an IRB application to create a research database from research and/or non-research sources. For example, a clinical department investigator may have collected data on a certain disease state that could be re-analyzed for a separate study. Can this occur without her fellow department member having to get consent or authorization from previous subjects? How do we adequately protect confidentiality and facilitate meaningful research at the same time? Christian LaMantia, Case Office of Research Compliance, will provide a framework to design an application that can be applied to both non-biomedical (i.e. student performance data) and biomedical research proposals. The discussion will cover DHHS, FDA, HIPPA and FERPA regulations. 4 CREC credits will be awarded to attendees.
Registration is online only. Click here to register.

Writing Informed Consent Documents
Friday, March 31, 2006
Nord Hall 310
CREC Credits: 4
Isabel Sanchez, Case Western Reserve University’s IRB Director, will discuss the essential components of the informed consent process for behavioral and social science human subjects research. Attendees will receive guidance on how to avoid common mistakes and omissions. Copies of model consent forms will be provided for future reference. 4 CREC credits will be awarded to attendees.
Registration is online only. Click here to register.

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Molecular Biotechnology Core Laboratory

The Molecular Biotechnology Core laboratory provides research support services and consultation to investigators in the areas of Biomolecular Interaction Analysis using Biacore 3000, N-terminal sequencing by Edman degradation, peptide design and synthesis, and peptide purification.

The Biacore system uses Surface Plasmon Resonance (SPR) technology to monitor the biomolecular interactions in real time. The Biacore 3000 is used to measure equilibrium and kinetic parameters in protein-nucleic acid interactions, protein-protein interactions and in competition assays. The Biacore technology can also be used to characterize mutant proteins, in epitope mapping and ranking the antibodies based on their affinities. The Core provides the basic training to use the system and help investigators to perform their Biacore experiments. An initial determination of the feasibility of a project takes only a day. 

The core laboratory offers N-terminal amino acid sequence analysis by Edman degradation chemistry using Procise 492 Protein sequencer from Applied Biosystems. Protein samples (5-10 pmoles) can be submitted as PVDF blots or samples dissolved in 10-20 ul of a suitable solvent, such as MilliQ water, 0.1% trifluoroacetic acid, 5% acetic acid, or aqueous acetonitrile.

The Core uses state-of-the art chemistries and automated instrumentation for small (50 umole) to medium (250 umole) scales of peptide synthesis by Fmoc solid-phase chemistry. The process of peptide synthesis requires several discrete steps such as; design of the peptides, chemical synthesis, modifications, cleavage of peptide from the resin, purification and quality evaluation.  Every peptide synthesized is rigorously evaluated routinely by mass spectrometry, HPLC analysis and by N-terminal sequencing if necessary with the ultimate goal of providing the correct intended peptide sequence to the investigators. The Core routinely synthesizes peptides with the following modifications: peptides containing unusual or modified amino acids (e.g., phospho-Tyr, phospho-Ser/Thr, D-amino acids or other analogs), biotinylation at N- or C- terminals, fatty acid conjugation (butyric, amino hexanoic acid, myristic acid, palmitic acid), fluorochrome conjugation (fluorescein, rhodamine, phycoerythrin) N-acetylation, peptides amides, and peptide cyclization via s-s bonds.  The Core provides thorough documentation of HPLC analysis and Mass spectral analysis of every peptide.

Contact:
Satya P. Yadav, Ph.D., Director
Molecular Biotechnology Core Laboratory
Bldg. NN1-13
Cleveland Clinic Foundation
9500 Euclid Avenue
Cleveland, Ohio 44195
Tel: (216) 445-7095
Fax: (216) 636-0556
Email: YADAVS@ccf.org

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Research Equipment Resources

Equipment to Borrow? -- or Give Away? -- or Lend?
Do you need some equipment but do not have the funds to purchase it? Do you have equipment you are not using and would be willing to lend or give away to other researchers at CWRU? This spot in the newsletter will be devoted to those needs. Send notices of equipment you are willing to lend or give away, or need to borrow, to Rosemary Alexander at rosemary.alexander@case.edu.

Free Sorvall Ultracentrifuge - a give-away!
The Case BL-3 Core Facility of the Center for AIDS Research has an OTD70B Ultracentrifuge from Sorvall to give away. It is on wheels and was completely paraformaldehyde decontaminated on Tuesday, January 10, 2006. The recipient must provide a means to move it. Interested parties should contact Heather Pilch by email (hap4@case.edu) or phone (368-1705).

Equipment Broken or Working Poorly?
The Scientific Instrument Repair Center (SIRC), directed by William M. Frank, services a wide variety of research equipment from small bench top equipment to X-ray generators for any laboratory on campus at reduced cost. The SIRC also offers advice when purchasing new equipment and extended warranties. The Center is located on the CWRU campus in the School of Medicine in TB07. Contact Mr. Frank at 368-3225 or william.frank@case.edu for details about fees and services or go to http://mediswww.cwru.edu/sirc/.

If you need to borrow equipment while yours is being serviced, you are welcome to post a notice in this space. Email Rosemary Alexander with your notice.


Need Specialized Equipment Built?
The Design and Fabrication Center (DFC), located on campus in the School of Medicine in EG-1, is a fully equipped machine shop, and will custom build new equipment or modify existing equipment to meet your needs at reduced cost. The DFC can provide technical and engineering support service for any mechanical, electrical, and computerized application, for significantly less money. The DFC provides services not only to any CWRU lab, but also to University Hospitals, Cleveland Clinic, and CWRU-affiliated biomedical companies. Contact Mr. Torontali at 368-3461 or steven.torontali@case.edu. The DFC website, currently under construction, will be available at http://mediswww.cwru.edu/DFC/.

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Funding Opportunities

OSPA Funding News
The Office of Sponsored Projects Administration (OSPA) maintains a funding page at the this link (http://ora.ra.cwru.edu/OSPA/News/Funding_news.cfm). This list of funding announcements is not meant to be comprehensive. It changes at least monthly, sometimes daily. Announcements will be displayed on the website until the letter of intent due date or the application due date and will not be archived, so be sure to save any announcements to which you wish to refer in a future month. The list may include internal funding opportunities as they arise, as well as some less publicized and/or cross-discipline funding announcements sent to us by various routes. OSPA assumes that the reader is also making use of Community of Science (see below), to which the university subscribes, as well as the other resources listed in the links which follow these announcements. If you know of funding announcements that you think should be posted on this page, please contact Rosemary Alexander at rosemary.alexander@case.edu.

Community of Science (COS)
Case is a subscriber to Community of Science (COS), which makes it possible for you as faculty or research staff to make use of this excellent service. If you have not already set up your own profile in Community of Science and need help in doing so, please do not hesitate to call OSPA for guidance (368-4510). You may also contact the Case campus COS liaisons, Monica Bradley (368-4432 or monica.bradley@case.edu) or Narinder Dhaliwal (368-2001 or narinder.dhaliwal@case.edu) for help.

School of Medicine Funding Alerts
While many of you may already receive hard copies of the School of Medicine Funding Alert, the School of Medicine's quarterly newsletter listing funding opportunities and grant-writing tips, you may not be aware that the Funding Alert is also available, in its entirety, online in PDF format. A comprehensive list of RFP's available for the current period, may be viewed at http://mediswww.cwru.edu/researchoffice/index.html. At this URL, click on "Funding Opportunities". Then choose the current School of Medicine Funding Alert. Contact Narinder Dhaliwal in the School of Medicine at 368-2001 or narinder.dhaliwal@case.edu if you have questions.

Links to Sponsors
For an ever-growing list of links to many sources of funding announcements, both public and private, to aid your searches, click on the OSPA Links page.

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Conferences & Symposiums

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Re. Printing this newsletter:

If you wish to save this newsletter as a pdf file, you may do so on PCs via Adobe Acrobat (the full version), which is downloadable for free to faculty, staff, and students from the Case Software Center. In Adobe Acrobat, choose "Open Web Page" from the "File" menu, then insert the URL and click "Download". Adobe Acrobat may display an error message re. one gif file which may not load correctly. Just ignore this, it does not affect the appearance of the newsletter. Mac users using the Safari browser, may choose to print to pdf. Internet Explorer also will print to pdf, but truncates the right portion of the page in doing so.

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To subscribe or unsubscribe to ORANews:
If you do not wish to receive notifications that this newsletter has been updated via ORANews, the OSPA e-list, please contact Rosemary Alexander at rosemary.alexander@case.edu. If you are aware of individuals who are not currently on our e-mailing list and would like to subscribe to ORANews, please have them email Rosemary Alexander.