Suzanne Rivera named new VP for research

Provost W.A. "Bud" Baeslack III announced, on November 4th, the appointment of Suzanne M. Rivera as Case Western Reserve´s new vice president for research, effective this month. Rivera, the university´s associate vice president for research since January 2011, emerged as the top choice after an extensive process involving campuswide nominations of internal university candidates. Since coming to CWRU, Rivera has distinguished herself through a commitment to collaboration and a focus on systems and processes.
Read more about her.


Research Matters

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Research Newsletter
December 9, 2014  

Did You Know?

Grant proposals are due in the Office of Research Administration (or Office of Grants & Contracts in SOM) at least 5 working days before the sponsor’s deadline. This allows time for an institutional review and correction of errors or omissions. As soon as you decide to submit a grant, contact your designated ORA or OGC specialist to let him/her know to expect your proposal. All funding proposals are now submitted on-line through the Sparta system.

Office of Research Administration: https://research.case.edu/index.cfm

Office of Grants & Contracts in SOM: http://casemed.case.edu/grantscontracts/

Sparta System: https://sparta.case.edu/.

 
The Cleveland Area Reliant IRB Review Process

The Cleveland Area Reliant Institutional Review Board (IRB) Review process includes participation by the Case Western Reserve University (CWRU) Social, Behavioral, and Educational Research (SBER) IRB, the Cleveland Clinic (CC) IRB, MetroHealth Medical Center (MHMC) IRB, and University Hospitals Case Medical Center (UHCMC) IRB. The process relies on executed IRB Authorization Agreements (IAA) between the institutions. These agreements document that all applicable human research subjects protection considerations will be made by one Institutional Review Board (IRB), which will be deemed the IRB of record. The IRBs of the other Cleveland area institutions will accept the approval of the IRB of record through the Reliant Review process. The goal is to eliminate duplication of effort and multiple applications for submission of the same protocol, and to encourage scientific collaboration among the affiliated institutions.

What types of studies are eligible for the Reliant Review Process?
Any type of human research study could be eligible for the Reliant Review process. These include but are not limited to investigator-initiated, federally-funded, foundation-supported, industry-sponsored, and non-funded studies.

The fundamental requirement is that a collaborating investigator must be named at each site where the research will occur. It is important for the Principal Investigator at the lead study site to work with the IRB of record throughout the Reliant Review Process to initiate acceptance of IRB approval at each collaborating site.

For further information, contact Kim Volarcik at (216) 368-0134 or kav6@case.edu.

 

Foundation Fighting Blindness and Harrington Discovery Institute

Foundation Fighting Blindness and Harrington Discovery Institute have partnered to form, the The National Center for Excellence in Fighting Blindness, a Gund-Harrington initiative. This initiative is focused on accelerating the translation of research findings in inherited retinal degenerative diseases (IRD) with the ultimate goal of developing new therapies to improve and/or restore vision.

• This Initiative seeks to award Gund-Harrington Scholar Awards that recognize innovators throughout the USA whose research has the potential to advance standards of care.
• There will be an average of three awards per year, which will be restricted to researchers working at institutions within the USA. Applications from outside the USA are not accepted.
• The Gund-Harrington Scholar Award provides funding for translational drug development and cell therapy along with non-financial project support to help bridge the gap between laboratory-based research and the clinic.
• Funding up to a total of $900,000 over three years and non-financial support will be provided by the The National Center for Excellence in Fighting Blindness. The non-financial support, provided by a team of pharmaceutical experts, will include project management and experienced industry advice in all aspects of drug development, encompassing chemistry, formulation, toxicology, regulatory, intellectual property and business development.
• Awards will be made to physician-scientists, or scientists with a research team that includes significant involvement of a physician with clinical expertise in the IRD.
• Selected projects must demonstrate a reasonable expectation that they can develop a lead product with strong potential for clinical and commercial application by the end of the three year funding period.
Multi-disciplinary investigators outside the field of retinal disease are particularly encouraged to apply.

Applicants interested in the Gund-Harrington Scholar Awards must apply through Foundation Fighting Blindness.

For more information about Foundation Fighting Blindness visit the Fighting Blindness website.

 
Guidance for Transferring Research Materials and Data

All data and materials transferred into and outside of the institution require either a Material Transfer Agreement (MTA), a Data Use Agreement (DUA), or both. Material Transfer Agreements are used for the transfer of tangible materials (cell lines, mice, metallurgical samples, biological specimens), whereas Data Use Agreements are used for electronic or hardcopy data (including Protected Health Information, de-identified patient data, and non-human data).

All MTAs and DUAs should be routed through the Technology Transfer Office by sending a request to Andrew Jarrell at andrew.jarrell@case.edu.

 
Shipping Abroad in Compliance with Export Regulations

The federal export control laws can apply when regulated items are being shipped abroad. Before shipping a device, materials, or other items abroad, CWRU personnel should contact either the Environmental Health and Safety Office or the Compliance Office so that an employee trained in export compliance can determine whether an export license is needed prior to making the shipment.

These are the steps that all CWRU researchers should follow when planning to make an outgoing international shipment of items or materials:

  1. The CWRU Principal Investigator works with the CWRU Technology Transfer Office (“TTO”) to determine whether a Material Transfer Agreement (“MTA”) is needed prior to the shipment. The CWRU PI initiates this by submitting a completed MTA Review Form found at https://research.case.edu/forms.cfm#tech_mgt.
  2. If the Technology Transfer Office determines that an MTA is needed between CWRU and the overseas organization to receive the items or materials, the Principal Investigator and TTO work together to put it in place. Once the MTA is completed and signed by CWRU and the recipient organization, the Technology Transfer Office will forward a copy of the final contract to the PI. The PI should keep a copy of the final MTA for easy reference. Note that MTAs not only help to ensure compliance with the federal export laws, but they also protect investigators’ intellectual property rights.
  3. Before making the shipment overseas, the PI should contact the CWRU Environmental Health and Safety Office. This step is necessary so that the Environmental Health and Safety Office can analyze the contents of the shipment in light of the export regulations and determine whether the shipment can proceed immediately, or whether federal pre-authorization is needed. If the Technology Transfer Office determined that an MTA was needed, then the PI should provide Environmental Health and Safety with a copy of the signed MTA so that it can match the requested shipment with the formal contract.
If you have questions on how the export regulations impact specific international shipments, contact the Compliance Office: Lisa Palazzo, Director of Export Control and Privacy Management, at 368-5791, or Boyd Kumher, University Chief Compliance, Export Control and Privacy Management Officer, at 368-0833; or email exportcontrol@case.edu.

For more information on the export control regulations, including the full text of CWRU’s Export Control Policy Statement, visit http:www.case.edu/compliance/exportcontrol/.

Questions regarding Material Transfer Agreements (MTAs), should be addressed to Andrew Jarrell in the Technology Transfer Office, Andrew.jarrell@case.edu, 368-1401.

 

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