Department of Defense
The Fiscal Year 2014 (FY14) Defense Appropriations Act provides research funding for the peer reviewed programs managed by the Department of Defense (DOD) office of Congressionally Directed Medical Research Programs (CDMRP).
Gulf War Illness Research Program (GWIRP)
Innovative Treatment Evaluation Award 2
Breast Cancer Research Program (BCRP)
Breakthrough Award Funding Levels 1 and 2
Breakthrough Award Funding Levels 3 and 4
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 email@example.com.
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:
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 firstname.lastname@example.org.
- 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.
- 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.
- 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.
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.email@example.com, 368-1401.
Department of Defense
The Department of Defense has announced the following new funding opportunities:
Department of the Army - USAMRAA
DoD Orthotics and Prosthetics Outcomes Research Award
U.S. Army Medical Research and Materiel Command Broad Agency Announcement (BAA) for Extramural Medical Research - Dept. of the Army -- USAMRAA — W81XWH-BAA-15-1
Opening date: October 1, 2014
Closing date: September 30, 2015
Pre-Proposals:Applicants are encouraged to submit their Pre-Proposals as early as possible in the fiscal year as funding is based on availability
Invitation to Submit: within 120 days of pre-proposal submission
Full Proposals: submitted within 90 days of the invitation
Notice of Awards: within 180 days of submission
Funding: Budgets are not capped and must reflect the scope of the work. Funding can be requested for up to 5 years.
Programs of interest:
1. Military Infectious Diseases Research
2. Combat Casualty Care Research
3. Military Operational Medicine Research
4. Clinical and Rehabilitative Medicine Research
5. Medical Biological Defense Research
6. Medical Chemical Defense Research
7. Medical Training and Health Information Sciences
8. Radiation Health Effects Research
9. Special Investment Areas
Office of Strategic Initiatives (OSI): CWRU School of Medicine's OSI can work with you to make sure that you meet the current goals and objectives of the USAMRMC.
Contact OSI: Irene Shaland - firstname.lastname@example.org - 216.368.4970.
The Ohio Clinical Trial Collaborative (OCTC)
The Ohio Clinical Trial Collaborative OCTC is developing partnerships with the drug industry to include Biotech and Pharmaceutical industries to perform clinical drug trials phase I-4. The OCTC is a network of Ohio based hospitals led by working groups in areas such as neuro oncology, pediatrics, infectious disease, and neuroscience. The OCTC was launched at the BIO2014 which was attended by 15,000 biotech and pharmaceutical executives in San Diego resulting in numerous leads for potential drug trials.
The OCTC has plans to attend additional biotech and pharmaceuticals shows. The OCTC is looking for additional working groups interested in developing a sell sheet that can then be searched on the World Wide Web and will begin sales and marketing activities to identify opportunities with industry. If there are companies that individuals would like OCTC to target, the group welcomes that feedback.
Review the OCTC working website at: http://ohioclintrials.org.
Contact Joe Peter at 216-702-5314 for more information.
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