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Case Research Weekly  
June 15, 2007  
Sponsored Projects News and Updates
Non-Salary Journals - Clarification
Please note that non-salary journals for internal discretionary accounts (OSA speedtype where there is no external sponsor) do NOT require any back-up documents for review and approval.

The Office of Sponsored Projects Administration is currently reviewing the process for non-salary journals and salary adjustments and will distribute draft guidelines in early July for comment. The goal is to improve the process such that it is streamlined, more timely and provides adequate notification to those requesting a non-salary journal or salary adjustment.

 
Promotions and Positions in OSPA
The Office of Sponsored Projects Administration (OSPA) is pleased to announce that, effective May 1, 2007, Robin Trail has been promoted to Associate Director, Sponsored Project Accounting and Carol Schwendeman has been promoted to Assistant Director, Pre-Award Services.

Additional positions in OSPA have or will be posted soon. They are:
  • Grants and Contracts Specialist - Pre-Award Services
  • Director, Sponsored Projects Accounting
  • Grants and Contracts Accountant (two new positions)
  • Information Systems Support Technician
Please check the CWRU Human Resources website for more complete descriptions of these positions. If you are aware of individuals who may be interested in one or more of these positions, please distribute this information to them.

Link: http://www.case.edu/finadmin/humres/emp/index.html

 
Genome Data Available From NIH
Those interested in genome data may now obtain these data from a genome database operated by the National Library of Medicine's National Center for Biotechnology Information. Researchers can request access to the individual-level data from the Age-Related Eye Diseases Study on macular degeneration and cataracts, the National Institute of Neurological Disorders and Stroke Parkinsonism Study, and six studies conducted under the Genetic Association Information Network. Link: http://grants.nih.gov/grants/guide/notice-files/NOT-LM-07-001.html.

 
NIH Posts FAQs Regarding Resubmission, Revision, and Renewal Through Grants.Gov
The NIH has recently posted FAQs regarding resubmission, revision, and renewal applications to NIH through grants.gov. Please see the following link: http://era.nih.gov/ElectronicReceipt/resubmission_FAQ.htm

 
NIH Examining Peer Review Process
The National Institutes of Health (NIH) has formed an external and an internal taskforce to examine the process for peer review of grant applications. These two groups will "study the context, criteria, and culture of peer review to make sure the most talented individuals and reviewers are engaged in the process." It is expected that the results from the working groups will be presented to advisory committees to the director in December 2007 and that a meeting will be held in January 2008 to develop a set of integrated recommendations for the next steps. For more information, please go to: http://www.nih.gov/news/pr/jun2007/od-08.htm.

 
Compliance News
COGR Asks for Harmonization in Adverse Event Guidance

The Council on Governmental Relations (COGR) and the Association of American Medical Colleges (AAMC) have asked the Food and Drug Administration (FDA) to work with the Office for Human Research Protections (OHRP) to harmonize adverse event reporting requirements between the two agencies. Both agencies have recently released guidance documents on adverse event reporting. OHRP's final version was released earlier this year, and in April, FDA released their draft policy. The two policies are not the same. While the OHRP guidance defined appropriate reporting timeframes and what is considered to be a reportable event, the FDA draft guidance does not. To read COGR's letter, see: http://206.151.87.67/docs/AdverseEventReporting.doc.

 
Genetic Research in Human Subjects
Wednesday, June 20, 2007
11 am – 1:30 pm
Wolstein Research Building, Room 1413

The Case Office of Research Compliance and the Center for Genetic Research Ethics and Law (CGREAL) jointly present this informative seminar and panel discussion. The purpose of the session is to provide Case investigators, research staff, and trainees with a survey of human subjects protections issues that arise in the conduct of genetic research with human tissue and blood samples. As whole genome scanning techniques make DNA analysis a more powerful and useful research tool across biomedical fields, increasing numbers of research teams find themselves contemplating the prospect of collecting genomic samples from human subjects enrolled in clinical trials, epidemiological surveys and other research projects.

While every situation is different, there are a number of issues that all such genetic studies must address during their planning -- or, less ideally, during the conduct of the research. In the absence of definitive regulatory guidance on these issues, individual research teams and Institutional Review Boards are currently the laboratories of policy development in this area, and this session represents one of a number of efforts to facilitate this process in our region. Introductory remarks by Eric Juengst and Georgia Wiesner will lead to a panel discussion including associates from CGREAL Mark Auliso, Susan Lewis, and Phil Cola, Kathy Lawry, Mariesa Malinowski and Linda Lewicki representing the local IRBs. 6 Continuing Research Education Credits (CREC) will be awarded to attendees.

Register at: http://ora.ra.cwru.edu/research/orc/education/onlinecalendar.cfm.

 

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