Restructured Application Forms and Instructions for Submissions for FY2011 Funding (NOT-OD-09-149), National Institutes of Health
OSU's Institutional Review Boards (IRBs) have successfully registered with the Food and Drug Administration (FDA) in compliance with the new FDA rule issued on July 14, 2009. The rule requires all U.S. IRBs reviewing clinical investigations involving FDA-regulated products to register with FDA. IRBs have until September 14, 2009 to register.
FDA's new requirement operates in coordination with the Office for Human Research Protections (OHRP), which already requires registration for IRBs reviewing federally-supported research. A single database of all U.S. IRBs, regardless of whether they review research regulated by FDA or other federal agencies, has been established.
IRBs are required to renew registration every three years, or sooner if contact information changes. IRBs do not provide specific protocol numbers as part of the registration process or routinely update registration information with the current number of active protocols under review. IRB registration does not represent accreditation or certification by FDA or OHRP. The agencies do not provide certificates confirming an IRB's registration.
Registration information can be accessed via OHRP's online database.
Please note that these numbers are linked to both FDA and OHRP registrations (as applicable).
For additional information, please view the Federal Register and FDA's FAQs Regarding IRB Registration, or contact the Office of Responsible Research Practices at (614) 688-8457.
The National Center for Education Research (NCER) and the National Center for Special Education Research (NCSER) within the Institute of Education Sciences (IES) have extended their series of webinars related to research funding opportunities.
Browse to http://ies.ed.gov/funding/webinars/ for information about upcoming and previous webinars.
The Office of Research maintains a web site containing information about the many available American Recovery and Reinvestment Act (ARRA) funding opportunities. The web site is updated frequently so please check back often.
Here are a few ARRA-related updates:
Visit these sites for information about research funding highlights for the coming fiscal year:
NIH reached a major milestone in our transition from Grants.gov's PureEdge-based application forms to their Adobe-based equivalents. NIH has updated more than 500 active Funding Opportunity Announcements (FOAs) with Adobe-based application packages and has closed their PureEdge predecessors (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-026.html).
The change was timed (accommodating the error correction window, application viewing window and late application policy) so that applicants submitting for the final PureEdge standard receipt dates could complete the submission process using the same form set. We also tried to transition to the Adobe forms with at least 3-4 weeks for applicants to prepare Adobe-based applications for the next receipt dates. The January 7, 2009 receipt date for AIDS and AIDS-Related Applications will be the first NIH standard receipt date to use the Adobe-based forms.
Last September, NIH began posting some announcements without associated application forms. NIH staff is now returning to those announcements to post Adobe-based application packages. This process will be finished early next week.
There are still a number of active FOAs that will continue to use PureEdge packages into January 2009, including some FOAs for grant programs with early December standard receipt dates (small business and conference programs) and FOAs due to expire in January. In early 2009, the remaining active FOAs with PureEdge forms will be updated and our transition to Adobe will be complete.
The university's policy on payments to individuals participating in research projects has been streamlined.
Major changes are:
The Office of Responsible Research Practices (ORRP) has recently posted its Investigator Guide which is an excellent resource that addresses many of the questions that we are asked about research that involves human subjects. You can view the guide at http://orrp.osu.edu/irb/guidance/.
The Pre-Elementary Education Longitudinal Study (PEELS) database includes a sample of over 3,000 children with disabilities and is designed to describe the characteristics of children receiving preschool special education, their educational programs and services, and their transitions from preschool programs to elementary schools. For more information about PEELS, see http://www.peels.org.
For more information about the PEELS database training seminar, see http://ies.ed.gov/whatsnew/conferences/?id=378&cid=4.
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