Research and Sponsored Programs
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| October, 2003 |
Research and Sponsored Programs
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| New Funding Opportunities Service Available - ResearchResearch |
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| Human Subjects | ||||||||||||
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IUPUI/Clarian SOP for Subject Confidentiality and Privacy Available for Public Comment; Investigational Device Accountability, Student Research, and Policies and Procedures for the SOPs Finalized As reported in the SOP Communication #1, (http://www.iupui.edu/~res-poly/human-sop/communication-1.htm), IUPUI/Clarian developed Standard Operating Procedures (SOPs) governing the policies and procedures for all human subjects research being conducted by researchers whose work is subject to review and approval by the IUPUI/Clarian Institutional Review Boards (IRBs). These SOPs will become the minimum required standards for conducting human subjects research and will be the framework against which all applications are evaluated and audited by the IRBs. The SOPs roll out plan calls for the SOPs to be released to the IUPUI/Clarian research community via this Web site. For a limited time, the SOPs will be open to the IUPUI/Clarian research community for review and comment. All comments must be received prior to the close of the comment date posted in the SOPs Table of Contents. Approved revisions to a SOP will be made in a timely manner and displayed on this Web site (http://www.iupui.edu/~respoly/human-sop/human-sop-menu.htm). Only comments that are appropriate, constructive and objective will be considered. Due to resource limitations, we can only accept comments transmitted electronically to the Research Compliance Administration mailbox at resrisk@iupui.edu. Comments received by other media (e.g., by telephone, fax, mail and to other e-mail addresses) will not be considered. A new release of a Standard Operating Procedure (SOP) governing the policies and procedures for all human subjects research being conducted by researchers whose work is subject to review and approval by the IUPUI/Clarian Institutional Review Boards (IRBs) is available online for public comment. The comment period for the following SOP will close November 21, 2003:
The final versions of the following three SOPs previously released for public comment are now available online:
OHRP Issues New Guidance for When Expedited IRB Review is Acceptable for Continuing Review of Research Involving Human Subjects The Office for Human Research Protections (OHRP) recently clarified the federal regulations pertaining to 45 CFR 46.110 and 21 CFR 56.110. The previous guidance included “Categories of Research that May Be Reviewed by an Institutional Review Board (IRB) through an Expedited Review Procedure.” One of those acceptable categories allowed for expedited review of continuing reviews “where no subjects have been enrolled and no additional risks have been identified.” This OHRP document can be accessed at the following URL: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/expedited98.htm. According to new OHRP guidance, “where no subjects have been enrolled” is not to be interpreted as meaning no enrollment since the last Institutional Review Board (IRB) review. The IUPUI/Clarian IRBs previously did understand “no subjects enrolled” to mean since the last review, thus some of our IRBs procedures for continuing review will be changing. If a study is still open to accrual and subjects are enrolled, either actively receiving treatment or intervention, or in follow–up, then the IRB is responsible for conducting continuing review at a convened IRB meeting regardless of whether or not subjects were enrolled since the last IRB review. This may not directly impact you as an investigator, but it may mean that the IRB could request additional information from you in order to provide a substantive review. For questions, contact the Research Compliance Administration: resrisk@iupui.edu. |
| Sponsored Program Development |
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New
Funding Opportunities Service Available – ResearchResearch Dear Research Colleagues: The University has recently subscribed to the new ResearchResearch news and funding opportunity service. This will go live on November 1, 2003. IUPUI will discontinue its subscription to the InfoEd (SPIN) funding opportunities service. IUPUI researchers will have unlimited access to the new subscription Web site at www.ResearchResearch.com. There you will find daily news of research policy, funding opportunities, profiles of thousands of sponsors and guidance on applying for funding. This system complements the premier subscription with Community of Science (COS). The news is similar in character to the front pages of Science or Nature, but there is an order of magnitude more of it. The funding opportunities database is also comprehensive, accurate and up-to-date. The Web site is fairly intuitive. To get started on November 1, I recommend you visit www.ResearchResearch.com and read our University¹s own Start Page there. Then download the Quick Start PDF. This will get you up and running in a few minutes. For further guidance, contact me at the email or phone number below. Yours Etta Ward Phone: 278-8427 |
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Research and Sponsored Programs UN 618 General - 274-8285 Research Compliance - 274-8289 Sponsored Program Development - 278-0249 |
