February
2006
IUPUI
HUMAN RESEARCH PROTECTION PROGRAM RECEIVES FULL ACCREDITATION IUPUI/Clarian SOP for IRB Operations and Study Approval Process (v 05/05 to v 08/05) Section 5.10.8 lists specific criteria the IRB will consider when determining which protocols require review more than annually. Select the HTML or PDF format below to view the SOP:
IUPUI/Clarian
SOP for Children in Research (v 05/05 to v 08/05)
IUPUI/Clarian
SOP for Subject Confidentiality and Privacy (v 9/15/04 to v 08/05)
Summary
Safeguard Statement (v 06/05 to v 08/05) Under Section III., Children, Categories 3 and 4 specify that permission must be solicited from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. Select the HTML or PDF format below to view the form: Application
for Research Not Subject to the FDA or Common Rule Definitions of
Human Subjects Research (v 05/05 to v 08/05) NIH ANNOUNCES PLANS TO TRANSITION FROM THE PHS 398 TO THE PHS 424 - GRANT APPLICATION FORM AND SUBMISSION OF THE NEW FORM WILL BE ELECTRONIC The new PHS 424 grant application forms are only available electronically and they must be submitted electronically. Paper copies of this grant form will not be accepted by the NIH. As has previously been true, an authorized representative of the University is required to submit the application through Grants.gov. IUPUI investigators must submit their applications to the IUPUI Office of Sponsored Research Services and an authorized representative in that office will submit the grant electronically. Investigators do not submit their grants directly to Grants.gov. As we transition to electronic grant submission, investigators are asked to submit their grant applications to the Office of Sponsored Research Services 7 business days prior to the NIH application receipt deadline. The Grants.gov system is vulnerable to heavy user loads and often becomes unstable at times of peak grant submission. Hence, the Office of Sponsored Research Services will not be able to guarantee successful grant submission without a 7 business day lead time. Sponsored Research Service (SRS) encourages faculty and staff to participate in a workshop on how to complete the PHS 424 electronic grant application forms. To sign up for an upcoming workshop please contact Michelle Artmeier, Director of Proposal Services, at 317.278.8644. The NIH notice in its entirety can be viewed at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH ANNOUNCES PLANS TO ELIMINATE MAILING OF SUMMARY STATEMENTS & PEER REVIEW OUTCOME LETTERS Review Outcome: Effective February 1, 2006, NIH will no longer send hard copies of the notification letter (also known as a “mailer”) to PIs and Fellows regarding the review outcome of an application by the Scientific Review Group (SRG). Review outcomes are accessible electronically to PIs and Fellows in the eRA Commons. Priority scores will be posted in the eRA Commons approximately 5 working days after the Scientific Review Group (SRG) meeting. When the Scientific Review Group (SRG) rosters and meeting dates become available, they may be accessed through http://www.csr.nih.gov/Committees/rosterindex.asp (Center for Scientific Review [CSR] reviews) or http://era.nih.gov/roster/ (Institute/Center reviews). Summary Statements: Effective October 1, 2005, NIH will no longer send hard copies of the Summary Statements to Principal Investigators (PIs) and Individual Fellows Applicants. Summary Statements are accessible electronically to PIs and Fellows in the eRA Commons within approximately 8 weeks of the Scientific Review Group (SRG) meeting. Full text of this NIH announcement can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-075.html. IRB UPDATES SIMPLIFIED Previously, investigators were required to report updates to their CIB in the form of a memo. The memo was required to document the study number and title, the changes to the CIB, a statement as to the effect of the changes on the risk: benefit ratio, and whether the Informed Consent Statement (ICS) should be updated. Subsequently, if the update resulted in changes to the ICS, this was reported separately via an amendment form. With the new requirement, the entire process is simplified. The amendment form requests all information previously required in the CIB memo, and should the informed consent require updating; this can be accomplished utilizing the same amendment form. Two copies of the updated CIB and ICS (if applicable) are required to be submitted with the amendment form. Please contact the Research Compliance Administration at 317.274.8289 with any questions. Take-Home Point:Updates to Clinical Investigator Brochures (CIBs) must be reported to the IRB via an amendment. UPDATE ON RISKS TO SUBJECTS OR OTHERS Thus, RCA recommends that when the prompt reporting form is completed and all 3 criteria (caused harm, was unexpected and related) are met, the investigator determine whether or not the UPIRTSO also requires revision to the informed consent document. If it does, the event should be promptly reported to the IRB. Additionally, the RCA office has received information that the 3-day (for on-site) and 10-day (for off-site) timeframes for promptly reporting UPIRTSOs to the IRB is difficult to adhere to. As a result, the IRB, noting that there are no national requirements, agreed to allow a 10-day timeframe for reporting on-site prompt UPIRTSOs and a 30-day timeframe for reporting off-site prompt UPIRTSOs to the IRB. The reporting form and Standard Operating Procedure (SOP) will eventually be revised to clarify these additional reporting requirements; however, in an attempt to reduce the number of revisions to documents, we will not be updating the form or the SOP at this time. We suggest that you reference this communication to support this newly-clarified reporting policy. Take-Home Point:
ACCESS TO THE HUMAN SUBJECTS TRACKING DATABASE However, we do hope to be able to grant these requests in the near future. In the meantime, we ask for your patience. We will notify you when this capability is available. Take-Home Point: Access to the read-only human subjects tracking database can be found on the Research & Sponsored Programs website at: http://www.iupui.edu/~resgrad/spon/spon_menu2.htm. ELECTRONIC IRB SUBMISSION Keeping in mind that these processes are being implemented and evaluated on an interim basis, we do recognize that there were some difficulties experienced during the first week. We have addressed the issues related to being unable to submit to the resrisk mailbox due to insufficient space in the mailbox. We have also tried to be as flexible as possible with those submissions that have come in on paper, rather than electronically, by offering to scan the documents when necessary. However, please note that beginning May 1, 2006, the IRB will only accept complete electronic submissions. Please request that your sponsors provide you with electronic versions of documentation (e.g., protocol, clinical investigator brochure, etc.); otherwise, you will need to scan the documents in order to submit electronically to the IRB after this date. Additionally, as you know the current policy for submitting document changes to the IRB (e.g., via amendments) is that changes must be highlighted on the document. With this new electronic process, we have learned that it is not possible to reflect such highlighting within PDF documents. Thus, we ask that a detailed list of all changes made to a PDF document be included with the IRB submission. Again, we ask for your patience in smoothing out the process. We do welcome comments or thoughts on the process if they will help make the process better. Some additional important information:
Take-Home Point: IU CFAR GRANTS PROGRAM Three types of applications will be considered:
Topics covered – Applications will be considered in the broad area of AIDS research including (but not limited to) HIV biology, epidemiology, or pathogenesis, pathogenesis of opportunistic infections or neoplasms, treatment of HIV or opportunistic infections, complications of HIV treatment, and prevention of HIV infections. Applications may be laboratory-based, clinical, translational, or behavioral. Amount and duration – Applicants may request funding up to $20,000 per year for 1 or 2 years. Awards will be made for one year with funding for a second year (if requested) contingent on progress during the first year and preparation of an application for external funding. Emerging opportunity awards will be limited to 1 year. Application format – Applications should be submitted electronically on PHS 398 forms (http://grants.nih.gov/grants/funding/phs398/phs398.html) using the instructions for an R03 application (http://grants.nih.gov/grants/funding/r03.htm), i.e., limited to 10 pages for the narrative portion. When appropriate, applicants are encouraged to submit the same or a similar application to NIH as an R03 with the understanding that if the proposal is funded by NIH, the remaining IU-CFAR funds would be returned. Application deadline – Applications for young investigator awards and new AIDS investigator awards are due February 17, 2006 with an anticipated start date of May 1, 2006. Emerging opportunity award applications may be submitted at any time (with the approval of the CFAR director) for a start date 8 -12 weeks after submission. To submit applications, questions, and to obtain a list of current CFAR investigators, contact:Dr. Kenneth Fife Emerson Hall 435 317.274.8114 kfife@iupui.edu |
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