November
2005
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| IUPUI
HRPP Receives Full AAHRPP Accreditation
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)
New Guidance for Submitting an Updated Clinical Investigator Brochure (CIB) to the IRB 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, whether the Informed Consent Statement (ICS) should be updated, and the signature of the principal investigator. Subsequently, if the updates resulted in changes to the ICS, this had to be reported in the form of a separate amendment. 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 Research Compliance Administration at 317.274.8289 with any questions. Internal Guidance for Registration of Clinical Research Studies Information is presented in a Frequently Asked Questions (FAQs) format. The grace period for registering studies that are already enrolling subjects was scheduled to end on September 13. Not all studies require registration, but it is clear that many do. The responsibility for study registration is shared between the lead investigator and the sponsoring organization. In some cases, the sponsor may assist and/or manage the registration, but the process varies somewhat depending upon the sponsor. In the case of many investigator-initiated studies, particularly investigator-held IND's or IDE's, the lead investigator is the responsible party. Compliance with this policy may require your immediate action and will remain a continuing obligation. If you still have questions after reading it, please contact: Pam DeWeese, Administrative Director, Clinical Trials Program P: 317.278.2865 F: 317.278.6870 http://medicine.iupui.edu/ctp |
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| NIH
Announces Plans to Transition to the SF424 Application and Electronic
Submission through Grants.gov Initial plans for proposal submission dates that must be submitted through Grants.gov are as follows: December 1, 2005 — Small Business Innovative Research (SBIR) and Small Business Technology Transfer Programs (STTR) (R41, R42, R43, R44) December 15, 2005 — Support for Conferences & Scientific Meetings (R13 & U13) January 25, 2006* — Academic Research Enhancement Awards (AREA) (R15) (*Changed to February 25, 2006 per NOT-OD-05-080) June 1, 2006 — Small Grant Programs (R03) & Exploratory/Development Research Grant Awards (R21) October 1, 2006 — Research Project Grant Program (R01) The NIH notice in its entirety can be viewed at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-067.html. For those submitting to programs using the Grants.gov application process, please allow ample time for processing as one issue with the Grants.gov system is that it is vulnerable to heavy user loads and often becomes unstable as deadlines approach. Full proposals should be routed and received three business days before the submission deadline. For those needing additional time to complete the narrative portion of the proposal, the budget should be pre-certified by Sponsored Research Services (SRS) or the partial proposal routing process should be used. If these alternatives are utilized, the final product for Grants.gov submissions should be received in SRS at least 48 hours before the time that the proposal is due because of the unreliability of the Grants.gov submission system. SRS is happy to provide training on the SF424 application and Grants.gov submission system to both faculty and staff. Please contact Michelle Artmeier, Director of Proposal Services, at 317.278.8644 to set up a time for your area. 2006 NIH Loan Repayment Program Announced To qualify, applicants must possess a doctoral-level degree, devote 50% or more of their time (20 hours per week based on a 40-hour work week) to research funded by a domestic non-profit organization or government entity (federal, state, or local), and have educational loan debt equal to or exceeding 20% of their institutional base salary. Applicants must also be U.S. citizens, permanent residents, or U.S. nationals to be eligible. All applications for 2006 awards must be submitted online by 8:00 PM EST, December 1, 2005. For an online application, program information, or other assistance, visit the LRP Web site at www.lrp.nih.gov, telephone the LRP Helpline at 866.849.4047, or send email inquiries to lrp@nih.gov. NIH Announces Plans to Eliminate Mailing of Paper Notifications: Summary Statements & Peer Review Outcome Letters Over the next two grant review cycles, the NIH will discontinue mailing the following two kinds of documents: Summary
Statements: Beginning February 1, 2006, the 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 SRG. When the 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). Scores will be posted in the eRA Commons approximately 5 working days after the SRG meeting. At this time, the NIH will continue to send assignment and change of assignment mailers. However, this information is also accessible on the eRA Commons. Full text of this NIH announcement can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-075.html. For those investigators needing an NIH eRA Commons account set up, please e-mail your full name and University user-ID to srsinfo@iupui.edu. Sponsored Research Services (SRS) will then initiate an account in your name and assist you with any questions concerning the system. |
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IUPUI Staff Nominated for the United Way Leadership Program Yaobin
Chen Etta Ward Holiday Hours IUPUI Office of the Vice Chancellor for Research and Graduate Education Additional holiday closing information is provided for the following offices: Research Compliance Administration (IRB/IBC) If there is a
life-threatening emergency which necessitates the use of an investigational
agent, please call University Hospital Pharmacy at 317.274.0362. Thanksgiving: SRS Bloomington:
resdev@indiana.edu Christmas/New
Year: SRS Bloomington:
resdev@indiana.edu Scientists and Subjects: An Online Seminar on the Ethics of Research with Human Subjects Six years of experience offering the Scientists and Subjects seminar has allowed us to develop an intensive, focused curriculum addressing core issues in human subjects research. To maximize interaction and attention to each seminar member's concerns, each cohort will be limited to 17 members on a first-come, first-served basis. The seminar fee is $200. Continuing Medical Education credits are available for an additional processing fee of $50 (16 credits). Prospective participants must submit a check or purchase order to cover the registration fee and complete an application form, available on the Web at http://poynter.indiana.edu/sas/, no later than Friday, December 9, 2005. For more information, contact: Kenneth D. Pimple, SAS Project Director, Poynter Center, Indiana University, 618 East Third Street, Bloomington, IN 47405-3602; 812.856.4986; FAX 855.3315; pimple@indiana.edu; http://poynter.indiana.edu/sas/.=20. Kenneth D. Pimple,
Ph.D. |
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| Submit
Your News to the R&SP Communicator Deadline for
R&SP Communicator news article submission: Submission
format: Shannon Walden Coordinator of Educational Programs for Responsible Conduct in Research UN 618 620 Union Drive, Room 618 Indianapolis, IN 46202-5167 Phone - (317) 274-2012 Fax - (317) 274-8744 E-mail: sfwalden@iupui.edu |
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Send COMMENTS,
QUESTIONS to: Shannon Walden - Editor |
Research
and Sponsored Programs |
