American Recovery and Reinvestment Act (ARRA)

A significant number of Vanderbilt faculty have received award notices for various projects funded through ARRA (American Recovery and Reinvestment Act). If you are one of the awardees and your project includes human subjects, please note that we have become aware that the various federal agencies have placed some extremely stringent timelines for IRB approval as funds must be released by a 9/27/2009 deadline. Some agencies are giving 9/4/2009 as the date that IRB approval must be complete. Thus, to help expedite your study through the review process, please designate your funder as ARRA in your application. A couple of other tips that will help expedite your proposal is a thorough complete application and making yourself available for quick resolution of issues/concerns. Please call us at (615) 322-2918 before you submit if you have any questions or concerns.

CITI Human Subjects Training Website Updates

On Monday, August 3rd (8:00 AM EST), the CITI Program website will be taken offline for a major system upgrade. Approximately 5 days of downtime is to be expected. If you need to take the initial/basic training, we encourage you to please do so by Friday, July 31st if at all possible. If you need to take a refresher course, you can register for an upcoming workshop or you can take the training course(s) offered by NIH.

Please contact Johny Tadros (936-8553) for assistance during the maintenance/upgrade period and he can help you get your study started or add/remove KSP. Once CITI is back online, you will have 5 business days to complete the required training or all work on your study must stop until the requirements are fulfilled.

OHRP’s Updated Web-based Electronic Submission System for Submitting FWAs and IRB Registrations

OHRP’s updated web-based electronic submission system for submitting Federalwide Assurance (FWA) and Institutional Review Board (IRB) registration documents is now available at http://ohrp.cit.nih.gov/efile.

We understand that some users are experiencing technical difficulties when attempting to access and use the enhanced electronic submission system.

We apologize for these technical difficulties and are working to resolve them. We encourage institutions and IRBs that do not immediately need to update an IRB registration or FWA to wait to submit any update while we focus our efforts on debugging the electronic submission system. Please be aware that OHRP will take into account the various problems with the implementation of the enhanced electronic submission system, and will use available flexibility in its decision making if an entity is unable to comply with registration and FWA submission requirements due to these implementation issues. This flexibility will continue until the implementation issues with the electronic submission system are resolved.

If you have any questions about, or problems in attempting to use, the electronic submission system, please contact your regional/country coordinator listed at http://www.hhs.gov/ohrp/daqi-staff.html#staff.

Device Encryption and Individually Identifiable Health Information

Any device (e.g., personal computer, laptop, etc.) used to save or store individually identifiable health information must be either encrypted or saved on a server housed in an approved data center. Vanderbilt Medical Center has agreed to use Check Point. For more information and how to obtain Check Point please visit the Information Privacy and Security website.

Dr. Todd Rice Named Medical Director of IRB

Todd Rice, M.D., M.Sc., has recently been appointed as the medical director of Vanderbilt’s IRB. Dr. Rice has served as a voting member, Vice-Chair, and Chair of the Health Sciences 2 committee over the past few years. In addition, he is an assistant professor and serves within the Division of Allergy, Pulmonary, and Critical Care Medicine.

Office/Word 2007 Users and Document Corruption

Some people have downloaded the Word (.doc) version of forms from our website only to have them become corrupted after editing and saving the document. We are currently searching for a pattern and resolution as to why this is happening. What we do know is that the corruption issues seem to be occurring most frequently for people using MS Office 2007 products (i.e., Word ‘07). While the 2007 software is backward compatible with Office 2003, there appears to be an issue with the newer version trying to interpret the older version of the document. Until we have a definite solution, we’d recommend that MS Office 2007 users download the RTF (shown by the Apple logo on our website) version of the document(s) and use it for your study submissions. An RTF is a “rich text file” that can be used by both PC and Mac office software packages. Sorry for any inconvenience.

New Metrics Posted

Our metrics page has been updated. Take a look and see the number of submissions we are getting, as well as the various types and how many days you can expect to receive a response from the IRB.

IRB Metrics

New Template Language

We have recently uploaded, to our templates page, language for suicidal ideations. Feel free to take a look and add it to your consent forms if appropriate.

Vanderbilt University PubMed Policy Certification

The NIH Public Access Policy, effective April 7, 2008, mandates that peer reviewed journal articles arising in whole or part from NIH funded research be deposited within 12 months of publication in the freely accessible PubMed Central (PMC) repository. Please see PubMed Central or contact the Eskind Biomedical Library for more information and assistance.

New Process for VICTR CRC Funds Request

The IRB no longer requests submission of the VICTR CRC Supplemental form for review. To request VICTR CRC Resource Services, the Principal Investigator must visit the link below and log in and complete a VICTR Resource Request. For any questions regarding this process, please contact Research Support Services at 322-7343.

https://www.mc.vanderbilt.edu/starbrite/funding/pilotfeasibility/?pfso