IRB Office Closed – November 26 and 27

The IRB office will be closed on November 26 and 27 to allow our staff members to celebrate the Thanksgiving holiday with family/friends. You can still submit items through DISCOVR-E during this time and we will process them as soon as possible when the office reopens on Monday, November 30.

Starting in December – IRB Office Hours

To help serve the research community better, the IRB has dedicated time to “IRB Office Hours.” What is this you ask? Think of it in the same way that a faculty member has time set aside to meet with students on a regular basis. Not only can you call, email, or schedule an appointment to discuss your study with someone, now you can just “drop in” if you have questions. Starting in December, the 1st and 3rd Fridays from 1:00-2:00 will be open sessions for people to come by the office to have your questions answered or to get assistance with a specific issue. There is no sign-up and no appointment is needed. We’ve also posted a calendar on our “Education” page so you can see upcoming Office Hours dates and other events hosted by the IRB.

So how do I subscribe to the blog?

When it comes to reading blogs (e.g., Really Simple Syndication (RSS), feeds, etc.) you have a wide variety of options. You can use a “reader” such as Google Reader or FeedDemon to consolidate all of the blogs you read into one convenient place. Or, if you are an Outlook 2007 user, you can subscribe to blogs and have the feeds delivered directly to your inbox. To do this use the following path: Tools > Account Settings > RSS Feeds > New > Paste the link below into the menu line > Add > Make any changes to the delivery options > OK

You can click on the RSS icon (orange square with three white arcs) in your browser’s address bar or you can use the link shown below to manually subscribe to the blog using one of the feed readers mentioned above.

http://irbtipoftheweek.wordpress.com/feed/

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