The FDA has added a new, required element of consent for all new studies moving forward. No amendments are required to add this to existing studies and no re-consenting is required for the new information. A new consent template has been added to our FORMS page
[Insert if your study is using an investigational drug, device or biologic] A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
This new element is Effective: March 7, 2011 however you will have until March 7, 2012 to comply with this update.
Please CLICK HERE to read an article about storing sensitive information on a flash drive.
On Saturday, August 28, at approximately 11:00 pm EST, the CITI Program web site will be taken offline. We expect the downtime to be approximately five hours. Please complete the module you are working on and log off prior to this time. You will not lose credit for any module that you have completed already. You may resume where you left off when the site is brought back on line. Thank You.
We’ve added a new workshop to our schedule. Come listen and learn about the new features and enhancements added to REDCap. CLICK HERE to register.
The KSP sections of the older IRB applications have been retired! DISCOVR-E will now serve as your official record for this information, which means that you no longer need to update your KSP tables in Sections 1-4, you can simply remove them when you submit amendments to update KSP. Please remember to change the version dates on your application as you remove these sections and give us a call if you have any questions.
According to VHRPP Policy VIII.A, the Vanderbilt HRPP requires all Investigators, Key Study Personnel, Students, and Faculty Advisors who are conducting human subjects research, to complete human subjects protections training using the online CITI course. It is mandatory that the CITI Basic Course, in either Biomedical or Social and Behavioral research be taken prior to any of the optional available courses (e.g., Good Clinical Practice, Responsible Conduct of Research, etc.) in order to meet the initial training requirement. In addition, all Investigators, Key Study Personnel, Students, and Faculty Advisors conducting human subjects research, must complete continuing education annually. Continuing education requirements may be met by attending an educational session approved by the VHRPP (e.g., IRB Essentials, Research Matters, News You Can Use, etc.), a national conference that addresses human subjects protections in research, completion of a CITI Refresher Course, or one of the available optional CITI courses (e.g., Good Clinical Practice, Responsible Conduct of Research, etc.). Furthermore, in keeping with the CITI Program curriculum, every four years personnel conducting human research – including those who have previously completed the Vanderbilt University Human Research Protection Training – must retake the CITI Basic Course to renew compliance with the VU IRB. Please click on the instructions link before logging into CITI for the first time. CITI Instructions.
A name tells people who we are and within an organization it should reflect our mission/goals.
After examination and consideration of all that we do, it appears our current name does not accurately reflect our role in protecting human research participants. Institutional Review Board (IRB), refers solely to an individual committee, which is only a segment of our department. Many of us are not members of the IRB committees and our primary mission is to support the committees, as well as to act as a liaison between the research community, the committee members, and the research participants in the protection of human research participants.
With the above in mind, we have officially re-named our department to be,
Vanderbilt’s Human Research Protection Program (VHRPP) “supporting the work of the IRB and providing HRPP oversight“
While our commitment to what we do and how we do it won’t change, our new department name now reflects our overall mission.
Just a reminder that we have an IRB Office Hours session coming up on Friday. No appointment or sign-up needed, just drop by and bring your questions.
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.
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.
