Q – What role can visiting or adjunct faculty members play in research studies?
A – The extent of the role is determined by the visiting/adjunct faculty member’s department. In order to work on a Vanderbilt research study, he/she must fulfill the human subjects training requirement (basic and continuing education), as well as have a valid VUnetID and e-password.
Q – Is the suggestion box on your website really anonymous?
A – Yes. If you wish to submit your comment anonymously, do not enter any contact information in the electronic form. There will be no way for us to tell who submitted the comment/suggestion. The suggestion box can be used for suggestions, comments, reporting of problems, concerns, questions, as well as other uses.
Please note that if you want someone to contact you to address your suggestion box item, you will need to include your contact information.
Q – Does VHRPP offer departmental education sessions?
A – YES!! The Process Improvement Team will come to your department and provide education tailored to your needs. To request education, please CLICK HERE and then click the “in service” option. You will be prompted to enter your VUnetID and e-password to gain access to the electronic request form. We have a number of pre-populated topics, but you can request any topic that suits the needs of your group/department. A member of the team will contact you for more details and to finalize the date and time.
Q – Sponsors ask how fast submissions to the IRB can be approved. What should I tell them?
A – The VHRPP has a publicly accessible Performance Metrics page on its website. Here you will find reports related to: total number of submissions, number of submissions by type, number of new studies, and number of days to first committee action letter.
Q – Is there a certain amount of time when articles of studies funded by NIH have to be added to the Vanderbilt University PubMed Central Repository?
A – The NIH Public Access Policy (effective April 7, 2008) mandates that peer reviewed journal articles arising in whole or in 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.
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
Q – How long after a new version of a form is posted will the IRB accept the previous version?
A – It is our practice to return forms that are submitted on an expired version. We will accept the previous version of a form for 60 days following the posting of the newest version. When you are preparing a submission, it is best to check our forms page to ensure you are using the current version of a form.
Q – Are subjects who failed screening after signing a consent document counted as a person consented for the study?
A – Yes. Anyone who signs a consent is counted as a subject consenting to participate in the study even if after signing the document he/she fails to pass the screening portion of the study.
Q – Which committee reviews a DNA buccal swab or blood draw that has no additional, clinical components?
A – The Behavioral and Social Sciences Committee reviews studies with no clinical components. The study should be submitted on a Behavioral/Social Sciences Application (Form #1124). All procedures listed in the application should be “standard of care” except for the blood draw or buccal swab. A separate protocol is not needed since the application incorporates the elements found within a protocol.
Q – Is there template language available for issues related to patient privacy and data confidentiality?
A – Yes there is. ResearchMatch.org and all other template language can be found by clicking the following link: http://www.mc.vanderbilt.edu/irb/templates/
The template language can be inserted into the appropriate sections of the consent forms for adults and minors.
