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Frequently Asked Questions (FAQs) Category

e-Consent (FAQs)

Mar. 23, 2015—Q1. What is e-Consent? A1. Electronic-Consent (e-Consent) is a newly evolving platform for consenting patients either on site or at home using a computer based consent form rather than traditional paper documentation. Consent forms can be implemented in REDCap and patients can access consent forms via computer, mobile phone, or tablet. Q2. Is e-Consent allowed...

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Visiting and Adjunct Faculty

Feb. 25, 2011—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...

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Length of Time from Submission to Approval

Feb. 23, 2011—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...

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Vanderbilt PubMed Central Repository

Feb. 23, 2011—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...

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Frequency of Taking the CITI Basic Course

Feb. 23, 2011—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...

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Posting of New Forms and Old Form Expiration

Feb. 23, 2011—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....

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Failed Screening and Consent

Feb. 23, 2011—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.

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Committee Review of Studies with No Clinical Components

Feb. 23, 2011—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”...

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Template Language for Patient/Data Privacy and Confidentiality

Feb. 23, 2011—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.

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Template Language for ResearchMatch.org

Feb. 23, 2011—Q – Is there template language available to use when ResearchMatch.org is used as a recruitment tool? 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/ This language can be inserted into the “Participant Identification, Inclusion/Exclusion, and Recruitment” section(s) of any applicable applications.

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