Did you know…

That the IRB recently created a blog to keep the Vanderbilt research community updated?  You can subscribe to the blog by clicking on the RSS links (entries and/or comments) at the bottom of the page.  All of the information posted in the blog will be delivered directly to you and you can make comments in response to the entries.  You will need to use Internet Explorer 7, Firefox 2 or higher, or an RSS reader such as Google Reader.  If you need help subscribing, please check with your IT support or drop us a line.

Updated Non-human/Non-research Forms

Form #1122 and accompanying instructions were updated to reflect the release of the Synthetic Derivative.  In addition, new template language has been added to the “templates” page for use with studies using the Synthetic Derivative.

Did you know…

There is a section to add your Business Officers to each study for invoicing purposes without submitting an amendment to the IRB. This allows them to view the individual study information through DISCOVR-E using their VUnet ID and password. The user’s manual for DISCOVR-E includes instructions for adding Business Officers.

The HIPAA Form

The HIPAA Compliance Form has been retired! The IRB now includes a question on the Key Study Personnel table in DISCOVR-E to ask if each individual will have access to PHI. All other questions on the HIPAA Compliance Form have been incorporated into existing applications.

Protocol Deviation

Q – What is the difference between a Protocol Deviation and an Amendment?
A – An amendment is a change or changes that are premeditated, intentional, and occur prior to implementation. Therefore, prior to any change in the protocol the submission of an amendment is required. It should be noted that the Committee approves a study in its totality. Once altered, the study is no longer that which the Committee approved. Therefore, the Principal Investigator cannot change a study prospectively without an approved amendment. To do so, would alter a study from one approved by the IRB to a study that has not been approved.

Alternatively, a protocol deviation does not occur as a deliberate, purposeful change to an approved protocol. It is an unplanned, unintended change to the protocol, which is a written plan. Sometimes an unplanned change will happen due to patient error, incidental oversight by the study staff, or to protect patient safety or welfare. It is for these occasions that the category of protocol deviation was designed. If this occurs it should be reported on a Protocol Deviation Form (#1123).

IRB Contact Information

Q – Where is the IRB located?
A – On the 5th Floor of the Oxford House

Q – What is the phone number for the IRB?
A – You can reach the IRB at (615) 322-2918 or (866) 224-8273 toll free.

Participant Enrollment

Q – When does an individual become enrolled in a study?
A – The IRB considers a person enrolled after he/she has agreed to participate in a study and has signed a consent form.

IRB Committee/Members

Q – When do the IRB Committees meet?
A – The Vanderbilt IRB has four committees that meet weekly. Three of the committees review biomedical/health science research. One of the committees reviews social/behavioral science research.

Grants

Q – Why does the IRB need to review my grant?
A – In the past, numerous instances have been identified in which human subject research described in a grant application differed significantly from how it was described in an IRB application/protocol. The grant included important elements (e.g., targeting of vulnerable subjects, additional arms, different doses, etc.) that were ultimately implemented without IRB review and approval. Department of Health and Human Services (HHS) regulations at 45 CFR 46.103(f) require that each grant application or proposal for HHS-supported human subject research be reviewed and approved by the IRB.

Consent Process/Document

Q – When should a participant be re-consented?
A – The IRB will consider, on a case-by-case basis, whether and when periodic re-consenting of individuals is required to assure that a participant’s continued involvement is voluntary. The IRB may require that the investigator re-consent subjects after taking into account the study’s anticipated length and the condition of the individuals to be included (e.g., participants with progressive neurological disorders, participants who may become incarcerated, an altered risk/benefit ratio, etc.). Additionaly, the IRB will consider whether and when to require a reassessment of decision-making capacity.