Frequently Asked Questions
- Adverse Events
- Amendments to Approved Studies
- Billing
- CITI On-line Course/Modules
- Communication with Participants
- Consent Process/Document
- Grants
- IRB Committee/Members
- IRB Contact Information
- Participant Enrollment
Adverse Events
Q - Should
serious adverse event summaries include relatedness?
A - Yes, the summary should include information about the event and its
relation to the study.
Amendments to Approved Studies
Q - How
do I make changes to a study that has already been approved?
A - You want to request an amendment to your study. Download and complete
Form #1104 (Amendment Request Form). Please read the accompanying form
instructions in order to determine what additional materials need to be
submitted with your request.
Q - Why
do FYI letters or upcoming change memos from the Sponsor need to be submitted
with an amendment form?
A - An amendment form needs to be submitted so the IRB can consistently
assess how these updates/changes impact the local research.
Billing
Q - What
items get billed?
A - The fees for Full Committee reviews of Industry Supported research
are as follows: $2250 (initial review), $750 (continuing review), and
$500 (amendment). Expedited reviews (e.g., initial, continuing, amendment,
etc.) of Industry Supported research will be charged $500. Please contact
researchratesrus@vanderbilt.edu
for questions related to fees/billing for in-study procedures.
CITI On-line Course/Modules
Q - What
if I can't remember my CITI username and password?
A - Go to the CITI
Home Page and click on the "Forgot username or password"
link in the menu on the left-hand side of the screen.
Communication with Participants
Q - For
participants who were previously enrolled and are no longer part of long-term
follow-up, how should new safety information about a drug be communicated
to them?
A - With each safety update or amendment, the local Principal Investigator
is responsible for assessing the potential impact on all current and previously
enrolled participants. This assessment should be submitted to the IRB
to be reviewed on a case-by-case basis. In some cases, re-consent may
be necessary.
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.
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.
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.
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.