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Continuing
Compliance
Communications to the IRB Office and IRB Chairperson
All correspondence, including Continuing Reivews, Protocol Modification
requests, adverse event reports which are addressed below, should
be hand delivered or mailed to the IRB Office, Library Room 176.
Regular office hours are 8 a.m. to 5 p.m., Monday through Friday.
Please be sure to provide the name of the Investigator and IRB number
on all correspondence relating to an existing study.
Periodic Progress Reports
When a study is approved by the IRB, an approval letter is sent
to the principal investigator. The approval letter states that the
approval is for a specified period, never more than one year. In
some cases, approval will be less than one year or will be for a
specific enrollment of subjects. To maintain the study in active
status, a periodic progress report or Application for Continuing
Review (CR) is required each year.
The CR must be reviewed by the IRB Chairperson or IRB Vice Chairperson
and approved by the Board no later than the date of expiration in
order for the study to be in compliance with federal regulations.
Federal regulations do not allow for ANY grace period for renewal.
For example, if a study is approved by the Board in July 2005 and
the initial approval is through June 2006; a satisfactory progress
report must be received, reviewed and on the agenda for the June
2006 IRB meeting. In order to facilitate the process, the IRB office
mails the first reminder notice about 90 days prior to the due date.
If no response is received a second notice is sent about three weeks
later. These dates do not necessarily reflect the date that your
IRB approval will expire, these dates will reflect the time which
the IRB office needs to receive your report in order to assure that
the Board has time to review, meet, discuss and approve this matter.
Once the expiration date of initial (or most recent) approval passes
with no response, the study is administratively inactivated and
a letter of notification is mailed to the investigator with a copy
to the department chair or section chief.
The CR must be typed and each section must be completed accurately:
*
Status of Study - Check one only. If the study is "active, continuing
to enroll," a copy of the currently approved consent form must be
attached.
*
Approved Study Sites - Sites approved in the original application
or by amendment.
*
Number of Subjects Enrolled - Each block should be, "NA," "0" or
another number, indicating the enrollment since the last PPR, and
the enrollment total.
*
Gender/Race/Age of Subjects Enrolled - Federal guidelines require
that the IRB verify that the appropriate balance of gender/race/age
enrollment is done in accordance with federal guidelines.
*
Study Results - Summarize results since initial approval or last
PPR. Please DO NOT leave this section blank. If no patients have
been enrolled or no results have been noted, then this can be stated.
*
Adverse Eventts - List adverse events with dates; if none, state
"none." Do not leave blank. This should include all adverse effects
(which were reported as necessary throughout the study year) whether
felt to be study related or not.
*
Signature - Investigator must sign and date.
If the CR is incomplete or appears to be inaccurate, the CR will
be sent back to the Investigator for completion.
Protocol Modifications
It is the responsibility of the principal investigator to ensure
that the study is conducted as approved by the Board. Protocol
Modifications to the inclusion/exclusion criteria, study population,
study procedures or consent process, requested by the investigator
or sponsor, must be approved by the IRB before the changes are implemented.
This could include an increase in numbers enrolled, change in age
range, change in risks from study drug or procedure or any form
of new recruitment tool that is to be used to attract subjects.
Any modifications or changes to previously approved research must
be reviewed and approved by the IRB before the revisions are implemented.
Requests must be submitted using the Protocol Modification Form.
All Protocol Modifications are reviewed by the IRB Chairperson or
IRB Vice Chairperson. A determination is made at that time as to
whether or not approval of the Full Board is required. If Full Board
review is required, these amendments will be put on the next meeting
agenda for discussion and vote. When determined that expedited review
is appropriate (if the amendment is minor in nature) the amendment
is approved via expedited review and an approval letter is sent
to the PI. These amendments are then reported to the committee in
a summary format at the next Board meeting. It is important to note
that the consent form may need to be modified when a protocol is
changed. The modified consent form must be sent with the amendment
request. The amendment can only be activated once approval is given
and, if applicable, the consent change made appropriately and approved.
If an amendment request is controversial, questionable or significant
in nature the IRB Chair will present it at the next Board meeting
for Full Board review. Alternatively, if an amendment request is
a substantial change to the approved study, the IRB Chair may deny
the request and ask that the revised study be submitted as a whole
new study, subject to full Board review.
Advertisements/Recruitment Material
Any document which is to be used as an advertisement or recruitment
tool must be reviewed and approved by the IRB prior to use. This
includes (but is not limited too) flyers, media (Newspaper, Radio,
TV) advertisements, press releases, internet advertisements and
brochures. The IRB must review the final advertisement (including
actual newspaper layout, tape for radio and video for TV) as well
as the draft copy. Please contact the IRB office for specific information
as to what must be included in the advertisement and specific items
which can not appear in advertisements.
Please also remember that all publicity related to University sponsored
activities must also be approved through the Public Affairs office.
This approval process is IN ADDITION to your IRB review of advertisement
and does not take the place of IRB approval.
Adverse Events
Prompt reporting of adverse events is a condition of IRB approval.
The IRB definition of adverse event is:
An adverse event is defined as "An unfavorable physical or
psychological event, injury or other problem that occurs to a human
participant which either occurs during the study, having been absent
at baseline, or, if present at baseline, appears to worsen.
An adverse event form must be completed and submitted to the IRB
Office within 10 calendar days of the occurrence. In the event of
a very serious adverse event, the IRB Chairperson should be notified
promptly by telephone with a follow-up written report. In addition,
a summary of adverse events (for the reporting period) must be documented
in the CR.
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