Here are some answers to some frequently asked questions. If you have any additional
questions, please
When should I report a protocol deviation?
The Independent IRB, Inc. only requires that problems in research that increase
the risk to research participants or others be reported. From the IRB standpoint,
a protocol deviation can either be classified as an unanticipated problem involving
risks to research participants or other, or non-compliance (including serious and/or
continuing non-compliance). It is important to note that a protocol deviation is
not the only type of problem in research.
For more information on reportable events view the
Investigator’s Guidebook.
What is an unanticipated problem?
Unanticipated problems in research include events that are both serious and unanticipated
and require IRB review to determine if the event is serious or represents continuing
non-compliance with research requirements. Unanticipated Problems can include protocol
deviations, adverse events or any other occurrence that may identify unanticipated
risks to subjects or others or indicate other problems in the research.
The Independent IRB, Inc. has a comprehensive listing of criteria to assist the
Principal Investigator in identifying unanticipated problems in research and has
completed a form for reporting potential unanticipated problems. To view this listing
please review the Unanticipated Problems section of the
Investigator’s Guidebook.
When would someone have a conflict of Interest?
Integrity in research and the protection of human research participants requires
full disclosure and review of any potential conflict of interest of those involved
in the conduct of research. The IIRB, is committed to preserving public trust through
a comprehensive potential conflict of interest program and plan which includes a
systematic review process. Actions are taken when necessary to minimize the significance
of potential conflict of interest.
The mechanism for conducting conflict of interest review includes review of both
financial and non-financial conflict of interest based on the criteria listed in
the
Investigator’s Guidebook.
To report a potential conflict of interest, submit a
Site Conflict of Interest Disclosure Form.
Who is considered a vulnerable population or population that needs additional
safeguards?
The FDA considers vulnerable populations to include children, prisoners, pregnant
women, handicapped, mentally disabled persons, or economically or educationally
disadvantaged persons. These populations are likely to be vulnerable to coercion
or undue influence and additional safeguards must be included in the study to protect
the rights and welfare of these subjects. The Independent IRB, Inc. has also identified
other populations that may need additional safeguards as well such as employees
and those with incurable disease.
Additional requirements to protect the rights and welfare of these subjects are
listed in the Informed Consent Process section of the
Investigator’s Guidebook.
What is HIPAA language?
The Independent IRB, Inc. has created suggested HIPAA Template language for the
Informed Consent Form (ICF) to meet HIPAA requirements for the Use and Disclosure
of Personal Health Information. The IRB does not require the use of this template
language and is willing to approve alternate language provided that it meets all
of the HIPAA required elements.
The IRB recommends that the Use and Disclosure of Personal Health Information Authorization
be formatted within the Research Informed Consent Form, versus it being issued as
a separate document. The basis for this recommendation is to decrease the opportunity
for consenting errors, however, this type of formatting is not required and separate
formatting can be approved if requested.
Do I need to attach a form to the 1572?
The Independent IRB, Inc. accepts a current curriculum vitae and license (as applicable)
to satisfy the qualification request listed in Box 2 of the Form FDA 1572.
Do you need hard copies of all documents (if not how can we submit)?
The Independent IRB, Inc. accepts submissions by email, fax, or hard copies. If
a submission is made electronically, submission of the originals is not required.
How long does it take do the CITI training?
The Independent IRB, Inc. offers Human Research Protection Training (HRP) through
Collaborative Institutional Training Initiative (CITI). Each CITI module consist
of 15-25 minutes of reading and 3-5 multiple choice questions. The HRP Training
consists of about 10 modules.
What is your FWA number?
The Independent IRB, Inc. does not conduct research; therefore, it does not require
a Federalwide Assurance (FWA) number. However, the Independent IRB, Inc. is registered
with FDA/OHRP. IORG0002954 represents the overall registration, and IRB00003563
is the IRB registration number.
Have you registered with the FDA?
The Independent IRB, Inc. is registered with FDA/OHRP. IORG0002954 represents the
overall registration, and IRB00003563 is the IRB registration number and is effective
through October 1, 2012.
How do I make a submission?
To make a submission, visit the
Getting
Started webpage. The IRB accepts submissions by email, fax, or hard copies.
If a submission is made electronically, submission of the originals is not required.
For a list of forms to assist in your submission, visit the
Forms webpage.
What is your turnaround time?
The IRB generally meets every Tuesday (see
IRB Meeting Schedule ). Submission for IRB review must be submitted in its
entirety by Friday 5:00 PM EST to ensure review by the IRB on the following Tuesday.
The following outlines the turnaround time:
If an item meets the criteria for expedited review, the item may be reviewed under
expedited review procedures. It is important to note that the turnaround time for
items reviewed by the IRB and items reviewed under expedited review procedures is
one week unless a critically needed now (CNN) review is requested at the
time of submission.
Is there a form to submit ads, revised protocols or amendments?
The Independent IRB, Inc. accepts submission of advertisements, and other submissions
by email, fax, or hard copies. If a submission is made electronically, submission
of the originals is not required. The Independent IRB, Inc. has developed a
Study Submission Letter that can be used for any type of submission. This
form is intended as a tool to simplify your submission process by outlining possible
documents needed for IRB review.
If I change a minor word on an IRB approved advertisement, do I have to
resubmit it?
A final version, if revisions or reformatting is required, must be submitted to
the Independent IRB, Inc. for review prior to use. The information contained in
the final copy of the recruitment material (advertisement) will be reviewed and
the mode of its communication will be evaluated.
Do I need to submit unanticipated adverse device effect (UADE) to the IRB?
The regulations define an unanticipated adverse device effect (UADE) as “any serious
adverse effect on health or safety or any life-threatening problem or death caused
by, or associated with, a device, if that effect, problem, or death was not previously
identified in nature, severity, or degree of incidence in the investigational plan
or application (including a supplementary plan or application), or any other unanticipated
serious problem associated with a device that relates to the rights, safety, or
welfare of subjects” (21 CFR 812.3(s)).
Per the IDE regulations and FDA Guidance, the Sponsor is required to submit UADE
reports to the IRB in a manner consistent with the recommendations made for the
reporting of unanticipated problems under the IND regulations. See the Reporting
of Unanticipated Problems in Research section of the
Investigator’s Guidebook for
more information.
To submit an UADE, complete the attached
form.