Frequently Asked Questions
Q: Does a pilot study have to be reviewed by the IRB?
A: Yes. Any study involving human subjects, regardless of the
number of subjects to be involved, must be reviewed and approved
by the IRB prior to initiation.
Q: If I am just looking at specimen samples (i.e., urine,
blood, skin, etc.) that are being collected for a clinical
purpose and that are otherwise going to be thrown away, do I
have to get IRB review.
A: Yes, all procedures that are looking at human samples
(that are identifiable directly, or through codes) in the
fashion of a systematic investigation outside of clinical care
have to be reviewed by the IRB. These studies will most likely
qualify for expedited review or be granted IRB exempt status
depending on the amount of confidential information accessed by
the PI.
Q: If I am doing research on cadavers or on samples obtained
from cadavers, do I have to get IRB review?
A: It depends. IRB review is not needed if the materials do
not contain any personal identifiers (PHI). However, if personal
identifying information is linked to the materials, then IRB
review is required. The review is required because the IRB also
acts as the privacy board and the HIPAA privacy regulation
extends to deceased individuals.
Q: If I want to make a change to my study after I've received
approval, do I need IRB approval again?
A: Yes. Any change to a previously approved study must be
reviewed and approved by the IRB prior to implementation. This
includes changes to any document related to the study (e.g.
informed consent form, surveys, advertisements, recruitment
letters, etc.) You will need to submit the form to request a
modification / addendum to a previously approved study. The only
exception to this is that a change can be implemented if it is
needed to eliminate immediate harm to subjects or others. Such
changes must be reported to the IRB within 5 business day.
[back to top]
Q: Once I submit my application, how long does the IRB review
process take?
A: Review of exempt and expedited applications occurs on an
on-going basis. Screening of the application will generally
occur within 7 to 10 business days of receipt. Any concerns will
be communicated to the investigator via e-mail so check your
messages. Once all concerns have been addressed the application
will be forwarded for official review. Studies requiring full
board review must be submitted at least 12 business days prior
to the meeting date. This allows sufficient time for the
committee to review the application prior to the meeting. After
the meeting the minutes must be prepared and approved by the
committee before letters are sent to the investigators.
Therefore, investigators should not expect an official letter
until 7 to 10 business days after the meeting. Note that you may
not begin your research until you have received final,
unconditional approval from the IRB.
Q: My study was deferred at the IRB meeting held on Monday
night. Can I have an extension to the submission deadline so
that my study can be reviewed at the next regularly scheduled
meeting of that panel?
A: Yes, you can have a one week extension on the submission
deadline. This is allowed for two reason. First because the IRB
recognizes that the turn-around-time without the extension is
quite difficult to meet. Second, because the reviewers have
already seen the initial version of the protocol and discussed
it at the board, allowing the reviewer one week to re-review is
sufficient. Note that if you study was deferred it must be
reviewed by the same IRB panel that conducted the initial
review.
Q: Do I have to submit every single protocol deviation (e.g.
instance of non-compliance with the protocol) to the IRB?
A: Yes, however the timing of when you report the
non-compliance may differ. If the non-compliance was within the
control of the research team (e.g. a follow-up appointment was
scheduled by the research team outside of the study window) it
should be reported within 5 days of becoming aware of it using
the problem report form available on the
Institutional Review Board Meetings, Instructions, Forms and Samples page. All reports should
contain a description of the deviation, why and when it
occurred, and corrective action implemented, if any, to prevent
future occurrence. If the non-compliance was not within the
control of the research team it (e.g. the subject canceled a
scheduled appointment and had to be rescheduled outside of the
study window) the event can be reported at the time of
continuation. However, if the event was not within the control
of the research team but has in impact on subject safety or data
integrity it should still be reported within 5 days of becoming
aware of it. If possible, investigators should allow for
"windows" within the protocol design to reduce the instances of
non-compliance. For example, rather than stating that a second
visit will occur in 2 weeks state that second visits will occur
within 10 to 18 days.
Q: How do I know which HIPAA form to submit?
A: You must address HIPAA within your application if your
study will involve the use of protected health information.
Protected health information means individually identifiable
health information transmitted or maintained in any form
(electronic means, on paper, or through oral communication) that
relates to the past, present or future physical or mental health
or conditions of an individual. In general,
- if you are obtaining informed consent you will also need to
obtain a HIPAA Authorization
- if you are not using or recording any identifiable information
you will submit a Certification of Using De-Identified data
form. On that form you must specify by which of three possible
ways you are de-identifying data.
- if you need to keep some identifiable information, and the
information will be kept within the Health Center, and you
cannot obtain an Authorization, you will apply for a Waiver of
HIPAA Authorization. A waiver of informed consent is also
typically requested when a Waiver if HIPAA Authorization is
requested. If you are collecting PHI during a screening session
prior to obtaining an authorization, e.g. telephone screening,
you should request a partial waiver of HIPAA for the screening
phase.
- if you need to keep some identifiable information, and the
information will be shared outside of the Health Center you will
use the Data Use Agreement and Limited Data Set forms.
- if you are trying to determine the feasibility of a conducting a
study, or or using information of deceased individuals you will
submit the Assurance Form for either preparatory to research or
on decedants.
Q: If the sponsor requires that a safety report be submitted
to the IRB, but the adverse event reporting policy requires that
it be reported only at the time of continuation (e.g., it is a
non-serious event), should I still submit it to the IRB?
A: You should inform the sponsor that our reporting policy is
that non-serious events will be submitted in summary format at
the time of continuation. The IRB will not review individual
non-serious reports.
Q: If my project will most likely qualify for exempt status
do I still have to submit the entire IRB application, write a
protocol, and make sure everyone has completed training in the
protection of human subjects?
A: Yes. Exempt status only means that your project will be
exempt from the requirement of continuing review. The Human
Subjects Protection Office holds research that qualifies for
exempt status to the same standard as any other research.
Q: I submitted an application for expedited review three days
ago. Why haven't I heard from the IRB yet?
A: Expedited review does not mean a quicker review. It simply
means that only the Chair or an IRB member designated by the
Chair has to review the project. All of the same criteria for
approval still apply and applications are reviewed with the same
level of scrutiny as a full board review.
Q: I will be doing research that will involve individuals who
speak a foreign language. If the IRB approved the English
version of the consent form do I have to submit a translated
version for approval?
A: Yes. The IRB must approve all translated documents that
will be presented to subject, e.g. the informed consent form and
surveys. Investigators may either use a professional translation
service or the back translation process. The full details are
available in the Human Subjects Protection Office/IRB operating
policies. Information on companies that provide translation
services is available on the
Information for Investigators page.
[back to top]
Q: How do I know when my study is due for continuing review?
A: When the IRB grants you final approval the approval letter
will include the date by which your study will expire if
continuing review is not sought. If your study has an informed
consent form, the date will also be stamped on that document.
This is referred to as the valid through date. Continuing review
will generally occur in the month prior to the valid through
date. As a courtesy, the IRB will send one reminder notice to
you to request continuing review approximately 8 to 10 weeks
before the valid through date. However, the investigator retains
the responsibility for seeking continuation of an approved
study.
Q: What happens if I miss the submission deadline for my
continuation that requires full board review?
A: A lapse in IRB approval for the study will occur. All
research related activity must cease as of the date approval
lapses. You will know what that date is from the approval letter
sent to you by the IRB or from the the valid through stamp on
the informed consent form. If a subject is on active treatment
and will be exposed by harm if treatment is withheld during the
lapse in approval, you must request in writing approval to
continue to treat the subject from
Dr. Richard Simon, the
Director of the Human Subjects Protection Office. You must also
confirm that you are seeking continuation and will meet the next
submission deadline.
Q: Why must I request continuation in less than one year when
my colleagues' studies where given approval for a full year?
A: Federal regulations require that continuing review occur
at least annually. However, the IRB has the authority to require
that review occur more frequently. Example scenarios of when the
IRB may exercise this option include studies that pose a high
risk to subjects or studies for which the investigator does not
have extensive experience in the field.
Q: Why do I have to submit the complete protocol again at the
time of continuing review if I haven't changed it since the
initial approval?
A: Federal guidance states that in order for continuing
review to be meaningful and substantive the IRB must review the
complete protocol. For studies requiring full board review four
copies are required. Each of the two reviewers get a copy, the
Chair gets a copy and a copy goes to the IRB file.
[back to top]
Q: What is informed consent?
A: Informed consent reflects an individuals voluntary
agreement to participate in a research study. In order to make
this agreement the individual must have adequate knowledge and
understanding of the relevant information (purpose of the study,
risks and benefits of the study, methods to be used, etc.). the
process of informing a subject about a study is documented using
the informed consent form.
Q: Who can provide informed consent?
A: Subject who have reached the age of majority and who are
competent can provide informed consent to participate in a
research study. If the subject is either a minor or lacks the
capacity to provide informed consent, a surrogate person must
provide consent and the subject will generally be asked to
provide assent. The policy to provide surrogate consent for
research studies follows the same standards as providing
surrogate consent for clinical care. The policy is available in
the Investigators Guide for Human Subject Research and in the
standard operating policies of the Human Subjects Protection
Office.
Q: What does a research subject need to be informed of during
the consent process?
A: The informed consent checklist outlines the regulatory
requirements of the informed consent form and the IRB sample
consent forms covers these topics. If these documents are used
as a guideline, you should address all required topics within
your consent document. However, consent is more than a document.
Consent must be a process in which the research subject has the
right to read and discuss the form and to ask any questions
regarding the study and have them answered in a satisfactory
manner.
Q: Is informed consent always required?
A: In the majority of studies informed consent is required.
However, there are situations in which the requirement to obtain
informed consent may be waived or altered. A retrospective chart
review study is an example of when the requirement to obtain
consent may be waived. The form to request a waiver or
alteration of informed consent must be completed and submitted
to the IRB for review and approval. The form describes the
criteria that must be satisfied in order for the IRB to grant
approval to the request.
[back to top]
|
